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Alvin牛仔背带裤

Alvin牛仔背带裤

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Alvin牛仔背带裤

2021-10-14

$老虎证券(TIGR)$They delete my comment!Ugly dirty rats!

Alvin牛仔背带裤

2021-10-15

$老虎证券(TIGR)$你们割完。股价就会暴力拉升

Alvin牛仔背带裤

2021-10-26

$老虎证券(TIGR)$今晚破12老虎不发威就被当病猫

Alvin牛仔背带裤

2021-10-20

Just buy

Novavax plunged over 20% in premarket trading<blockquote>Novavax盘前交易暴跌逾20%</blockquote>

Alvin牛仔背带裤

2021-11-03

$fuboTV Inc.(FUBO)$congrats to those diamond hands!谁都不能和趋势作对，不然就是自掘fm

Alvin牛仔背带裤

2021-11-01

$诺瓦瓦克斯医药(NVAX)$congrats to those bought below $120

Alvin牛仔背带裤

2021-09-21

$老虎证券(TIGR)$跌多一点才能all in致富

Alvin牛仔背带裤

2021-11-01

$蔚来(NIO)$just buy the dip

Alvin牛仔背带裤

2021-10-20

BullshitJust buy the dip

Novavax plunged over 20% in premarket trading<blockquote>Novavax盘前交易暴跌逾20%</blockquote>

