FDA grants full approval to Pfizer-BioNTech’s Covid shot, clearing path to more vaccine mandates

CNBC2021-08-23

KEY POINTS The FDA granted Pfizer and BioNTech full U.S. approval of their Covid-19 vaccine. The move may encourage some unvaccinated Americans to get the shots as well as give more private ...

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精彩评论

Humble_Teoh
2021-08-25
Humble_Teoh
Wow
Dcagency
2021-08-24
Dcagency
More profit for the pharma!
A68
2021-08-24
A68
Leading again
koolgal
2021-08-24
koolgal
This FDA approval will be a catalyst to bumper profits for Pfizer💸💸💸🎊🎉
- Abbas99m:
  PartY soon 🎉
- koolgal:
  Definitely! Pfizer investors will celebrate 🎉🎊👍😊
- ocean_wave:
  [龇牙]
- koolgal:
  👍😊
- JQJQJQ:
  for sure! 💙💚💛🧡❤
CKF68
2021-08-24
CKF68
Buy time
Tan123
2021-08-24
Tan123
matter of time

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}\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\">\nFDA grants full approval to Pfizer-BioNTech’s Covid shot, clearing path to more vaccine mandates\n</h2>\n\n<h4 class=\"meta\">\n\n\n2021-08-23 21:45 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://www.cnbc.com/2021/08/23/fda-pfizer-biontech-covid-vaccine-wins-full-approval-clearing-path-to-mandates.html><strong>CNBC</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>KEY POINTS\n\nThe FDA granted Pfizer and BioNTech full U.S. approval of their Covid-19 vaccine.\nThe move may encourage some unvaccinated Americans to get the shots as well as give more private ...</p>\n\n<a href=\"https://www.cnbc.com/2021/08/23/fda-pfizer-biontech-covid-vaccine-wins-full-approval-clearing-path-to-mandates.html\">网页链接</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BNTX","symbol_name":"BioNTech SE","start_time":0,"source_url":"https://www.cnbc.com/2021/08/23/fda-pfizer-biontech-covid-vaccine-wins-full-approval-clearing-path-to-mandates.html","article_id":"1189910879","we_media_id":null,"thumbnails":[],"rights":{"source":"cnbc_highlight","url":"https://www.cnbc.com/2021/08/23/fda-pfizer-biontech-covid-vaccine-wins-full-approval-clearing-path-to-mandates.html","rn_cache_url":null,"customStyle":"body{padding-top:10px;}.ArticleHeader-headline{#titleStyle#}a{#lv2TextColor#}.ArticleHeader-time, .Author-authorNameAndSocial a{#sourceStyle#;}","selectors":".PageBuilder-pageWrapper","filters":".ArticleHeader-eyebrow, .RelatedTags-relatedTags","directOrigin":true},"url":"https://stock-news.laohu8.com/highlight/detail?id=1189910879","pubTimestamp":1629726358,"sourceInfo":{"source_id":"cnbc_highlight","name":"CNBC"},"weMediaInfo":null,"summary":"KEY POINTS\n\nThe FDA granted Pfizer and BioNTech full U.S. approval of their Covid-19 vaccine.\nThe mo","collect":0,"end_time":0,"defaultTopTitle":"cnbc.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"BNTX":"BioNTech SE","PFE":"辉瑞"},"translate_title":"美国食品和药物管理局完全批准辉瑞-生物技术公司的Covid注射，为更多疫苗授权扫清了道路","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"BNTX":0.9,"PFE":0.9},"content_text":"KEY POINTS\n\nThe FDA granted Pfizer and BioNTech full U.S. approval of their Covid-19 vaccine.\nThe move may encourage some unvaccinated Americans to get the shots as well as give more private businesses across the nation greater confidence to implement vaccine mandates.\nUp until now, the mRNA vaccine was on the U.S. market under an Emergency Use Authorization.\n\nThe Food and Drug Administration granted Pfizer and BioNTech full U.S. approval of their Covid-19 vaccine – becoming the first in the U.S. to win the coveted designation and giving even more businesses, schools and universities greater confidence to adopt vaccine mandates.\nUp until now, the mRNA vaccine was on the U.S. market under an Emergency Use Authorization, which was granted by the FDA in December. Since then, more than 204 million of the Pfizer shots have been administered, according to data compiled by the Centers for Disease Control and Prevention.\nFederal health officials had been under mounting pressure from the scientific community and advocacy groups to fully approve Pfizer and BioNTech’s vaccine ever since the drugmakers submitted their application to the agency in early May. The companies submitted a Biologics License Application, which secures full approval, to the FDA on May 7 for patients age 16 and up.