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2021-09-03

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FDA Weighing Dose of Moderna Covid-19 Booster<blockquote>FDA称重Moderna Covid-19加强剂的剂量</blockquote>

Vaccine maker has asked agency to authorize booster at half the dose given in the first two shots.

FDA Weighing Dose of Moderna Covid-19 Booster<blockquote>FDA称重Moderna Covid-19加强剂的剂量</blockquote>

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Endemic creat revenue.","highlighted":1,"essential":1,"paper":1,"likeSize":3,"commentSize":2,"repostSize":0,"favoriteSize":0,"link":"https://laohu8.com/post/815328317","repostId":1194913620,"repostType":4,"repost":{"id":"1194913620","kind":"news","pubTimestamp":1630637588,"share":"https://www.laohu8.com/m/news/1194913620?lang=zh_CN&edition=full","pubTime":"2021-09-03 10:53","market":"us","language":"en","title":"FDA Weighing Dose of Moderna Covid-19 Booster<blockquote>FDA称重Moderna Covid-19加强剂的剂量</blockquote>","url":"https://stock-news.laohu8.com/highlight/detail?id=1194913620","media":"The Wall Street Journal","summary":"Vaccine maker has asked agency to authorize booster at half the dose given in the first two shots.\n\n","content":" Vaccine maker has asked agency to authorize booster at half the dose given in the first two shots. The Food and Drug Administration is considering whether to authorize a lower dose ofModernaInc.’sCovid-19 vaccine for boostersthan the dose given in the first two shots, people familiar with the deliberations said.<blockquote>疫苗制造商已要求机构授权前两次注射一半剂量的加强剂。知情人士称，美国食品和药物管理局正在考虑是否批准ModernaInc.的新冠肺炎疫苗加强剂剂量低于前两次注射的剂量。</blockquote> Moderna said Wednesday it is asking the FDA to authorize a 50 microgram dose, half the dosage of the first two shots. Some in the government are leaning toward authorizing the 100 microgram dose, the people said, because of concerns a lower-dose booster might not offer a durable enough boost to counterfast-changing variants of Covid-19.<blockquote>Moderna周三表示，正在要求FDA批准50微克的剂量，是前两次注射剂量的一半。知情人士说，政府中的一些人倾向于授权100微克的剂量，因为担心较低剂量的加强剂可能无法提供足够持久的加强来对抗快速变化的新冠肺炎变种。</blockquote> No final decision has been made, the people said, as the FDA is still reviewing data from studies that tested boosters using the different doses. People who have seen the data said both doses produce a strong immune response.<blockquote>知情人士表示，尚未做出最终决定，因为FDA仍在审查使用不同剂量测试加强剂的研究数据。看过数据的人表示，两种剂量都会产生强烈的免疫反应。</blockquote> Complicating the decision is the fact that the FDA has limited comparative data on which to base their choice, one person familiar with the discussions said.<blockquote>一位知情人士表示，FDA做出选择所依据的比较数据有限，这一决定变得更加复杂。</blockquote> The continuing deliberations are a reason the agency hasn’t yet authorized boosters, though the people expect a decision soon.<blockquote>持续的审议是该机构尚未授权助推器的一个原因，尽管人们预计很快就会做出决定。</blockquote> One possible benefit of a lower dose is fewer side effects, people familiar with the matter said.<blockquote>知情人士说，较低剂量的一个可能好处是副作用更少。</blockquote> Last month, the Biden administration recommended that adults who got a messenger RNA vaccine from either Moderna orPfizerInc.and partnerBioNTech SEstartgetting boosters this month.<blockquote>上个月，拜登政府建议从Moderna或辉瑞公司及其合作伙伴BioNTech接种信使RNA疫苗的成年人本月开始接种加强剂。</blockquote> Johnson &amp; Johnson’svaccine is also expected to be included in the boosting strategy,after releasing the first resultsabout its boosters last month. The company said it is engaging with the FDA.<blockquote>强生公司的疫苗在上个月发布了第一批加强剂结果后，预计也将被纳入加强策略。该公司表示正在与FDA合作。</blockquote> There is no debate about the booster doses to administer for the Pfizer-BioNTech or J&amp;J vaccines, one of the people said, though a decision on the J&amp;J booster might take longer. Their boosters will be the same doses as the first shots, the person said.<blockquote>其中一位知情人士表示，关于辉瑞-BioNTech或强生疫苗的加强剂量没有争议，尽管强生加强剂量的决定可能需要更长时间。