Alvin牛仔背带裤

2021-10-01

X$诺瓦瓦克斯医药(NVAX)$just buy yolo

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time to load up more 加仓同志们","listText":"Last time to load up more 加仓同志们","text":"Last time to load up more 加仓同志们","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/846703640","isVote":1,"tweetType":1,"viewCount":481,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":841310693,"gmtCreate":1635885690227,"gmtModify":1635885690291,"author":{"id":"3573538012135697","authorId":"3573538012135697","name":"Alvin牛仔背带裤","avatar":"https://static.tigerbbs.com/d141be403ec6eb25b1c85b5c797f9c49","crmLevel":11,"crmLevelSwitch":0,"followedFlag":false,"authorIdStr":"3573538012135697","idStr":"3573538012135697"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/FUBO\">$fuboTV Inc.(FUBO)$</a>congrats to those diamond hands!谁都不能和趋势作对，不然就是自掘fm","listText":"<a href=\"https://laohu8.com/S/FUBO\">$fuboTV Inc.(FUBO)$</a>congrats to those diamond hands!谁都不能和趋势作对，不然就是自掘fm","text":"$fuboTV Inc.(FUBO)$congrats to those diamond hands!谁都不能和趋势作对，不然就是自掘fm","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":2,"commentSize":1,"repostSize":0,"link":"https://laohu8.com/post/841310693","isVote":1,"tweetType":1,"viewCount":800,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":849582614,"gmtCreate":1635766943738,"gmtModify":1635766962052,"author":{"id":"3573538012135697","authorId":"3573538012135697","name":"Alvin牛仔背带裤","avatar":"https://static.tigerbbs.com/d141be403ec6eb25b1c85b5c797f9c49","crmLevel":11,"crmLevelSwitch":0,"followedFlag":false,"authorIdStr":"3573538012135697","idStr":"3573538012135697"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/NIO\">$蔚来(NIO)$</a>just buy the dip&nbsp;","listText":"<a href=\"https://laohu8.com/S/NIO\">$蔚来(NIO)$</a>just buy the dip&nbsp;","text":"$蔚来(NIO)$just buy the dip","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":2,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/849582614","isVote":1,"tweetType":1,"viewCount":712,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":849598298,"gmtCreate":1635764250829,"gmtModify":1635764251828,"author":{"id":"3573538012135697","authorId":"3573538012135697","name":"Alvin牛仔背带裤","avatar":"https://static.tigerbbs.com/d141be403ec6eb25b1c85b5c797f9c49","crmLevel":11,"crmLevelSwitch":0,"followedFlag":false,"authorIdStr":"3573538012135697","idStr":"3573538012135697"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/NVAX\">$诺瓦瓦克斯医药(NVAX)$</a>congrats to those bought below $120","listText":"<a href=\"https://laohu8.com/S/NVAX\">$诺瓦瓦克斯医药(NVAX)$</a>congrats to those bought below $120","text":"$诺瓦瓦克斯医药(NVAX)$congrats to those bought below $120","images":[{"img":"https://static.tigerbbs.com/318d0038cd9d05e1c1270e51f95523b6","width":"1242","height":"2208"}],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":4,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/849598298","isVote":1,"tweetType":1,"viewCount":548,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":1,"langContent":"CN","totalScore":0},{"id":852948853,"gmtCreate":1635236989989,"gmtModify":1635237622305,"author":{"id":"3573538012135697","authorId":"3573538012135697","name":"Alvin牛仔背带裤","avatar":"https://static.tigerbbs.com/d141be403ec6eb25b1c85b5c797f9c49","crmLevel":11,"crmLevelSwitch":0,"followedFlag":false,"authorIdStr":"3573538012135697","idStr":"3573538012135697"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/TIGR\">$老虎证券(TIGR)$</a>今晚破12老虎不发威就被当病猫","listText":"<a href=\"https://laohu8.com/S/TIGR\">$老虎证券(TIGR)$</a>今晚破12老虎不发威就被当病猫","text":"$老虎证券(TIGR)$今晚破12老虎不发威就被当病猫","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":4,"commentSize":2,"repostSize":0,"link":"https://laohu8.com/post/852948853","isVote":1,"tweetType":1,"viewCount":663,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":859401602,"gmtCreate":1634718106851,"gmtModify":1634718402099,"author":{"id":"3573538012135697","authorId":"3573538012135697","name":"Alvin牛仔背带裤","avatar":"https://static.tigerbbs.com/d141be403ec6eb25b1c85b5c797f9c49","crmLevel":11,"crmLevelSwitch":0,"followedFlag":false,"authorIdStr":"3573538012135697","idStr":"3573538012135697"},"themes":[],"htmlText":"Just buy","listText":"Just buy","text":"Just buy","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":7,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/859401602","repostId":"1174375951","repostType":2,"repost":{"id":"1174375951","kind":"news","weMediaInfo":{"introduction":"Providing stock market headlines, business news, financials and earnings ","home_visible":1,"media_name":"Tiger Newspress","id":"1079075236","head_image":"https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba"},"pubTimestamp":1634717661,"share":"https://www.laohu8.com/m/news/1174375951?lang=zh_CN&edition=full","pubTime":"2021-10-20 16:14","market":"us","language":"en","title":"Novavax plunged over 20% in premarket trading<blockquote>Novavax盘前交易暴跌逾20%</blockquote>","url":"https://stock-news.laohu8.com/highlight/detail?id=1174375951","media":"Tiger Newspress","summary":"(Oct 20)  Novavax may delay the delivery of 1 billion doses of coronavirus vaccine because of the pr","content":"<p>(Oct 20)&nbsp; <a href=\"https://laohu8.com/S/NVAX\">Novavax</a>&nbsp;may delay the delivery of 1 billion doses of coronavirus vaccine because of the production problems.</p><p><blockquote>（10月20日）<a href=\"https://laohu8.com/S/NVAX\">Novavax</a>可能因生产问题推迟10亿剂冠状病毒疫苗的交付。</blockquote></p><p> <img src=\"https://static.tigerbbs.com/f3995877f1c786d310a457ababf9ee9e\" tg-width=\"1043\" tg-height=\"564\" referrerpolicy=\"no-referrer\">The world’s vaccine distributor has been counting on U.S. companies to provide more than 2 billion doses to lower and middle-income countries by the end of 2022 — a crucial step in ending the Covid-19 pandemic.</p><p><blockquote>这家全球疫苗分销商一直指望美国公司在2022年底前向中低收入国家提供超过20亿剂疫苗——这是结束Covid-19大流行的关键一步。</blockquote></p><p> But the campaign run by the international consortium known as COVAX, which has already been delayed significantly because of production lags, is now likely to fall short by more than 1 billion doses as a key supplier faces significant hurdles in proving it can manufacture a shot that meets regulators’ quality standards, according to three people with direct knowledge of the company’s problems.</p><p><blockquote>但由名为COVAX的国际联盟发起的活动由于生产滞后而被大幅推迟，现在可能会短缺超过10亿剂，因为一家主要供应商在证明其能够生产疫苗方面面临重大障碍据三位直接了解该公司问题的人士透露，符合监管机构的质量标准。</blockquote></p><p> The delay, which was confirmed by three other people familiar with the discussions between Maryland-based Novavax and the Biden administration, represents a major setback in the effort to vaccinate the world in the wake of new, more transmissible variants.</p><p><blockquote>另外三名熟悉总部位于马里兰州的Novavax和拜登政府之间讨论的人士证实了这一延迟，这代表着在新的、更具传染性的变种出现后，为世界接种疫苗的努力遭遇重大挫折。</blockquote></p><p> The U.S. government invested $1.6 billion in Novavax in 2020 — the most it devoted to any vaccine maker at the time — in hopes that it would offer the world another option for a safe and effective vaccine to help protect against Covid-19. But the company has consistently run into production problems. The methods it used to test the purity of the vaccine have fallen short of regulators’ standards and the company has not been able to prove that it can produce a shot that is consistently up to snuff, according to multiple people familiar with Novavax’s difficulties. All spoke on the condition of anonymity to discuss sensitive company conversations.</p><p><blockquote>美国政府在2020年向Novavax投资了16亿美元，这是当时向所有疫苗制造商投入的最多资金，希望它能为世界提供另一种安全有效的疫苗选择，以帮助预防Covid-19。但该公司一直遇到生产问题。据多位熟悉Novavax困难的人士透露，其用于测试疫苗纯度的方法未达到监管机构的标准，该公司也无法证明其能够生产出始终符合标准的疫苗。所有人都要求匿名，讨论敏感的公司对话。</blockquote></p><p> Although Novavax recently attested to some of its analytics and testing issues in aquarterly filing with the Securities and Exchange Commission, the company’s issues are more concerning than previously understood, according to two of the people with direct knowledge of the matter.</p><p><blockquote>据两位直接了解此事的人士透露，尽管Novavax最近在向美国证券交易委员会提交的季度文件中证实了其一些分析和测试问题，但该公司的问题比之前理解的更令人担忧。</blockquote></p><p> The Food and Drug Administration works out purity levels with each manufacturer according to June 2020 guidance for coronavirus vaccines, but it is generally understood that each vaccine batch should reach at least 90 percent. The company has struggled to attain anywhere close to that, <a href=\"https://laohu8.com/S/AONE.U\">one</a> of the people with direct knowledge of the situation said. Another person familiar with the company’s manufacturing process said Novavax has recently shown purity levels hovering around 70 percent. Low purity levels increase the chance that contaminants or unnecessary substances are in the final product, rendering the vaccine less effective or introducing the chance that patients could react to unknown ingredients.</p><p><blockquote>美国食品药品监督管理局根据2020年6月的冠状病毒疫苗指南，与每个制造商一起制定纯度水平，但普遍认为每个疫苗批次应至少达到90%。该公司一直在努力实现这一目标，<a href=\"https://laohu8.com/S/AONE.U\">一</a>的直接了解情况的人说。另一位熟悉该公司制造工艺的人士表示，Novavax最近的纯度水平徘徊在70%左右。低纯度水平会增加最终产品中存在污染物或不必要物质的机会，从而降低疫苗的有效性或增加患者对未知成分产生反应的机会。</blockquote></p><p> COVAX, which recently downgraded its 2021 goal from 2 billion to 1.425 billion doses, has already estimated that it faces a supply shortfall of as many as 1 billion doses in its effort to vaccinate the developing world. If Novavax falters, it could double the deficit through 2022, leaving hundreds of millions of people without immunity against Covid-19 and extending the pandemic.</p><p><blockquote>COVAX最近将2021年的目标从20亿剂下调至14.25亿剂，并已经估计，在为发展中国家接种疫苗的努力中，它面临着多达10亿剂的供应短缺。如果Novavax步履蹒跚，到2022年赤字可能会增加一倍，使数亿人对Covid-19没有免疫力，并延长疫情。</blockquote></p><p> “COVAX continues to be challenged for adequate supply … in that context, Novavax’s manufacturing challenges and delays have been massively disruptive,” said Krishna Udayakumar, director of the <a href=\"https://laohu8.com/S/DRE\">Duke</a> Global Health Innovation Center.</p><p><blockquote>“COVAX继续面临充足供应的挑战……在这种背景下，Novavax的制造挑战和延误具有巨大的破坏性，”<a href=\"https://laohu8.com/S/DRE\">公爵</a>全球健康创新中心。</blockquote></p><p> The global coalition is already behind on hundreds of millions of planned doses this month, having shipped just 371 million of its 700 million dose target for October. It is now also at risk of missing its already downgraded 2021 target.</p><p><blockquote>全球联盟本月已经落后于数亿剂计划剂量，仅运送了10月份7亿剂目标中的3.71亿剂。它现在还面临着达不到已经下调的2021年目标的风险。</blockquote></p><p> Between Novavax and other manufacturers’ hurdles, “COVAX has had to scramble to revise its supply strategy significantly in real time,” Udayakumar said. As a result, global health groups are emphasizing more donations to cover immediate needs, he added.</p><p><blockquote>在Novavax和其他制造商的障碍之间，“COVAX不得不争先恐后地实时大幅修改其供应策略，”Udayakumar说。他补充说，因此，全球卫生组织强调提供更多捐款来满足眼前的需求。</blockquote></p><p> In a statement, Novavax Senior Vice President of Investor Relations and Corporate Affairs Silvia Taylor told POLITICO that the company’s analytical testing methods have been “validated” — but did not answer questions about whether the FDA had signed off on them. The company still plans on filing an emergency use authorization by the end of the year, Taylor said.</p><p><blockquote>Novavax投资者关系和公司事务高级副总裁Silvia Taylor在一份声明中告诉POLITICO，该公司的分析测试方法已经过“验证”，但没有回答有关FDA是否已批准这些方法的问题。泰勒说，该公司仍计划在今年年底前提交紧急使用授权。</blockquote></p><p> “The vaccine development and regulatory submission processes are highly complex and often require years to advance to the point where we are now. We will fulfill all of our committed doses both in the US and globally,” Taylor said.</p><p><blockquote>泰勒说：“疫苗开发和监管提交过程非常复杂，通常需要数年时间才能达到我们现在的水平。我们将在美国和全球范围内履行所有承诺的剂量。”</blockquote></p><p> The White House and the Department of Health and Human Services did not respond to multiple requests for comment.</p><p><blockquote>白宫和卫生与公众服务部没有回应多次置评请求。</blockquote></p><p></p><p> But three people familiar with the matter said they are not confident that the company has the resources needed to reproduce a high-quality vaccine on a consistent basis — a benchmark Novavax must meet before that time. Those same people said Novavax could potentially fix its manufacturing issues and reach full licensure by the end of 2022.</p><p><blockquote>但三位知情人士表示，他们不相信该公司拥有持续复制高质量疫苗所需的资源——Novavax在此之前必须达到的基准。这些人表示，Novavax可能会解决其制造问题，并在2022年底前获得全面许可。</blockquote></p><p> Novavax — which has never produced a vaccine before — declined to answer specific questions about its product’s purity levels and whether it had been successful in addressing its longstanding manufacturing issues.</p><p><blockquote>Novavax以前从未生产过疫苗，拒绝回答有关其产品纯度水平以及是否成功解决了长期存在的生产问题的具体问题。</blockquote></p><p> Unlike <a href=\"https://laohu8.com/S/PFE\">Pfizer</a> and Moderna, the first manufacturers to launch vaccines using rapidly produced messenger RNA, Novavax is employing the previously used but complicated approach of creating the key ingredient with bug cells. While the process, which involves infecting the cells to produce spike proteins, is familiar to scientists, it is difficult to scale.</p><p><blockquote>不像<a href=\"https://laohu8.com/S/PFE\">辉瑞</a>Moderna是第一家使用快速产生的信使RNA推出疫苗的制造商，Novavax正在采用以前使用但复杂的方法，即用细菌细胞制造关键成分。虽然科学家们对感染细胞产生刺突蛋白的过程很熟悉，但很难扩大规模。</blockquote></p><p> The revelations about Novavax’s continued manufacturing problems come at a time when only 36 percent of the world is vaccinated and as leaders of developing nations continue to pressure the U.S. to deliver more doses. In Africa alone, only 4.4 percent of the population is vaccinated.</p><p><blockquote>Novavax持续存在的生产问题被曝光之际，世界上只有36%的人接种了疫苗，而且发展中国家的领导人继续向美国施压，要求其提供更多剂量。仅在非洲，只有4.4%的人口接种了疫苗。</blockquote></p><p> That includes some of the continent’s most populous nations, like Nigeria and Uganda, where about 1 percent of citizens are fully vaccinated.</p><p><blockquote>这包括非洲大陆一些人口最多的国家，如尼日利亚和乌干达，这些国家约有1%的公民完全接种了疫苗。</blockquote></p><p> Novavax is just the latest vaccine maker to run into core production problems after promising to serve as a major vaccine contributor to the developing world. In April, Johnson &amp; Johnsonhalted work at a Baltimore facilityrun by contract manufacturer <a href=\"https://laohu8.com/S/EBS\">Emergent BioSolutions</a> after it found that 15 million doses had been accidentally contaminated with ingredients from a separate Covid-19 vaccine.</p><p><blockquote>Novavax只是最新一家在承诺成为发展中国家主要疫苗供应商后遇到核心生产问题的疫苗制造商。四月，强生公司停止了巴尔的摩一家由合同制造商运营的工厂的工作<a href=\"https://laohu8.com/S/EBS\">新兴生物解决方案</a>在发现1500万剂疫苗意外被另一种Covid-19疫苗的成分污染后。</blockquote></p><p> J&amp;J’s manufacturing process has been slow to recover, and to date it has produced just a fraction of the 200 million shots it initially pledged to COVAX by the end of the year, according to records kept by UNICEF.</p><p><blockquote>根据联合国儿童基金会保存的记录，强生公司的生产流程恢复缓慢，迄今为止，该公司仅生产了最初承诺在年底前向COVAX生产的2亿剂疫苗的一小部分。</blockquote></p><p> “Overpromising and underdelivering is the name of the game for these manufacturers,” said Asia Russell, executive director of international advocacy group Health GAP. “And that’s the infrastructure of the global response, which is terrifying.”</p><p><blockquote>国际倡导组织Health GAP的执行董事亚洲·拉塞尔(Asia Russell)表示：“承诺过多而兑现不足是这些制造商的游戏名称。”“这就是全球应对措施的基础设施，这太可怕了。”</blockquote></p><p> Unlike Johnson &amp; Johnson, Novavax is a novice in the vaccine world. It has never successfully launched a vaccine, and had struggled financially prior to the pandemic. After a string of drug development failures, it sold its manufacturing facilities in 2019 — a deal that also included parting with 100 employees. In May of that year, Novavax’s stock price dropped as low as 36 cents per share.</p><p><blockquote>与强生不同，Novavax是疫苗界的新手。它从未成功推出过疫苗，并且在大流行之前一直在财务上苦苦挣扎。在经历了一系列药物开发失败后，该公司于2019年出售了其生产设施，这笔交易还包括解雇100名员工。当年5月，Novavax股价曾一度跌至每股36美分。</blockquote></p><p> Yet the company’s fortunes shifted as Covid-19 took hold. Amid a scramble early in the pandemic to develop a range of vaccine candidates, the Trump administration awarded Novavax $1.6 billion to aid work on its Covid-19 shot — the largest deal given to any Covid-19 vaccine maker at that time.</p><p><blockquote>然而，随着Covid-19的出现，该公司的命运发生了变化。在大流行初期争相开发一系列候选疫苗的过程中，特朗普政府向Novavax提供了16亿美元，以帮助其开发Covid-19疫苗——这是当时向所有Covid-19疫苗制造商提供的最大一笔交易。</blockquote></p><p> The contract represented a major vote of confidence in Novavax’s capabilities — and a bet that appeared to pay off after late-stage trials showed the vaccine was 90 percent effective against the virus.</p><p><blockquote>该合同代表了对Novavax能力的重大信任票，在后期试验显示该疫苗对病毒的有效性为90%后，这一赌注似乎得到了回报。</blockquote></p><p> But even then, senior Trump administration officials on Operation Warp Speed — a group tasked with accelerating vaccine development — repeatedly warned the company that it risked running into problems in scaling up manufacturing of the shot, two people with direct knowledge of those discussions said.</p><p><blockquote>但两名直接了解这些讨论的人士表示，即便如此，负责加速疫苗开发的“曲速行动”（Operation Warp Speed）的特朗普政府高级官员也一再警告该公司，在扩大疫苗生产规模时可能会遇到问题。</blockquote></p><p> In particular, they worried that Novavax would have difficulty ensuring that the vaccine consistently met the FDA’s rigorous quality standards once the vaccine went into mass production — the exact problem that has now stymied the company for months.</p><p><blockquote>他们特别担心，一旦疫苗投入大规模生产，Novavax将难以确保疫苗始终符合FDA严格的质量标准——这正是困扰该公司数月的问题。</blockquote></p><p> “They rushed the process,” one of the people with knowledge of the matter said. “It’s hard to make. And they can’t make it.”</p><p><blockquote>“他们仓促行事，”一位知情人士说。“这很难做到。而且他们也做不到。”</blockquote></p><p> Taylor, the Novavax spokesperson, said in a statement that it has incorporated feedback from regulators and has made “tremendous progress with the scale-up of our commercial manufacturing processes.” The company is still on track to produce 150 million doses a month by the end of the year, she said, and has stockpiled tens of millions of doses ahead of regulatory filings in the U.S. and internationally.</p><p><blockquote>Novavax发言人泰勒在一份声明中表示，该公司已纳入监管机构的反馈，并“在扩大我们的商业制造流程方面取得了巨大进展”。她说，该公司仍有望在今年年底前每月生产1.5亿剂疫苗，并在美国和国际监管机构备案之前储备了数千万剂疫苗。</blockquote></p><p> Company executives in recent presentations to investors have struck a similarly optimistic tone, downplaying the manufacturing snags and predicting it will soon be cleared to begin distributing doses. During aSept. 29 investor event, Chief Commercial Officer John Trizzino said the company had “resolved” its problems and was close to submitting a final regulatory application.</p><p><blockquote>公司高管在最近给投资者的演讲中也表现出了类似的乐观语气，淡化了制造障碍，并预测很快就会获得批准，开始分发剂量。在aSept期间。29日投资者活动，首席商务官John Trizzino表示，该公司已经“解决”了问题，并接近提交最终监管申请。</blockquote></p><p> “We’re really moving along with testing our lots now,” added Gregory Glenn, president of Novavax’s research and development, referring to batches of its vaccine. “We think that this is shortly going to come to a close.”</p><p><blockquote>Novavax研发总裁格雷戈里·格伦(Gregory Glenn)在谈到其疫苗批次时补充道：“我们现在确实在测试我们的批次。”“我们认为这很快就会结束。”</blockquote></p><p></p><p> U.S. officials working with the company are not as confident, according to three people with knowledge of the matter. Novavax’s manufacturing problems are seen as far more difficult to fix than the sanitary and design concerns that halted production of J&amp;J’s vaccine at the Emergent plant earlier this year, those people said.</p><p><blockquote>据三位知情人士透露，与该公司合作的美国官员没有那么自信。这些人士表示，Novavax的制造问题被认为比今年早些时候导致强生在Emergent工厂停止生产疫苗的卫生和设计问题更难解决。</blockquote></p><p> And even as the company begins to seek regulatory approval in other countries, there remains doubt in the U.S. that it has solved the fundamental vaccine purity flaws that the people with knowledge said have affected its ability to make doses at plants around the world.</p><p><blockquote>尽管该公司开始在其他国家寻求监管部门的批准，但美国仍怀疑该公司是否解决了根本的疫苗纯度缺陷，知情人士称，这些缺陷影响了该公司在世界各地工厂生产疫苗的能力。</blockquote></p><p> Several vaccine batches have already been discarded, and four people with knowledge of the matter say U.S. officials now no longer expect the company to win FDA sign-off on the vaccine until next year at the earliest.</p><p><blockquote>几批疫苗已经被丢弃，四名知情人士表示，美国官员现在预计该公司最早要到明年才能获得FDA对疫苗的批准。</blockquote></p><p> “At some level, I think the efficacy was never going to outweigh the risk associated with the impurity that was in there,” said one of the people with knowledge of the matter. “I’m not surprised this is where we are.”</p><p><blockquote>“在某种程度上，我认为功效永远不会超过与其中杂质相关的风险，”一位知情人士说。“我并不惊讶我们会在这里。”</blockquote></p><p></p>","collect":0,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; 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overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 12.5px; color: #7E829C; margin: 0;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nNovavax plunged over 20% in premarket trading<blockquote>Novavax盘前交易暴跌逾20%</blockquote>\n</h2>\n<h4 class=\"meta\">\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1079075236\">\n\n<div class=\"h-thumb\" style=\"background-image:url(https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Tiger Newspress </p>\n<p class=\"h-time smaller\">2021-10-20 16:14</p>\n</div>\n</a>\n</h4>\n</header>\n<article>\n<p>(Oct 20)&nbsp; <a href=\"https://laohu8.com/S/NVAX\">Novavax</a>&nbsp;may delay the delivery of 1 billion doses of coronavirus vaccine because of the production problems.</p><p><blockquote>（10月20日）<a href=\"https://laohu8.com/S/NVAX\">Novavax</a>可能因生产问题推迟10亿剂冠状病毒疫苗的交付。</blockquote></p><p> <img src=\"https://static.tigerbbs.com/f3995877f1c786d310a457ababf9ee9e\" tg-width=\"1043\" tg-height=\"564\" referrerpolicy=\"no-referrer\">The world’s vaccine distributor has been counting on U.S. companies to provide more than 2 billion doses to lower and middle-income countries by the end of 2022 — a crucial step in ending the Covid-19 pandemic.</p><p><blockquote>这家全球疫苗分销商一直指望美国公司在2022年底前向中低收入国家提供超过20亿剂疫苗——这是结束Covid-19大流行的关键一步。</blockquote></p><p> But the campaign run by the international consortium known as COVAX, which has already been delayed significantly because of production lags, is now likely to fall short by more than 1 billion doses as a key supplier faces significant hurdles in proving it can manufacture a shot that meets regulators’ quality standards, according to three people with direct knowledge of the company’s problems.</p><p><blockquote>但由名为COVAX的国际联盟发起的活动由于生产滞后而被大幅推迟，现在可能会短缺超过10亿剂，因为一家主要供应商在证明其能够生产疫苗方面面临重大障碍据三位直接了解该公司问题的人士透露，符合监管机构的质量标准。</blockquote></p><p> The delay, which was confirmed by three other people familiar with the discussions between Maryland-based Novavax and the Biden administration, represents a major setback in the effort to vaccinate the world in the wake of new, more transmissible variants.</p><p><blockquote>另外三名熟悉总部位于马里兰州的Novavax和拜登政府之间讨论的人士证实了这一延迟，这代表着在新的、更具传染性的变种出现后，为世界接种疫苗的努力遭遇重大挫折。</blockquote></p><p> The U.S. government invested $1.6 billion in Novavax in 2020 — the most it devoted to any vaccine maker at the time — in hopes that it would offer the world another option for a safe and effective vaccine to help protect against Covid-19. But the company has consistently run into production problems. The methods it used to test the purity of the vaccine have fallen short of regulators’ standards and the company has not been able to prove that it can produce a shot that is consistently up to snuff, according to multiple people familiar with Novavax’s difficulties. All spoke on the condition of anonymity to discuss sensitive company conversations.</p><p><blockquote>美国政府在2020年向Novavax投资了16亿美元，这是当时向所有疫苗制造商投入的最多资金，希望它能为世界提供另一种安全有效的疫苗选择，以帮助预防Covid-19。但该公司一直遇到生产问题。据多位熟悉Novavax困难的人士透露，其用于测试疫苗纯度的方法未达到监管机构的标准，该公司也无法证明其能够生产出始终符合标准的疫苗。所有人都要求匿名，讨论敏感的公司对话。</blockquote></p><p> Although Novavax recently attested to some of its analytics and testing issues in aquarterly filing with the Securities and Exchange Commission, the company’s issues are more concerning than previously understood, according to two of the people with direct knowledge of the matter.</p><p><blockquote>据两位直接了解此事的人士透露，尽管Novavax最近在向美国证券交易委员会提交的季度文件中证实了其一些分析和测试问题，但该公司的问题比之前理解的更令人担忧。</blockquote></p><p> The Food and Drug Administration works out purity levels with each manufacturer according to June 2020 guidance for coronavirus vaccines, but it is generally understood that each vaccine batch should reach at least 90 percent. The company has struggled to attain anywhere close to that, <a href=\"https://laohu8.com/S/AONE.U\">one</a> of the people with direct knowledge of the situation said. Another person familiar with the company’s manufacturing process said Novavax has recently shown purity levels hovering around 70 percent. Low purity levels increase the chance that contaminants or unnecessary substances are in the final product, rendering the vaccine less effective or introducing the chance that patients could react to unknown ingredients.</p><p><blockquote>美国食品药品监督管理局根据2020年6月的冠状病毒疫苗指南，与每个制造商一起制定纯度水平，但普遍认为每个疫苗批次应至少达到90%。该公司一直在努力实现这一目标，<a href=\"https://laohu8.com/S/AONE.U\">一</a>的直接了解情况的人说。另一位熟悉该公司制造工艺的人士表示，Novavax最近的纯度水平徘徊在70%左右。低纯度水平会增加最终产品中存在污染物或不必要物质的机会，从而降低疫苗的有效性或增加患者对未知成分产生反应的机会。</blockquote></p><p> COVAX, which recently downgraded its 2021 goal from 2 billion to 1.425 billion doses, has already estimated that it faces a supply shortfall of as many as 1 billion doses in its effort to vaccinate the developing world. If Novavax falters, it could double the deficit through 2022, leaving hundreds of millions of people without immunity against Covid-19 and extending the pandemic.</p><p><blockquote>COVAX最近将2021年的目标从20亿剂下调至14.25亿剂，并已经估计，在为发展中国家接种疫苗的努力中，它面临着多达10亿剂的供应短缺。如果Novavax步履蹒跚，到2022年赤字可能会增加一倍，使数亿人对Covid-19没有免疫力，并延长疫情。</blockquote></p><p> “COVAX continues to be challenged for adequate supply … in that context, Novavax’s manufacturing challenges and delays have been massively disruptive,” said Krishna Udayakumar, director of the <a href=\"https://laohu8.com/S/DRE\">Duke</a> Global Health Innovation Center.</p><p><blockquote>“COVAX继续面临充足供应的挑战……在这种背景下，Novavax的制造挑战和延误具有巨大的破坏性，”<a href=\"https://laohu8.com/S/DRE\">公爵</a>全球健康创新中心。</blockquote></p><p> The global coalition is already behind on hundreds of millions of planned doses this month, having shipped just 371 million of its 700 million dose target for October. It is now also at risk of missing its already downgraded 2021 target.</p><p><blockquote>全球联盟本月已经落后于数亿剂计划剂量，仅运送了10月份7亿剂目标中的3.71亿剂。它现在还面临着达不到已经下调的2021年目标的风险。</blockquote></p><p> Between Novavax and other manufacturers’ hurdles, “COVAX has had to scramble to revise its supply strategy significantly in real time,” Udayakumar said. As a result, global health groups are emphasizing more donations to cover immediate needs, he added.</p><p><blockquote>在Novavax和其他制造商的障碍之间，“COVAX不得不争先恐后地实时大幅修改其供应策略，”Udayakumar说。他补充说，因此，全球卫生组织强调提供更多捐款来满足眼前的需求。</blockquote></p><p> In a statement, Novavax Senior Vice President of Investor Relations and Corporate Affairs Silvia Taylor told POLITICO that the company’s analytical testing methods have been “validated” — but did not answer questions about whether the FDA had signed off on them. The company still plans on filing an emergency use authorization by the end of the year, Taylor said.</p><p><blockquote>Novavax投资者关系和公司事务高级副总裁Silvia Taylor在一份声明中告诉POLITICO，该公司的分析测试方法已经过“验证”，但没有回答有关FDA是否已批准这些方法的问题。泰勒说，该公司仍计划在今年年底前提交紧急使用授权。</blockquote></p><p> “The vaccine development and regulatory submission processes are highly complex and often require years to advance to the point where we are now. We will fulfill all of our committed doses both in the US and globally,” Taylor said.</p><p><blockquote>泰勒说：“疫苗开发和监管提交过程非常复杂，通常需要数年时间才能达到我们现在的水平。我们将在美国和全球范围内履行所有承诺的剂量。”</blockquote></p><p> The White House and the Department of Health and Human Services did not respond to multiple requests for comment.</p><p><blockquote>白宫和卫生与公众服务部没有回应多次置评请求。</blockquote></p><p></p><p> But three people familiar with the matter said they are not confident that the company has the resources needed to reproduce a high-quality vaccine on a consistent basis — a benchmark Novavax must meet before that time. Those same people said Novavax could potentially fix its manufacturing issues and reach full licensure by the end of 2022.