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2021-12-17

Is who liable for what they recommended?

CDC Advisers Recommend Pfizer, Moderna Covid-19 Vaccines Over J&J’s

U.S. vaccine advisers recommended adults take a Covid-19 vaccine from Pfizer Inc. PFE 4.17% or Moder

CDC Advisers Recommend Pfizer, Moderna Covid-19 Vaccines Over J&J’s

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PFE 4.17% or Moder","content":"U.S. vaccine advisers recommended adults take a Covid-19 vaccine from Pfizer Inc. PFE 4.17% or Moderna Inc. MRNA -0.44% over Johnson &amp; Johnson’s JNJ 1.09% after health authorities said the rate of a rare but serious blood-clotting condition was higher than previously detected.\n\nThe Advisory Committee on Immunization Practices voted 15 to 0 to make the recommendation Thursday after hearing updates from Centers for Disease Control and Prevention officials on reports of J&amp;J vaccine recipients experiencing blood clots combined with low blood-platelet levels.\n\nThe updated position is likely to deal another blow to the use of the J&amp;J shot, whose uptake had been hurt by manufacturing issues and earlier reports of the blood-clotting condition.\n\nThere have been at least 54 cases of the condition, thrombosis with thrombocytopenia syndrome, or TTS, among J&amp;J vaccine recipients in the U.S., including nine resulting in deaths, CDC officials said Thursday.\n\nThe rate of cases is higher than previously estimated in both men and women, and in a wider age range, the officials said.\n\n“I just cannot recommend vaccines associated with a condition that may lead to death,” said committee member Pablo Sanchez, a pediatric infectious-disease specialist at the Ohio State University-Nationwide Children’s Hospital in Columbus, Ohio.\n\nJ&amp;J said it remained confident in the overall positive benefit-risk profile of its vaccine. “The safety and well-being of those who use the Johnson &amp; Johnson vaccine continues to be our number one priority,” said Mathai Mammen, global head of J&amp;J’s pharmaceutical research and development.\n\nHe said the company will work with the CDC on next steps, and strongly supports education about rare events such as TTS, and how to manage it.\n\nJ&amp;J’s Covid-19 vaccine is based on a different technology than the messenger RNA used in the Pfizer and Moderna shots.\n\nJ&amp;J’s vaccine includes a harmless version of a virus that can cause the common cold, which is engineered to contain genetic instructions that set off an immune response against the coronavirus. The mRNA vaccines don’t contain any viral material, and use a different way of delivering a genetic code that sets off an immune response against the coronavirus.\n\nEarlier this year, federal health authorities paused the use of J&amp;J’s vaccine while they investigated the condition TTS. Use of the vaccine resumed in April after health authorities concluded its benefits still outweighed the risks.\n\nThe ACIP, which advises the CDC on vaccine policy, voted in April to resume use of J&amp;J’s vaccine, after meeting twice to discuss the issue. Warnings about the risk were added to fact sheets given to vaccine providers and recipients, including that the risk appeared highest among women ages 30 to 49.\nAt that time, a total of 15 cases of TTS had been reported among nearly 7 million vaccine doses administered. All of the cases occurred in women between the ages of 18 and 59, with a median age of 37 years. Symptoms developed between six and 15 days after vaccination.\n\nAs of Aug. 31, CDC officials said at the advisers’ meeting, about 3.8 cases of TTS were reported for every million doses of J&amp;J vaccine administered, across all recipients. The rate was highest among women ages 30 to 39, at 10.6 per million doses.\n\nCDC officials also said that among those who develop TTS, the fatality rate was about 15%. The people who died deteriorated quickly after being admitted to the hospital, officials said.\n\nCDC officials said getting J&amp;J’s vaccine was still superior to not getting vaccinated, but the balance between the benefits and risks for the messenger RNA vaccines from Pfizer-BioNTech and Moderna was superior to J&amp;J’s. And the current supply of mRNA vaccines in the U.S. is adequate, unlike earlier in the year.\n\nA recommendation by the ACIP isn’t binding on vaccine providers or recipients, but it will carry significant weight because it has been rare for the committee to express a preference for one vaccine over another.\n\n\nSome committee members said that the J&amp;J vaccine should remain available for people who aren’t able to take the mRNA vaccines.\n\nHealth officials say people with an allergy to ingredients in the mRNA vaccines, or who have had a severe allergic reaction to a dose of those vaccines, should not receive them.\n\nThe mRNA vaccines also carry a risk of causing heart-inflammation conditions including myocarditis, particularly among males under the age of 30. Yet health officials have said the benefits of preventing Covid-19 hospitalizations and deaths outweigh the myocarditis risk.