该人士说，他们的加强剂量将与第一针相同。</blockquote> After initially spurning talk about boosters, federal health officials embraced the idea as the contagious Delta variant drove up case counts, even among some peoplewho were vaccinated.<blockquote>在最初拒绝有关加强剂的讨论后，联邦卫生官员接受了这一想法，因为传染性德尔塔变异毒株导致病例数上升，甚至在一些接种疫苗的人中也是如此。</blockquote> Also contributing to the change of mind was emerging but inconclusive evidence, from researchers in Israel and elsewhere, suggesting the molecular defenses triggered by vaccinationwanes after several months.<blockquote>来自以色列和其他地方的研究人员的新证据表明，接种疫苗引发的分子防御在几个月后减弱，这也有助于人们改变想法。</blockquote> Whether boosters are needed remains up for debate. Some researchers say the evidence is insufficient, while the World Health Organization has urged giving shots to peoplein countries with limited supplies.<blockquote>是否需要助推器仍有争议。一些研究人员表示，证据不足，而世界卫生组织敦促为供应有限的国家的人们注射疫苗。</blockquote> Moderna and the National Institutes of Health tested both 50 mcg and 100 mcg booster doses in clinical trials.<blockquote>Moderna和美国国立卫生研究院在临床试验中测试了50微克和100微克的加强剂量。</blockquote> Last month, Modernareleased initial datashowing that a 50 mcg booster strengthened antibodies against Delta and other variants of concern significantly higher than the levels after trial subjects received their two initial doses.<blockquote>上个月，ModernA发布的初步数据显示，50 mcg加强剂增强了针对Delta和其他令人担忧的变体的抗体，明显高于试验受试者接受两次初始剂量后的水平。</blockquote> The Cambridge, Mass., company has been urging the FDA in recent weeks to authorize a 50 mcg booster, according to people familiar with the matter and a statement announcing its submission on Wednesday.<blockquote>马萨诸塞州剑桥。据知情人士和周三宣布提交的一份声明称，该公司最近几周一直在敦促FDA授权一种50微克的加强剂。</blockquote> The company declined to answer questions early this week about its talks with the FDA, before issuing a statement, saying it had applied for the booster dose authorization at the 50 mcg level.<blockquote>该公司本周早些时候拒绝回答有关其与FDA谈判的问题，然后发表声明称，它已申请50微克水平的加强剂量授权。</blockquote> Authorization of a lower dose would allow Moderna to manufacture up to three billion boosters next year, as many as one billion more than it could make of the higher dose.<blockquote>较低剂量的授权将使Moderna明年能够生产多达30亿个加强剂，比较高剂量的多出多达10亿个。</blockquote> Yet it would pose several logistical challenges, another person familiar with the discussions said.<blockquote>然而，另一位知情人士表示，这将带来一些后勤挑战。</blockquote> The different dosages may cause confusion at vaccination sites, the people said. Pharmacists would have to prepare the doses in different ways. Nurses would have to be careful to give people the right dose.<blockquote>知情人士说，不同的剂量可能会在疫苗接种点造成混乱。药剂师将不得不以不同的方式准备剂量。护士必须小心给人们正确的剂量。</blockquote> Another issue, the person said, is a lower dose would lead to some wasted vaccine, at least until new, smaller vials begin arriving in October.<blockquote>这位人士说，另一个问题是，较低的剂量会导致一些疫苗被浪费，至少在10月份新的、更小的疫苗瓶开始到达之前是这样。</blockquote> Current Moderna vials contain enough vaccine for 14 100 mcg doses, but not all of that could be used for smaller doses because the vials can only be entered a certain number of times.<blockquote>目前的Moderna小瓶包含足够14 100 mcg剂量的疫苗，但并非所有这些都可以用于较小剂量，因为小瓶只能进入一定次数。</blockquote> The U.S. has ordered smaller vials already because they are easier for doctors’ offices and other providers to administer, the person said.<blockquote>这位人士说，美国已经订购了较小的小瓶，因为它们更容易被医生办公室和其他供应商管理。</blockquote> It couldn’t be determined why people getting a Moderna booster might need a lower dose than people getting another manufacturer’s vaccine.<blockquote>无法确定为什么接种Moderna加强剂的人可能比接种另一家制造商疫苗的人需要更低的剂量。</blockquote> Astudy of Belgian healthcare workerspublished Monday in a letter to the Journal of American Medical Association found that Moderna’s vaccine created twice as many antibodies as the Pfizer-BioNTech vaccine.<blockquote>周一在致《美国医学会杂志》的一封信中发表的一项针对比利时医护人员的研究发现，Moderna的疫苗产生的抗体是辉瑞BioNTech疫苗的两倍。