</p><p><blockquote>但三位知情人士表示，他们不相信该公司拥有持续复制高质量疫苗所需的资源——Novavax在此之前必须达到的基准。这些人表示，Novavax可能会解决其制造问题，并在2022年底前获得全面许可。</blockquote></p><p> Novavax — which has never produced a vaccine before — declined to answer specific questions about its product’s purity levels and whether it had been successful in addressing its longstanding manufacturing issues.</p><p><blockquote>Novavax以前从未生产过疫苗，拒绝回答有关其产品纯度水平以及是否成功解决了长期存在的生产问题的具体问题。</blockquote></p><p> Unlike <a href=\"https://laohu8.com/S/PFE\">Pfizer</a> and Moderna, the first manufacturers to launch vaccines using rapidly produced messenger RNA, Novavax is employing the previously used but complicated approach of creating the key ingredient with bug cells. While the process, which involves infecting the cells to produce spike proteins, is familiar to scientists, it is difficult to scale.</p><p><blockquote>不像<a href=\"https://laohu8.com/S/PFE\">辉瑞</a>Moderna是第一家使用快速产生的信使RNA推出疫苗的制造商，Novavax正在采用以前使用但复杂的方法，即用细菌细胞制造关键成分。虽然科学家们对感染细胞产生刺突蛋白的过程很熟悉，但很难扩大规模。</blockquote></p><p> The revelations about Novavax’s continued manufacturing problems come at a time when only 36 percent of the world is vaccinated and as leaders of developing nations continue to pressure the U.S. to deliver more doses. In Africa alone, only 4.4 percent of the population is vaccinated.</p><p><blockquote>Novavax持续存在的生产问题被曝光之际，世界上只有36%的人接种了疫苗，而且发展中国家的领导人继续向美国施压，要求其提供更多剂量。仅在非洲，只有4.4%的人口接种了疫苗。</blockquote></p><p> That includes some of the continent’s most populous nations, like Nigeria and Uganda, where about 1 percent of citizens are fully vaccinated.</p><p><blockquote>这包括非洲大陆一些人口最多的国家，如尼日利亚和乌干达，这些国家约有1%的公民完全接种了疫苗。</blockquote></p><p> Novavax is just the latest vaccine maker to run into core production problems after promising to serve as a major vaccine contributor to the developing world. In April, Johnson &amp; Johnsonhalted work at a Baltimore facilityrun by contract manufacturer <a href=\"https://laohu8.com/S/EBS\">Emergent BioSolutions</a> after it found that 15 million doses had been accidentally contaminated with ingredients from a separate Covid-19 vaccine.</p><p><blockquote>Novavax只是最新一家在承诺成为发展中国家主要疫苗供应商后遇到核心生产问题的疫苗制造商。四月，强生公司停止了巴尔的摩一家由合同制造商运营的工厂的工作<a href=\"https://laohu8.com/S/EBS\">新兴生物解决方案</a>在发现1500万剂疫苗意外被另一种Covid-19疫苗的成分污染后。</blockquote></p><p> J&amp;J’s manufacturing process has been slow to recover, and to date it has produced just a fraction of the 200 million shots it initially pledged to COVAX by the end of the year, according to records kept by UNICEF.</p><p><blockquote>根据联合国儿童基金会保存的记录，强生公司的生产流程恢复缓慢，迄今为止，该公司仅生产了最初承诺在年底前向COVAX生产的2亿剂疫苗的一小部分。</blockquote></p><p> “Overpromising and underdelivering is the name of the game for these manufacturers,” said Asia Russell, executive director of international advocacy group Health GAP. “And that’s the infrastructure of the global response, which is terrifying.”</p><p><blockquote>国际倡导组织Health GAP的执行董事亚洲·拉塞尔(Asia Russell)表示：“承诺过多而兑现不足是这些制造商的游戏名称。”“这就是全球应对措施的基础设施，这太可怕了。”</blockquote></p><p> Unlike Johnson &amp; Johnson, Novavax is a novice in the vaccine world. It has never successfully launched a vaccine, and had struggled financially prior to the pandemic. After a string of drug development failures, it sold its manufacturing facilities in 2019 — a deal that also included parting with 100 employees. In May of that year, Novavax’s stock price dropped as low as 36 cents per share.</p><p><blockquote>与强生不同，Novavax是疫苗界的新手。它从未成功推出过疫苗，并且在大流行之前一直在财务上苦苦挣扎。在经历了一系列药物开发失败后，该公司于2019年出售了其生产设施，这笔交易还包括解雇100名员工。当年5月，Novavax股价曾一度跌至每股36美分。</blockquote></p><p> Yet the company’s fortunes shifted as Covid-19 took hold. Amid a scramble early in the pandemic to develop a range of vaccine candidates, the Trump administration awarded Novavax $1.6 billion to aid work on its Covid-19 shot — the largest deal given to any Covid-19 vaccine maker at that time.</p><p><blockquote>然而，随着Covid-19的出现，该公司的命运发生了变化。在大流行初期争相开发一系列候选疫苗的过程中，特朗普政府向Novavax提供了16亿美元，以帮助其开发Covid-19疫苗——这是当时向所有Covid-19疫苗制造商提供的最大一笔交易。</blockquote></p><p> The contract represented a major vote of confidence in Novavax’s capabilities — and a bet that appeared to pay off after late-stage trials showed the vaccine was 90 percent effective against the virus.</p><p><blockquote>该合同代表了对Novavax能力的重大信任票，在后期试验显示该疫苗对病毒的有效性为90%后，这一赌注似乎得到了回报。</blockquote></p><p> But even then, senior Trump administration officials on Operation Warp Speed — a group tasked with accelerating vaccine development — repeatedly warned the company that it risked running into problems in scaling up manufacturing of the shot, two people with direct knowledge of those discussions said.</p><p><blockquote>但两名直接了解这些讨论的人士表示，即便如此，负责加速疫苗开发的“曲速行动”（Operation Warp Speed）的特朗普政府高级官员也一再警告该公司，在扩大疫苗生产规模时可能会遇到问题。</blockquote></p><p> In particular, they worried that Novavax would have difficulty ensuring that the vaccine consistently met the FDA’s rigorous quality standards once the vaccine went into mass production — the exact problem that has now stymied the company for months.</p><p><blockquote>他们特别担心，一旦疫苗投入大规模生产，Novavax将难以确保疫苗始终符合FDA严格的质量标准——这正是困扰该公司数月的问题。</blockquote></p><p> “They rushed the process,” one of the people with knowledge of the matter said. “It’s hard to make. And they can’t make it.”</p><p><blockquote>“他们仓促行事，”一位知情人士说。“这很难做到。而且他们也做不到。”</blockquote></p><p> Taylor, the Novavax spokesperson, said in a statement that it has incorporated feedback from regulators and has made “tremendous progress with the scale-up of our commercial manufacturing processes.” The company is still on track to produce 150 million doses a month by the end of the year, she said, and has stockpiled tens of millions of doses ahead of regulatory filings in the U.S. and internationally.</p><p><blockquote>Novavax发言人泰勒在一份声明中表示，该公司已纳入监管机构的反馈，并“在扩大我们的商业制造流程方面取得了巨大进展”。她说，该公司仍有望在今年年底前每月生产1.5亿剂疫苗，并在美国和国际监管机构备案之前储备了数千万剂疫苗。</blockquote></p><p> Company executives in recent presentations to investors have struck a similarly optimistic tone, downplaying the manufacturing snags and predicting it will soon be cleared to begin distributing doses. During aSept. 29 investor event, Chief Commercial Officer John Trizzino said the company had “resolved” its problems and was close to submitting a final regulatory application.</p><p><blockquote>公司高管在最近给投资者的演讲中也表现出了类似的乐观语气，淡化了制造障碍，并预测很快就会获得批准，开始分发剂量。在aSept期间。29日投资者活动，首席商务官John Trizzino表示，该公司已经“解决”了问题，并接近提交最终监管申请。</blockquote></p><p> “We’re really moving along with testing our lots now,” added Gregory Glenn, president of Novavax’s research and development, referring to batches of its vaccine. “We think that this is shortly going to come to a close.”</p><p><blockquote>Novavax研发总裁格雷戈里·格伦(Gregory Glenn)在谈到其疫苗批次时补充道：“我们现在确实在测试我们的批次。”“我们认为这很快就会结束。”</blockquote></p><p></p><p> U.S. officials working with the company are not as confident, according to three people with knowledge of the matter. Novavax’s manufacturing problems are seen as far more difficult to fix than the sanitary and design concerns that halted production of J&amp;J’s vaccine at the Emergent plant earlier this year, those people said.</p><p><blockquote>据三位知情人士透露，与该公司合作的美国官员没有那么自信。这些人士表示，Novavax的制造问题被认为比今年早些时候导致强生在Emergent工厂停止生产疫苗的卫生和设计问题更难解决。</blockquote></p><p> And even as the company begins to seek regulatory approval in other countries, there remains doubt in the U.S. that it has solved the fundamental vaccine purity flaws that the people with knowledge said have affected its ability to make doses at plants around the world.</p><p><blockquote>尽管该公司开始在其他国家寻求监管部门的批准，但美国仍怀疑该公司是否解决了根本的疫苗纯度缺陷，知情人士称，这些缺陷影响了该公司在世界各地工厂生产疫苗的能力。</blockquote></p><p> Several vaccine batches have already been discarded, and four people with knowledge of the matter say U.S. officials now no longer expect the company to win FDA sign-off on the vaccine until next year at the earliest.</p><p><blockquote>几批疫苗已经被丢弃，四名知情人士表示，美国官员现在预计该公司最早要到明年才能获得FDA对疫苗的批准。</blockquote></p><p> “At some level, I think the efficacy was never going to outweigh the risk associated with the impurity that was in there,” said one of the people with knowledge of the matter. “I’m not surprised this is where we are.”</p><p><blockquote>“在某种程度上，我认为功效永远不会超过与其中杂质相关的风险，”一位知情人士说。“我并不惊讶我们会在这里。”</blockquote></p><p></p>\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"NVAX":"诺瓦瓦克斯医药"},"is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1174375951","content_text":"(Oct 20)  Novavax may delay the delivery of 1 billion doses of coronavirus vaccine because of the production problems.\nThe world’s vaccine distributor has been counting on U.S. companies to provide more than 2 billion doses to lower and middle-income countries by the end of 2022 — a crucial step in ending the Covid-19 pandemic.\nBut the campaign run by the international consortium known as COVAX, which has already been delayed significantly because of production lags, is now likely to fall short by more than 1 billion doses as a key supplier faces significant hurdles in proving it can manufacture a shot that meets regulators’ quality standards, according to three people with direct knowledge of the company’s problems.\nThe delay, which was confirmed by three other people familiar with the discussions between Maryland-based Novavax and the Biden administration, represents a major setback in the effort to vaccinate the world in the wake of new, more transmissible variants.\nThe U.S. government invested $1.6 billion in Novavax in 2020 — the most it devoted to any vaccine maker at the time — in hopes that it would offer the world another option for a safe and effective vaccine to help protect against Covid-19. But the company has consistently run into production problems. The methods it used to test the purity of the vaccine have fallen short of regulators’ standards and the company has not been able to prove that it can produce a shot that is consistently up to snuff, according to multiple people familiar with Novavax’s difficulties. All spoke on the condition of anonymity to discuss sensitive company conversations.\nAlthough Novavax recently attested to some of its analytics and testing issues in aquarterly filing with the Securities and Exchange Commission, the company’s issues are more concerning than previously understood, according to two of the people with direct knowledge of the matter.\nThe Food and Drug Administration works out purity levels with each manufacturer according to June 2020 guidance for coronavirus vaccines, but it is generally understood that each vaccine batch should reach at least 90 percent. The company has struggled to attain anywhere close to that, one of the people with direct knowledge of the situation said. Another person familiar with the company’s manufacturing process said Novavax has recently shown purity levels hovering around 70 percent. Low purity levels increase the chance that contaminants or unnecessary substances are in the final product, rendering the vaccine less effective or introducing the chance that patients could react to unknown ingredients.\nCOVAX, which recently downgraded its 2021 goal from 2 billion to 1.425 billion doses, has already estimated that it faces a supply shortfall of as many as 1 billion doses in its effort to vaccinate the developing world. If Novavax falters, it could double the deficit through 2022, leaving hundreds of millions of people without immunity against Covid-19 and extending the pandemic.\n“COVAX continues to be challenged for adequate supply … in that context, Novavax’s manufacturing challenges and delays have been massively disruptive,” said Krishna Udayakumar, director of the Duke Global Health Innovation Center.\nThe global coalition is already behind on hundreds of millions of planned doses this month, having shipped just 371 million of its 700 million dose target for October. It is now also at risk of missing its already downgraded 2021 target.\nBetween Novavax and other manufacturers’ hurdles, “COVAX has had to scramble to revise its supply strategy significantly in real time,” Udayakumar said. As a result, global health groups are emphasizing more donations to cover immediate needs, he added.\nIn a statement, Novavax Senior Vice President of Investor Relations and Corporate Affairs Silvia Taylor told POLITICO that the company’s analytical testing methods have been “validated” — but did not answer questions about whether the FDA had signed off on them. The company still plans on filing an emergency use authorization by the end of the year, Taylor said.\n“The vaccine development and regulatory submission processes are highly complex and often require years to advance to the point where we are now. We will fulfill all of our committed doses both in the US and globally,” Taylor said.\nThe White House and the Department of Health and Human Services did not respond to multiple requests for comment.\nBut three people familiar with the matter said they are not confident that the company has the resources needed to reproduce a high-quality vaccine on a consistent basis — a benchmark Novavax must meet before that time. Those same people said Novavax could potentially fix its manufacturing issues and reach full licensure by the end of 2022.\nNovavax — which has never produced a vaccine before — declined to answer specific questions about its product’s purity levels and whether it had been successful in addressing its longstanding manufacturing issues.\nUnlike Pfizer and Moderna, the first manufacturers to launch vaccines using rapidly produced messenger RNA, Novavax is employing the previously used but complicated approach of creating the key ingredient with bug cells. While the process, which involves infecting the cells to produce spike proteins, is familiar to scientists, it is difficult to scale.\nThe revelations about Novavax’s continued manufacturing problems come at a time when only 36 percent of the world is vaccinated and as leaders of developing nations continue to pressure the U.S. to deliver more doses. In Africa alone, only 4.4 percent of the population is vaccinated.\nThat includes some of the continent’s most populous nations, like Nigeria and Uganda, where about 1 percent of citizens are fully vaccinated.\nNovavax is just the latest vaccine maker to run into core production problems after promising to serve as a major vaccine contributor to the developing world. In April, Johnson & Johnsonhalted work at a Baltimore facilityrun by contract manufacturer Emergent BioSolutions after it found that 15 million doses had been accidentally contaminated with ingredients from a separate Covid-19 vaccine.\nJ&J’s manufacturing process has been slow to recover, and to date it has produced just a fraction of the 200 million shots it initially pledged to COVAX by the end of the year, according to records kept by UNICEF.\n“Overpromising and underdelivering is the name of the game for these manufacturers,” said Asia Russell, executive director of international advocacy group Health GAP. “And that’s the infrastructure of the global response, which is terrifying.”\nUnlike Johnson & Johnson, Novavax is a novice in the vaccine world. It has never successfully launched a vaccine, and had struggled financially prior to the pandemic. After a string of drug development failures, it sold its manufacturing facilities in 2019 — a deal that also included parting with 100 employees. In May of that year, Novavax’s stock price dropped as low as 36 cents per share.\nYet the company’s fortunes shifted as Covid-19 took hold. Amid a scramble early in the pandemic to develop a range of vaccine candidates, the Trump administration awarded Novavax $1.6 billion to aid work on its Covid-19 shot — the largest deal given to any Covid-19 vaccine maker at that time.\nThe contract represented a major vote of confidence in Novavax’s capabilities — and a bet that appeared to pay off after late-stage trials showed the vaccine was 90 percent effective against the virus.\nBut even then, senior Trump administration officials on Operation Warp Speed — a group tasked with accelerating vaccine development — repeatedly warned the company that it risked running into problems in scaling up manufacturing of the shot, two people with direct knowledge of those discussions said.\nIn particular, they worried that Novavax would have difficulty ensuring that the vaccine consistently met the FDA’s rigorous quality standards once the vaccine went into mass production — the exact problem that has now stymied the company for months.\n“They rushed the process,” one of the people with knowledge of the matter said. “It’s hard to make. And they can’t make it.”\nTaylor, the Novavax spokesperson, said in a statement that it has incorporated feedback from regulators and has made “tremendous progress with the scale-up of our commercial manufacturing processes.” The company is still on track to produce 150 million doses a month by the end of the year, she said, and has stockpiled tens of millions of doses ahead of regulatory filings in the U.S. and internationally.\nCompany executives in recent presentations to investors have struck a similarly optimistic tone, downplaying the manufacturing snags and predicting it will soon be cleared to begin distributing doses. During aSept. 29 investor event, Chief Commercial Officer John Trizzino said the company had “resolved” its problems and was close to submitting a final regulatory application.\n“We’re really moving along with testing our lots now,” added Gregory Glenn, president of Novavax’s research and development, referring to batches of its vaccine. “We think that this is shortly going to come to a close.”\nU.S. officials working with the company are not as confident, according to three people with knowledge of the matter. Novavax’s manufacturing problems are seen as far more difficult to fix than the sanitary and design concerns that halted production of J&J’s vaccine at the Emergent plant earlier this year, those people said.\nAnd even as the company begins to seek regulatory approval in other countries, there remains doubt in the U.S. that it has solved the fundamental vaccine purity flaws that the people with knowledge said have affected its ability to make doses at plants around the world.\nSeveral vaccine batches have already been discarded, and four people with knowledge of the matter say U.S. officials now no longer expect the company to win FDA sign-off on the vaccine until next year at the earliest.\n“At some level, I think the efficacy was never going to outweigh the risk associated with the impurity that was in there,” said one of the people with knowledge of the matter. “I’m not surprised this is where we are.”","news_type":1,"symbols_score_info":{"NVAX":0.9}},"isVote":1,"tweetType":1,"viewCount":491,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":859401923,"gmtCreate":1634718076630,"gmtModify":1634720846257,"author":{"id":"3573538012135697","authorId":"3573538012135697","name":"Alvin牛仔背带裤","avatar":"https://static.tigerbbs.com/d141be403ec6eb25b1c85b5c797f9c49","crmLevel":11,"crmLevelSwitch":0,"followedFlag":false,"authorIdStr":"3573538012135697","idStr":"3573538012135697"},"themes":[],"htmlText":"BullshitJust buy the dip","listText":"BullshitJust buy the dip","text":"BullshitJust buy the dip","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":2,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/859401923","repostId":"1174375951","repostType":2,"repost":{"id":"1174375951","kind":"news","weMediaInfo":{"introduction":"Providing stock market headlines, business news, financials and earnings ","home_visible":1,"media_name":"Tiger Newspress","id":"1079075236","head_image":"https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba"},"pubTimestamp":1634717661,"share":"https://www.laohu8.com/m/news/1174375951?lang=zh_CN&edition=full","pubTime":"2021-10-20 16:14","market":"us","language":"en","title":"Novavax plunged over 20% in premarket trading<blockquote>Novavax盘前交易暴跌逾20%</blockquote>","url":"https://stock-news.laohu8.com/highlight/detail?id=1174375951","media":"Tiger Newspress","summary":"(Oct 20)  Novavax may delay the delivery of 1 billion doses of coronavirus vaccine because of the pr","content":"<p>(Oct 20)&nbsp; <a href=\"https://laohu8.com/S/NVAX\">Novavax</a>&nbsp;may delay the delivery of 1 billion doses of coronavirus vaccine because of the production problems.</p><p><blockquote>（10月20日）<a href=\"https://laohu8.com/S/NVAX\">Novavax</a>可能因生产问题推迟10亿剂冠状病毒疫苗的交付。</blockquote></p><p> <img src=\"https://static.tigerbbs.com/f3995877f1c786d310a457ababf9ee9e\" tg-width=\"1043\" tg-height=\"564\" referrerpolicy=\"no-referrer\">The world’s vaccine distributor has been counting on U.S. companies to provide more than 2 billion doses to lower and middle-income countries by the end of 2022 — a crucial step in ending the Covid-19 pandemic.</p><p><blockquote>这家全球疫苗分销商一直指望美国公司在2022年底前向中低收入国家提供超过20亿剂疫苗——这是结束Covid-19大流行的关键一步。</blockquote></p><p> But the campaign run by the international consortium known as COVAX, which has already been delayed significantly because of production lags, is now likely to fall short by more than 1 billion doses as a key supplier faces significant hurdles in proving it can manufacture a shot that meets regulators’ quality standards, according to three people with direct knowledge of the company’s problems.</p><p><blockquote>但由名为COVAX的国际联盟发起的活动由于生产滞后而被大幅推迟，现在可能会短缺超过10亿剂，因为一家主要供应商在证明其能够生产疫苗方面面临重大障碍据三位直接了解该公司问题的人士透露，符合监管机构的质量标准。</blockquote></p><p> The delay, which was confirmed by three other people familiar with the discussions between Maryland-based Novavax and the Biden administration, represents a major setback in the effort to vaccinate the world in the wake of new, more transmissible variants.</p><p><blockquote>另外三名熟悉总部位于马里兰州的Novavax和拜登政府之间讨论的人士证实了这一延迟，这代表着在新的、更具传染性的变种出现后，为世界接种疫苗的努力遭遇重大挫折。</blockquote></p><p> The U.S. government invested $1.6 billion in Novavax in 2020 — the most it devoted to any vaccine maker at the time — in hopes that it would offer the world another option for a safe and effective vaccine to help protect against Covid-19. But the company has consistently run into production problems. The methods it used to test the purity of the vaccine have fallen short of regulators’ standards and the company has not been able to prove that it can produce a shot that is consistently up to snuff, according to multiple people familiar with Novavax’s difficulties. All spoke on the condition of anonymity to discuss sensitive company conversations.</p><p><blockquote>美国政府在2020年向Novavax投资了16亿美元，这是当时向所有疫苗制造商投入的最多资金，希望它能为世界提供另一种安全有效的疫苗选择，以帮助预防Covid-19。但该公司一直遇到生产问题。据多位熟悉Novavax困难的人士透露，其用于测试疫苗纯度的方法未达到监管机构的标准，该公司也无法证明其能够生产出始终符合标准的疫苗。所有人都要求匿名，讨论敏感的公司对话。</blockquote></p><p> Although Novavax recently attested to some of its analytics and testing issues in aquarterly filing with the Securities and Exchange Commission, the company’s issues are more concerning than previously understood, according to two of the people with direct knowledge of the matter.</p><p><blockquote>据两位直接了解此事的人士透露，尽管Novavax最近在向美国证券交易委员会提交的季度文件中证实了其一些分析和测试问题，但该公司的问题比之前理解的更令人担忧。</blockquote></p><p> The Food and Drug Administration works out purity levels with each manufacturer according to June 2020 guidance for coronavirus vaccines, but it is generally understood that each vaccine batch should reach at least 90 percent. The company has struggled to attain anywhere close to that, <a href=\"https://laohu8.com/S/AONE.U\">one</a> of the people with direct knowledge of the situation said. Another person familiar with the company’s manufacturing process said Novavax has recently shown purity levels hovering around 70 percent. Low purity levels increase the chance that contaminants or unnecessary substances are in the final product, rendering the vaccine less effective or introducing the chance that patients could react to unknown ingredients.</p><p><blockquote>美国食品药品监督管理局根据2020年6月的冠状病毒疫苗指南，与每个制造商一起制定纯度水平，但普遍认为每个疫苗批次应至少达到90%。该公司一直在努力实现这一目标，<a href=\"https://laohu8.com/S/AONE.U\">一</a>的直接了解情况的人说。另一位熟悉该公司制造工艺的人士表示，Novavax最近的纯度水平徘徊在70%左右。低纯度水平会增加最终产品中存在污染物或不必要物质的机会，从而降低疫苗的有效性或增加患者对未知成分产生反应的机会。</blockquote></p><p> COVAX, which recently downgraded its 2021 goal from 2 billion to 1.425 billion doses, has already estimated that it faces a supply shortfall of as many as 1 billion doses in its effort to vaccinate the developing world. If Novavax falters, it could double the deficit through 2022, leaving hundreds of millions of people without immunity against Covid-19 and extending the pandemic.</p><p><blockquote>COVAX最近将2021年的目标从20亿剂下调至14.25亿剂，并已经估计，在为发展中国家接种疫苗的努力中，它面临着多达10亿剂的供应短缺。如果Novavax步履蹒跚，到2022年赤字可能会增加一倍，使数亿人对Covid-19没有免疫力，并延长疫情。</blockquote></p><p> “COVAX continues to be challenged for adequate supply … in that context, Novavax’s manufacturing challenges and delays have been massively disruptive,” said Krishna Udayakumar, director of the <a href=\"https://laohu8.com/S/DRE\">Duke</a> Global Health Innovation Center.</p><p><blockquote>“COVAX继续面临充足供应的挑战……在这种背景下，Novavax的制造挑战和延误具有巨大的破坏性，”<a href=\"https://laohu8.com/S/DRE\">公爵</a>全球健康创新中心。</blockquote></p><p> The global coalition is already behind on hundreds of millions of planned doses this month, having shipped just 371 million of its 700 million dose target for October. It is now also at risk of missing its already downgraded 2021 target.</p><p><blockquote>全球联盟本月已经落后于数亿剂计划剂量，仅运送了10月份7亿剂目标中的3.71亿剂。它现在还面临着达不到已经下调的2021年目标的风险。</blockquote></p><p> Between Novavax and other manufacturers’ hurdles, “COVAX has had to scramble to revise its supply strategy significantly in real time,” Udayakumar said. As a result, global health groups are emphasizing more donations to cover immediate needs, he added.</p><p><blockquote>在Novavax和其他制造商的障碍之间，“COVAX不得不争先恐后地实时大幅修改其供应策略，”Udayakumar说。他补充说，因此，全球卫生组织强调提供更多捐款来满足眼前的需求。</blockquote></p><p> In a statement, Novavax Senior Vice President of Investor Relations and Corporate Affairs Silvia Taylor told POLITICO that the company’s analytical testing methods have been “validated” — but did not answer questions about whether the FDA had signed off on them. The company still plans on filing an emergency use authorization by the end of the year, Taylor said.</p><p><blockquote>Novavax投资者关系和公司事务高级副总裁Silvia Taylor在一份声明中告诉POLITICO，该公司的分析测试方法已经过“验证”，但没有回答有关FDA是否已批准这些方法的问题。泰勒说，该公司仍计划在今年年底前提交紧急使用授权。</blockquote></p><p> “The vaccine development and regulatory submission processes are highly complex and often require years to advance to the point where we are now. We will fulfill all of our committed doses both in the US and globally,” Taylor said.</p><p><blockquote>泰勒说：“疫苗开发和监管提交过程非常复杂，通常需要数年时间才能达到我们现在的水平。我们将在美国和全球范围内履行所有承诺的剂量。”</blockquote></p><p> The White House and the Department of Health and Human Services did not respond to multiple requests for comment.</p><p><blockquote>白宫和卫生与公众服务部没有回应多次置评请求。</blockquote></p><p></p><p> But three people familiar with the matter said they are not confident that the company has the resources needed to reproduce a high-quality vaccine on a consistent basis — a benchmark Novavax must meet before that time. Those same people said Novavax could potentially fix its manufacturing issues and reach full licensure by the end of 2022.</p><p><blockquote>但三位知情人士表示，他们不相信该公司拥有持续复制高质量疫苗所需的资源——Novavax在此之前必须达到的基准。这些人表示，Novavax可能会解决其制造问题，并在2022年底前获得全面许可。</blockquote></p><p> Novavax — which has never produced a vaccine before — declined to answer specific questions about its product’s purity levels and whether it had been successful in addressing its longstanding manufacturing issues.</p><p><blockquote>Novavax以前从未生产过疫苗，拒绝回答有关其产品纯度水平以及是否成功解决了长期存在的生产问题的具体问题。</blockquote></p><p> Unlike <a href=\"https://laohu8.com/S/PFE\">Pfizer</a> and Moderna, the first manufacturers to launch vaccines using rapidly produced messenger RNA, Novavax is employing the previously used but complicated approach of creating the key ingredient with bug cells. While the process, which involves infecting the cells to produce spike proteins, is familiar to scientists, it is difficult to scale.