\nAlthough more than 60% of the total U.S. population has had at least one dose of a Covid vaccine, many Americans say they are still hesitant about getting vaccinated, even as the highly contagious delta variant spreads. Full approval may convince some Americans that the shots are safe, doctors and epidemiologists say. In fact, a survey from the Kaiser Family Foundation found 3 in 10 unvaccinated adults said they would be more likely to get vaccinated if one of the vaccines receives full approval.\nFull approval is “more psychological than anything else,” said Dr. Paul Offit, a voting member of the agency’s Vaccines and Related Biological Products Advisory Committee. “I mean you already have more than 320 million doses administered that are out there. The vaccines already have an enormous safety and efficacy profile.”\nU.S. approval is also likely to spur a new wave of vaccine mandates from corporate America. Major companies – fromWalt DisneytoWalmart– have already told some or all of their employees that they must get fully vaccinated againstCovidthis fall. Still, some private businesses may have felt hesitant about requiring the shots, before full approval, even though they had the legal authority to do so, said Dorit Reiss, a professor of law at UC Hastings College of the Law.\nThe Pentagon said it would make vaccinations mandatory for service members “no later” than the middle of September, or sooner if the FDA grants full approval earlier.\n“You’re going to see the empowerment of local enterprises, giving mandates that could be colleges, universities, places of business, a whole variety and I strongly support that,” White House chief medical officer Dr. Anthony Faucisaid Aug 8, when asked about full approval of the vaccines. “The time has come. ... We’ve got to go the extra step to get people vaccinated.”\nPfizer’s shot is the first Covid vaccine to receive full regulatory approval in the U.S. Federal regulators had previously said they would work as quickly as possible to clear Pfizer’s vaccines.\nStandard vaccine reviews generally take several months to a year or more to determine whether they are safe and effective for use in the general public. But due to the pandemic, which has killed more than 628,000 Americans, the FDA permitted the use of the shots under an EUA.\nIn a public health emergency, the manufacturing and approval of vaccines can be streamlined through emergency authorizations. Former Health Secretary Alex Azar declared a public health emergency on Jan. 31, 2020. The health emergency has been renewed several times, most recentlyin late July. The FDA allowed the use of the shots with just two months of safety data under an EUA. It’s not the same as a Biologic License Application, or a request for full approval, which requires at least six months of data.\nBefore granting full approval, FDA scientists must painstakingly look through the companies’ clinical trial data, including for any discrepancies or safety concerns, said Offit, who is also director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.\nIt’s a lot of data, Offit said. He previously said when Merck submitted its data from its 70,000-person rotavirus vaccine trial, the pages that were generated could have exceeded the height of the Sears Tower — a 1,450-foot skyscraper in Chicago that’s now known as Willis Tower.\n“The FDA will do what it thinks it needs to do to make sure that the American public is safe,” he said.\nFull approval is also very beneficial to companies that submit an application, former FDA Commissioner Dr. Robert Califf said in a phone interview in May.\nWith it, Pfizer and BioNTech are now able to market the shots directly to U.S. consumers. Companies can’t promote their products under an EUA, he said. It also allows the shot to stay on the market once the pandemic is over and the U.S. is no longer considered in an “emergency.”\n“The vaccines will still have to be administered under the supervision of a professional who’s qualified,” Califf said. “It’s not like they can send the vaccines to people’s homes. However, they can advertise on TV and promote their products under the watchful eye of the FDA.”