</blockquote> The researchers said the difference might be explained by the higher mRNA content in Moderna’s vaccine as compared with Pfizer-BioNTech’s, as well as the week longer interval between shots for the Moderna vaccine.<blockquote>研究人员表示，与辉瑞-BioNTech的疫苗相比，Moderna疫苗的mRNA含量更高，以及Moderna疫苗的注射间隔更长一周。</blockquote> U.S. health officials are still figuring out the timing of exactly when people will be eligible to receive boosters.<blockquote>美国卫生官员仍在计算人们何时有资格接受加强剂的确切时间。</blockquote> Federal health officials initially said it would be eight months after people have received two doses. The Wall Street Journal has reported the FDA is likelyto authorize boosters at six months.<blockquote>联邦卫生官员最初表示，人们接种两剂疫苗需要八个月后。《华尔街日报》报道称，FDA可能会在六个月后批准加强剂。</blockquote> President Biden said last week that his administration is weighing whether to begin before eight months, perhaps as early as five months.<blockquote>拜登总统上周表示，他的政府正在权衡是否在八个月前开始，也许最早五个月。</blockquote>","collect":0,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>FDA Weighing Dose of Moderna Covid-19 Booster<blockquote>FDA称重Moderna Covid-19加强剂的剂量</blockquote></title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\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: 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\">\nFDA Weighing Dose of Moderna Covid-19 Booster<blockquote>FDA称重Moderna Covid-19加强剂的剂量</blockquote>\n</h2>\n<h4 class=\"meta\">\n\nThe Wall Street Journal2021-09-03 10:53\n\n</h4>\n</header>\n<article>\n Vaccine maker has asked agency to authorize booster at half the dose given in the first two shots. The Food and Drug Administration is considering whether to authorize a lower dose ofModernaInc.’sCovid-19 vaccine for boostersthan the dose given in the first two shots, people familiar with the deliberations said.<blockquote>疫苗制造商已要求机构授权前两次注射一半剂量的加强剂。知情人士称，美国食品和药物管理局正在考虑是否批准ModernaInc.的新冠肺炎疫苗加强剂剂量低于前两次注射的剂量。</blockquote> Moderna said Wednesday it is asking the FDA to authorize a 50 microgram dose, half the dosage of the first two shots. Some in the government are leaning toward authorizing the 100 microgram dose, the people said, because of concerns a lower-dose booster might not offer a durable enough boost to counterfast-changing variants of Covid-19.<blockquote>Moderna周三表示，正在要求FDA批准50微克的剂量，是前两次注射剂量的一半。知情人士说，政府中的一些人倾向于授权100微克的剂量，因为担心较低剂量的加强剂可能无法提供足够持久的加强来对抗快速变化的新冠肺炎变种。</blockquote> No final decision has been made, the people said, as the FDA is still reviewing data from studies that tested boosters using the different doses. People who have seen the data said both doses produce a strong immune response.<blockquote>知情人士表示，尚未做出最终决定，因为FDA仍在审查使用不同剂量测试加强剂的研究数据。看过数据的人表示，两种剂量都会产生强烈的免疫反应。</blockquote> Complicating the decision is the fact that the FDA has limited comparative data on which to base their choice, one person familiar with the discussions said.<blockquote>一位知情人士表示，FDA做出选择所依据的比较数据有限，这一决定变得更加复杂。</blockquote> The continuing deliberations are a reason the agency hasn’t yet authorized boosters, though the people expect a decision soon.<blockquote>持续的审议是该机构尚未授权助推器的一个原因，尽管人们预计很快就会做出决定。</blockquote> One possible benefit of a lower dose is fewer side effects, people familiar with the matter said.<blockquote>知情人士说，较低剂量的一个可能好处是副作用更少。</blockquote> Last month, the Biden administration recommended that adults who got a messenger RNA vaccine from either Moderna orPfizerInc.and partnerBioNTech SEstartgetting boosters this month.<blockquote>上个月，拜登政府建议从Moderna或辉瑞公司及其合作伙伴BioNTech接种信使RNA疫苗的成年人本月开始接种加强剂。</blockquote> Johnson &amp; Johnson’svaccine is also expected to be included in the boosting strategy,after releasing the first resultsabout its boosters last month. The company said it is engaging with the FDA.<blockquote>强生公司的疫苗在上个月发布了第一批加强剂结果后，预计也将被纳入加强策略。该公司表示正在与FDA合作。