</p><p><blockquote>不像<a href=\"https://laohu8.com/S/PFE\">辉瑞</a>Moderna是第一家使用快速产生的信使RNA推出疫苗的制造商，Novavax正在采用以前使用但复杂的方法，即用细菌细胞制造关键成分。虽然科学家们对感染细胞产生刺突蛋白的过程很熟悉，但很难扩大规模。</blockquote></p><p> The revelations about Novavax’s continued manufacturing problems come at a time when only 36 percent of the world is vaccinated and as leaders of developing nations continue to pressure the U.S. to deliver more doses. In Africa alone, only 4.4 percent of the population is vaccinated.</p><p><blockquote>Novavax持续存在的生产问题被曝光之际，世界上只有36%的人接种了疫苗，而且发展中国家的领导人继续向美国施压，要求其提供更多剂量。仅在非洲，只有4.4%的人口接种了疫苗。</blockquote></p><p> That includes some of the continent’s most populous nations, like Nigeria and Uganda, where about 1 percent of citizens are fully vaccinated.</p><p><blockquote>这包括非洲大陆一些人口最多的国家，如尼日利亚和乌干达，这些国家约有1%的公民完全接种了疫苗。</blockquote></p><p> Novavax is just the latest vaccine maker to run into core production problems after promising to serve as a major vaccine contributor to the developing world. In April, Johnson &amp; Johnsonhalted work at a Baltimore facilityrun by contract manufacturer <a href=\"https://laohu8.com/S/EBS\">Emergent BioSolutions</a> after it found that 15 million doses had been accidentally contaminated with ingredients from a separate Covid-19 vaccine.</p><p><blockquote>Novavax只是最新一家在承诺成为发展中国家主要疫苗供应商后遇到核心生产问题的疫苗制造商。四月，强生公司停止了巴尔的摩一家由合同制造商运营的工厂的工作<a href=\"https://laohu8.com/S/EBS\">新兴生物解决方案</a>在发现1500万剂疫苗意外被另一种Covid-19疫苗的成分污染后。</blockquote></p><p> J&amp;J’s manufacturing process has been slow to recover, and to date it has produced just a fraction of the 200 million shots it initially pledged to COVAX by the end of the year, according to records kept by UNICEF.</p><p><blockquote>根据联合国儿童基金会保存的记录，强生公司的生产流程恢复缓慢，迄今为止，该公司仅生产了最初承诺在年底前向COVAX生产的2亿剂疫苗的一小部分。</blockquote></p><p> “Overpromising and underdelivering is the name of the game for these manufacturers,” said Asia Russell, executive director of international advocacy group Health GAP. “And that’s the infrastructure of the global response, which is terrifying.”</p><p><blockquote>国际倡导组织Health GAP的执行董事亚洲·拉塞尔(Asia Russell)表示：“承诺过多而兑现不足是这些制造商的游戏名称。”“这就是全球应对措施的基础设施，这太可怕了。”</blockquote></p><p> Unlike Johnson &amp; Johnson, Novavax is a novice in the vaccine world. It has never successfully launched a vaccine, and had struggled financially prior to the pandemic. After a string of drug development failures, it sold its manufacturing facilities in 2019 — a deal that also included parting with 100 employees. In May of that year, Novavax’s stock price dropped as low as 36 cents per share.</p><p><blockquote>与强生不同，Novavax是疫苗界的新手。它从未成功推出过疫苗，并且在大流行之前一直在财务上苦苦挣扎。在经历了一系列药物开发失败后，该公司于2019年出售了其生产设施，这笔交易还包括解雇100名员工。当年5月，Novavax股价曾一度跌至每股36美分。</blockquote></p><p> Yet the company’s fortunes shifted as Covid-19 took hold. Amid a scramble early in the pandemic to develop a range of vaccine candidates, the Trump administration awarded Novavax $1.6 billion to aid work on its Covid-19 shot — the largest deal given to any Covid-19 vaccine maker at that time.</p><p><blockquote>然而，随着Covid-19的出现，该公司的命运发生了变化。在大流行初期争相开发一系列候选疫苗的过程中，特朗普政府向Novavax提供了16亿美元，以帮助其开发Covid-19疫苗——这是当时向所有Covid-19疫苗制造商提供的最大一笔交易。</blockquote></p><p> The contract represented a major vote of confidence in Novavax’s capabilities — and a bet that appeared to pay off after late-stage trials showed the vaccine was 90 percent effective against the virus.</p><p><blockquote>该合同代表了对Novavax能力的重大信任票，在后期试验显示该疫苗对病毒的有效性为90%后，这一赌注似乎得到了回报。</blockquote></p><p> But even then, senior Trump administration officials on Operation Warp Speed — a group tasked with accelerating vaccine development — repeatedly warned the company that it risked running into problems in scaling up manufacturing of the shot, two people with direct knowledge of those discussions said.</p><p><blockquote>但两名直接了解这些讨论的人士表示，即便如此，负责加速疫苗开发的“曲速行动”（Operation Warp Speed）的特朗普政府高级官员也一再警告该公司，在扩大疫苗生产规模时可能会遇到问题。</blockquote></p><p> In particular, they worried that Novavax would have difficulty ensuring that the vaccine consistently met the FDA’s rigorous quality standards once the vaccine went into mass production — the exact problem that has now stymied the company for months.</p><p><blockquote>他们特别担心，一旦疫苗投入大规模生产，Novavax将难以确保疫苗始终符合FDA严格的质量标准——这正是困扰该公司数月的问题。</blockquote></p><p> “They rushed the process,” one of the people with knowledge of the matter said. “It’s hard to make. And they can’t make it.”</p><p><blockquote>“他们仓促行事，”一位知情人士说。“这很难做到。而且他们也做不到。”</blockquote></p><p> Taylor, the Novavax spokesperson, said in a statement that it has incorporated feedback from regulators and has made “tremendous progress with the scale-up of our commercial manufacturing processes.” The company is still on track to produce 150 million doses a month by the end of the year, she said, and has stockpiled tens of millions of doses ahead of regulatory filings in the U.S. and internationally.</p><p><blockquote>Novavax发言人泰勒在一份声明中表示，该公司已纳入监管机构的反馈，并“在扩大我们的商业制造流程方面取得了巨大进展”。她说，该公司仍有望在今年年底前每月生产1.5亿剂疫苗，并在美国和国际监管机构备案之前储备了数千万剂疫苗。</blockquote></p><p> Company executives in recent presentations to investors have struck a similarly optimistic tone, downplaying the manufacturing snags and predicting it will soon be cleared to begin distributing doses. During aSept. 29 investor event, Chief Commercial Officer John Trizzino said the company had “resolved” its problems and was close to submitting a final regulatory application.</p><p><blockquote>公司高管在最近给投资者的演讲中也表现出了类似的乐观语气，淡化了制造障碍，并预测很快就会获得批准，开始分发剂量。在aSept期间。29日投资者活动，首席商务官John Trizzino表示，该公司已经“解决”了问题，并接近提交最终监管申请。</blockquote></p><p> “We’re really moving along with testing our lots now,” added Gregory Glenn, president of Novavax’s research and development, referring to batches of its vaccine. “We think that this is shortly going to come to a close.”</p><p><blockquote>Novavax研发总裁格雷戈里·格伦(Gregory Glenn)在谈到其疫苗批次时补充道：“我们现在确实在测试我们的批次。”“我们认为这很快就会结束。”</blockquote></p><p></p><p> U.S. officials working with the company are not as confident, according to three people with knowledge of the matter. Novavax’s manufacturing problems are seen as far more difficult to fix than the sanitary and design concerns that halted production of J&amp;J’s vaccine at the Emergent plant earlier this year, those people said.</p><p><blockquote>据三位知情人士透露，与该公司合作的美国官员没有那么自信。这些人士表示，Novavax的制造问题被认为比今年早些时候导致强生在Emergent工厂停止生产疫苗的卫生和设计问题更难解决。</blockquote></p><p> And even as the company begins to seek regulatory approval in other countries, there remains doubt in the U.S. that it has solved the fundamental vaccine purity flaws that the people with knowledge said have affected its ability to make doses at plants around the world.</p><p><blockquote>尽管该公司开始在其他国家寻求监管部门的批准，但美国仍怀疑该公司是否解决了根本的疫苗纯度缺陷，知情人士称，这些缺陷影响了该公司在世界各地工厂生产疫苗的能力。</blockquote></p><p> Several vaccine batches have already been discarded, and four people with knowledge of the matter say U.S. officials now no longer expect the company to win FDA sign-off on the vaccine until next year at the earliest.</p><p><blockquote>几批疫苗已经被丢弃，四名知情人士表示，美国官员现在预计该公司最早要到明年才能获得FDA对疫苗的批准。</blockquote></p><p> “At some level, I think the efficacy was never going to outweigh the risk associated with the impurity that was in there,” said one of the people with knowledge of the matter. “I’m not surprised this is where we are.”</p><p><blockquote>“在某种程度上，我认为功效永远不会超过与其中杂质相关的风险，”一位知情人士说。“我并不惊讶我们会在这里。”</blockquote></p><p></p>","collect":0,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; 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<a href=\"https://laohu8.com/S/NVAX\">Novavax</a>&nbsp;may delay the delivery of 1 billion doses of coronavirus vaccine because of the production problems.</p><p><blockquote>（10月20日）<a href=\"https://laohu8.com/S/NVAX\">Novavax</a>可能因生产问题推迟10亿剂冠状病毒疫苗的交付。</blockquote></p><p> <img src=\"https://static.tigerbbs.com/f3995877f1c786d310a457ababf9ee9e\" tg-width=\"1043\" tg-height=\"564\" referrerpolicy=\"no-referrer\">The world’s vaccine distributor has been counting on U.S. companies to provide more than 2 billion doses to lower and middle-income countries by the end of 2022 — a crucial step in ending the Covid-19 pandemic.</p><p><blockquote>这家全球疫苗分销商一直指望美国公司在2022年底前向中低收入国家提供超过20亿剂疫苗——这是结束Covid-19大流行的关键一步。</blockquote></p><p> But the campaign run by the international consortium known as COVAX, which has already been delayed significantly because of production lags, is now likely to fall short by more than 1 billion doses as a key supplier faces significant hurdles in proving it can manufacture a shot that meets regulators’ quality standards, according to three people with direct knowledge of the company’s problems.</p><p><blockquote>但由名为COVAX的国际联盟发起的活动由于生产滞后而被大幅推迟，现在可能会短缺超过10亿剂，因为一家主要供应商在证明其能够生产疫苗方面面临重大障碍据三位直接了解该公司问题的人士透露，符合监管机构的质量标准。</blockquote></p><p> The delay, which was confirmed by three other people familiar with the discussions between Maryland-based Novavax and the Biden administration, represents a major setback in the effort to vaccinate the world in the wake of new, more transmissible variants.</p><p><blockquote>另外三名熟悉总部位于马里兰州的Novavax和拜登政府之间讨论的人士证实了这一延迟，这代表着在新的、更具传染性的变种出现后，为世界接种疫苗的努力遭遇重大挫折。</blockquote></p><p> The U.S. government invested $1.6 billion in Novavax in 2020 — the most it devoted to any vaccine maker at the time — in hopes that it would offer the world another option for a safe and effective vaccine to help protect against Covid-19. But the company has consistently run into production problems. The methods it used to test the purity of the vaccine have fallen short of regulators’ standards and the company has not been able to prove that it can produce a shot that is consistently up to snuff, according to multiple people familiar with Novavax’s difficulties. All spoke on the condition of anonymity to discuss sensitive company conversations.</p><p><blockquote>美国政府在2020年向Novavax投资了16亿美元，这是当时向所有疫苗制造商投入的最多资金，希望它能为世界提供另一种安全有效的疫苗选择，以帮助预防Covid-19。但该公司一直遇到生产问题。据多位熟悉Novavax困难的人士透露，其用于测试疫苗纯度的方法未达到监管机构的标准，该公司也无法证明其能够生产出始终符合标准的疫苗。所有人都要求匿名，讨论敏感的公司对话。</blockquote></p><p> Although Novavax recently attested to some of its analytics and testing issues in aquarterly filing with the Securities and Exchange Commission, the company’s issues are more concerning than previously understood, according to two of the people with direct knowledge of the matter.</p><p><blockquote>据两位直接了解此事的人士透露，尽管Novavax最近在向美国证券交易委员会提交的季度文件中证实了其一些分析和测试问题，但该公司的问题比之前理解的更令人担忧。</blockquote></p><p> The Food and Drug Administration works out purity levels with each manufacturer according to June 2020 guidance for coronavirus vaccines, but it is generally understood that each vaccine batch should reach at least 90 percent. The company has struggled to attain anywhere close to that, <a href=\"https://laohu8.com/S/AONE.U\">one</a> of the people with direct knowledge of the situation said. Another person familiar with the company’s manufacturing process said Novavax has recently shown purity levels hovering around 70 percent. Low purity levels increase the chance that contaminants or unnecessary substances are in the final product, rendering the vaccine less effective or introducing the chance that patients could react to unknown ingredients.</p><p><blockquote>美国食品药品监督管理局根据2020年6月的冠状病毒疫苗指南，与每个制造商一起制定纯度水平，但普遍认为每个疫苗批次应至少达到90%。该公司一直在努力实现这一目标，<a href=\"https://laohu8.com/S/AONE.U\">一</a>的直接了解情况的人说。另一位熟悉该公司制造工艺的人士表示，Novavax最近的纯度水平徘徊在70%左右。低纯度水平会增加最终产品中存在污染物或不必要物质的机会，从而降低疫苗的有效性或增加患者对未知成分产生反应的机会。</blockquote></p><p> COVAX, which recently downgraded its 2021 goal from 2 billion to 1.425 billion doses, has already estimated that it faces a supply shortfall of as many as 1 billion doses in its effort to vaccinate the developing world. If Novavax falters, it could double the deficit through 2022, leaving hundreds of millions of people without immunity against Covid-19 and extending the pandemic.</p><p><blockquote>COVAX最近将2021年的目标从20亿剂下调至14.25亿剂，并已经估计，在为发展中国家接种疫苗的努力中，它面临着多达10亿剂的供应短缺。如果Novavax步履蹒跚，到2022年赤字可能会增加一倍，使数亿人对Covid-19没有免疫力，并延长疫情。</blockquote></p><p> “COVAX continues to be challenged for adequate supply … in that context, Novavax’s manufacturing challenges and delays have been massively disruptive,” said Krishna Udayakumar, director of the <a href=\"https://laohu8.com/S/DRE\">Duke</a> Global Health Innovation Center.</p><p><blockquote>“COVAX继续面临充足供应的挑战……在这种背景下，Novavax的制造挑战和延误具有巨大的破坏性，”<a href=\"https://laohu8.com/S/DRE\">公爵</a>全球健康创新中心。</blockquote></p><p> The global coalition is already behind on hundreds of millions of planned doses this month, having shipped just 371 million of its 700 million dose target for October. It is now also at risk of missing its already downgraded 2021 target.</p><p><blockquote>全球联盟本月已经落后于数亿剂计划剂量，仅运送了10月份7亿剂目标中的3.71亿剂。它现在还面临着达不到已经下调的2021年目标的风险。</blockquote></p><p> Between Novavax and other manufacturers’ hurdles, “COVAX has had to scramble to revise its supply strategy significantly in real time,” Udayakumar said. As a result, global health groups are emphasizing more donations to cover immediate needs, he added.</p><p><blockquote>在Novavax和其他制造商的障碍之间，“COVAX不得不争先恐后地实时大幅修改其供应策略，”Udayakumar说。他补充说，因此，全球卫生组织强调提供更多捐款来满足眼前的需求。</blockquote></p><p> In a statement, Novavax Senior Vice President of Investor Relations and Corporate Affairs Silvia Taylor told POLITICO that the company’s analytical testing methods have been “validated” — but did not answer questions about whether the FDA had signed off on them. The company still plans on filing an emergency use authorization by the end of the year, Taylor said.</p><p><blockquote>Novavax投资者关系和公司事务高级副总裁Silvia Taylor在一份声明中告诉POLITICO，该公司的分析测试方法已经过“验证”，但没有回答有关FDA是否已批准这些方法的问题。泰勒说，该公司仍计划在今年年底前提交紧急使用授权。</blockquote></p><p> “The vaccine development and regulatory submission processes are highly complex and often require years to advance to the point where we are now. We will fulfill all of our committed doses both in the US and globally,” Taylor said.</p><p><blockquote>泰勒说：“疫苗开发和监管提交过程非常复杂，通常需要数年时间才能达到我们现在的水平。我们将在美国和全球范围内履行所有承诺的剂量。”</blockquote></p><p> The White House and the Department of Health and Human Services did not respond to multiple requests for comment.</p><p><blockquote>白宫和卫生与公众服务部没有回应多次置评请求。</blockquote></p><p></p><p> But three people familiar with the matter said they are not confident that the company has the resources needed to reproduce a high-quality vaccine on a consistent basis — a benchmark Novavax must meet before that time. Those same people said Novavax could potentially fix its manufacturing issues and reach full licensure by the end of 2022.</p><p><blockquote>但三位知情人士表示，他们不相信该公司拥有持续复制高质量疫苗所需的资源——Novavax在此之前必须达到的基准。这些人表示，Novavax可能会解决其制造问题，并在2022年底前获得全面许可。</blockquote></p><p> Novavax — which has never produced a vaccine before — declined to answer specific questions about its product’s purity levels and whether it had been successful in addressing its longstanding manufacturing issues.</p><p><blockquote>Novavax以前从未生产过疫苗，拒绝回答有关其产品纯度水平以及是否成功解决了长期存在的生产问题的具体问题。</blockquote></p><p> Unlike <a href=\"https://laohu8.com/S/PFE\">Pfizer</a> and Moderna, the first manufacturers to launch vaccines using rapidly produced messenger RNA, Novavax is employing the previously used but complicated approach of creating the key ingredient with bug cells. While the process, which involves infecting the cells to produce spike proteins, is familiar to scientists, it is difficult to scale.</p><p><blockquote>不像<a href=\"https://laohu8.com/S/PFE\">辉瑞</a>Moderna是第一家使用快速产生的信使RNA推出疫苗的制造商，Novavax正在采用以前使用但复杂的方法，即用细菌细胞制造关键成分。虽然科学家们对感染细胞产生刺突蛋白的过程很熟悉，但很难扩大规模。</blockquote></p><p> The revelations about Novavax’s continued manufacturing problems come at a time when only 36 percent of the world is vaccinated and as leaders of developing nations continue to pressure the U.S. to deliver more doses. In Africa alone, only 4.4 percent of the population is vaccinated.</p><p><blockquote>Novavax持续存在的生产问题被曝光之际，世界上只有36%的人接种了疫苗，而且发展中国家的领导人继续向美国施压，要求其提供更多剂量。仅在非洲，只有4.4%的人口接种了疫苗。</blockquote></p><p> That includes some of the continent’s most populous nations, like Nigeria and Uganda, where about 1 percent of citizens are fully vaccinated.</p><p><blockquote>这包括非洲大陆一些人口最多的国家，如尼日利亚和乌干达，这些国家约有1%的公民完全接种了疫苗。</blockquote></p><p> Novavax is just the latest vaccine maker to run into core production problems after promising to serve as a major vaccine contributor to the developing world. In April, Johnson &amp; Johnsonhalted work at a Baltimore facilityrun by contract manufacturer <a href=\"https://laohu8.com/S/EBS\">Emergent BioSolutions</a> after it found that 15 million doses had been accidentally contaminated with ingredients from a separate Covid-19 vaccine.</p><p><blockquote>Novavax只是最新一家在承诺成为发展中国家主要疫苗供应商后遇到核心生产问题的疫苗制造商。四月，强生公司停止了巴尔的摩一家由合同制造商运营的工厂的工作<a href=\"https://laohu8.com/S/EBS\">新兴生物解决方案</a>在发现1500万剂疫苗意外被另一种Covid-19疫苗的成分污染后。</blockquote></p><p> J&amp;J’s manufacturing process has been slow to recover, and to date it has produced just a fraction of the 200 million shots it initially pledged to COVAX by the end of the year, according to records kept by UNICEF.</p><p><blockquote>根据联合国儿童基金会保存的记录，强生公司的生产流程恢复缓慢，迄今为止，该公司仅生产了最初承诺在年底前向COVAX生产的2亿剂疫苗的一小部分。</blockquote></p><p> “Overpromising and underdelivering is the name of the game for these manufacturers,” said Asia Russell, executive director of international advocacy group Health GAP. “And that’s the infrastructure of the global response, which is terrifying.”</p><p><blockquote>国际倡导组织Health GAP的执行董事亚洲·拉塞尔(Asia Russell)表示：“承诺过多而兑现不足是这些制造商的游戏名称。”“这就是全球应对措施的基础设施，这太可怕了。”</blockquote></p><p> Unlike Johnson &amp; Johnson, Novavax is a novice in the vaccine world. It has never successfully launched a vaccine, and had struggled financially prior to the pandemic. After a string of drug development failures, it sold its manufacturing facilities in 2019 — a deal that also included parting with 100 employees. In May of that year, Novavax’s stock price dropped as low as 36 cents per share.</p><p><blockquote>与强生不同，Novavax是疫苗界的新手。它从未成功推出过疫苗，并且在大流行之前一直在财务上苦苦挣扎。在经历了一系列药物开发失败后，该公司于2019年出售了其生产设施，这笔交易还包括解雇100名员工。当年5月，Novavax股价曾一度跌至每股36美分。</blockquote></p><p> Yet the company’s fortunes shifted as Covid-19 took hold. Amid a scramble early in the pandemic to develop a range of vaccine candidates, the Trump administration awarded Novavax $1.6 billion to aid work on its Covid-19 shot — the largest deal given to any Covid-19 vaccine maker at that time.</p><p><blockquote>然而，随着Covid-19的出现，该公司的命运发生了变化。在大流行初期争相开发一系列候选疫苗的过程中，特朗普政府向Novavax提供了16亿美元，以帮助其开发Covid-19疫苗——这是当时向所有Covid-19疫苗制造商提供的最大一笔交易。</blockquote></p><p> The contract represented a major vote of confidence in Novavax’s capabilities — and a bet that appeared to pay off after late-stage trials showed the vaccine was 90 percent effective against the virus.</p><p><blockquote>该合同代表了对Novavax能力的重大信任票，在后期试验显示该疫苗对病毒的有效性为90%后，这一赌注似乎得到了回报。</blockquote></p><p> But even then, senior Trump administration officials on Operation Warp Speed — a group tasked with accelerating vaccine development — repeatedly warned the company that it risked running into problems in scaling up manufacturing of the shot, two people with direct knowledge of those discussions said.</p><p><blockquote>但两名直接了解这些讨论的人士表示，即便如此，负责加速疫苗开发的“曲速行动”（Operation Warp Speed）的特朗普政府高级官员也一再警告该公司，在扩大疫苗生产规模时可能会遇到问题。</blockquote></p><p> In particular, they worried that Novavax would have difficulty ensuring that the vaccine consistently met the FDA’s rigorous quality standards once the vaccine went into mass production — the exact problem that has now stymied the company for months.</p><p><blockquote>他们特别担心，一旦疫苗投入大规模生产，Novavax将难以确保疫苗始终符合FDA严格的质量标准——这正是困扰该公司数月的问题。</blockquote></p><p> “They rushed the process,” one of the people with knowledge of the matter said. “It’s hard to make. And they can’t make it.”</p><p><blockquote>“他们仓促行事，”一位知情人士说。“这很难做到。而且他们也做不到。”</blockquote></p><p> Taylor, the Novavax spokesperson, said in a statement that it has incorporated feedback from regulators and has made “tremendous progress with the scale-up of our commercial manufacturing processes.” The company is still on track to produce 150 million doses a month by the end of the year, she said, and has stockpiled tens of millions of doses ahead of regulatory filings in the U.S. and internationally.</p><p><blockquote>Novavax发言人泰勒在一份声明中表示，该公司已纳入监管机构的反馈，并“在扩大我们的商业制造流程方面取得了巨大进展”。她说，该公司仍有望在今年年底前每月生产1.5亿剂疫苗，并在美国和国际监管机构备案之前储备了数千万剂疫苗。</blockquote></p><p> Company executives in recent presentations to investors have struck a similarly optimistic tone, downplaying the manufacturing snags and predicting it will soon be cleared to begin distributing doses. During aSept. 29 investor event, Chief Commercial Officer John Trizzino said the company had “resolved” its problems and was close to submitting a final regulatory application.</p><p><blockquote>公司高管在最近给投资者的演讲中也表现出了类似的乐观语气，淡化了制造障碍，并预测很快就会获得批准，开始分发剂量。在aSept期间。29日投资者活动，首席商务官John Trizzino表示，该公司已经“解决”了问题，并接近提交最终监管申请。</blockquote></p><p> “We’re really moving along with testing our lots now,” added Gregory Glenn, president of Novavax’s research and development, referring to batches of its vaccine. “We think that this is shortly going to come to a close.”</p><p><blockquote>Novavax研发总裁格雷戈里·格伦(Gregory Glenn)在谈到其疫苗批次时补充道：“我们现在确实在测试我们的批次。”“我们认为这很快就会结束。”</blockquote></p><p></p><p> U.S. officials working with the company are not as confident, according to three people with knowledge of the matter. Novavax’s manufacturing problems are seen as far more difficult to fix than the sanitary and design concerns that halted production of J&amp;J’s vaccine at the Emergent plant earlier this year, those people said.</p><p><blockquote>据三位知情人士透露，与该公司合作的美国官员没有那么自信。这些人士表示，Novavax的制造问题被认为比今年早些时候导致强生在Emergent工厂停止生产疫苗的卫生和设计问题更难解决。</blockquote></p><p> And even as the company begins to seek regulatory approval in other countries, there remains doubt in the U.S. that it has solved the fundamental vaccine purity flaws that the people with knowledge said have affected its ability to make doses at plants around the world.</p><p><blockquote>尽管该公司开始在其他国家寻求监管部门的批准，但美国仍怀疑该公司是否解决了根本的疫苗纯度缺陷，知情人士称，这些缺陷影响了该公司在世界各地工厂生产疫苗的能力。</blockquote></p><p> Several vaccine batches have already been discarded, and four people with knowledge of the matter say U.S. officials now no longer expect the company to win FDA sign-off on the vaccine until next year at the earliest.</p><p><blockquote>几批疫苗已经被丢弃，四名知情人士表示，美国官员现在预计该公司最早要到明年才能获得FDA对疫苗的批准。</blockquote></p><p> “At some level, I think the efficacy was never going to outweigh the risk associated with the impurity that was in there,” said one of the people with knowledge of the matter. “I’m not surprised this is where we are.”</p><p><blockquote>“在某种程度上，我认为功效永远不会超过与其中杂质相关的风险，”一位知情人士说。“我并不惊讶我们会在这里。”</blockquote></p><p></p>\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"NVAX":"诺瓦瓦克斯医药"},"is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1174375951","content_text":"(Oct 20)  Novavax may delay the delivery of 1 billion doses of coronavirus vaccine because of the production problems.\nThe world’s vaccine distributor has been counting on U.S. companies to provide more than 2 billion doses to lower and middle-income countries by the end of 2022 — a crucial step in ending the Covid-19 pandemic.\nBut the campaign run by the international consortium known as COVAX, which has already been delayed significantly because of production lags, is now likely to fall short by more than 1 billion doses as a key supplier faces significant hurdles in proving it can manufacture a shot that meets regulators’ quality standards, according to three people with direct knowledge of the company’s problems.\nThe delay, which was confirmed by three other people familiar with the discussions between Maryland-based Novavax and the Biden administration, represents a major setback in the effort to vaccinate the world in the wake of new, more transmissible variants.\nThe U.S. government invested $1.6 billion in Novavax in 2020 — the most it devoted to any vaccine maker at the time — in hopes that it would offer the world another option for a safe and effective vaccine to help protect against Covid-19. But the company has consistently run into production problems. The methods it used to test the purity of the vaccine have fallen short of regulators’ standards and the company has not been able to prove that it can produce a shot that is consistently up to snuff, according to multiple people familiar with Novavax’s difficulties. All spoke on the condition of anonymity to discuss sensitive company conversations.\nAlthough Novavax recently attested to some of its analytics and testing issues in aquarterly filing with the Securities and Exchange Commission, the company’s issues are more concerning than previously understood, according to two of the people with direct knowledge of the matter.\nThe Food and Drug Administration works out purity levels with each manufacturer according to June 2020 guidance for coronavirus vaccines, but it is generally understood that each vaccine batch should reach at least 90 percent. The company has struggled to attain anywhere close to that, one of the people with direct knowledge of the situation said. Another person familiar with the company’s manufacturing process said Novavax has recently shown purity levels hovering around 70 percent. Low purity levels increase the chance that contaminants or unnecessary substances are in the final product, rendering the vaccine less effective or introducing the chance that patients could react to unknown ingredients.\nCOVAX, which recently downgraded its 2021 goal from 2 billion to 1.425 billion doses, has already estimated that it faces a supply shortfall of as many as 1 billion doses in its effort to vaccinate the developing world. If Novavax falters, it could double the deficit through 2022, leaving hundreds of millions of people without immunity against Covid-19 and extending the pandemic.\n“COVAX continues to be challenged for adequate supply … in that context, Novavax’s manufacturing challenges and delays have been massively disruptive,” said Krishna Udayakumar, director of the Duke Global Health Innovation Center.\nThe global coalition is already behind on hundreds of millions of planned doses this month, having shipped just 371 million of its 700 million dose target for October. It is now also at risk of missing its already downgraded 2021 target.\nBetween Novavax and other manufacturers’ hurdles, “COVAX has had to scramble to revise its supply strategy significantly in real time,” Udayakumar said. As a result, global health groups are emphasizing more donations to cover immediate needs, he added.\nIn a statement, Novavax Senior Vice President of Investor Relations and Corporate Affairs Silvia Taylor told POLITICO that the company’s analytical testing methods have been “validated” — but did not answer questions about whether the FDA had signed off on them. The company still plans on filing an emergency use authorization by the end of the year, Taylor said.\n“The vaccine development and regulatory submission processes are highly complex and often require years to advance to the point where we are now. We will fulfill all of our committed doses both in the US and globally,” Taylor said.\nThe White House and the Department of Health and Human Services did not respond to multiple requests for comment.\nBut three people familiar with the matter said they are not confident that the company has the resources needed to reproduce a high-quality vaccine on a consistent basis — a benchmark Novavax must meet before that time. Those same people said Novavax could potentially fix its manufacturing issues and reach full licensure by the end of 2022.\nNovavax — which has never produced a vaccine before — declined to answer specific questions about its product’s purity levels and whether it had been successful in addressing its longstanding manufacturing issues.