\n\nPenny Heaton, global therapeutic area head of vaccines at J&amp;J, told committee members that the company has been monitoring the safety of the vaccine, including the TTS risk. The vaccine is a life-saving tool, she said, and the company is supplying hundreds of millions of doses around the world.\n\nPartly because of the safety concerns, J&amp;J’s single-dose vaccine has been used much less than the two-dose vaccines from Moderna and Pfizer with its partner BioNTech SE.\n\nAbout 16.1 million people in the U.S. have received J&amp;J’s vaccine, according to the CDC. About 870,000 booster doses of J&amp;J’s vaccine have been administered.\n\nMore than 113 million people have received two doses of the Pfizer-BioNTech vaccine and more than 72 million have received the two-dose Moderna vaccine in the U.S. More than 30 million booster doses of the Pfizer vaccine and 24 million Moderna booster doses have been administered in the U.S., according to the CDC.\n\nJ&amp;J said Thursday it recently updated the fact sheet for its vaccine to say that it shouldn’t be administered to people who previously experienced TTS after receiving a prior dose of either the J&amp;J vaccine or other vaccines with a similar adenovirus-based design.\n\nOther shots with a similar design include AstraZeneca PLC’s Covid-19 vaccine, which is available outside the U.S. but not in the U.S.\n\nThe recommendation threatens to affect support for J&amp;J’s vaccine outside the U.S., including in countries struggling to increase their supplies of doses, just as J&amp;J has begun shipping shots that Merck &amp; Co. helped produce.\n\nThe CDC advisory committee members didn’t consider a recommendation against the use of J&amp;J’s vaccine partly because such a move could undermine confidence in the vaccine in countries where people have better access to J&amp;J’s vaccine over the mRNA vaccines.","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>CDC Advisers Recommend Pfizer, Moderna Covid-19 Vaccines Over J&J’s</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: 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\">\nCDC Advisers Recommend Pfizer, Moderna Covid-19 Vaccines Over J&J’s\n</h2>\n\n<h4 class=\"meta\">\n\n\n2021-12-17 07:00 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://www.wsj.com/articles/cdc-advisers-review-blood-clotting-risk-associated-with-j-js-covid-19-vaccine-11639662363?mod=hp_lead_pos1>The Wall Street Journal</a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\nU.S. vaccine advisers recommended adults take a Covid-19 vaccine from Pfizer Inc. PFE 4.17% or Moderna Inc. MRNA -0.44% over Johnson & Johnson’s JNJ 1.09% after health authorities said the rate of a ...\n\n<a href=\"https://www.wsj.com/articles/cdc-advisers-review-blood-clotting-risk-associated-with-j-js-covid-19-vaccine-11639662363?mod=hp_lead_pos1\">Web Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"MRNA":"Moderna, Inc.","PFE":"辉瑞"},"source_url":"https://www.wsj.com/articles/cdc-advisers-review-blood-clotting-risk-associated-with-j-js-covid-19-vaccine-11639662363?mod=hp_lead_pos1","is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1154960652","content_text":"U.S. vaccine advisers recommended adults take a Covid-19 vaccine from Pfizer Inc. PFE 4.17% or Moderna Inc. MRNA -0.44% over Johnson & Johnson’s JNJ 1.09% after health authorities said the rate of a rare but serious blood-clotting condition was higher than previously detected.\n\nThe Advisory Committee on Immunization Practices voted 15 to 0 to make the recommendation Thursday after hearing updates from Centers for Disease Control and Prevention officials on reports of J&J vaccine recipients experiencing blood clots combined with low blood-platelet levels.\n\nThe updated position is likely to deal another blow to the use of the J&J shot, whose uptake had been hurt by manufacturing issues and earlier reports of the blood-clotting condition.\n\nThere have been at least 54 cases of the condition, thrombosis with thrombocytopenia syndrome, or TTS, among J&J vaccine recipients in the U.S., including nine resulting in deaths, CDC officials said Thursday.\n\nThe rate of cases is higher than previously estimated in both men and women, and in a wider age range, the officials said.\n\n“I just cannot recommend vaccines associated with a condition that may lead to death,” said committee member Pablo Sanchez, a pediatric infectious-disease specialist at the Ohio State University-Nationwide Children’s Hospital in Columbus, Ohio.\n\nJ&J said it remained confident in the overall positive benefit-risk profile of its vaccine. “The safety and well-being of those who use the Johnson & Johnson vaccine continues to be our number one priority,” said Mathai Mammen, global head of J&J’s pharmaceutical research and development.\n\nHe said the company will work with the CDC on next steps, and strongly supports education about rare events such as TTS, and how to manage it.\n\nJ&J’s Covid-19 vaccine is based on a different technology than the messenger RNA used in the Pfizer and Moderna shots.