</blockquote> There is no debate about the booster doses to administer for the Pfizer-BioNTech or J&amp;J vaccines, one of the people said, though a decision on the J&amp;J booster might take longer. Their boosters will be the same doses as the first shots, the person said.<blockquote>其中一位知情人士表示，关于辉瑞-BioNTech或强生疫苗的加强剂量没有争议，尽管强生加强剂量的决定可能需要更长时间。该人士说，他们的加强剂量将与第一针相同。</blockquote> After initially spurning talk about boosters, federal health officials embraced the idea as the contagious Delta variant drove up case counts, even among some peoplewho were vaccinated.<blockquote>在最初拒绝有关加强剂的讨论后，联邦卫生官员接受了这一想法，因为传染性德尔塔变异毒株导致病例数上升，甚至在一些接种疫苗的人中也是如此。</blockquote> Also contributing to the change of mind was emerging but inconclusive evidence, from researchers in Israel and elsewhere, suggesting the molecular defenses triggered by vaccinationwanes after several months.<blockquote>来自以色列和其他地方的研究人员的新证据表明，接种疫苗引发的分子防御在几个月后减弱，这也有助于人们改变想法。</blockquote> Whether boosters are needed remains up for debate. Some researchers say the evidence is insufficient, while the World Health Organization has urged giving shots to peoplein countries with limited supplies.<blockquote>是否需要助推器仍有争议。一些研究人员表示，证据不足，而世界卫生组织敦促为供应有限的国家的人们注射疫苗。</blockquote> Moderna and the National Institutes of Health tested both 50 mcg and 100 mcg booster doses in clinical trials.<blockquote>Moderna和美国国立卫生研究院在临床试验中测试了50微克和100微克的加强剂量。</blockquote> Last month, Modernareleased initial datashowing that a 50 mcg booster strengthened antibodies against Delta and other variants of concern significantly higher than the levels after trial subjects received their two initial doses.<blockquote>上个月，ModernA发布的初步数据显示，50 mcg加强剂增强了针对Delta和其他令人担忧的变体的抗体，明显高于试验受试者接受两次初始剂量后的水平。</blockquote> The Cambridge, Mass., company has been urging the FDA in recent weeks to authorize a 50 mcg booster, according to people familiar with the matter and a statement announcing its submission on Wednesday.<blockquote>马萨诸塞州剑桥。据知情人士和周三宣布提交的一份声明称，该公司最近几周一直在敦促FDA授权一种50微克的加强剂。</blockquote> The company declined to answer questions early this week about its talks with the FDA, before issuing a statement, saying it had applied for the booster dose authorization at the 50 mcg level.<blockquote>该公司本周早些时候拒绝回答有关其与FDA谈判的问题，然后发表声明称，它已申请50微克水平的加强剂量授权。</blockquote> Authorization of a lower dose would allow Moderna to manufacture up to three billion boosters next year, as many as one billion more than it could make of the higher dose.<blockquote>较低剂量的授权将使Moderna明年能够生产多达30亿个加强剂，比较高剂量的多出多达10亿个。</blockquote> Yet it would pose several logistical challenges, another person familiar with the discussions said.<blockquote>然而，另一位知情人士表示，这将带来一些后勤挑战。</blockquote> The different dosages may cause confusion at vaccination sites, the people said. Pharmacists would have to prepare the doses in different ways. Nurses would have to be careful to give people the right dose.<blockquote>知情人士说，不同的剂量可能会在疫苗接种点造成混乱。药剂师将不得不以不同的方式准备剂量。护士必须小心给人们正确的剂量。</blockquote> Another issue, the person said, is a lower dose would lead to some wasted vaccine, at least until new, smaller vials begin arriving in October.<blockquote>这位人士说，另一个问题是，较低的剂量会导致一些疫苗被浪费，至少在10月份新的、更小的疫苗瓶开始到达之前是这样。</blockquote> Current Moderna vials contain enough vaccine for 14 100 mcg doses, but not all of that could be used for smaller doses because the vials can only be entered a certain number of times.<blockquote>目前的Moderna小瓶包含足够14 100 mcg剂量的疫苗，但并非所有这些都可以用于较小剂量，因为小瓶只能进入一定次数。</blockquote> The U.S. has ordered smaller vials already because they are easier for doctors’ offices and other providers to administer, the person said.<blockquote>这位人士说，美国已经订购了较小的小瓶，因为它们更容易被医生办公室和其他供应商管理。</blockquote> It couldn’t be determined why people getting a Moderna booster might need a lower dose than people getting another manufacturer’s vaccine.<blockquote>无法确定为什么接种Moderna加强剂的人可能比接种另一家制造商疫苗的人需要更低的剂量。