\nUnlike Pfizer and Moderna, the first manufacturers to launch vaccines using rapidly produced messenger RNA, Novavax is employing the previously used but complicated approach of creating the key ingredient with bug cells. While the process, which involves infecting the cells to produce spike proteins, is familiar to scientists, it is difficult to scale.\nThe revelations about Novavax’s continued manufacturing problems come at a time when only 36 percent of the world is vaccinated and as leaders of developing nations continue to pressure the U.S. to deliver more doses. In Africa alone, only 4.4 percent of the population is vaccinated.\nThat includes some of the continent’s most populous nations, like Nigeria and Uganda, where about 1 percent of citizens are fully vaccinated.\nNovavax is just the latest vaccine maker to run into core production problems after promising to serve as a major vaccine contributor to the developing world. In April, Johnson & Johnsonhalted work at a Baltimore facilityrun by contract manufacturer Emergent BioSolutions after it found that 15 million doses had been accidentally contaminated with ingredients from a separate Covid-19 vaccine.\nJ&J’s manufacturing process has been slow to recover, and to date it has produced just a fraction of the 200 million shots it initially pledged to COVAX by the end of the year, according to records kept by UNICEF.\n“Overpromising and underdelivering is the name of the game for these manufacturers,” said Asia Russell, executive director of international advocacy group Health GAP. “And that’s the infrastructure of the global response, which is terrifying.”\nUnlike Johnson & Johnson, Novavax is a novice in the vaccine world. It has never successfully launched a vaccine, and had struggled financially prior to the pandemic. After a string of drug development failures, it sold its manufacturing facilities in 2019 — a deal that also included parting with 100 employees. In May of that year, Novavax’s stock price dropped as low as 36 cents per share.\nYet the company’s fortunes shifted as Covid-19 took hold. Amid a scramble early in the pandemic to develop a range of vaccine candidates, the Trump administration awarded Novavax $1.6 billion to aid work on its Covid-19 shot — the largest deal given to any Covid-19 vaccine maker at that time.\nThe contract represented a major vote of confidence in Novavax’s capabilities — and a bet that appeared to pay off after late-stage trials showed the vaccine was 90 percent effective against the virus.\nBut even then, senior Trump administration officials on Operation Warp Speed — a group tasked with accelerating vaccine development — repeatedly warned the company that it risked running into problems in scaling up manufacturing of the shot, two people with direct knowledge of those discussions said.\nIn particular, they worried that Novavax would have difficulty ensuring that the vaccine consistently met the FDA’s rigorous quality standards once the vaccine went into mass production — the exact problem that has now stymied the company for months.\n“They rushed the process,” one of the people with knowledge of the matter said. “It’s hard to make. And they can’t make it.”\nTaylor, the Novavax spokesperson, said in a statement that it has incorporated feedback from regulators and has made “tremendous progress with the scale-up of our commercial manufacturing processes.” The company is still on track to produce 150 million doses a month by the end of the year, she said, and has stockpiled tens of millions of doses ahead of regulatory filings in the U.S. and internationally.\nCompany executives in recent presentations to investors have struck a similarly optimistic tone, downplaying the manufacturing snags and predicting it will soon be cleared to begin distributing doses. During aSept. 29 investor event, Chief Commercial Officer John Trizzino said the company had “resolved” its problems and was close to submitting a final regulatory application.\n“We’re really moving along with testing our lots now,” added Gregory Glenn, president of Novavax’s research and development, referring to batches of its vaccine. “We think that this is shortly going to come to a close.”\nU.S. officials working with the company are not as confident, according to three people with knowledge of the matter. Novavax’s manufacturing problems are seen as far more difficult to fix than the sanitary and design concerns that halted production of J&J’s vaccine at the Emergent plant earlier this year, those people said.\nAnd even as the company begins to seek regulatory approval in other countries, there remains doubt in the U.S. that it has solved the fundamental vaccine purity flaws that the people with knowledge said have affected its ability to make doses at plants around the world.\nSeveral vaccine batches have already been discarded, and four people with knowledge of the matter say U.S. officials now no longer expect the company to win FDA sign-off on the vaccine until next year at the earliest.\n“At some level, I think the efficacy was never going to outweigh the risk associated with the impurity that was in there,” said one of the people with knowledge of the matter. “I’m not surprised this is where we are.”","news_type":1,"symbols_score_info":{"NVAX":0.9}},"isVote":1,"tweetType":1,"viewCount":340,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":824168615,"gmtCreate":1634291440908,"gmtModify":1634291441022,"author":{"id":"3573538012135697","authorId":"3573538012135697","name":"Alvin牛仔背带裤","avatar":"https://static.tigerbbs.com/d141be403ec6eb25b1c85b5c797f9c49","crmLevel":11,"crmLevelSwitch":0,"followedFlag":false,"authorIdStr":"3573538012135697","idStr":"3573538012135697"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/TIGR\">$老虎证券(TIGR)$</a>你们割完。股价就会暴力拉升","listText":"<a href=\"https://laohu8.com/S/TIGR\">$老虎证券(TIGR)$</a>你们割完。股价就会暴力拉升","text":"$老虎证券(TIGR)$你们割完。股价就会暴力拉升","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":13,"commentSize":1,"repostSize":0,"link":"https://laohu8.com/post/824168615","isVote":1,"tweetType":1,"viewCount":735,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":825167311,"gmtCreate":1634210785958,"gmtModify":1634210845485,"author":{"id":"3573538012135697","authorId":"3573538012135697","name":"Alvin牛仔背带裤","avatar":"https://static.tigerbbs.com/d141be403ec6eb25b1c85b5c797f9c49","crmLevel":11,"crmLevelSwitch":0,"followedFlag":false,"authorIdStr":"3573538012135697","idStr":"3573538012135697"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/TIGR\">$老虎证券(TIGR)$</a>They delete my comment!Ugly dirty rats!","listText":"<a href=\"https://laohu8.com/S/TIGR\">$老虎证券(TIGR)$</a>They delete my comment!Ugly dirty rats!","text":"$老虎证券(TIGR)$They delete my comment!Ugly dirty rats!","images":[{"img":"https://static.tigerbbs.com/4254a2cb940c55c4a0fd11f1340e34e8","width":"873","height":"1920"}],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":25,"commentSize":1,"repostSize":0,"link":"https://laohu8.com/post/825167311","isVote":1,"tweetType":1,"viewCount":1256,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":1,"langContent":"CN","totalScore":0},{"id":864833285,"gmtCreate":1633084991826,"gmtModify":1633084991917,"author":{"id":"3573538012135697","authorId":"3573538012135697","name":"Alvin牛仔背带裤","avatar":"https://static.tigerbbs.com/d141be403ec6eb25b1c85b5c797f9c49","crmLevel":11,"crmLevelSwitch":0,"followedFlag":false,"authorIdStr":"3573538012135697","idStr":"3573538012135697"},"themes":[],"htmlText":"X<a href=\"https://laohu8.com/S/NVAX\">$诺瓦瓦克斯医药(NVAX)$</a>just buy yolo","listText":"X<a href=\"https://laohu8.com/S/NVAX\">$诺瓦瓦克斯医药(NVAX)$</a>just buy yolo","text":"X$诺瓦瓦克斯医药(NVAX)$just buy yolo","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":1,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/864833285","isVote":1,"tweetType":1,"viewCount":443,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":866359275,"gmtCreate":1632738091097,"gmtModify":1632798203106,"author":{"id":"3573538012135697","authorId":"3573538012135697","name":"Alvin牛仔背带裤","avatar":"https://static.tigerbbs.com/d141be403ec6eb25b1c85b5c797f9c49","crmLevel":11,"crmLevelSwitch":0,"followedFlag":false,"authorIdStr":"3573538012135697","idStr":"3573538012135697"},"themes":[],"htmlText":"自圆其说","listText":"自圆其说","text":"自圆其说","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":1,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/866359275","repostId":"2170438346","repostType":4,"repost":{"id":"2170438346","kind":"highlight","pubTimestamp":1632725681,"share":"https://www.laohu8.com/m/news/2170438346?lang=zh_CN&edition=full","pubTime":"2021-09-27 14:54","market":"sh","language":"zh","title":"关于“能耗双控”的五大误读：真相只有一个！","url":"https://stock-news.laohu8.com/highlight/detail?id=2170438346","media":"格隆汇","summary":"近期，不少地区开始拉闸限电，“能耗双控”成为关注焦点。\n关于能耗双控，各方都给出了不同的解读，但很多的理解基本属于“想当然”，与现实是矛盾的。\n在本文中，我们首先阐述一些关于“能耗双控”的常见误读，然","content":"<p>近期，不少地区开始拉闸限电，“能耗双控”成为关注焦点。</p>\n<p>关于能耗双控，各方都给出了不同的解读，但<b>很多的理解基本属于“想当然”，与现实是矛盾的。</b></p>\n<p>在本文中，我们首先阐述一些关于“能耗双控”的常见误读，然后在<b>排除掉这些不可能之后，剩下的就是真相。</b></p>\n<p><b>错误观点之一：“能耗双控”是为了碳达峰、碳中和推出的新政策。</b></p>\n<p>“能耗双控”指的是“单位GDP能耗”和“能源消费总量”两项指标，其中“单位GDP能耗”早在“十一五”时期就已经作为约束性指标（约束性指标是五年规划中定量且必须完成的指标），“十三五”规划已经明确为“能耗双控”，“十四五”只是沿用了该指标。</p>\n<p>从年度来看，除2020年疫情冲击之外，之前历年的政府工作目标中，均有单位GDP能耗降低的具体指标要求，2021年的“能耗双控”只是恢复了2020年之前的政策。</p>\n<p><b>真相一：“能耗双控”是执行了很多年的老政策。</b></p>\n<p><b>错误观点之二：由于“运动式减碳”，2021年8月之后，“能耗双控”显著加码。</b></p>\n<p><b>对比“十二五”、“十三五”和“十四五”的能耗双控指标</b>，“十二五”要求单位GDP能耗降低16%，“十三五”要求单位GDP能耗降低15%，“十四五”要求单位GDP能耗降低13.5%，<b>“十四五”的要求并没有加码。</b></p>\n<p><b>从年度来看，2021年政府工作报告要求，单位GDP能耗降低3%左右</b>，之前的2017年要求是单位GDP能耗下降3.4%以上，2018年是3%以上，2019年是3%左右，<b>2021年跟2019年要求相同，比2017、2018年要求是低的。</b></p>\n<p>还一个需要注意的点是，由于2020年没有要求单位GDP能耗下降，事实上起到了做大基数的作用，2021年仅需要完成降低3%左右，<b>这本来是2020年应该做的事情，延后了一年完成，理论上难度应当更小了。</b></p>\n<p>就好像2021年GDP目标，在去年低基数的情况下，仅需要完成2020年本该完成的6%，这实际是一个非常容易完成的目标。</p>\n<p><b>从历史执行情况看，“能耗双控”指标都很容易完成，以至于根本没有什么人关注这个事情。</b>例如“十二五”要求是降低16%，实际完成降低18%，“十三五”要求降低15%，其中2016-2019年降低13.7%，2020年如果不是因为疫情，很容易完成剩余的1.3%。</p>\n<p>此外，之前的“能耗双控”也不是“五年考核一次”，而是“每年考核一次”。</p>\n<p>以2019年为例，北京等10省超额完成；河北等18省完成；辽宁基本完成；仅有内蒙古未完成。<b>也就是说，2019年的“能耗双控”只有1个省没有完成。</b></p>\n<p><b>真相二：之所以很少有人知道一直就有“能耗双控”，是因为之前每年都很容易就完成了；2021年的“能耗双控”指标不仅没有加码，反而是变松了（只是要求做在2020年本就该做的事情）；</b></p>\n<p><b>因此，“拉闸限电”的问题不在于指标设置变严，而在于之前的执行实行太差（不是zy的突击收紧政策，而是df的突击执行）。</b></p>\n<p><b>错误观点之三：“拉闸限电”是为了提高出口利润、输出通胀。</b></p>\n<p><b>最近一个比较流行的观点，将“拉闸限电”解读为“一盘大棋”：</b>由于中国出口的产能太多，导致出口价格偏低，而能源、资源价格偏高，所以中国出口多但是不赚钱，因此需要“能耗双控”来提高出口价格，从而避免被美国“割羊毛”。</p>\n<p><b>另一种类似的观点是，中国要对美国“输出通胀”，</b>从而让美国难受，其底层逻辑同样是，拉闸限电能导致出口的价格提高。</p>\n<p><b>这两种观点的错误是一样的。</b></p>\n<p><b>希望提高出口利润的期望是好的，但首先要用经济学的逻辑分析，为何出口价格上不去？</b></p>\n<p><b>出口价格之所以无法提升，完全是由于内需太弱的结果。</b>企业出厂产品的定价主要参考内需，国内内需在2021年是显著弱于疫情前，这导致企业的出厂定价就不可能提高。</p>\n<p><b>那么国内价格不变，只提高出口品价格可能吗？从无套利原理来讲，是不可能的。</b>举个例子，假定A企业想要对国内、外差异化定价，比如给国内价格100块，给国外价格200块，那么就会有B企业给国内价格100块，给国外价格150块，那么B企业就会吃掉A企业的海外订单。然后C企业给海外120块，C企业可以吃掉B企业的海外订单；最终，会有D企业给海外的价格和给国内的价格一样，都是100块，D企业吃掉所有海外订单。</p>\n<p><b>按这个逻辑很容易推演，除非出口企业是垄断企业，否则，是无法对国内外差异化定价的，对国外的价格只能跟对国内的价格一致；而国内价格由于国内的终端需求太弱，是提不了的。</b></p>\n<p><b>问题搞清楚了，那么办法确实有：政府组织下游企业集中限产，理论上是可以提高出口价格的。</b></p>\n<p><b>但这是现在发生的事情吗？显然不是。</b></p>\n<p><b>“能耗双控”下的“拉闸限电”，主要限制的是上游高能耗行业，比如硅铁等，而没有限制下游出口企业</b>（只有个别地区限产上游之后还是完不成，才限产下游，根本不是普遍现象）。</p>\n<p>对下游出口企业限产，才能起到类似“减产联盟”或者垄断的效果，才能提高出口利润、输出通胀，限制上游企业有什么用？</p>\n<p>“拉闸限电”的结果是，原材料进一步供不应求，下游企业的成本进一步提高，结果是出口企业的利润进一步被挤压。</p>\n<p>事实上，如果真的组织下游企业限产，其副作用更大。主要有两点：</p>\n<p><b>一是“拉闸限电”是为了降低单位GDP的能耗，那么只有限产高能耗才有用</b>（尽管产出的GDP下降，但消耗能量下降的更多），而高能耗基本都是上游。</p>\n<p><b>二是如果限产下游企业，按照前面的无套利原理，必然导致国内外价格一起大幅上涨，才能提高出口价格，那样将导致CPI显著上升，国内陷入“滞胀”</b>（尽管当前已经类似滞胀，但好歹居民端的CPI没上，还可以接受）。</p>\n<p>所谓“输出通胀”，一定会导致国内先通胀；而中国的内需本来就弱，结果只能是“杀敌五百自损一千”，在内循环为主的背景下，完全不合实际。</p>\n<p><b>真相三：拉闸限电集中于上游，只会导致上游涨价、下游成本抬升，无法提高下游的出口利润、无法输出通胀；</b></p>\n<p><b>在无套利原理下，只提高出口价格是不现实的，所谓的“输出通胀”一定会导致国内“滞胀”。</b></p>\n<p><b>错误观点之四：“能耗双控”是为了抑制PPI。</b></p>\n<p>有观点认为，通过“能耗双控”来减少对原材料的需求，进而抑制PPI，这种说法也与现实不符。</p>\n<p>按照这种观点，是无法解释近期大宗商品价格暴涨的。</p>\n<p><b>一个显然的现实是，拉闸限电越厉害的行业，价格涨的越多</b>，比如硅铁能耗最高、限产最严的行业，现货可以一天涨将近40%。</p>\n<p><b>“能耗双控”只能提高PPI，而不能抑制了PPI。</b></p>\n<p><b>真相四：拉闸限电集中于上游，只会导致PPI进一步上升。</b></p>\n<p><b>错误观点之五：“拉闸限电”将长期存在，大宗商品价格将长期大幅上涨。</b></p>\n<p><b>这种说法忽略了两个基本事实：</b></p>\n<p><b>第一，忽略了需求下降的问题。</b></p>\n<p><b>周期品之所以称为周期品，是因为其“价格-需求”存在周期性的循环关系。</b></p>\n<p>尽管本轮涨价是供给端驱动的，但是价格不能涨到天上去。价格高，必然会导致需求下降，进而导致价格回落，这就是周期的内涵。</p>\n<p><b>需求的弹性实际是非常大的，近期已经出现了很明显的下游不接货，这决定了大宗商品价格不可能持续长期大幅上涨。</b></p>\n<p><b>第二，该观点是建立在“能耗双控”的错误理解之上的。</b></p>\n<p>正如我们第一部分所述，“能耗双控”是一个已经实行了很久的政策，而且2021年指标实际上是容易完成的，只是2021年由于某些特殊的原因（下文会具体解释），导致今年8月之前执行情况非常差，这才导致了9-10月的集中拉闸限电，补上1-8月本该交的作业。</p>\n<p><b>作业补上之后，“拉闸限电”就会告一段落，11-12月将显著好转。</b></p>\n<p>到了明年，只要各地区吸取今年的教训，不再搞“假期临近结束，才疯狂补作业”，就不会再重演今年的局面。</p>\n<p><b>我们基本可以认为，2021年9-10月就是大宗商品价格的高点，之后将趋势性下行（供给缓解+需求走弱）。</b></p>\n<p><b>真相五：能耗双控在2021年之前就已经是长期政策，拉闸限电是特殊情况下的权宜之计，9-10月之后会缓解；</b></p>\n<p><b>明年是新的考核周期，只要地方不再犯今年的错误，就不会再出现当前的“拉闸限电”。</b></p>\n<p><b>综上所述，在排除了诸多错误选项之后，我们认为正确答案是：</b></p>\n<p><b>1、“能耗双控”是一个已经执行了很多年的政策</b>，每年都在政府工作报告中写的明明白白，只是由于之前完成的都太容易，所以没人关注到。</p>\n<p><b>2、2021年的“能耗双控”并没有因为碳达峰、碳中和而加码</b>，甚至是比之前更容易完成的，只是要求完成早在2020年就应当完成的事情而已，没有新增要求。</p>\n<p><b>3、“拉闸限电”不是指标设置太严的问题，而是9月之前执行的太差了。至于为何今年执行的如此之差，我们猜测有以下几个原因：</b></p>\n<p><b>（1）2020年疫情后到现在，中国的GDP结构出了问题。</b>之前每年之所以都很容易实现“能耗双控”指标，是因为中国的经济结构在逐渐向消费转型，单位GDP需要的能源本来就是下降的；然而，<b>2020年疫情之后，内需显著弱于疫情前，而出口显著高于正常时期</b>（中国出口主要是工业品，带动高能耗需求上升），<b>这导致单位GDP的耗能客观上难以下降。</b></p>\n<p><b>（2）部分地区存在“碳冲锋”的情况。</b>根据人民日报海外版，部分地区在2030年碳达峰预期下，将近10年理解为“攀高峰”的时间窗口，抢着上高耗能、高排放的“两高项目”。</p>\n<p><b>“碳冲锋”有两种动机：一是趁着碳达峰之前，抓紧上项目，有利于提高地方的GDP，二是做大2030年之前的碳排放基数，从而更容易实现“碳达峰”。</b></p>\n<p>一个技术细节是，2030年碳达峰，意味着要求2030年的“单位GDP的碳排放减少”与当年的“GDP增速”相同，因此做大2030年之前的碳排放基数，就会导致2030年“单位GDP的碳排放减少”变得容易，从而容易实现2030年碳达峰。</p>\n<p><b>（3）2020年由于疫情冲击，没有考核“能耗双控”，导致部分省市放松了警惕，以为2021年可能也不会考核，存在严重的侥幸心理。</b></p>\n<p><b>4、2021年是碳达峰、碳中和的第一年，“能耗双控”指标不可能放松（特别是本来指标设置的就不高）。</b></p>\n<p><b>综上所述，“拉闸限电”的真相只有一个：</b></p>\n<p><b>假期只顾着玩了</b>（侥幸心理、碳冲锋、GDP结构出问题）<b>，临近假期结束</b>（全年过去三分之二）<b>，突然发现还有作业没写</b>（“能耗双控”指标）<b>，而且发现必须要交</b>（碳达峰、碳中和第一年）<b>，于是最后几天疯狂补作业</b>（拉闸限电）<b>。</b></p>\n<p>这就是当前发生的事情的全部逻辑。</p>\n<p>既不是“反抗美国剥削”，也不是“运动式减碳”，无法起到提高出口企业利润、输出通胀、压低PPI的作用。</p>\n<p><b>客观地讲，“拉闸限电”补作业，会导致以下几个影响：</b></p>\n<p>第一，大宗商品价格短期进一步大涨，阶段性提高PPI；</p>\n<p>第二，进一步抬高下游制造业的生产成本，利润继续向上游转移，下游、小微企业更难过；</p>\n<p>第三，高价格下，下游对上游的需求进一步走弱，大宗商品“有价无市”；</p>\n<p>第四，部分生产停滞，经济增速下降；</p>\n<p>第五，拉闸限电扩大化，居民正常生活受到影响。</p>\n<p><b>我们看不到“拉闸限电”有什么好处，基本上有百害而无一利，这难道就是所谓的“一盘大棋”？</b></p>\n<p><b>既然“拉闸限电”有害无利，为何还要执行？因为真的没有办法。</b></p>\n<p><b>能耗双控目标是年初就定好的，而且并不难实现；难道能因为部分地区不守规矩，就把规矩改了吗？</b></p>\n<p>今年才第一年，如果一个不难的指标都完不成，那以后的碳达峰、碳中和还怎么弄呢？</p>\n<p>因此，“拉闸限电”已经是没办法的事情。</p>\n<p><b>唯一能做的，就是让下游企业、小微企业尽量好受一点。</b></p>\n<p><b>这也是为何我们仍然认为，降准、降息仍然可期的原因。</b></p>\n<p><b>对大类资产配置，我们的建议是：</b></p>\n<p><b>1、当前的大宗商品价格已经脱离需求，且不可持续</b>（拉闸限电高峰是9-10月，之后将缓解，明年又是新的考核周期，只要地方吸取教训，就不会重演今年，更何况终端需求持续走弱）。<b>周期意味着轮回，现在涨得越高，将来跌得越惨，建议回避大宗商品相关的期货、股票；</b></p>\n<p><b>2、债券市场继续看好，</b>内需偏弱背景下，拉闸限电导致下游更难受，降成本、宽货币仍可期，更何况当前的债市收益率是偏高而不是偏低；</p>\n<p><b>3、股票市场，</b>尽管可能阶段性阵痛，但考虑当前估值和市场预期差，仍值得长期投资，<b>杀跌是买入机会，重点推荐估值仍然处于历史低位的价值蓝筹股，以及年内跌幅较大、估值已经合理的消费白马。</b></p>","source":"gelonghui_highlight","collect":0,"html":"<!DOCTYPE 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}\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\n关于“能耗双控”的五大误读：真相只有一个！\n</h2>\n\n<h4 class=\"meta\">\n\n\n2021-09-27 14:54 北京时间&nbsp;&nbsp;&nbsp;<a href=http://www.gelonghui.com/p/488405><strong>格隆汇</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>近期，不少地区开始拉闸限电，“能耗双控”成为关注焦点。\n关于能耗双控，各方都给出了不同的解读，但很多的理解基本属于“想当然”，与现实是矛盾的。\n在本文中，我们首先阐述一些关于“能耗双控”的常见误读，然后在排除掉这些不可能之后，剩下的就是真相。\n错误观点之一：“能耗双控”是为了碳达峰、碳中和推出的新政策。\n“能耗双控”指的是“单位GDP能耗”和“能源消费总量”两项指标，其中“单位GDP能耗”早在“...</p>\n\n<a href=\"http://www.gelonghui.com/p/488405\">网页链接</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"https://static.tigerbbs.com/3c3d58a87ba00dcdd958e2bbeb59449f","relate_stocks":{"000001.SH":"上证指数"},"source_url":"http://www.gelonghui.com/p/488405","is_english":false,"share_image_url":"https://static.laohu8.com/6b8fa6424aebe95f6781d04ef17a1852","article_id":"2170438346","content_text":"近期，不少地区开始拉闸限电，“能耗双控”成为关注焦点。\n关于能耗双控，各方都给出了不同的解读，但很多的理解基本属于“想当然”，与现实是矛盾的。\n在本文中，我们首先阐述一些关于“能耗双控”的常见误读，然后在排除掉这些不可能之后，剩下的就是真相。\n错误观点之一：“能耗双控”是为了碳达峰、碳中和推出的新政策。\n“能耗双控”指的是“单位GDP能耗”和“能源消费总量”两项指标，其中“单位GDP能耗”早在“十一五”时期就已经作为约束性指标（约束性指标是五年规划中定量且必须完成的指标），“十三五”规划已经明确为“能耗双控”，“十四五”只是沿用了该指标。\n从年度来看，除2020年疫情冲击之外，之前历年的政府工作目标中，均有单位GDP能耗降低的具体指标要求，2021年的“能耗双控”只是恢复了2020年之前的政策。\n真相一：“能耗双控”是执行了很多年的老政策。\n错误观点之二：由于“运动式减碳”，2021年8月之后，“能耗双控”显著加码。\n对比“十二五”、“十三五”和“十四五”的能耗双控指标，“十二五”要求单位GDP能耗降低16%，“十三五”要求单位GDP能耗降低15%，“十四五”要求单位GDP能耗降低13.5%，“十四五”的要求并没有加码。\n从年度来看，2021年政府工作报告要求，单位GDP能耗降低3%左右，之前的2017年要求是单位GDP能耗下降3.4%以上，2018年是3%以上，2019年是3%左右，2021年跟2019年要求相同，比2017、2018年要求是低的。\n还一个需要注意的点是，由于2020年没有要求单位GDP能耗下降，事实上起到了做大基数的作用，2021年仅需要完成降低3%左右，这本来是2020年应该做的事情，延后了一年完成，理论上难度应当更小了。\n就好像2021年GDP目标，在去年低基数的情况下，仅需要完成2020年本该完成的6%，这实际是一个非常容易完成的目标。\n从历史执行情况看，“能耗双控”指标都很容易完成，以至于根本没有什么人关注这个事情。例如“十二五”要求是降低16%，实际完成降低18%，“十三五”要求降低15%，其中2016-2019年降低13.7%，2020年如果不是因为疫情，很容易完成剩余的1.3%。\n此外，之前的“能耗双控”也不是“五年考核一次”，而是“每年考核一次”。\n以2019年为例，北京等10省超额完成；河北等18省完成；辽宁基本完成；仅有内蒙古未完成。也就是说，2019年的“能耗双控”只有1个省没有完成。\n真相二：之所以很少有人知道一直就有“能耗双控”，是因为之前每年都很容易就完成了；2021年的“能耗双控”指标不仅没有加码，反而是变松了（只是要求做在2020年本就该做的事情）；\n因此，“拉闸限电”的问题不在于指标设置变严，而在于之前的执行实行太差（不是zy的突击收紧政策，而是df的突击执行）。\n错误观点之三：“拉闸限电”是为了提高出口利润、输出通胀。\n最近一个比较流行的观点，将“拉闸限电”解读为“一盘大棋”：由于中国出口的产能太多，导致出口价格偏低，而能源、资源价格偏高，所以中国出口多但是不赚钱，因此需要“能耗双控”来提高出口价格，从而避免被美国“割羊毛”。\n另一种类似的观点是，中国要对美国“输出通胀”，从而让美国难受，其底层逻辑同样是，拉闸限电能导致出口的价格提高。\n这两种观点的错误是一样的。\n希望提高出口利润的期望是好的，但首先要用经济学的逻辑分析，为何出口价格上不去？\n出口价格之所以无法提升，完全是由于内需太弱的结果。企业出厂产品的定价主要参考内需，国内内需在2021年是显著弱于疫情前，这导致企业的出厂定价就不可能提高。\n那么国内价格不变，只提高出口品价格可能吗？从无套利原理来讲，是不可能的。举个例子，假定A企业想要对国内、外差异化定价，比如给国内价格100块，给国外价格200块，那么就会有B企业给国内价格100块，给国外价格150块，那么B企业就会吃掉A企业的海外订单。然后C企业给海外120块，C企业可以吃掉B企业的海外订单；最终，会有D企业给海外的价格和给国内的价格一样，都是100块，D企业吃掉所有海外订单。\n按这个逻辑很容易推演，除非出口企业是垄断企业，否则，是无法对国内外差异化定价的，对国外的价格只能跟对国内的价格一致；而国内价格由于国内的终端需求太弱，是提不了的。\n问题搞清楚了，那么办法确实有：政府组织下游企业集中限产，理论上是可以提高出口价格的。\n但这是现在发生的事情吗？显然不是。\n“能耗双控”下的“拉闸限电”，主要限制的是上游高能耗行业，比如硅铁等，而没有限制下游出口企业（只有个别地区限产上游之后还是完不成，才限产下游，根本不是普遍现象）。\n对下游出口企业限产，才能起到类似“减产联盟”或者垄断的效果，才能提高出口利润、输出通胀，限制上游企业有什么用？\n“拉闸限电”的结果是，原材料进一步供不应求，下游企业的成本进一步提高，结果是出口企业的利润进一步被挤压。\n事实上，如果真的组织下游企业限产，其副作用更大。主要有两点：\n一是“拉闸限电”是为了降低单位GDP的能耗，那么只有限产高能耗才有用（尽管产出的GDP下降，但消耗能量下降的更多），而高能耗基本都是上游。\n二是如果限产下游企业，按照前面的无套利原理，必然导致国内外价格一起大幅上涨，才能提高出口价格，那样将导致CPI显著上升，国内陷入“滞胀”（尽管当前已经类似滞胀，但好歹居民端的CPI没上，还可以接受）。\n所谓“输出通胀”，一定会导致国内先通胀；而中国的内需本来就弱，结果只能是“杀敌五百自损一千”，在内循环为主的背景下，完全不合实际。\n真相三：拉闸限电集中于上游，只会导致上游涨价、下游成本抬升，无法提高下游的出口利润、无法输出通胀；\n在无套利原理下，只提高出口价格是不现实的，所谓的“输出通胀”一定会导致国内“滞胀”。\n错误观点之四：“能耗双控”是为了抑制PPI。\n有观点认为，通过“能耗双控”来减少对原材料的需求，进而抑制PPI，这种说法也与现实不符。\n按照这种观点，是无法解释近期大宗商品价格暴涨的。\n一个显然的现实是，拉闸限电越厉害的行业，价格涨的越多，比如硅铁能耗最高、限产最严的行业，现货可以一天涨将近40%。\n“能耗双控”只能提高PPI，而不能抑制了PPI。\n真相四：拉闸限电集中于上游，只会导致PPI进一步上升。\n错误观点之五：“拉闸限电”将长期存在，大宗商品价格将长期大幅上涨。\n这种说法忽略了两个基本事实：\n第一，忽略了需求下降的问题。\n周期品之所以称为周期品，是因为其“价格-需求”存在周期性的循环关系。\n尽管本轮涨价是供给端驱动的，但是价格不能涨到天上去。价格高，必然会导致需求下降，进而导致价格回落，这就是周期的内涵。\n需求的弹性实际是非常大的，近期已经出现了很明显的下游不接货，这决定了大宗商品价格不可能持续长期大幅上涨。\n第二，该观点是建立在“能耗双控”的错误理解之上的。\n正如我们第一部分所述，“能耗双控”是一个已经实行了很久的政策，而且2021年指标实际上是容易完成的，只是2021年由于某些特殊的原因（下文会具体解释），导致今年8月之前执行情况非常差，这才导致了9-10月的集中拉闸限电，补上1-8月本该交的作业。\n作业补上之后，“拉闸限电”就会告一段落，11-12月将显著好转。\n到了明年，只要各地区吸取今年的教训，不再搞“假期临近结束，才疯狂补作业”，就不会再重演今年的局面。\n我们基本可以认为，2021年9-10月就是大宗商品价格的高点，之后将趋势性下行（供给缓解+需求走弱）。\n真相五：能耗双控在2021年之前就已经是长期政策，拉闸限电是特殊情况下的权宜之计，9-10月之后会缓解；\n明年是新的考核周期，只要地方不再犯今年的错误，就不会再出现当前的“拉闸限电”。\n综上所述，在排除了诸多错误选项之后，我们认为正确答案是：\n1、“能耗双控”是一个已经执行了很多年的政策，每年都在政府工作报告中写的明明白白，只是由于之前完成的都太容易，所以没人关注到。\n2、2021年的“能耗双控”并没有因为碳达峰、碳中和而加码，甚至是比之前更容易完成的，只是要求完成早在2020年就应当完成的事情而已，没有新增要求。\n3、“拉闸限电”不是指标设置太严的问题，而是9月之前执行的太差了。至于为何今年执行的如此之差，我们猜测有以下几个原因：\n（1）2020年疫情后到现在，中国的GDP结构出了问题。之前每年之所以都很容易实现“能耗双控”指标，是因为中国的经济结构在逐渐向消费转型，单位GDP需要的能源本来就是下降的；然而，2020年疫情之后，内需显著弱于疫情前，而出口显著高于正常时期（中国出口主要是工业品，带动高能耗需求上升），这导致单位GDP的耗能客观上难以下降。\n（2）部分地区存在“碳冲锋”的情况。根据人民日报海外版，部分地区在2030年碳达峰预期下，将近10年理解为“攀高峰”的时间窗口，抢着上高耗能、高排放的“两高项目”。\n“碳冲锋”有两种动机：一是趁着碳达峰之前，抓紧上项目，有利于提高地方的GDP，二是做大2030年之前的碳排放基数，从而更容易实现“碳达峰”。\n一个技术细节是，2030年碳达峰，意味着要求2030年的“单位GDP的碳排放减少”与当年的“GDP增速”相同，因此做大2030年之前的碳排放基数，就会导致2030年“单位GDP的碳排放减少”变得容易，从而容易实现2030年碳达峰。\n（3）2020年由于疫情冲击，没有考核“能耗双控”，导致部分省市放松了警惕，以为2021年可能也不会考核，存在严重的侥幸心理。\n4、2021年是碳达峰、碳中和的第一年，“能耗双控”指标不可能放松（特别是本来指标设置的就不高）。\n综上所述，“拉闸限电”的真相只有一个：\n假期只顾着玩了（侥幸心理、碳冲锋、GDP结构出问题），临近假期结束（全年过去三分之二），突然发现还有作业没写（“能耗双控”指标），而且发现必须要交（碳达峰、碳中和第一年），于是最后几天疯狂补作业（拉闸限电）。\n这就是当前发生的事情的全部逻辑。\n既不是“反抗美国剥削”，也不是“运动式减碳”，无法起到提高出口企业利润、输出通胀、压低PPI的作用。\n客观地讲，“拉闸限电”补作业，会导致以下几个影响：\n第一，大宗商品价格短期进一步大涨，阶段性提高PPI；\n第二，进一步抬高下游制造业的生产成本，利润继续向上游转移，下游、小微企业更难过；\n第三，高价格下，下游对上游的需求进一步走弱，大宗商品“有价无市”；\n第四，部分生产停滞，经济增速下降；\n第五，拉闸限电扩大化，居民正常生活受到影响。\n我们看不到“拉闸限电”有什么好处，基本上有百害而无一利，这难道就是所谓的“一盘大棋”？\n既然“拉闸限电”有害无利，为何还要执行？因为真的没有办法。\n能耗双控目标是年初就定好的，而且并不难实现；难道能因为部分地区不守规矩，就把规矩改了吗？\n今年才第一年，如果一个不难的指标都完不成，那以后的碳达峰、碳中和还怎么弄呢？\n因此，“拉闸限电”已经是没办法的事情。\n唯一能做的，就是让下游企业、小微企业尽量好受一点。\n这也是为何我们仍然认为，降准、降息仍然可期的原因。\n对大类资产配置，我们的建议是：\n1、当前的大宗商品价格已经脱离需求，且不可持续（拉闸限电高峰是9-10月，之后将缓解，明年又是新的考核周期，只要地方吸取教训，就不会重演今年，更何况终端需求持续走弱）。周期意味着轮回，现在涨得越高，将来跌得越惨，建议回避大宗商品相关的期货、股票；\n2、债券市场继续看好，内需偏弱背景下，拉闸限电导致下游更难受，降成本、宽货币仍可期，更何况当前的债市收益率是偏高而不是偏低；\n3、股票市场，尽管可能阶段性阵痛，但考虑当前估值和市场预期差，仍值得长期投资，杀跌是买入机会，重点推荐估值仍然处于历史低位的价值蓝筹股，以及年内跌幅较大、估值已经合理的消费白马。","news_type":1,"symbols_score_info":{"000001.SH":0.9}},"isVote":1,"tweetType":1,"viewCount":106,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":860752918,"gmtCreate":1632218773334,"gmtModify":1632802007535,"author":{"id":"3573538012135697","authorId":"3573538012135697","name":"Alvin牛仔背带裤","avatar":"https://static.tigerbbs.com/d141be403ec6eb25b1c85b5c797f9c49","crmLevel":11,"crmLevelSwitch":0,"followedFlag":false,"authorIdStr":"3573538012135697","idStr":"3573538012135697"},"themes":[],"htmlText":"<a 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href=\"https://laohu8.com/S/TIGR\">$老虎证券(TIGR)$</a>你们割完。股价就会暴力拉升","text":"$老虎证券(TIGR)$你们割完。股价就会暴力拉升","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":13,"commentSize":1,"repostSize":0,"link":"https://laohu8.com/post/824168615","isVote":1,"tweetType":1,"viewCount":735,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":852948853,"gmtCreate":1635236989989,"gmtModify":1635237622305,"author":{"id":"3573538012135697","authorId":"3573538012135697","name":"Alvin牛仔背带裤","avatar":"https://static.tigerbbs.com/d141be403ec6eb25b1c85b5c797f9c49","crmLevel":11,"crmLevelSwitch":0,"followedFlag":false,"authorIdStr":"3573538012135697","idStr":"3573538012135697"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/TIGR\">$老虎证券(TIGR)$</a>今晚破12老虎不发威就被当病猫","listText":"<a href=\"https://laohu8.com/S/TIGR\">$老虎证券(TIGR)$</a>今晚破12老虎不发威就被当病猫","text":"$老虎证券(TIGR)$今晚破12老虎不发威就被当病猫","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":4,"commentSize":2,"repostSize":0,"link":"https://laohu8.com/post/852948853","isVote":1,"tweetType":1,"viewCount":663,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":859401602,"gmtCreate":1634718106851,"gmtModify":1634718402099,"author":{"id":"3573538012135697","authorId":"3573538012135697","name":"Alvin牛仔背带裤","avatar":"https://static.tigerbbs.com/d141be403ec6eb25b1c85b5c797f9c49","crmLevel":11,"crmLevelSwitch":0,"followedFlag":false,"authorIdStr":"3573538012135697","idStr":"3573538012135697"},"themes":[],"htmlText":"Just buy","listText":"Just buy","text":"Just buy","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":7,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/859401602","repostId":"1174375951","repostType":2,"repost":{"id":"1174375951","kind":"news","weMediaInfo":{"introduction":"Providing stock market headlines, business news, financials and earnings ","home_visible":1,"media_name":"Tiger Newspress","id":"1079075236","head_image":"https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba"},"pubTimestamp":1634717661,"share":"https://www.laohu8.com/m/news/1174375951?lang=zh_CN&edition=full","pubTime":"2021-10-20 16:14","market":"us","language":"en","title":"Novavax plunged over 20% in premarket trading<blockquote>Novavax盘前交易暴跌逾20%</blockquote>","url":"https://stock-news.laohu8.com/highlight/detail?id=1174375951","media":"Tiger Newspress","summary":"(Oct 20)  Novavax may delay the delivery of 1 billion doses of coronavirus vaccine because of the pr","content":"<p>(Oct 20)&nbsp; <a href=\"https://laohu8.com/S/NVAX\">Novavax</a>&nbsp;may delay the delivery of 1 billion doses of coronavirus vaccine because of the production problems.</p><p><blockquote>（10月20日）<a href=\"https://laohu8.com/S/NVAX\">Novavax</a>可能因生产问题推迟10亿剂冠状病毒疫苗的交付。</blockquote></p><p> <img src=\"https://static.tigerbbs.com/f3995877f1c786d310a457ababf9ee9e\" tg-width=\"1043\" tg-height=\"564\" referrerpolicy=\"no-referrer\">The world’s vaccine distributor has been counting on U.S. companies to provide more than 2 billion doses to lower and middle-income countries by the end of 2022 — a crucial step in ending the Covid-19 pandemic.</p><p><blockquote>这家全球疫苗分销商一直指望美国公司在2022年底前向中低收入国家提供超过20亿剂疫苗——这是结束Covid-19大流行的关键一步。</blockquote></p><p> But the campaign run by the international consortium known as COVAX, which has already been delayed significantly because of production lags, is now likely to fall short by more than 1 billion doses as a key supplier faces significant hurdles in proving it can manufacture a shot that meets regulators’ quality standards, according to three people with direct knowledge of the company’s problems.</p><p><blockquote>但由名为COVAX的国际联盟发起的活动由于生产滞后而被大幅推迟，现在可能会短缺超过10亿剂，因为一家主要供应商在证明其能够生产疫苗方面面临重大障碍据三位直接了解该公司问题的人士透露，符合监管机构的质量标准。</blockquote></p><p> The delay, which was confirmed by three other people familiar with the discussions between Maryland-based Novavax and the Biden administration, represents a major setback in the effort to vaccinate the world in the wake of new, more transmissible variants.</p><p><blockquote>另外三名熟悉总部位于马里兰州的Novavax和拜登政府之间讨论的人士证实了这一延迟，这代表着在新的、更具传染性的变种出现后，为世界接种疫苗的努力遭遇重大挫折。</blockquote></p><p> The U.S. government invested $1.6 billion in Novavax in 2020 — the most it devoted to any vaccine maker at the time — in hopes that it would offer the world another option for a safe and effective vaccine to help protect against Covid-19. But the company has consistently run into production problems. The methods it used to test the purity of the vaccine have fallen short of regulators’ standards and the company has not been able to prove that it can produce a shot that is consistently up to snuff, according to multiple people familiar with Novavax’s difficulties. All spoke on the condition of anonymity to discuss sensitive company conversations.</p><p><blockquote>美国政府在2020年向Novavax投资了16亿美元，这是当时向所有疫苗制造商投入的最多资金，希望它能为世界提供另一种安全有效的疫苗选择，以帮助预防Covid-19。但该公司一直遇到生产问题。据多位熟悉Novavax困难的人士透露，其用于测试疫苗纯度的方法未达到监管机构的标准，该公司也无法证明其能够生产出始终符合标准的疫苗。所有人都要求匿名，讨论敏感的公司对话。</blockquote></p><p> Although Novavax recently attested to some of its analytics and testing issues in aquarterly filing with the Securities and Exchange Commission, the company’s issues are more concerning than previously understood, according to two of the people with direct knowledge of the matter.</p><p><blockquote>据两位直接了解此事的人士透露，尽管Novavax最近在向美国证券交易委员会提交的季度文件中证实了其一些分析和测试问题，但该公司的问题比之前理解的更令人担忧。</blockquote></p><p> The Food and Drug Administration works out purity levels with each manufacturer according to June 2020 guidance for coronavirus vaccines, but it is generally understood that each vaccine batch should reach at least 90 percent. The company has struggled to attain anywhere close to that, <a href=\"https://laohu8.com/S/AONE.U\">one</a> of the people with direct knowledge of the situation said. Another person familiar with the company’s manufacturing process said Novavax has recently shown purity levels hovering around 70 percent. Low purity levels increase the chance that contaminants or unnecessary substances are in the final product, rendering the vaccine less effective or introducing the chance that patients could react to unknown ingredients.</p><p><blockquote>美国食品药品监督管理局根据2020年6月的冠状病毒疫苗指南，与每个制造商一起制定纯度水平，但普遍认为每个疫苗批次应至少达到90%。该公司一直在努力实现这一目标，<a href=\"https://laohu8.com/S/AONE.U\">一</a>的直接了解情况的人说。另一位熟悉该公司制造工艺的人士表示，Novavax最近的纯度水平徘徊在70%左右。低纯度水平会增加最终产品中存在污染物或不必要物质的机会，从而降低疫苗的有效性或增加患者对未知成分产生反应的机会。</blockquote></p><p> COVAX, which recently downgraded its 2021 goal from 2 billion to 1.425 billion doses, has already estimated that it faces a supply shortfall of as many as 1 billion doses in its effort to vaccinate the developing world. If Novavax falters, it could double the deficit through 2022, leaving hundreds of millions of people without immunity against Covid-19 and extending the pandemic.