\n\nJ&J’s vaccine includes a harmless version of a virus that can cause the common cold, which is engineered to contain genetic instructions that set off an immune response against the coronavirus. The mRNA vaccines don’t contain any viral material, and use a different way of delivering a genetic code that sets off an immune response against the coronavirus.\n\nEarlier this year, federal health authorities paused the use of J&J’s vaccine while they investigated the condition TTS. Use of the vaccine resumed in April after health authorities concluded its benefits still outweighed the risks.\n\nThe ACIP, which advises the CDC on vaccine policy, voted in April to resume use of J&J’s vaccine, after meeting twice to discuss the issue. Warnings about the risk were added to fact sheets given to vaccine providers and recipients, including that the risk appeared highest among women ages 30 to 49.\nAt that time, a total of 15 cases of TTS had been reported among nearly 7 million vaccine doses administered. All of the cases occurred in women between the ages of 18 and 59, with a median age of 37 years. Symptoms developed between six and 15 days after vaccination.\n\nAs of Aug. 31, CDC officials said at the advisers’ meeting, about 3.8 cases of TTS were reported for every million doses of J&J vaccine administered, across all recipients. The rate was highest among women ages 30 to 39, at 10.6 per million doses.\n\nCDC officials also said that among those who develop TTS, the fatality rate was about 15%. The people who died deteriorated quickly after being admitted to the hospital, officials said.\n\nCDC officials said getting J&J’s vaccine was still superior to not getting vaccinated, but the balance between the benefits and risks for the messenger RNA vaccines from Pfizer-BioNTech and Moderna was superior to J&J’s. And the current supply of mRNA vaccines in the U.S. is adequate, unlike earlier in the year.\n\nA recommendation by the ACIP isn’t binding on vaccine providers or recipients, but it will carry significant weight because it has been rare for the committee to express a preference for one vaccine over another.\n\n\nSome committee members said that the J&J vaccine should remain available for people who aren’t able to take the mRNA vaccines.\n\nHealth officials say people with an allergy to ingredients in the mRNA vaccines, or who have had a severe allergic reaction to a dose of those vaccines, should not receive them.\n\nThe mRNA vaccines also carry a risk of causing heart-inflammation conditions including myocarditis, particularly among males under the age of 30. Yet health officials have said the benefits of preventing Covid-19 hospitalizations and deaths outweigh the myocarditis risk.\n\nPenny Heaton, global therapeutic area head of vaccines at J&J, told committee members that the company has been monitoring the safety of the vaccine, including the TTS risk. The vaccine is a life-saving tool, she said, and the company is supplying hundreds of millions of doses around the world.\n\nPartly because of the safety concerns, J&J’s single-dose vaccine has been used much less than the two-dose vaccines from Moderna and Pfizer with its partner BioNTech SE.\n\nAbout 16.1 million people in the U.S. have received J&J’s vaccine, according to the CDC. About 870,000 booster doses of J&J’s vaccine have been administered.\n\nMore than 113 million people have received two doses of the Pfizer-BioNTech vaccine and more than 72 million have received the two-dose Moderna vaccine in the U.S. More than 30 million booster doses of the Pfizer vaccine and 24 million Moderna booster doses have been administered in the U.S., according to the CDC.\n\nJ&J said Thursday it recently updated the fact sheet for its vaccine to say that it shouldn’t be administered to people who previously experienced TTS after receiving a prior dose of either the J&J vaccine or other vaccines with a similar adenovirus-based design.\n\nOther shots with a similar design include AstraZeneca PLC’s Covid-19 vaccine, which is available outside the U.S. but not in the U.S.\n\nThe recommendation threatens to affect support for J&J’s vaccine outside the U.S., including in countries struggling to increase their supplies of doses, just as J&J has begun shipping shots that Merck & Co. helped produce.\n\nThe CDC advisory committee members didn’t consider a recommendation against the use of J&J’s vaccine partly because such a move could undermine confidence in the vaccine in countries where people have better access to J&J’s vaccine over the mRNA vaccines.","news_type":1},"isVote":1,"tweetType":1,"viewCount":734,"commentLimit":10,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"symbols":[],"verified":2,"subType":0,"readableState":1,"langContent":"CN","currentLanguage":"CN","warmUpFlag":false,"orderFlag":false,"shareable":true,"causeOfNotShareable":"","featuresForAnalytics":[],"commentAndTweetFlag":false,"upFlag":false,"length":34,"xxTargetLangEnum":"ZH_CN"},"commentList":[],"hasMoreComment":false,"orderType":2}