</blockquote> Astudy of Belgian healthcare workerspublished Monday in a letter to the Journal of American Medical Association found that Moderna’s vaccine created twice as many antibodies as the Pfizer-BioNTech vaccine.<blockquote>周一在致《美国医学会杂志》的一封信中发表的一项针对比利时医护人员的研究发现，Moderna的疫苗产生的抗体是辉瑞BioNTech疫苗的两倍。</blockquote> The researchers said the difference might be explained by the higher mRNA content in Moderna’s vaccine as compared with Pfizer-BioNTech’s, as well as the week longer interval between shots for the Moderna vaccine.<blockquote>研究人员表示，与辉瑞-BioNTech的疫苗相比，Moderna疫苗的mRNA含量更高，以及Moderna疫苗的注射间隔更长一周。</blockquote> U.S. health officials are still figuring out the timing of exactly when people will be eligible to receive boosters.<blockquote>美国卫生官员仍在计算人们何时有资格接受加强剂的确切时间。</blockquote> Federal health officials initially said it would be eight months after people have received two doses. The Wall Street Journal has reported the FDA is likelyto authorize boosters at six months.<blockquote>联邦卫生官员最初表示，人们接种两剂疫苗需要八个月后。《华尔街日报》报道称，FDA可能会在六个月后批准加强剂。</blockquote> President Biden said last week that his administration is weighing whether to begin before eight months, perhaps as early as five months.<blockquote>拜登总统上周表示，他的政府正在权衡是否在八个月前开始，也许最早五个月。</blockquote>\n<div class=\"bt-text\">\n\n\n 来源：<a href=\"https://www.wsj.com/articles/fda-weighing-dose-of-moderna-covid-19-booster-11630593980?mod=business_lead_pos5\">The Wall Street Journal</a>\n为提升您的阅读体验，我们对本页面进行了排版优化\n\n\n</div>\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"MRNA":"Moderna, Inc."},"source_url":"https://www.wsj.com/articles/fda-weighing-dose-of-moderna-covid-19-booster-11630593980?mod=business_lead_pos5","is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1194913620","content_text":"Vaccine maker has asked agency to authorize booster at half the dose given in the first two shots.\n\nThe Food and Drug Administration is considering whether to authorize a lower dose ofModernaInc.’sCovid-19 vaccine for boostersthan the dose given in the first two shots, people familiar with the deliberations said.\nModerna said Wednesday it is asking the FDA to authorize a 50 microgram dose, half the dosage of the first two shots. Some in the government are leaning toward authorizing the 100 microgram dose, the people said, because of concerns a lower-dose booster might not offer a durable enough boost to counterfast-changing variants of Covid-19.\nNo final decision has been made, the people said, as the FDA is still reviewing data from studies that tested boosters using the different doses. People who have seen the data said both doses produce a strong immune response.\nComplicating the decision is the fact that the FDA has limited comparative data on which to base their choice, one person familiar with the discussions said.\nThe continuing deliberations are a reason the agency hasn’t yet authorized boosters, though the people expect a decision soon.\nOne possible benefit of a lower dose is fewer side effects, people familiar with the matter said.\nLast month, the Biden administration recommended that adults who got a messenger RNA vaccine from either Moderna orPfizerInc.and partnerBioNTech SEstartgetting boosters this month.\nJohnson & Johnson’svaccine is also expected to be included in the boosting strategy,after releasing the first resultsabout its boosters last month. The company said it is engaging with the FDA.\nThere is no debate about the booster doses to administer for the Pfizer-BioNTech or J&J vaccines, one of the people said, though a decision on the J&J booster might take longer. Their boosters will be the same doses as the first shots, the person said.\nAfter initially spurning talk about boosters, federal health officials embraced the idea as the contagious Delta variant drove up case counts, even among some peoplewho were vaccinated.