</p><p><blockquote>COVAX最近将2021年的目标从20亿剂下调至14.25亿剂，并已经估计，在为发展中国家接种疫苗的努力中，它面临着多达10亿剂的供应短缺。如果Novavax步履蹒跚，到2022年赤字可能会增加一倍，使数亿人对Covid-19没有免疫力，并延长疫情。</blockquote></p><p> “COVAX continues to be challenged for adequate supply … in that context, Novavax’s manufacturing challenges and delays have been massively disruptive,” said Krishna Udayakumar, director of the <a href=\"https://laohu8.com/S/DRE\">Duke</a> Global Health Innovation Center.</p><p><blockquote>“COVAX继续面临充足供应的挑战……在这种背景下，Novavax的制造挑战和延误具有巨大的破坏性，”<a href=\"https://laohu8.com/S/DRE\">公爵</a>全球健康创新中心。</blockquote></p><p> The global coalition is already behind on hundreds of millions of planned doses this month, having shipped just 371 million of its 700 million dose target for October. It is now also at risk of missing its already downgraded 2021 target.</p><p><blockquote>全球联盟本月已经落后于数亿剂计划剂量，仅运送了10月份7亿剂目标中的3.71亿剂。它现在还面临着达不到已经下调的2021年目标的风险。</blockquote></p><p> Between Novavax and other manufacturers’ hurdles, “COVAX has had to scramble to revise its supply strategy significantly in real time,” Udayakumar said. As a result, global health groups are emphasizing more donations to cover immediate needs, he added.</p><p><blockquote>在Novavax和其他制造商的障碍之间，“COVAX不得不争先恐后地实时大幅修改其供应策略，”Udayakumar说。他补充说，因此，全球卫生组织强调提供更多捐款来满足眼前的需求。</blockquote></p><p> In a statement, Novavax Senior Vice President of Investor Relations and Corporate Affairs Silvia Taylor told POLITICO that the company’s analytical testing methods have been “validated” — but did not answer questions about whether the FDA had signed off on them. The company still plans on filing an emergency use authorization by the end of the year, Taylor said.</p><p><blockquote>Novavax投资者关系和公司事务高级副总裁Silvia Taylor在一份声明中告诉POLITICO，该公司的分析测试方法已经过“验证”，但没有回答有关FDA是否已批准这些方法的问题。泰勒说，该公司仍计划在今年年底前提交紧急使用授权。</blockquote></p><p> “The vaccine development and regulatory submission processes are highly complex and often require years to advance to the point where we are now. We will fulfill all of our committed doses both in the US and globally,” Taylor said.</p><p><blockquote>泰勒说：“疫苗开发和监管提交过程非常复杂，通常需要数年时间才能达到我们现在的水平。我们将在美国和全球范围内履行所有承诺的剂量。”</blockquote></p><p> The White House and the Department of Health and Human Services did not respond to multiple requests for comment.</p><p><blockquote>白宫和卫生与公众服务部没有回应多次置评请求。</blockquote></p><p></p><p> But three people familiar with the matter said they are not confident that the company has the resources needed to reproduce a high-quality vaccine on a consistent basis — a benchmark Novavax must meet before that time. Those same people said Novavax could potentially fix its manufacturing issues and reach full licensure by the end of 2022.</p><p><blockquote>但三位知情人士表示，他们不相信该公司拥有持续复制高质量疫苗所需的资源——Novavax在此之前必须达到的基准。这些人表示，Novavax可能会解决其制造问题，并在2022年底前获得全面许可。</blockquote></p><p> Novavax — which has never produced a vaccine before — declined to answer specific questions about its product’s purity levels and whether it had been successful in addressing its longstanding manufacturing issues.</p><p><blockquote>Novavax以前从未生产过疫苗，拒绝回答有关其产品纯度水平以及是否成功解决了长期存在的生产问题的具体问题。</blockquote></p><p> Unlike <a href=\"https://laohu8.com/S/PFE\">Pfizer</a> and Moderna, the first manufacturers to launch vaccines using rapidly produced messenger RNA, Novavax is employing the previously used but complicated approach of creating the key ingredient with bug cells. While the process, which involves infecting the cells to produce spike proteins, is familiar to scientists, it is difficult to scale.</p><p><blockquote>不像<a href=\"https://laohu8.com/S/PFE\">辉瑞</a>Moderna是第一家使用快速产生的信使RNA推出疫苗的制造商，Novavax正在采用以前使用但复杂的方法，即用细菌细胞制造关键成分。虽然科学家们对感染细胞产生刺突蛋白的过程很熟悉，但很难扩大规模。</blockquote></p><p> The revelations about Novavax’s continued manufacturing problems come at a time when only 36 percent of the world is vaccinated and as leaders of developing nations continue to pressure the U.S. to deliver more doses. In Africa alone, only 4.4 percent of the population is vaccinated.</p><p><blockquote>Novavax持续存在的生产问题被曝光之际，世界上只有36%的人接种了疫苗，而且发展中国家的领导人继续向美国施压，要求其提供更多剂量。仅在非洲，只有4.4%的人口接种了疫苗。</blockquote></p><p> That includes some of the continent’s most populous nations, like Nigeria and Uganda, where about 1 percent of citizens are fully vaccinated.</p><p><blockquote>这包括非洲大陆一些人口最多的国家，如尼日利亚和乌干达，这些国家约有1%的公民完全接种了疫苗。</blockquote></p><p> Novavax is just the latest vaccine maker to run into core production problems after promising to serve as a major vaccine contributor to the developing world. In April, Johnson &amp; Johnsonhalted work at a Baltimore facilityrun by contract manufacturer <a href=\"https://laohu8.com/S/EBS\">Emergent BioSolutions</a> after it found that 15 million doses had been accidentally contaminated with ingredients from a separate Covid-19 vaccine.</p><p><blockquote>Novavax只是最新一家在承诺成为发展中国家主要疫苗供应商后遇到核心生产问题的疫苗制造商。四月，强生公司停止了巴尔的摩一家由合同制造商运营的工厂的工作<a href=\"https://laohu8.com/S/EBS\">新兴生物解决方案</a>在发现1500万剂疫苗意外被另一种Covid-19疫苗的成分污染后。</blockquote></p><p> J&amp;J’s manufacturing process has been slow to recover, and to date it has produced just a fraction of the 200 million shots it initially pledged to COVAX by the end of the year, according to records kept by UNICEF.</p><p><blockquote>根据联合国儿童基金会保存的记录，强生公司的生产流程恢复缓慢，迄今为止，该公司仅生产了最初承诺在年底前向COVAX生产的2亿剂疫苗的一小部分。</blockquote></p><p> “Overpromising and underdelivering is the name of the game for these manufacturers,” said Asia Russell, executive director of international advocacy group Health GAP. “And that’s the infrastructure of the global response, which is terrifying.”</p><p><blockquote>国际倡导组织Health GAP的执行董事亚洲·拉塞尔(Asia Russell)表示：“承诺过多而兑现不足是这些制造商的游戏名称。”“这就是全球应对措施的基础设施，这太可怕了。”</blockquote></p><p> Unlike Johnson &amp; Johnson, Novavax is a novice in the vaccine world. It has never successfully launched a vaccine, and had struggled financially prior to the pandemic. After a string of drug development failures, it sold its manufacturing facilities in 2019 — a deal that also included parting with 100 employees. In May of that year, Novavax’s stock price dropped as low as 36 cents per share.</p><p><blockquote>与强生不同，Novavax是疫苗界的新手。它从未成功推出过疫苗，并且在大流行之前一直在财务上苦苦挣扎。在经历了一系列药物开发失败后，该公司于2019年出售了其生产设施，这笔交易还包括解雇100名员工。当年5月，Novavax股价曾一度跌至每股36美分。</blockquote></p><p> Yet the company’s fortunes shifted as Covid-19 took hold. Amid a scramble early in the pandemic to develop a range of vaccine candidates, the Trump administration awarded Novavax $1.6 billion to aid work on its Covid-19 shot — the largest deal given to any Covid-19 vaccine maker at that time.</p><p><blockquote>然而，随着Covid-19的出现，该公司的命运发生了变化。在大流行初期争相开发一系列候选疫苗的过程中，特朗普政府向Novavax提供了16亿美元，以帮助其开发Covid-19疫苗——这是当时向所有Covid-19疫苗制造商提供的最大一笔交易。</blockquote></p><p> The contract represented a major vote of confidence in Novavax’s capabilities — and a bet that appeared to pay off after late-stage trials showed the vaccine was 90 percent effective against the virus.</p><p><blockquote>该合同代表了对Novavax能力的重大信任票，在后期试验显示该疫苗对病毒的有效性为90%后，这一赌注似乎得到了回报。</blockquote></p><p> But even then, senior Trump administration officials on Operation Warp Speed — a group tasked with accelerating vaccine development — repeatedly warned the company that it risked running into problems in scaling up manufacturing of the shot, two people with direct knowledge of those discussions said.</p><p><blockquote>但两名直接了解这些讨论的人士表示，即便如此，负责加速疫苗开发的“曲速行动”（Operation Warp Speed）的特朗普政府高级官员也一再警告该公司，在扩大疫苗生产规模时可能会遇到问题。</blockquote></p><p> In particular, they worried that Novavax would have difficulty ensuring that the vaccine consistently met the FDA’s rigorous quality standards once the vaccine went into mass production — the exact problem that has now stymied the company for months.</p><p><blockquote>他们特别担心，一旦疫苗投入大规模生产，Novavax将难以确保疫苗始终符合FDA严格的质量标准——这正是困扰该公司数月的问题。</blockquote></p><p> “They rushed the process,” one of the people with knowledge of the matter said. “It’s hard to make. And they can’t make it.”</p><p><blockquote>“他们仓促行事，”一位知情人士说。“这很难做到。而且他们也做不到。”</blockquote></p><p> Taylor, the Novavax spokesperson, said in a statement that it has incorporated feedback from regulators and has made “tremendous progress with the scale-up of our commercial manufacturing processes.” The company is still on track to produce 150 million doses a month by the end of the year, she said, and has stockpiled tens of millions of doses ahead of regulatory filings in the U.S. and internationally.</p><p><blockquote>Novavax发言人泰勒在一份声明中表示，该公司已纳入监管机构的反馈，并“在扩大我们的商业制造流程方面取得了巨大进展”。她说，该公司仍有望在今年年底前每月生产1.5亿剂疫苗，并在美国和国际监管机构备案之前储备了数千万剂疫苗。</blockquote></p><p> Company executives in recent presentations to investors have struck a similarly optimistic tone, downplaying the manufacturing snags and predicting it will soon be cleared to begin distributing doses. During aSept. 29 investor event, Chief Commercial Officer John Trizzino said the company had “resolved” its problems and was close to submitting a final regulatory application.</p><p><blockquote>公司高管在最近给投资者的演讲中也表现出了类似的乐观语气，淡化了制造障碍，并预测很快就会获得批准，开始分发剂量。在aSept期间。29日投资者活动，首席商务官John Trizzino表示，该公司已经“解决”了问题，并接近提交最终监管申请。</blockquote></p><p> “We’re really moving along with testing our lots now,” added Gregory Glenn, president of Novavax’s research and development, referring to batches of its vaccine. “We think that this is shortly going to come to a close.”</p><p><blockquote>Novavax研发总裁格雷戈里·格伦(Gregory Glenn)在谈到其疫苗批次时补充道：“我们现在确实在测试我们的批次。”“我们认为这很快就会结束。”</blockquote></p><p></p><p> U.S. officials working with the company are not as confident, according to three people with knowledge of the matter. Novavax’s manufacturing problems are seen as far more difficult to fix than the sanitary and design concerns that halted production of J&amp;J’s vaccine at the Emergent plant earlier this year, those people said.</p><p><blockquote>据三位知情人士透露，与该公司合作的美国官员没有那么自信。这些人士表示，Novavax的制造问题被认为比今年早些时候导致强生在Emergent工厂停止生产疫苗的卫生和设计问题更难解决。</blockquote></p><p> And even as the company begins to seek regulatory approval in other countries, there remains doubt in the U.S. that it has solved the fundamental vaccine purity flaws that the people with knowledge said have affected its ability to make doses at plants around the world.</p><p><blockquote>尽管该公司开始在其他国家寻求监管部门的批准，但美国仍怀疑该公司是否解决了根本的疫苗纯度缺陷，知情人士称，这些缺陷影响了该公司在世界各地工厂生产疫苗的能力。</blockquote></p><p> Several vaccine batches have already been discarded, and four people with knowledge of the matter say U.S. officials now no longer expect the company to win FDA sign-off on the vaccine until next year at the earliest.</p><p><blockquote>几批疫苗已经被丢弃，四名知情人士表示，美国官员现在预计该公司最早要到明年才能获得FDA对疫苗的批准。</blockquote></p><p> “At some level, I think the efficacy was never going to outweigh the risk associated with the impurity that was in there,” said one of the people with knowledge of the matter. “I’m not surprised this is where we are.”</p><p><blockquote>“在某种程度上，我认为功效永远不会超过与其中杂质相关的风险，”一位知情人士说。“我并不惊讶我们会在这里。”</blockquote></p><p></p>","collect":0,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; 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overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 12.5px; color: #7E829C; margin: 0;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nNovavax plunged over 20% in premarket trading<blockquote>Novavax盘前交易暴跌逾20%</blockquote>\n</h2>\n<h4 class=\"meta\">\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1079075236\">\n\n<div class=\"h-thumb\" style=\"background-image:url(https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Tiger Newspress </p>\n<p class=\"h-time smaller\">2021-10-20 16:14</p>\n</div>\n</a>\n</h4>\n</header>\n<article>\n<p>(Oct 20)&nbsp; <a href=\"https://laohu8.com/S/NVAX\">Novavax</a>&nbsp;may delay the delivery of 1 billion doses of coronavirus vaccine because of the production problems.</p><p><blockquote>（10月20日）<a href=\"https://laohu8.com/S/NVAX\">Novavax</a>可能因生产问题推迟10亿剂冠状病毒疫苗的交付。</blockquote></p><p> <img src=\"https://static.tigerbbs.com/f3995877f1c786d310a457ababf9ee9e\" tg-width=\"1043\" tg-height=\"564\" referrerpolicy=\"no-referrer\">The world’s vaccine distributor has been counting on U.S. companies to provide more than 2 billion doses to lower and middle-income countries by the end of 2022 — a crucial step in ending the Covid-19 pandemic.</p><p><blockquote>这家全球疫苗分销商一直指望美国公司在2022年底前向中低收入国家提供超过20亿剂疫苗——这是结束Covid-19大流行的关键一步。</blockquote></p><p> But the campaign run by the international consortium known as COVAX, which has already been delayed significantly because of production lags, is now likely to fall short by more than 1 billion doses as a key supplier faces significant hurdles in proving it can manufacture a shot that meets regulators’ quality standards, according to three people with direct knowledge of the company’s problems.</p><p><blockquote>但由名为COVAX的国际联盟发起的活动由于生产滞后而被大幅推迟，现在可能会短缺超过10亿剂，因为一家主要供应商在证明其能够生产疫苗方面面临重大障碍据三位直接了解该公司问题的人士透露，符合监管机构的质量标准。</blockquote></p><p> The delay, which was confirmed by three other people familiar with the discussions between Maryland-based Novavax and the Biden administration, represents a major setback in the effort to vaccinate the world in the wake of new, more transmissible variants.</p><p><blockquote>另外三名熟悉总部位于马里兰州的Novavax和拜登政府之间讨论的人士证实了这一延迟，这代表着在新的、更具传染性的变种出现后，为世界接种疫苗的努力遭遇重大挫折。</blockquote></p><p> The U.S. government invested $1.6 billion in Novavax in 2020 — the most it devoted to any vaccine maker at the time — in hopes that it would offer the world another option for a safe and effective vaccine to help protect against Covid-19. But the company has consistently run into production problems. The methods it used to test the purity of the vaccine have fallen short of regulators’ standards and the company has not been able to prove that it can produce a shot that is consistently up to snuff, according to multiple people familiar with Novavax’s difficulties. All spoke on the condition of anonymity to discuss sensitive company conversations.</p><p><blockquote>美国政府在2020年向Novavax投资了16亿美元，这是当时向所有疫苗制造商投入的最多资金，希望它能为世界提供另一种安全有效的疫苗选择，以帮助预防Covid-19。但该公司一直遇到生产问题。据多位熟悉Novavax困难的人士透露，其用于测试疫苗纯度的方法未达到监管机构的标准，该公司也无法证明其能够生产出始终符合标准的疫苗。所有人都要求匿名，讨论敏感的公司对话。</blockquote></p><p> Although Novavax recently attested to some of its analytics and testing issues in aquarterly filing with the Securities and Exchange Commission, the company’s issues are more concerning than previously understood, according to two of the people with direct knowledge of the matter.</p><p><blockquote>据两位直接了解此事的人士透露，尽管Novavax最近在向美国证券交易委员会提交的季度文件中证实了其一些分析和测试问题，但该公司的问题比之前理解的更令人担忧。</blockquote></p><p> The Food and Drug Administration works out purity levels with each manufacturer according to June 2020 guidance for coronavirus vaccines, but it is generally understood that each vaccine batch should reach at least 90 percent. The company has struggled to attain anywhere close to that, <a href=\"https://laohu8.com/S/AONE.U\">one</a> of the people with direct knowledge of the situation said. Another person familiar with the company’s manufacturing process said Novavax has recently shown purity levels hovering around 70 percent. Low purity levels increase the chance that contaminants or unnecessary substances are in the final product, rendering the vaccine less effective or introducing the chance that patients could react to unknown ingredients.</p><p><blockquote>美国食品药品监督管理局根据2020年6月的冠状病毒疫苗指南，与每个制造商一起制定纯度水平，但普遍认为每个疫苗批次应至少达到90%。该公司一直在努力实现这一目标，<a href=\"https://laohu8.com/S/AONE.U\">一</a>的直接了解情况的人说。另一位熟悉该公司制造工艺的人士表示，Novavax最近的纯度水平徘徊在70%左右。低纯度水平会增加最终产品中存在污染物或不必要物质的机会，从而降低疫苗的有效性或增加患者对未知成分产生反应的机会。</blockquote></p><p> COVAX, which recently downgraded its 2021 goal from 2 billion to 1.425 billion doses, has already estimated that it faces a supply shortfall of as many as 1 billion doses in its effort to vaccinate the developing world. If Novavax falters, it could double the deficit through 2022, leaving hundreds of millions of people without immunity against Covid-19 and extending the pandemic.</p><p><blockquote>COVAX最近将2021年的目标从20亿剂下调至14.25亿剂，并已经估计，在为发展中国家接种疫苗的努力中，它面临着多达10亿剂的供应短缺。如果Novavax步履蹒跚，到2022年赤字可能会增加一倍，使数亿人对Covid-19没有免疫力，并延长疫情。</blockquote></p><p> “COVAX continues to be challenged for adequate supply … in that context, Novavax’s manufacturing challenges and delays have been massively disruptive,” said Krishna Udayakumar, director of the <a href=\"https://laohu8.com/S/DRE\">Duke</a> Global Health Innovation Center.</p><p><blockquote>“COVAX继续面临充足供应的挑战……在这种背景下，Novavax的制造挑战和延误具有巨大的破坏性，”<a href=\"https://laohu8.com/S/DRE\">公爵</a>全球健康创新中心。</blockquote></p><p> The global coalition is already behind on hundreds of millions of planned doses this month, having shipped just 371 million of its 700 million dose target for October. It is now also at risk of missing its already downgraded 2021 target.</p><p><blockquote>全球联盟本月已经落后于数亿剂计划剂量，仅运送了10月份7亿剂目标中的3.71亿剂。它现在还面临着达不到已经下调的2021年目标的风险。</blockquote></p><p> Between Novavax and other manufacturers’ hurdles, “COVAX has had to scramble to revise its supply strategy significantly in real time,” Udayakumar said. As a result, global health groups are emphasizing more donations to cover immediate needs, he added.</p><p><blockquote>在Novavax和其他制造商的障碍之间，“COVAX不得不争先恐后地实时大幅修改其供应策略，”Udayakumar说。他补充说，因此，全球卫生组织强调提供更多捐款来满足眼前的需求。</blockquote></p><p> In a statement, Novavax Senior Vice President of Investor Relations and Corporate Affairs Silvia Taylor told POLITICO that the company’s analytical testing methods have been “validated” — but did not answer questions about whether the FDA had signed off on them. The company still plans on filing an emergency use authorization by the end of the year, Taylor said.</p><p><blockquote>Novavax投资者关系和公司事务高级副总裁Silvia Taylor在一份声明中告诉POLITICO，该公司的分析测试方法已经过“验证”，但没有回答有关FDA是否已批准这些方法的问题。泰勒说，该公司仍计划在今年年底前提交紧急使用授权。</blockquote></p><p> “The vaccine development and regulatory submission processes are highly complex and often require years to advance to the point where we are now. We will fulfill all of our committed doses both in the US and globally,” Taylor said.</p><p><blockquote>泰勒说：“疫苗开发和监管提交过程非常复杂，通常需要数年时间才能达到我们现在的水平。我们将在美国和全球范围内履行所有承诺的剂量。”</blockquote></p><p> The White House and the Department of Health and Human Services did not respond to multiple requests for comment.</p><p><blockquote>白宫和卫生与公众服务部没有回应多次置评请求。</blockquote></p><p></p><p> But three people familiar with the matter said they are not confident that the company has the resources needed to reproduce a high-quality vaccine on a consistent basis — a benchmark Novavax must meet before that time. Those same people said Novavax could potentially fix its manufacturing issues and reach full licensure by the end of 2022.</p><p><blockquote>但三位知情人士表示，他们不相信该公司拥有持续复制高质量疫苗所需的资源——Novavax在此之前必须达到的基准。这些人表示，Novavax可能会解决其制造问题，并在2022年底前获得全面许可。</blockquote></p><p> Novavax — which has never produced a vaccine before — declined to answer specific questions about its product’s purity levels and whether it had been successful in addressing its longstanding manufacturing issues.</p><p><blockquote>Novavax以前从未生产过疫苗，拒绝回答有关其产品纯度水平以及是否成功解决了长期存在的生产问题的具体问题。</blockquote></p><p> Unlike <a href=\"https://laohu8.com/S/PFE\">Pfizer</a> and Moderna, the first manufacturers to launch vaccines using rapidly produced messenger RNA, Novavax is employing the previously used but complicated approach of creating the key ingredient with bug cells. While the process, which involves infecting the cells to produce spike proteins, is familiar to scientists, it is difficult to scale.</p><p><blockquote>不像<a href=\"https://laohu8.com/S/PFE\">辉瑞</a>Moderna是第一家使用快速产生的信使RNA推出疫苗的制造商，Novavax正在采用以前使用但复杂的方法，即用细菌细胞制造关键成分。虽然科学家们对感染细胞产生刺突蛋白的过程很熟悉，但很难扩大规模。</blockquote></p><p> The revelations about Novavax’s continued manufacturing problems come at a time when only 36 percent of the world is vaccinated and as leaders of developing nations continue to pressure the U.S. to deliver more doses. In Africa alone, only 4.4 percent of the population is vaccinated.</p><p><blockquote>Novavax持续存在的生产问题被曝光之际，世界上只有36%的人接种了疫苗，而且发展中国家的领导人继续向美国施压，要求其提供更多剂量。仅在非洲，只有4.4%的人口接种了疫苗。</blockquote></p><p> That includes some of the continent’s most populous nations, like Nigeria and Uganda, where about 1 percent of citizens are fully vaccinated.</p><p><blockquote>这包括非洲大陆一些人口最多的国家，如尼日利亚和乌干达，这些国家约有1%的公民完全接种了疫苗。</blockquote></p><p> Novavax is just the latest vaccine maker to run into core production problems after promising to serve as a major vaccine contributor to the developing world. In April, Johnson &amp; Johnsonhalted work at a Baltimore facilityrun by contract manufacturer <a href=\"https://laohu8.com/S/EBS\">Emergent BioSolutions</a> after it found that 15 million doses had been accidentally contaminated with ingredients from a separate Covid-19 vaccine.</p><p><blockquote>Novavax只是最新一家在承诺成为发展中国家主要疫苗供应商后遇到核心生产问题的疫苗制造商。四月，强生公司停止了巴尔的摩一家由合同制造商运营的工厂的工作<a href=\"https://laohu8.com/S/EBS\">新兴生物解决方案</a>在发现1500万剂疫苗意外被另一种Covid-19疫苗的成分污染后。</blockquote></p><p> J&amp;J’s manufacturing process has been slow to recover, and to date it has produced just a fraction of the 200 million shots it initially pledged to COVAX by the end of the year, according to records kept by UNICEF.</p><p><blockquote>根据联合国儿童基金会保存的记录，强生公司的生产流程恢复缓慢，迄今为止，该公司仅生产了最初承诺在年底前向COVAX生产的2亿剂疫苗的一小部分。</blockquote></p><p> “Overpromising and underdelivering is the name of the game for these manufacturers,” said Asia Russell, executive director of international advocacy group Health GAP. “And that’s the infrastructure of the global response, which is terrifying.”</p><p><blockquote>国际倡导组织Health GAP的执行董事亚洲·拉塞尔(Asia Russell)表示：“承诺过多而兑现不足是这些制造商的游戏名称。”“这就是全球应对措施的基础设施，这太可怕了。”</blockquote></p><p> Unlike Johnson &amp; Johnson, Novavax is a novice in the vaccine world. It has never successfully launched a vaccine, and had struggled financially prior to the pandemic. After a string of drug development failures, it sold its manufacturing facilities in 2019 — a deal that also included parting with 100 employees. In May of that year, Novavax’s stock price dropped as low as 36 cents per share.</p><p><blockquote>与强生不同，Novavax是疫苗界的新手。它从未成功推出过疫苗，并且在大流行之前一直在财务上苦苦挣扎。在经历了一系列药物开发失败后，该公司于2019年出售了其生产设施，这笔交易还包括解雇100名员工。当年5月，Novavax股价曾一度跌至每股36美分。</blockquote></p><p> Yet the company’s fortunes shifted as Covid-19 took hold. Amid a scramble early in the pandemic to develop a range of vaccine candidates, the Trump administration awarded Novavax $1.6 billion to aid work on its Covid-19 shot — the largest deal given to any Covid-19 vaccine maker at that time.</p><p><blockquote>然而，随着Covid-19的出现，该公司的命运发生了变化。在大流行初期争相开发一系列候选疫苗的过程中，特朗普政府向Novavax提供了16亿美元，以帮助其开发Covid-19疫苗——这是当时向所有Covid-19疫苗制造商提供的最大一笔交易。</blockquote></p><p> The contract represented a major vote of confidence in Novavax’s capabilities — and a bet that appeared to pay off after late-stage trials showed the vaccine was 90 percent effective against the virus.</p><p><blockquote>该合同代表了对Novavax能力的重大信任票，在后期试验显示该疫苗对病毒的有效性为90%后，这一赌注似乎得到了回报。</blockquote></p><p> But even then, senior Trump administration officials on Operation Warp Speed — a group tasked with accelerating vaccine development — repeatedly warned the company that it risked running into problems in scaling up manufacturing of the shot, two people with direct knowledge of those discussions said.</p><p><blockquote>但两名直接了解这些讨论的人士表示，即便如此，负责加速疫苗开发的“曲速行动”（Operation Warp Speed）的特朗普政府高级官员也一再警告该公司，在扩大疫苗生产规模时可能会遇到问题。</blockquote></p><p> In particular, they worried that Novavax would have difficulty ensuring that the vaccine consistently met the FDA’s rigorous quality standards once the vaccine went into mass production — the exact problem that has now stymied the company for months.</p><p><blockquote>他们特别担心，一旦疫苗投入大规模生产，Novavax将难以确保疫苗始终符合FDA严格的质量标准——这正是困扰该公司数月的问题。</blockquote></p><p> “They rushed the process,” one of the people with knowledge of the matter said. “It’s hard to make. And they can’t make it.”</p><p><blockquote>“他们仓促行事，”一位知情人士说。“这很难做到。而且他们也做不到。”</blockquote></p><p> Taylor, the Novavax spokesperson, said in a statement that it has incorporated feedback from regulators and has made “tremendous progress with the scale-up of our commercial manufacturing processes.” The company is still on track to produce 150 million doses a month by the end of the year, she said, and has stockpiled tens of millions of doses ahead of regulatory filings in the U.S. and internationally.</p><p><blockquote>Novavax发言人泰勒在一份声明中表示，该公司已纳入监管机构的反馈，并“在扩大我们的商业制造流程方面取得了巨大进展”。她说，该公司仍有望在今年年底前每月生产1.5亿剂疫苗，并在美国和国际监管机构备案之前储备了数千万剂疫苗。</blockquote></p><p> Company executives in recent presentations to investors have struck a similarly optimistic tone, downplaying the manufacturing snags and predicting it will soon be cleared to begin distributing doses. During aSept. 29 investor event, Chief Commercial Officer John Trizzino said the company had “resolved” its problems and was close to submitting a final regulatory application.</p><p><blockquote>公司高管在最近给投资者的演讲中也表现出了类似的乐观语气，淡化了制造障碍，并预测很快就会获得批准，开始分发剂量。在aSept期间。29日投资者活动，首席商务官John Trizzino表示，该公司已经“解决”了问题，并接近提交最终监管申请。</blockquote></p><p> “We’re really moving along with testing our lots now,” added Gregory Glenn, president of Novavax’s research and development, referring to batches of its vaccine. “We think that this is shortly going to come to a close.”</p><p><blockquote>Novavax研发总裁格雷戈里·格伦(Gregory Glenn)在谈到其疫苗批次时补充道：“我们现在确实在测试我们的批次。”“我们认为这很快就会结束。”</blockquote></p><p></p><p> U.S. officials working with the company are not as confident, according to three people with knowledge of the matter. Novavax’s manufacturing problems are seen as far more difficult to fix than the sanitary and design concerns that halted production of J&amp;J’s vaccine at the Emergent plant earlier this year, those people said.</p><p><blockquote>据三位知情人士透露，与该公司合作的美国官员没有那么自信。这些人士表示，Novavax的制造问题被认为比今年早些时候导致强生在Emergent工厂停止生产疫苗的卫生和设计问题更难解决。</blockquote></p><p> And even as the company begins to seek regulatory approval in other countries, there remains doubt in the U.S. that it has solved the fundamental vaccine purity flaws that the people with knowledge said have affected its ability to make doses at plants around the world.</p><p><blockquote>尽管该公司开始在其他国家寻求监管部门的批准，但美国仍怀疑该公司是否解决了根本的疫苗纯度缺陷，知情人士称，这些缺陷影响了该公司在世界各地工厂生产疫苗的能力。</blockquote></p><p> Several vaccine batches have already been discarded, and four people with knowledge of the matter say U.S. officials now no longer expect the company to win FDA sign-off on the vaccine until next year at the earliest.</p><p><blockquote>几批疫苗已经被丢弃，四名知情人士表示，美国官员现在预计该公司最早要到明年才能获得FDA对疫苗的批准。</blockquote></p><p> “At some level, I think the efficacy was never going to outweigh the risk associated with the impurity that was in there,” said one of the people with knowledge of the matter. “I’m not surprised this is where we are.”</p><p><blockquote>“在某种程度上，我认为功效永远不会超过与其中杂质相关的风险，”一位知情人士说。“我并不惊讶我们会在这里。”</blockquote></p><p></p>\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"NVAX":"诺瓦瓦克斯医药"},"is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1174375951","content_text":"(Oct 20)  Novavax may delay the delivery of 1 billion doses of coronavirus vaccine because of the production problems.\nThe world’s vaccine distributor has been counting on U.S. companies to provide more than 2 billion doses to lower and middle-income countries by the end of 2022 — a crucial step in ending the Covid-19 pandemic.\nBut the campaign run by the international consortium known as COVAX, which has already been delayed significantly because of production lags, is now likely to fall short by more than 1 billion doses as a key supplier faces significant hurdles in proving it can manufacture a shot that meets regulators’ quality standards, according to three people with direct knowledge of the company’s problems.\nThe delay, which was confirmed by three other people familiar with the discussions between Maryland-based Novavax and the Biden administration, represents a major setback in the effort to vaccinate the world in the wake of new, more transmissible variants.\nThe U.S. government invested $1.6 billion in Novavax in 2020 — the most it devoted to any vaccine maker at the time — in hopes that it would offer the world another option for a safe and effective vaccine to help protect against Covid-19. But the company has consistently run into production problems. The methods it used to test the purity of the vaccine have fallen short of regulators’ standards and the company has not been able to prove that it can produce a shot that is consistently up to snuff, according to multiple people familiar with Novavax’s difficulties. All spoke on the condition of anonymity to discuss sensitive company conversations.\nAlthough Novavax recently attested to some of its analytics and testing issues in aquarterly filing with the Securities and Exchange Commission, the company’s issues are more concerning than previously understood, according to two of the people with direct knowledge of the matter.\nThe Food and Drug Administration works out purity levels with each manufacturer according to June 2020 guidance for coronavirus vaccines, but it is generally understood that each vaccine batch should reach at least 90 percent. The company has struggled to attain anywhere close to that, one of the people with direct knowledge of the situation said. Another person familiar with the company’s manufacturing process said Novavax has recently shown purity levels hovering around 70 percent. Low purity levels increase the chance that contaminants or unnecessary substances are in the final product, rendering the vaccine less effective or introducing the chance that patients could react to unknown ingredients.\nCOVAX, which recently downgraded its 2021 goal from 2 billion to 1.425 billion doses, has already estimated that it faces a supply shortfall of as many as 1 billion doses in its effort to vaccinate the developing world. If Novavax falters, it could double the deficit through 2022, leaving hundreds of millions of people without immunity against Covid-19 and extending the pandemic.\n“COVAX continues to be challenged for adequate supply … in that context, Novavax’s manufacturing challenges and delays have been massively disruptive,” said Krishna Udayakumar, director of the Duke Global Health Innovation Center.\nThe global coalition is already behind on hundreds of millions of planned doses this month, having shipped just 371 million of its 700 million dose target for October. It is now also at risk of missing its already downgraded 2021 target.\nBetween Novavax and other manufacturers’ hurdles, “COVAX has had to scramble to revise its supply strategy significantly in real time,” Udayakumar said. As a result, global health groups are emphasizing more donations to cover immediate needs, he added.\nIn a statement, Novavax Senior Vice President of Investor Relations and Corporate Affairs Silvia Taylor told POLITICO that the company’s analytical testing methods have been “validated” — but did not answer questions about whether the FDA had signed off on them. The company still plans on filing an emergency use authorization by the end of the year, Taylor said.\n“The vaccine development and regulatory submission processes are highly complex and often require years to advance to the point where we are now. We will fulfill all of our committed doses both in the US and globally,” Taylor said.\nThe White House and the Department of Health and Human Services did not respond to multiple requests for comment.\nBut three people familiar with the matter said they are not confident that the company has the resources needed to reproduce a high-quality vaccine on a consistent basis — a benchmark Novavax must meet before that time. Those same people said Novavax could potentially fix its manufacturing issues and reach full licensure by the end of 2022.\nNovavax — which has never produced a vaccine before — declined to answer specific questions about its product’s purity levels and whether it had been successful in addressing its longstanding manufacturing issues.\nUnlike Pfizer and Moderna, the first manufacturers to launch vaccines using rapidly produced messenger RNA, Novavax is employing the previously used but complicated approach of creating the key ingredient with bug cells. While the process, which involves infecting the cells to produce spike proteins, is familiar to scientists, it is difficult to scale.\nThe revelations about Novavax’s continued manufacturing problems come at a time when only 36 percent of the world is vaccinated and as leaders of developing nations continue to pressure the U.S. to deliver more doses. In Africa alone, only 4.4 percent of the population is vaccinated.\nThat includes some of the continent’s most populous nations, like Nigeria and Uganda, where about 1 percent of citizens are fully vaccinated.\nNovavax is just the latest vaccine maker to run into core production problems after promising to serve as a major vaccine contributor to the developing world. In April, Johnson & Johnsonhalted work at a Baltimore facilityrun by contract manufacturer Emergent BioSolutions after it found that 15 million doses had been accidentally contaminated with ingredients from a separate Covid-19 vaccine.\nJ&J’s manufacturing process has been slow to recover, and to date it has produced just a fraction of the 200 million shots it initially pledged to COVAX by the end of the year, according to records kept by UNICEF.\n“Overpromising and underdelivering is the name of the game for these manufacturers,” said Asia Russell, executive director of international advocacy group Health GAP. “And that’s the infrastructure of the global response, which is terrifying.”\nUnlike Johnson & Johnson, Novavax is a novice in the vaccine world. It has never successfully launched a vaccine, and had struggled financially prior to the pandemic. After a string of drug development failures, it sold its manufacturing facilities in 2019 — a deal that also included parting with 100 employees. In May of that year, Novavax’s stock price dropped as low as 36 cents per share.\nYet the company’s fortunes shifted as Covid-19 took hold. Amid a scramble early in the pandemic to develop a range of vaccine candidates, the Trump administration awarded Novavax $1.6 billion to aid work on its Covid-19 shot — the largest deal given to any Covid-19 vaccine maker at that time.\nThe contract represented a major vote of confidence in Novavax’s capabilities — and a bet that appeared to pay off after late-stage trials showed the vaccine was 90 percent effective against the virus.\nBut even then, senior Trump administration officials on Operation Warp Speed — a group tasked with accelerating vaccine development — repeatedly warned the company that it risked running into problems in scaling up manufacturing of the shot, two people with direct knowledge of those discussions said.\nIn particular, they worried that Novavax would have difficulty ensuring that the vaccine consistently met the FDA’s rigorous quality standards once the vaccine went into mass production — the exact problem that has now stymied the company for months.\n“They rushed the process,” one of the people with knowledge of the matter said. “It’s hard to make. And they can’t make it.”\nTaylor, the Novavax spokesperson, said in a statement that it has incorporated feedback from regulators and has made “tremendous progress with the scale-up of our commercial manufacturing processes.” The company is still on track to produce 150 million doses a month by the end of the year, she said, and has stockpiled tens of millions of doses ahead of regulatory filings in the U.S. and internationally.\nCompany executives in recent presentations to investors have struck a similarly optimistic tone, downplaying the manufacturing snags and predicting it will soon be cleared to begin distributing doses. During aSept. 29 investor event, Chief Commercial Officer John Trizzino said the company had “resolved” its problems and was close to submitting a final regulatory application.\n“We’re really moving along with testing our lots now,” added Gregory Glenn, president of Novavax’s research and development, referring to batches of its vaccine. “We think that this is shortly going to come to a close.”\nU.S. officials working with the company are not as confident, according to three people with knowledge of the matter. Novavax’s manufacturing problems are seen as far more difficult to fix than the sanitary and design concerns that halted production of J&J’s vaccine at the Emergent plant earlier this year, those people said.\nAnd even as the company begins to seek regulatory approval in other countries, there remains doubt in the U.S. that it has solved the fundamental vaccine purity flaws that the people with knowledge said have affected its ability to make doses at plants around the world.\nSeveral vaccine batches have already been discarded, and four people with knowledge of the matter say U.S. officials now no longer expect the company to win FDA sign-off on the vaccine until next year at the earliest.\n“At some level, I think the efficacy was never going to outweigh the risk associated with the impurity that was in there,” said one of the people with knowledge of the matter. “I’m not surprised this is where we are.”","news_type":1,"symbols_score_info":{"NVAX":0.9}},"isVote":1,"tweetType":1,"viewCount":491,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":841310693,"gmtCreate":1635885690227,"gmtModify":1635885690291,"author":{"id":"3573538012135697","authorId":"3573538012135697","name":"Alvin牛仔背带裤","avatar":"https://static.tigerbbs.com/d141be403ec6eb25b1c85b5c797f9c49","crmLevel":11,"crmLevelSwitch":0,"followedFlag":false,"authorIdStr":"3573538012135697","idStr":"3573538012135697"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/FUBO\">$fuboTV Inc.(FUBO)$</a>congrats to those diamond hands!谁都不能和趋势作对，不然就是自掘fm","listText":"<a href=\"https://laohu8.com/S/FUBO\">$fuboTV Inc.(FUBO)$</a>congrats to those diamond hands!谁都不能和趋势作对，不然就是自掘fm","text":"$fuboTV Inc.(FUBO)$congrats to those diamond hands!谁都不能和趋势作对，不然就是自掘fm","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":2,"commentSize":1,"repostSize":0,"link":"https://laohu8.com/post/841310693","isVote":1,"tweetType":1,"viewCount":800,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":849598298,"gmtCreate":1635764250829,"gmtModify":1635764251828,"author":{"id":"3573538012135697","authorId":"3573538012135697","name":"Alvin牛仔背带裤","avatar":"https://static.tigerbbs.com/d141be403ec6eb25b1c85b5c797f9c49","crmLevel":11,"crmLevelSwitch":0,"followedFlag":false,"authorIdStr":"3573538012135697","idStr":"3573538012135697"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/NVAX\">$诺瓦瓦克斯医药(NVAX)$</a>congrats to those bought below $120","listText":"<a href=\"https://laohu8.com/S/NVAX\">$诺瓦瓦克斯医药(NVAX)$</a>congrats to those bought below $120","text":"$诺瓦瓦克斯医药(NVAX)$congrats to those bought below $120","images":[{"img":"https://static.tigerbbs.com/318d0038cd9d05e1c1270e51f95523b6","width":"1242","height":"2208"}],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":4,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/849598298","isVote":1,"tweetType":1,"viewCount":548,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":1,"langContent":"CN","totalScore":0},{"id":860752918,"gmtCreate":1632218773334,"gmtModify":1632802007535,"author":{"id":"3573538012135697","authorId":"3573538012135697","name":"Alvin牛仔背带裤","avatar":"https://static.tigerbbs.com/d141be403ec6eb25b1c85b5c797f9c49","crmLevel":11,"crmLevelSwitch":0,"followedFlag":false,"authorIdStr":"3573538012135697","idStr":"3573538012135697"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/TIGR\">$老虎证券(TIGR)$</a>跌多一点才能all in致富","listText":"<a href=\"https://laohu8.com/S/TIGR\">$老虎证券(TIGR)$</a>跌多一点才能all in致富","text":"$老虎证券(TIGR)$跌多一点才能all in致富","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":4,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/860752918","isVote":1,"tweetType":1,"viewCount":692,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":849582614,"gmtCreate":1635766943738,"gmtModify":1635766962052,"author":{"id":"3573538012135697","authorId":"3573538012135697","name":"Alvin牛仔背带裤","avatar":"https://static.tigerbbs.com/d141be403ec6eb25b1c85b5c797f9c49","crmLevel":11,"crmLevelSwitch":0,"followedFlag":false,"authorIdStr":"3573538012135697","idStr":"3573538012135697"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/NIO\">$蔚来(NIO)$</a>just buy the dip&nbsp;","listText":"<a href=\"https://laohu8.com/S/NIO\">$蔚来(NIO)$</a>just buy the dip&nbsp;","text":"$蔚来(NIO)$just buy the dip","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":2,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/849582614","isVote":1,"tweetType":1,"viewCount":712,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":859401923,"gmtCreate":1634718076630,"gmtModify":1634720846257,"author":{"id":"3573538012135697","authorId":"3573538012135697","name":"Alvin牛仔背带裤","avatar":"https://static.tigerbbs.com/d141be403ec6eb25b1c85b5c797f9c49","crmLevel":11,"crmLevelSwitch":0,"followedFlag":false,"authorIdStr":"3573538012135697","idStr":"3573538012135697"},"themes":[],"htmlText":"BullshitJust buy the dip","listText":"BullshitJust buy the dip","text":"BullshitJust buy the dip","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":2,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/859401923","repostId":"1174375951","repostType":2,"repost":{"id":"1174375951","kind":"news","weMediaInfo":{"introduction":"Providing stock market headlines, business news, financials and earnings ","home_visible":1,"media_name":"Tiger Newspress","id":"1079075236","head_image":"https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba"},"pubTimestamp":1634717661,"share":"https://www.laohu8.com/m/news/1174375951?lang=zh_CN&edition=full","pubTime":"2021-10-20 16:14","market":"us","language":"en","title":"Novavax plunged over 20% in premarket trading<blockquote>Novavax盘前交易暴跌逾20%</blockquote>","url":"https://stock-news.laohu8.com/highlight/detail?id=1174375951","media":"Tiger Newspress","summary":"(Oct 20)  Novavax may delay the delivery of 1 billion doses of coronavirus vaccine because of the pr","content":"<p>(Oct 20)&nbsp; <a href=\"https://laohu8.com/S/NVAX\">Novavax</a>&nbsp;may delay the delivery of 1 billion doses of coronavirus vaccine because of the production problems.</p><p><blockquote>（10月20日）<a href=\"https://laohu8.com/S/NVAX\">Novavax</a>可能因生产问题推迟10亿剂冠状病毒疫苗的交付。</blockquote></p><p> <img src=\"https://static.tigerbbs.com/f3995877f1c786d310a457ababf9ee9e\" tg-width=\"1043\" tg-height=\"564\" referrerpolicy=\"no-referrer\">The world’s vaccine distributor has been counting on U.S. companies to provide more than 2 billion doses to lower and middle-income countries by the end of 2022 — a crucial step in ending the Covid-19 pandemic.</p><p><blockquote>这家全球疫苗分销商一直指望美国公司在2022年底前向中低收入国家提供超过20亿剂疫苗——这是结束Covid-19大流行的关键一步。</blockquote></p><p> But the campaign run by the international consortium known as COVAX, which has already been delayed significantly because of production lags, is now likely to fall short by more than 1 billion doses as a key supplier faces significant hurdles in proving it can manufacture a shot that meets regulators’ quality standards, according to three people with direct knowledge of the company’s problems.</p><p><blockquote>但由名为COVAX的国际联盟发起的活动由于生产滞后而被大幅推迟，现在可能会短缺超过10亿剂，因为一家主要供应商在证明其能够生产疫苗方面面临重大障碍据三位直接了解该公司问题的人士透露，符合监管机构的质量标准。</blockquote></p><p> The delay, which was confirmed by three other people familiar with the discussions between Maryland-based Novavax and the Biden administration, represents a major setback in the effort to vaccinate the world in the wake of new, more transmissible variants.</p><p><blockquote>另外三名熟悉总部位于马里兰州的Novavax和拜登政府之间讨论的人士证实了这一延迟，这代表着在新的、更具传染性的变种出现后，为世界接种疫苗的努力遭遇重大挫折。</blockquote></p><p> The U.S. government invested $1.6 billion in Novavax in 2020 — the most it devoted to any vaccine maker at the time — in hopes that it would offer the world another option for a safe and effective vaccine to help protect against Covid-19. But the company has consistently run into production problems. The methods it used to test the purity of the vaccine have fallen short of regulators’ standards and the company has not been able to prove that it can produce a shot that is consistently up to snuff, according to multiple people familiar with Novavax’s difficulties. All spoke on the condition of anonymity to discuss sensitive company conversations.</p><p><blockquote>美国政府在2020年向Novavax投资了16亿美元，这是当时向所有疫苗制造商投入的最多资金，希望它能为世界提供另一种安全有效的疫苗选择，以帮助预防Covid-19。但该公司一直遇到生产问题。据多位熟悉Novavax困难的人士透露，其用于测试疫苗纯度的方法未达到监管机构的标准，该公司也无法证明其能够生产出始终符合标准的疫苗。所有人都要求匿名，讨论敏感的公司对话。</blockquote></p><p> Although Novavax recently attested to some of its analytics and testing issues in aquarterly filing with the Securities and Exchange Commission, the company’s issues are more concerning than previously understood, according to two of the people with direct knowledge of the matter.</p><p><blockquote>据两位直接了解此事的人士透露，尽管Novavax最近在向美国证券交易委员会提交的季度文件中证实了其一些分析和测试问题，但该公司的问题比之前理解的更令人担忧。</blockquote></p><p> The Food and Drug Administration works out purity levels with each manufacturer according to June 2020 guidance for coronavirus vaccines, but it is generally understood that each vaccine batch should reach at least 90 percent. The company has struggled to attain anywhere close to that, <a href=\"https://laohu8.com/S/AONE.U\">one</a> of the people with direct knowledge of the situation said. Another person familiar with the company’s manufacturing process said Novavax has recently shown purity levels hovering around 70 percent. Low purity levels increase the chance that contaminants or unnecessary substances are in the final product, rendering the vaccine less effective or introducing the chance that patients could react to unknown ingredients.</p><p><blockquote>美国食品药品监督管理局根据2020年6月的冠状病毒疫苗指南，与每个制造商一起制定纯度水平，但普遍认为每个疫苗批次应至少达到90%。该公司一直在努力实现这一目标，<a href=\"https://laohu8.com/S/AONE.U\">一</a>的直接了解情况的人说。另一位熟悉该公司制造工艺的人士表示，Novavax最近的纯度水平徘徊在70%左右。低纯度水平会增加最终产品中存在污染物或不必要物质的机会，从而降低疫苗的有效性或增加患者对未知成分产生反应的机会。</blockquote></p><p> COVAX, which recently downgraded its 2021 goal from 2 billion to 1.425 billion doses, has already estimated that it faces a supply shortfall of as many as 1 billion doses in its effort to vaccinate the developing world. If Novavax falters, it could double the deficit through 2022, leaving hundreds of millions of people without immunity against Covid-19 and extending the pandemic.</p><p><blockquote>COVAX最近将2021年的目标从20亿剂下调至14.25亿剂，并已经估计，在为发展中国家接种疫苗的努力中，它面临着多达10亿剂的供应短缺。如果Novavax步履蹒跚，到2022年赤字可能会增加一倍，使数亿人对Covid-19没有免疫力，并延长疫情。</blockquote></p><p> “COVAX continues to be challenged for adequate supply … in that context, Novavax’s manufacturing challenges and delays have been massively disruptive,” said Krishna Udayakumar, director of the <a href=\"https://laohu8.com/S/DRE\">Duke</a> Global Health Innovation Center.</p><p><blockquote>“COVAX继续面临充足供应的挑战……在这种背景下，Novavax的制造挑战和延误具有巨大的破坏性，”<a href=\"https://laohu8.com/S/DRE\">公爵</a>全球健康创新中心。</blockquote></p><p> The global coalition is already behind on hundreds of millions of planned doses this month, having shipped just 371 million of its 700 million dose target for October. It is now also at risk of missing its already downgraded 2021 target.</p><p><blockquote>全球联盟本月已经落后于数亿剂计划剂量，仅运送了10月份7亿剂目标中的3.71亿剂。它现在还面临着达不到已经下调的2021年目标的风险。</blockquote></p><p> Between Novavax and other manufacturers’ hurdles, “COVAX has had to scramble to revise its supply strategy significantly in real time,” Udayakumar said. As a result, global health groups are emphasizing more donations to cover immediate needs, he added.</p><p><blockquote>在Novavax和其他制造商的障碍之间，“COVAX不得不争先恐后地实时大幅修改其供应策略，”Udayakumar说。他补充说，因此，全球卫生组织强调提供更多捐款来满足眼前的需求。</blockquote></p><p> In a statement, Novavax Senior Vice President of Investor Relations and Corporate Affairs Silvia Taylor told POLITICO that the company’s analytical testing methods have been “validated” — but did not answer questions about whether the FDA had signed off on them. The company still plans on filing an emergency use authorization by the end of the year, Taylor said.</p><p><blockquote>Novavax投资者关系和公司事务高级副总裁Silvia Taylor在一份声明中告诉POLITICO，该公司的分析测试方法已经过“验证”，但没有回答有关FDA是否已批准这些方法的问题。泰勒说，该公司仍计划在今年年底前提交紧急使用授权。</blockquote></p><p> “The vaccine development and regulatory submission processes are highly complex and often require years to advance to the point where we are now. We will fulfill all of our committed doses both in the US and globally,” Taylor said.</p><p><blockquote>泰勒说：“疫苗开发和监管提交过程非常复杂，通常需要数年时间才能达到我们现在的水平。我们将在美国和全球范围内履行所有承诺的剂量。”</blockquote></p><p> The White House and the Department of Health and Human Services did not respond to multiple requests for comment.</p><p><blockquote>白宫和卫生与公众服务部没有回应多次置评请求。</blockquote></p><p></p><p> But three people familiar with the matter said they are not confident that the company has the resources needed to reproduce a high-quality vaccine on a consistent basis — a benchmark Novavax must meet before that time. Those same people said Novavax could potentially fix its manufacturing issues and reach full licensure by the end of 2022.</p><p><blockquote>但三位知情人士表示，他们不相信该公司拥有持续复制高质量疫苗所需的资源——Novavax在此之前必须达到的基准。这些人表示，Novavax可能会解决其制造问题，并在2022年底前获得全面许可。</blockquote></p><p> Novavax — which has never produced a vaccine before — declined to answer specific questions about its product’s purity levels and whether it had been successful in addressing its longstanding manufacturing issues.</p><p><blockquote>Novavax以前从未生产过疫苗，拒绝回答有关其产品纯度水平以及是否成功解决了长期存在的生产问题的具体问题。</blockquote></p><p> Unlike <a href=\"https://laohu8.com/S/PFE\">Pfizer</a> and Moderna, the first manufacturers to launch vaccines using rapidly produced messenger RNA, Novavax is employing the previously used but complicated approach of creating the key ingredient with bug cells. While the process, which involves infecting the cells to produce spike proteins, is familiar to scientists, it is difficult to scale.</p><p><blockquote>不像<a href=\"https://laohu8.com/S/PFE\">辉瑞</a>Moderna是第一家使用快速产生的信使RNA推出疫苗的制造商，Novavax正在采用以前使用但复杂的方法，即用细菌细胞制造关键成分。虽然科学家们对感染细胞产生刺突蛋白的过程很熟悉，但很难扩大规模。</blockquote></p><p> The revelations about Novavax’s continued manufacturing problems come at a time when only 36 percent of the world is vaccinated and as leaders of developing nations continue to pressure the U.S. to deliver more doses. In Africa alone, only 4.4 percent of the population is vaccinated.</p><p><blockquote>Novavax持续存在的生产问题被曝光之际，世界上只有36%的人接种了疫苗，而且发展中国家的领导人继续向美国施压，要求其提供更多剂量。仅在非洲，只有4.4%的人口接种了疫苗。</blockquote></p><p> That includes some of the continent’s most populous nations, like Nigeria and Uganda, where about 1 percent of citizens are fully vaccinated.</p><p><blockquote>这包括非洲大陆一些人口最多的国家，如尼日利亚和乌干达，这些国家约有1%的公民完全接种了疫苗。</blockquote></p><p> Novavax is just the latest vaccine maker to run into core production problems after promising to serve as a major vaccine contributor to the developing world. In April, Johnson &amp; Johnsonhalted work at a Baltimore facilityrun by contract manufacturer <a href=\"https://laohu8.com/S/EBS\">Emergent BioSolutions</a> after it found that 15 million doses had been accidentally contaminated with ingredients from a separate Covid-19 vaccine.</p><p><blockquote>Novavax只是最新一家在承诺成为发展中国家主要疫苗供应商后遇到核心生产问题的疫苗制造商。四月，强生公司停止了巴尔的摩一家由合同制造商运营的工厂的工作<a href=\"https://laohu8.com/S/EBS\">新兴生物解决方案</a>在发现1500万剂疫苗意外被另一种Covid-19疫苗的成分污染后。</blockquote></p><p> J&amp;J’s manufacturing process has been slow to recover, and to date it has produced just a fraction of the 200 million shots it initially pledged to COVAX by the end of the year, according to records kept by UNICEF.</p><p><blockquote>根据联合国儿童基金会保存的记录，强生公司的生产流程恢复缓慢，迄今为止，该公司仅生产了最初承诺在年底前向COVAX生产的2亿剂疫苗的一小部分。</blockquote></p><p> “Overpromising and underdelivering is the name of the game for these manufacturers,” said Asia Russell, executive director of international advocacy group Health GAP. “And that’s the infrastructure of the global response, which is terrifying.”</p><p><blockquote>国际倡导组织Health GAP的执行董事亚洲·拉塞尔(Asia Russell)表示：“承诺过多而兑现不足是这些制造商的游戏名称。”“这就是全球应对措施的基础设施，这太可怕了。”</blockquote></p><p> Unlike Johnson &amp; Johnson, Novavax is a novice in the vaccine world. It has never successfully launched a vaccine, and had struggled financially prior to the pandemic. After a string of drug development failures, it sold its manufacturing facilities in 2019 — a deal that also included parting with 100 employees. In May of that year, Novavax’s stock price dropped as low as 36 cents per share.</p><p><blockquote>与强生不同，Novavax是疫苗界的新手。它从未成功推出过疫苗，并且在大流行之前一直在财务上苦苦挣扎。在经历了一系列药物开发失败后，该公司于2019年出售了其生产设施，这笔交易还包括解雇100名员工。当年5月，Novavax股价曾一度跌至每股36美分。</blockquote></p><p> Yet the company’s fortunes shifted as Covid-19 took hold. Amid a scramble early in the pandemic to develop a range of vaccine candidates, the Trump administration awarded Novavax $1.6 billion to aid work on its Covid-19 shot — the largest deal given to any Covid-19 vaccine maker at that time.</p><p><blockquote>然而，随着Covid-19的出现，该公司的命运发生了变化。在大流行初期争相开发一系列候选疫苗的过程中，特朗普政府向Novavax提供了16亿美元，以帮助其开发Covid-19疫苗——这是当时向所有Covid-19疫苗制造商提供的最大一笔交易。</blockquote></p><p> The contract represented a major vote of confidence in Novavax’s capabilities — and a bet that appeared to pay off after late-stage trials showed the vaccine was 90 percent effective against the virus.</p><p><blockquote>该合同代表了对Novavax能力的重大信任票，在后期试验显示该疫苗对病毒的有效性为90%后，这一赌注似乎得到了回报。</blockquote></p><p> But even then, senior Trump administration officials on Operation Warp Speed — a group tasked with accelerating vaccine development — repeatedly warned the company that it risked running into problems in scaling up manufacturing of the shot, two people with direct knowledge of those discussions said.</p><p><blockquote>但两名直接了解这些讨论的人士表示，即便如此，负责加速疫苗开发的“曲速行动”（Operation Warp Speed）的特朗普政府高级官员也一再警告该公司，在扩大疫苗生产规模时可能会遇到问题。</blockquote></p><p> In particular, they worried that Novavax would have difficulty ensuring that the vaccine consistently met the FDA’s rigorous quality standards once the vaccine went into mass production — the exact problem that has now stymied the company for months.</p><p><blockquote>他们特别担心，一旦疫苗投入大规模生产，Novavax将难以确保疫苗始终符合FDA严格的质量标准——这正是困扰该公司数月的问题。</blockquote></p><p> “They rushed the process,” one of the people with knowledge of the matter said. “It’s hard to make. And they can’t make it.”</p><p><blockquote>“他们仓促行事，”一位知情人士说。“这很难做到。而且他们也做不到。”</blockquote></p><p> Taylor, the Novavax spokesperson, said in a statement that it has incorporated feedback from regulators and has made “tremendous progress with the scale-up of our commercial manufacturing processes.” The company is still on track to produce 150 million doses a month by the end of the year, she said, and has stockpiled tens of millions of doses ahead of regulatory filings in the U.S. and internationally.</p><p><blockquote>Novavax发言人泰勒在一份声明中表示，该公司已纳入监管机构的反馈，并“在扩大我们的商业制造流程方面取得了巨大进展”。她说，该公司仍有望在今年年底前每月生产1.5亿剂疫苗，并在美国和国际监管机构备案之前储备了数千万剂疫苗。</blockquote></p><p> Company executives in recent presentations to investors have struck a similarly optimistic tone, downplaying the manufacturing snags and predicting it will soon be cleared to begin distributing doses. During aSept. 29 investor event, Chief Commercial Officer John Trizzino said the company had “resolved” its problems and was close to submitting a final regulatory application.</p><p><blockquote>公司高管在最近给投资者的演讲中也表现出了类似的乐观语气，淡化了制造障碍，并预测很快就会获得批准，开始分发剂量。在aSept期间。29日投资者活动，首席商务官John Trizzino表示，该公司已经“解决”了问题，并接近提交最终监管申请。</blockquote></p><p> “We’re really moving along with testing our lots now,” added Gregory Glenn, president of Novavax’s research and development, referring to batches of its vaccine. “We think that this is shortly going to come to a close.”</p><p><blockquote>Novavax研发总裁格雷戈里·格伦(Gregory Glenn)在谈到其疫苗批次时补充道：“我们现在确实在测试我们的批次。”“我们认为这很快就会结束。”