\nAlso contributing to the change of mind was emerging but inconclusive evidence, from researchers in Israel and elsewhere, suggesting the molecular defenses triggered by vaccinationwanes after several months.\nWhether boosters are needed remains up for debate. Some researchers say the evidence is insufficient, while the World Health Organization has urged giving shots to peoplein countries with limited supplies.\nModerna and the National Institutes of Health tested both 50 mcg and 100 mcg booster doses in clinical trials.\nLast month, Modernareleased initial datashowing that a 50 mcg booster strengthened antibodies against Delta and other variants of concern significantly higher than the levels after trial subjects received their two initial doses.\nThe Cambridge, Mass., company has been urging the FDA in recent weeks to authorize a 50 mcg booster, according to people familiar with the matter and a statement announcing its submission on Wednesday.\nThe company declined to answer questions early this week about its talks with the FDA, before issuing a statement, saying it had applied for the booster dose authorization at the 50 mcg level.\nAuthorization of a lower dose would allow Moderna to manufacture up to three billion boosters next year, as many as one billion more than it could make of the higher dose.\nYet it would pose several logistical challenges, another person familiar with the discussions said.\nThe different dosages may cause confusion at vaccination sites, the people said. Pharmacists would have to prepare the doses in different ways. Nurses would have to be careful to give people the right dose.\nAnother issue, the person said, is a lower dose would lead to some wasted vaccine, at least until new, smaller vials begin arriving in October.\nCurrent Moderna vials contain enough vaccine for 14 100 mcg doses, but not all of that could be used for smaller doses because the vials can only be entered a certain number of times.\nThe U.S. has ordered smaller vials already because they are easier for doctors’ offices and other providers to administer, the person said.\nIt couldn’t be determined why people getting a Moderna booster might need a lower dose than people getting another manufacturer’s vaccine.\nAstudy of Belgian healthcare workerspublished Monday in a letter to the Journal of American Medical Association found that Moderna’s vaccine created twice as many antibodies as the Pfizer-BioNTech vaccine.\nThe researchers said the difference might be explained by the higher mRNA content in Moderna’s vaccine as compared with Pfizer-BioNTech’s, as well as the week longer interval between shots for the Moderna vaccine.\nU.S. health officials are still figuring out the timing of exactly when people will be eligible to receive boosters.\nFederal health officials initially said it would be eight months after people have received two doses. The Wall Street Journal has reported the FDA is likelyto authorize boosters at six months.\nPresident Biden said last week that his administration is weighing whether to begin before eight months, perhaps as early as five months.","news_type":1,"symbols_score_info":{"MRNA":0.9}},"isVote":1,"tweetType":1,"viewCount":1515,"commentLimit":10,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"symbols":[],"verified":2,"subType":0,"readableState":1,"langContent":"EN","currentLanguage":"EN","warmUpFlag":false,"orderFlag":false,"shareable":true,"causeOfNotShareable":"","featuresForAnalytics":[],"commentAndTweetFlag":false,"andRepostAutoSelectedFlag":false,"upFlag":false,"length":46,"xxTargetLangEnum":"ORIG"},"commentList":[],"hasMoreComment":false,"orderType":2}

FDA Weighing Dose of Moderna Covid-19 Booster<blockquote>FDA称重Moderna Covid-19加强剂的剂量</blockquote>

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