</blockquote></p><p></p><p> U.S. officials working with the company are not as confident, according to three people with knowledge of the matter. Novavax’s manufacturing problems are seen as far more difficult to fix than the sanitary and design concerns that halted production of J&amp;J’s vaccine at the Emergent plant earlier this year, those people said.</p><p><blockquote>据三位知情人士透露，与该公司合作的美国官员没有那么自信。这些人士表示，Novavax的制造问题被认为比今年早些时候导致强生在Emergent工厂停止生产疫苗的卫生和设计问题更难解决。</blockquote></p><p> And even as the company begins to seek regulatory approval in other countries, there remains doubt in the U.S. that it has solved the fundamental vaccine purity flaws that the people with knowledge said have affected its ability to make doses at plants around the world.</p><p><blockquote>尽管该公司开始在其他国家寻求监管部门的批准，但美国仍怀疑该公司是否解决了根本的疫苗纯度缺陷，知情人士称，这些缺陷影响了该公司在世界各地工厂生产疫苗的能力。</blockquote></p><p> Several vaccine batches have already been discarded, and four people with knowledge of the matter say U.S. officials now no longer expect the company to win FDA sign-off on the vaccine until next year at the earliest.</p><p><blockquote>几批疫苗已经被丢弃，四名知情人士表示，美国官员现在预计该公司最早要到明年才能获得FDA对疫苗的批准。</blockquote></p><p> “At some level, I think the efficacy was never going to outweigh the risk associated with the impurity that was in there,” said one of the people with knowledge of the matter. “I’m not surprised this is where we are.”</p><p><blockquote>“在某种程度上，我认为功效永远不会超过与其中杂质相关的风险，”一位知情人士说。“我并不惊讶我们会在这里。”</blockquote></p><p></p>","collect":0,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; 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<a href=\"https://laohu8.com/S/NVAX\">Novavax</a>&nbsp;may delay the delivery of 1 billion doses of coronavirus vaccine because of the production problems.</p><p><blockquote>（10月20日）<a href=\"https://laohu8.com/S/NVAX\">Novavax</a>可能因生产问题推迟10亿剂冠状病毒疫苗的交付。</blockquote></p><p> <img src=\"https://static.tigerbbs.com/f3995877f1c786d310a457ababf9ee9e\" tg-width=\"1043\" tg-height=\"564\" referrerpolicy=\"no-referrer\">The world’s vaccine distributor has been counting on U.S. companies to provide more than 2 billion doses to lower and middle-income countries by the end of 2022 — a crucial step in ending the Covid-19 pandemic.</p><p><blockquote>这家全球疫苗分销商一直指望美国公司在2022年底前向中低收入国家提供超过20亿剂疫苗——这是结束Covid-19大流行的关键一步。</blockquote></p><p> But the campaign run by the international consortium known as COVAX, which has already been delayed significantly because of production lags, is now likely to fall short by more than 1 billion doses as a key supplier faces significant hurdles in proving it can manufacture a shot that meets regulators’ quality standards, according to three people with direct knowledge of the company’s problems.</p><p><blockquote>但由名为COVAX的国际联盟发起的活动由于生产滞后而被大幅推迟，现在可能会短缺超过10亿剂，因为一家主要供应商在证明其能够生产疫苗方面面临重大障碍据三位直接了解该公司问题的人士透露，符合监管机构的质量标准。</blockquote></p><p> The delay, which was confirmed by three other people familiar with the discussions between Maryland-based Novavax and the Biden administration, represents a major setback in the effort to vaccinate the world in the wake of new, more transmissible variants.</p><p><blockquote>另外三名熟悉总部位于马里兰州的Novavax和拜登政府之间讨论的人士证实了这一延迟，这代表着在新的、更具传染性的变种出现后，为世界接种疫苗的努力遭遇重大挫折。</blockquote></p><p> The U.S. government invested $1.6 billion in Novavax in 2020 — the most it devoted to any vaccine maker at the time — in hopes that it would offer the world another option for a safe and effective vaccine to help protect against Covid-19. But the company has consistently run into production problems. The methods it used to test the purity of the vaccine have fallen short of regulators’ standards and the company has not been able to prove that it can produce a shot that is consistently up to snuff, according to multiple people familiar with Novavax’s difficulties. All spoke on the condition of anonymity to discuss sensitive company conversations.</p><p><blockquote>美国政府在2020年向Novavax投资了16亿美元，这是当时向所有疫苗制造商投入的最多资金，希望它能为世界提供另一种安全有效的疫苗选择，以帮助预防Covid-19。但该公司一直遇到生产问题。据多位熟悉Novavax困难的人士透露，其用于测试疫苗纯度的方法未达到监管机构的标准，该公司也无法证明其能够生产出始终符合标准的疫苗。所有人都要求匿名，讨论敏感的公司对话。</blockquote></p><p> Although Novavax recently attested to some of its analytics and testing issues in aquarterly filing with the Securities and Exchange Commission, the company’s issues are more concerning than previously understood, according to two of the people with direct knowledge of the matter.</p><p><blockquote>据两位直接了解此事的人士透露，尽管Novavax最近在向美国证券交易委员会提交的季度文件中证实了其一些分析和测试问题，但该公司的问题比之前理解的更令人担忧。</blockquote></p><p> The Food and Drug Administration works out purity levels with each manufacturer according to June 2020 guidance for coronavirus vaccines, but it is generally understood that each vaccine batch should reach at least 90 percent. The company has struggled to attain anywhere close to that, <a href=\"https://laohu8.com/S/AONE.U\">one</a> of the people with direct knowledge of the situation said. Another person familiar with the company’s manufacturing process said Novavax has recently shown purity levels hovering around 70 percent. Low purity levels increase the chance that contaminants or unnecessary substances are in the final product, rendering the vaccine less effective or introducing the chance that patients could react to unknown ingredients.</p><p><blockquote>美国食品药品监督管理局根据2020年6月的冠状病毒疫苗指南，与每个制造商一起制定纯度水平，但普遍认为每个疫苗批次应至少达到90%。该公司一直在努力实现这一目标，<a href=\"https://laohu8.com/S/AONE.U\">一</a>的直接了解情况的人说。另一位熟悉该公司制造工艺的人士表示，Novavax最近的纯度水平徘徊在70%左右。低纯度水平会增加最终产品中存在污染物或不必要物质的机会，从而降低疫苗的有效性或增加患者对未知成分产生反应的机会。</blockquote></p><p> COVAX, which recently downgraded its 2021 goal from 2 billion to 1.425 billion doses, has already estimated that it faces a supply shortfall of as many as 1 billion doses in its effort to vaccinate the developing world. If Novavax falters, it could double the deficit through 2022, leaving hundreds of millions of people without immunity against Covid-19 and extending the pandemic.</p><p><blockquote>COVAX最近将2021年的目标从20亿剂下调至14.25亿剂，并已经估计，在为发展中国家接种疫苗的努力中，它面临着多达10亿剂的供应短缺。如果Novavax步履蹒跚，到2022年赤字可能会增加一倍，使数亿人对Covid-19没有免疫力，并延长疫情。</blockquote></p><p> “COVAX continues to be challenged for adequate supply … in that context, Novavax’s manufacturing challenges and delays have been massively disruptive,” said Krishna Udayakumar, director of the <a href=\"https://laohu8.com/S/DRE\">Duke</a> Global Health Innovation Center.</p><p><blockquote>“COVAX继续面临充足供应的挑战……在这种背景下，Novavax的制造挑战和延误具有巨大的破坏性，”<a href=\"https://laohu8.com/S/DRE\">公爵</a>全球健康创新中心。</blockquote></p><p> The global coalition is already behind on hundreds of millions of planned doses this month, having shipped just 371 million of its 700 million dose target for October. It is now also at risk of missing its already downgraded 2021 target.</p><p><blockquote>全球联盟本月已经落后于数亿剂计划剂量，仅运送了10月份7亿剂目标中的3.71亿剂。它现在还面临着达不到已经下调的2021年目标的风险。</blockquote></p><p> Between Novavax and other manufacturers’ hurdles, “COVAX has had to scramble to revise its supply strategy significantly in real time,” Udayakumar said. As a result, global health groups are emphasizing more donations to cover immediate needs, he added.</p><p><blockquote>在Novavax和其他制造商的障碍之间，“COVAX不得不争先恐后地实时大幅修改其供应策略，”Udayakumar说。他补充说，因此，全球卫生组织强调提供更多捐款来满足眼前的需求。</blockquote></p><p> In a statement, Novavax Senior Vice President of Investor Relations and Corporate Affairs Silvia Taylor told POLITICO that the company’s analytical testing methods have been “validated” — but did not answer questions about whether the FDA had signed off on them. The company still plans on filing an emergency use authorization by the end of the year, Taylor said.</p><p><blockquote>Novavax投资者关系和公司事务高级副总裁Silvia Taylor在一份声明中告诉POLITICO，该公司的分析测试方法已经过“验证”，但没有回答有关FDA是否已批准这些方法的问题。泰勒说，该公司仍计划在今年年底前提交紧急使用授权。</blockquote></p><p> “The vaccine development and regulatory submission processes are highly complex and often require years to advance to the point where we are now. We will fulfill all of our committed doses both in the US and globally,” Taylor said.</p><p><blockquote>泰勒说：“疫苗开发和监管提交过程非常复杂，通常需要数年时间才能达到我们现在的水平。我们将在美国和全球范围内履行所有承诺的剂量。”</blockquote></p><p> The White House and the Department of Health and Human Services did not respond to multiple requests for comment.</p><p><blockquote>白宫和卫生与公众服务部没有回应多次置评请求。</blockquote></p><p></p><p> But three people familiar with the matter said they are not confident that the company has the resources needed to reproduce a high-quality vaccine on a consistent basis — a benchmark Novavax must meet before that time. Those same people said Novavax could potentially fix its manufacturing issues and reach full licensure by the end of 2022.</p><p><blockquote>但三位知情人士表示，他们不相信该公司拥有持续复制高质量疫苗所需的资源——Novavax在此之前必须达到的基准。这些人表示，Novavax可能会解决其制造问题，并在2022年底前获得全面许可。</blockquote></p><p> Novavax — which has never produced a vaccine before — declined to answer specific questions about its product’s purity levels and whether it had been successful in addressing its longstanding manufacturing issues.</p><p><blockquote>Novavax以前从未生产过疫苗，拒绝回答有关其产品纯度水平以及是否成功解决了长期存在的生产问题的具体问题。</blockquote></p><p> Unlike <a href=\"https://laohu8.com/S/PFE\">Pfizer</a> and Moderna, the first manufacturers to launch vaccines using rapidly produced messenger RNA, Novavax is employing the previously used but complicated approach of creating the key ingredient with bug cells. While the process, which involves infecting the cells to produce spike proteins, is familiar to scientists, it is difficult to scale.</p><p><blockquote>不像<a href=\"https://laohu8.com/S/PFE\">辉瑞</a>Moderna是第一家使用快速产生的信使RNA推出疫苗的制造商，Novavax正在采用以前使用但复杂的方法，即用细菌细胞制造关键成分。虽然科学家们对感染细胞产生刺突蛋白的过程很熟悉，但很难扩大规模。</blockquote></p><p> The revelations about Novavax’s continued manufacturing problems come at a time when only 36 percent of the world is vaccinated and as leaders of developing nations continue to pressure the U.S. to deliver more doses. In Africa alone, only 4.4 percent of the population is vaccinated.</p><p><blockquote>Novavax持续存在的生产问题被曝光之际，世界上只有36%的人接种了疫苗，而且发展中国家的领导人继续向美国施压，要求其提供更多剂量。仅在非洲，只有4.4%的人口接种了疫苗。</blockquote></p><p> That includes some of the continent’s most populous nations, like Nigeria and Uganda, where about 1 percent of citizens are fully vaccinated.</p><p><blockquote>这包括非洲大陆一些人口最多的国家，如尼日利亚和乌干达，这些国家约有1%的公民完全接种了疫苗。</blockquote></p><p> Novavax is just the latest vaccine maker to run into core production problems after promising to serve as a major vaccine contributor to the developing world. In April, Johnson &amp; Johnsonhalted work at a Baltimore facilityrun by contract manufacturer <a href=\"https://laohu8.com/S/EBS\">Emergent BioSolutions</a> after it found that 15 million doses had been accidentally contaminated with ingredients from a separate Covid-19 vaccine.</p><p><blockquote>Novavax只是最新一家在承诺成为发展中国家主要疫苗供应商后遇到核心生产问题的疫苗制造商。四月，强生公司停止了巴尔的摩一家由合同制造商运营的工厂的工作<a href=\"https://laohu8.com/S/EBS\">新兴生物解决方案</a>在发现1500万剂疫苗意外被另一种Covid-19疫苗的成分污染后。</blockquote></p><p> J&amp;J’s manufacturing process has been slow to recover, and to date it has produced just a fraction of the 200 million shots it initially pledged to COVAX by the end of the year, according to records kept by UNICEF.</p><p><blockquote>根据联合国儿童基金会保存的记录，强生公司的生产流程恢复缓慢，迄今为止，该公司仅生产了最初承诺在年底前向COVAX生产的2亿剂疫苗的一小部分。</blockquote></p><p> “Overpromising and underdelivering is the name of the game for these manufacturers,” said Asia Russell, executive director of international advocacy group Health GAP. “And that’s the infrastructure of the global response, which is terrifying.”</p><p><blockquote>国际倡导组织Health GAP的执行董事亚洲·拉塞尔(Asia Russell)表示：“承诺过多而兑现不足是这些制造商的游戏名称。”“这就是全球应对措施的基础设施，这太可怕了。”</blockquote></p><p> Unlike Johnson &amp; Johnson, Novavax is a novice in the vaccine world. It has never successfully launched a vaccine, and had struggled financially prior to the pandemic. After a string of drug development failures, it sold its manufacturing facilities in 2019 — a deal that also included parting with 100 employees. In May of that year, Novavax’s stock price dropped as low as 36 cents per share.</p><p><blockquote>与强生不同，Novavax是疫苗界的新手。它从未成功推出过疫苗，并且在大流行之前一直在财务上苦苦挣扎。在经历了一系列药物开发失败后，该公司于2019年出售了其生产设施，这笔交易还包括解雇100名员工。当年5月，Novavax股价曾一度跌至每股36美分。</blockquote></p><p> Yet the company’s fortunes shifted as Covid-19 took hold. Amid a scramble early in the pandemic to develop a range of vaccine candidates, the Trump administration awarded Novavax $1.6 billion to aid work on its Covid-19 shot — the largest deal given to any Covid-19 vaccine maker at that time.</p><p><blockquote>然而，随着Covid-19的出现，该公司的命运发生了变化。在大流行初期争相开发一系列候选疫苗的过程中，特朗普政府向Novavax提供了16亿美元，以帮助其开发Covid-19疫苗——这是当时向所有Covid-19疫苗制造商提供的最大一笔交易。</blockquote></p><p> The contract represented a major vote of confidence in Novavax’s capabilities — and a bet that appeared to pay off after late-stage trials showed the vaccine was 90 percent effective against the virus.</p><p><blockquote>该合同代表了对Novavax能力的重大信任票，在后期试验显示该疫苗对病毒的有效性为90%后，这一赌注似乎得到了回报。</blockquote></p><p> But even then, senior Trump administration officials on Operation Warp Speed — a group tasked with accelerating vaccine development — repeatedly warned the company that it risked running into problems in scaling up manufacturing of the shot, two people with direct knowledge of those discussions said.</p><p><blockquote>但两名直接了解这些讨论的人士表示，即便如此，负责加速疫苗开发的“曲速行动”（Operation Warp Speed）的特朗普政府高级官员也一再警告该公司，在扩大疫苗生产规模时可能会遇到问题。</blockquote></p><p> In particular, they worried that Novavax would have difficulty ensuring that the vaccine consistently met the FDA’s rigorous quality standards once the vaccine went into mass production — the exact problem that has now stymied the company for months.</p><p><blockquote>他们特别担心，一旦疫苗投入大规模生产，Novavax将难以确保疫苗始终符合FDA严格的质量标准——这正是困扰该公司数月的问题。</blockquote></p><p> “They rushed the process,” one of the people with knowledge of the matter said. “It’s hard to make. And they can’t make it.”</p><p><blockquote>“他们仓促行事，”一位知情人士说。“这很难做到。而且他们也做不到。”</blockquote></p><p> Taylor, the Novavax spokesperson, said in a statement that it has incorporated feedback from regulators and has made “tremendous progress with the scale-up of our commercial manufacturing processes.” The company is still on track to produce 150 million doses a month by the end of the year, she said, and has stockpiled tens of millions of doses ahead of regulatory filings in the U.S. and internationally.</p><p><blockquote>Novavax发言人泰勒在一份声明中表示，该公司已纳入监管机构的反馈，并“在扩大我们的商业制造流程方面取得了巨大进展”。她说，该公司仍有望在今年年底前每月生产1.5亿剂疫苗，并在美国和国际监管机构备案之前储备了数千万剂疫苗。</blockquote></p><p> Company executives in recent presentations to investors have struck a similarly optimistic tone, downplaying the manufacturing snags and predicting it will soon be cleared to begin distributing doses. During aSept. 29 investor event, Chief Commercial Officer John Trizzino said the company had “resolved” its problems and was close to submitting a final regulatory application.</p><p><blockquote>公司高管在最近给投资者的演讲中也表现出了类似的乐观语气，淡化了制造障碍，并预测很快就会获得批准，开始分发剂量。在aSept期间。29日投资者活动，首席商务官John Trizzino表示，该公司已经“解决”了问题，并接近提交最终监管申请。</blockquote></p><p> “We’re really moving along with testing our lots now,” added Gregory Glenn, president of Novavax’s research and development, referring to batches of its vaccine. “We think that this is shortly going to come to a close.”</p><p><blockquote>Novavax研发总裁格雷戈里·格伦(Gregory Glenn)在谈到其疫苗批次时补充道：“我们现在确实在测试我们的批次。”“我们认为这很快就会结束。”</blockquote></p><p></p><p> U.S. officials working with the company are not as confident, according to three people with knowledge of the matter. Novavax’s manufacturing problems are seen as far more difficult to fix than the sanitary and design concerns that halted production of J&amp;J’s vaccine at the Emergent plant earlier this year, those people said.</p><p><blockquote>据三位知情人士透露，与该公司合作的美国官员没有那么自信。这些人士表示，Novavax的制造问题被认为比今年早些时候导致强生在Emergent工厂停止生产疫苗的卫生和设计问题更难解决。</blockquote></p><p> And even as the company begins to seek regulatory approval in other countries, there remains doubt in the U.S. that it has solved the fundamental vaccine purity flaws that the people with knowledge said have affected its ability to make doses at plants around the world.</p><p><blockquote>尽管该公司开始在其他国家寻求监管部门的批准，但美国仍怀疑该公司是否解决了根本的疫苗纯度缺陷，知情人士称，这些缺陷影响了该公司在世界各地工厂生产疫苗的能力。</blockquote></p><p> Several vaccine batches have already been discarded, and four people with knowledge of the matter say U.S. officials now no longer expect the company to win FDA sign-off on the vaccine until next year at the earliest.</p><p><blockquote>几批疫苗已经被丢弃，四名知情人士表示，美国官员现在预计该公司最早要到明年才能获得FDA对疫苗的批准。</blockquote></p><p> “At some level, I think the efficacy was never going to outweigh the risk associated with the impurity that was in there,” said one of the people with knowledge of the matter. “I’m not surprised this is where we are.”</p><p><blockquote>“在某种程度上，我认为功效永远不会超过与其中杂质相关的风险，”一位知情人士说。“我并不惊讶我们会在这里。”</blockquote></p><p></p>\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"NVAX":"诺瓦瓦克斯医药"},"is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1174375951","content_text":"(Oct 20)  Novavax may delay the delivery of 1 billion doses of coronavirus vaccine because of the production problems.\nThe world’s vaccine distributor has been counting on U.S. companies to provide more than 2 billion doses to lower and middle-income countries by the end of 2022 — a crucial step in ending the Covid-19 pandemic.\nBut the campaign run by the international consortium known as COVAX, which has already been delayed significantly because of production lags, is now likely to fall short by more than 1 billion doses as a key supplier faces significant hurdles in proving it can manufacture a shot that meets regulators’ quality standards, according to three people with direct knowledge of the company’s problems.\nThe delay, which was confirmed by three other people familiar with the discussions between Maryland-based Novavax and the Biden administration, represents a major setback in the effort to vaccinate the world in the wake of new, more transmissible variants.\nThe U.S. government invested $1.6 billion in Novavax in 2020 — the most it devoted to any vaccine maker at the time — in hopes that it would offer the world another option for a safe and effective vaccine to help protect against Covid-19. But the company has consistently run into production problems. The methods it used to test the purity of the vaccine have fallen short of regulators’ standards and the company has not been able to prove that it can produce a shot that is consistently up to snuff, according to multiple people familiar with Novavax’s difficulties. All spoke on the condition of anonymity to discuss sensitive company conversations.\nAlthough Novavax recently attested to some of its analytics and testing issues in aquarterly filing with the Securities and Exchange Commission, the company’s issues are more concerning than previously understood, according to two of the people with direct knowledge of the matter.\nThe Food and Drug Administration works out purity levels with each manufacturer according to June 2020 guidance for coronavirus vaccines, but it is generally understood that each vaccine batch should reach at least 90 percent. The company has struggled to attain anywhere close to that, one of the people with direct knowledge of the situation said. Another person familiar with the company’s manufacturing process said Novavax has recently shown purity levels hovering around 70 percent. Low purity levels increase the chance that contaminants or unnecessary substances are in the final product, rendering the vaccine less effective or introducing the chance that patients could react to unknown ingredients.\nCOVAX, which recently downgraded its 2021 goal from 2 billion to 1.425 billion doses, has already estimated that it faces a supply shortfall of as many as 1 billion doses in its effort to vaccinate the developing world. If Novavax falters, it could double the deficit through 2022, leaving hundreds of millions of people without immunity against Covid-19 and extending the pandemic.\n“COVAX continues to be challenged for adequate supply … in that context, Novavax’s manufacturing challenges and delays have been massively disruptive,” said Krishna Udayakumar, director of the Duke Global Health Innovation Center.\nThe global coalition is already behind on hundreds of millions of planned doses this month, having shipped just 371 million of its 700 million dose target for October. It is now also at risk of missing its already downgraded 2021 target.\nBetween Novavax and other manufacturers’ hurdles, “COVAX has had to scramble to revise its supply strategy significantly in real time,” Udayakumar said. As a result, global health groups are emphasizing more donations to cover immediate needs, he added.\nIn a statement, Novavax Senior Vice President of Investor Relations and Corporate Affairs Silvia Taylor told POLITICO that the company’s analytical testing methods have been “validated” — but did not answer questions about whether the FDA had signed off on them. The company still plans on filing an emergency use authorization by the end of the year, Taylor said.\n“The vaccine development and regulatory submission processes are highly complex and often require years to advance to the point where we are now. We will fulfill all of our committed doses both in the US and globally,” Taylor said.\nThe White House and the Department of Health and Human Services did not respond to multiple requests for comment.\nBut three people familiar with the matter said they are not confident that the company has the resources needed to reproduce a high-quality vaccine on a consistent basis — a benchmark Novavax must meet before that time. Those same people said Novavax could potentially fix its manufacturing issues and reach full licensure by the end of 2022.\nNovavax — which has never produced a vaccine before — declined to answer specific questions about its product’s purity levels and whether it had been successful in addressing its longstanding manufacturing issues.\nUnlike Pfizer and Moderna, the first manufacturers to launch vaccines using rapidly produced messenger RNA, Novavax is employing the previously used but complicated approach of creating the key ingredient with bug cells. While the process, which involves infecting the cells to produce spike proteins, is familiar to scientists, it is difficult to scale.\nThe revelations about Novavax’s continued manufacturing problems come at a time when only 36 percent of the world is vaccinated and as leaders of developing nations continue to pressure the U.S. to deliver more doses. In Africa alone, only 4.4 percent of the population is vaccinated.\nThat includes some of the continent’s most populous nations, like Nigeria and Uganda, where about 1 percent of citizens are fully vaccinated.\nNovavax is just the latest vaccine maker to run into core production problems after promising to serve as a major vaccine contributor to the developing world. In April, Johnson & Johnsonhalted work at a Baltimore facilityrun by contract manufacturer Emergent BioSolutions after it found that 15 million doses had been accidentally contaminated with ingredients from a separate Covid-19 vaccine.\nJ&J’s manufacturing process has been slow to recover, and to date it has produced just a fraction of the 200 million shots it initially pledged to COVAX by the end of the year, according to records kept by UNICEF.\n“Overpromising and underdelivering is the name of the game for these manufacturers,” said Asia Russell, executive director of international advocacy group Health GAP. “And that’s the infrastructure of the global response, which is terrifying.”\nUnlike Johnson & Johnson, Novavax is a novice in the vaccine world. It has never successfully launched a vaccine, and had struggled financially prior to the pandemic. After a string of drug development failures, it sold its manufacturing facilities in 2019 — a deal that also included parting with 100 employees. In May of that year, Novavax’s stock price dropped as low as 36 cents per share.\nYet the company’s fortunes shifted as Covid-19 took hold. Amid a scramble early in the pandemic to develop a range of vaccine candidates, the Trump administration awarded Novavax $1.6 billion to aid work on its Covid-19 shot — the largest deal given to any Covid-19 vaccine maker at that time.\nThe contract represented a major vote of confidence in Novavax’s capabilities — and a bet that appeared to pay off after late-stage trials showed the vaccine was 90 percent effective against the virus.\nBut even then, senior Trump administration officials on Operation Warp Speed — a group tasked with accelerating vaccine development — repeatedly warned the company that it risked running into problems in scaling up manufacturing of the shot, two people with direct knowledge of those discussions said.\nIn particular, they worried that Novavax would have difficulty ensuring that the vaccine consistently met the FDA’s rigorous quality standards once the vaccine went into mass production — the exact problem that has now stymied the company for months.\n“They rushed the process,” one of the people with knowledge of the matter said. “It’s hard to make. And they can’t make it.”\nTaylor, the Novavax spokesperson, said in a statement that it has incorporated feedback from regulators and has made “tremendous progress with the scale-up of our commercial manufacturing processes.” The company is still on track to produce 150 million doses a month by the end of the year, she said, and has stockpiled tens of millions of doses ahead of regulatory filings in the U.S. and internationally.\nCompany executives in recent presentations to investors have struck a similarly optimistic tone, downplaying the manufacturing snags and predicting it will soon be cleared to begin distributing doses. During aSept. 29 investor event, Chief Commercial Officer John Trizzino said the company had “resolved” its problems and was close to submitting a final regulatory application.\n“We’re really moving along with testing our lots now,” added Gregory Glenn, president of Novavax’s research and development, referring to batches of its vaccine. “We think that this is shortly going to come to a close.”\nU.S. officials working with the company are not as confident, according to three people with knowledge of the matter. Novavax’s manufacturing problems are seen as far more difficult to fix than the sanitary and design concerns that halted production of J&J’s vaccine at the Emergent plant earlier this year, those people said.\nAnd even as the company begins to seek regulatory approval in other countries, there remains doubt in the U.S. that it has solved the fundamental vaccine purity flaws that the people with knowledge said have affected its ability to make doses at plants around the world.\nSeveral vaccine batches have already been discarded, and four people with knowledge of the matter say U.S. officials now no longer expect the company to win FDA sign-off on the vaccine until next year at the earliest.\n“At some level, I think the efficacy was never going to outweigh the risk associated with the impurity that was in there,” said one of the people with knowledge of the matter. “I’m not surprised this is where we are.”","news_type":1,"symbols_score_info":{"NVAX":0.9}},"isVote":1,"tweetType":1,"viewCount":340,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":864833285,"gmtCreate":1633084991826,"gmtModify":1633084991917,"author":{"id":"3573538012135697","authorId":"3573538012135697","name":"Alvin牛仔背带裤","avatar":"https://static.tigerbbs.com/d141be403ec6eb25b1c85b5c797f9c49","crmLevel":11,"crmLevelSwitch":0,"followedFlag":false,"authorIdStr":"3573538012135697","idStr":"3573538012135697"},"themes":[],"htmlText":"X<a href=\"https://laohu8.com/S/NVAX\">$诺瓦瓦克斯医药(NVAX)$</a>just buy yolo","listText":"X<a href=\"https://laohu8.com/S/NVAX\">$诺瓦瓦克斯医药(NVAX)$</a>just buy yolo","text":"X$诺瓦瓦克斯医药(NVAX)$just buy yolo","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":1,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/864833285","isVote":1,"tweetType":1,"viewCount":443,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0}],"lives":[]}