\nPfizer and BioNTech have said they expect to generate billions from the vaccine. Under full approval, the companies could also decide to charge more for the vaccines, health experts say.\nThe companies have already raised the price of their vaccine in the European Union,according to the Financial Times. They are now charging $23 per dose, up from their previous price of $18.40, according to the report.\nPfizer and BioNTech also plan to ask the FDA to approve a third dose as a booster shot following full approval. Last week, the Biden administration said it was preparing to offer booster shots to all eligible Americans beginning the week of Sept. 20.","kind":null,"is_publish_news":false,"is_publish_highlight":false,"is_publish_live":null,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1},"commentList":[{"id":834778654,"gmtCreate":1629845179978,"gmtModify":1633682100972,"author":{"id":"3572139599881104","authorId":"3572139599881104","name":"Humble_Teoh","avatar":"https://static.tigerbbs.com/5fd84204122d47f9ce31185f7bf7276f","vip":1,"crmLevel":2,"crmLevelSwitch":0},"htmlText":"Wow","listText":"Wow","text":"Wow","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":1,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/834778654","repostId":1189910879,"repostType":4,"isVote":1,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"tweetType":1,"langContent":"EN"},{"id":834692345,"gmtCreate":1629794907287,"gmtModify":1633682394667,"author":{"id":"3557142354281361","authorId":"3557142354281361","name":"Dcagency","avatar":"https://static.tigerbbs.com/811d507c3458decd0eacd9028472dcf4","vip":1,"crmLevel":1,"crmLevelSwitch":0},"htmlText":"More profit for the pharma!","listText":"More profit for the pharma!","text":"More profit for the pharma!","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/834692345","repostId":1189910879,"repostType":4,"isVote":1,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"tweetType":1,"langContent":"EN"},{"id":834605571,"gmtCreate":1629794250793,"gmtModify":1631889864015,"author":{"id":"3576813955258325","authorId":"3576813955258325","name":"A68","avatar":"https://static.tigerbbs.com/d209afa981c29a4dc34bd7c1c986fb4a","vip":1,"crmLevel":2,"crmLevelSwitch":0},"htmlText":"Leading again","listText":"Leading again","text":"Leading again","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":1,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/834605571","repostId":1189910879,"repostType":4,"isVote":1,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"tweetType":1,"langContent":"EN"},{"id":834809884,"gmtCreate":1629785757548,"gmtModify":1629863661527,"author":{"id":"3559581955535845","authorId":"3559581955535845","name":"koolgal","avatar":"https://static.tigerbbs.com/c05274d88ffc0434623e57350c52c70a","vip":2,"crmLevel":6,"crmLevelSwitch":0},"htmlText":"This FDA approval&nbsp;will be a catalyst to bumper profits for Pfizer💸💸💸🎊🎉","listText":"This FDA approval&nbsp;will be a catalyst to bumper profits for Pfizer💸💸💸🎊🎉","text":"This FDA approval will be a catalyst to bumper profits for Pfizer💸💸💸🎊🎉","images":[],"top":1,"highlighted":2,"essential":1,"paper":1,"likeSize":20,"commentSize":11,"repostSize":0,"link":"https://laohu8.com/post/834809884","repostId":1189910879,"repostType":4,"isVote":1,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"tweetType":1,"comments":[{"id":5631466,"gmtCreate":1629792578576,"gmtModify":1635143828714,"authorId":4091932914422900,"author":{"id":4091932914422900,"authorId":4091932914422900,"name":"Abbas99m","avatar":"https://static.tigerbbs.com/a026254fe4800d31971dee7f5e269073","vip":1,"crmLevel":1,"crmLevelSwitch":0,"individualDisplayBadges":[]},"repliedAuthorId":0,"objectId":834809884,"type":1,"supId":0,"prevId":0,"content":"PartY soon 🎉","text":"PartY soon 🎉","html":"PartY soon 🎉"},{"id":5632198,"gmtCreate":1629797557166,"gmtModify":1635143782063,"authorId":3559581955535845,"author":{"id":3559581955535845,"authorId":3559581955535845,"name":"koolgal","avatar":"https://static.tigerbbs.com/c05274d88ffc0434623e57350c52c70a","vip":2,"crmLevel":6,"crmLevelSwitch":0,"individualDisplayBadges":[]},"repliedAuthorId":0,"objectId":834809884,"type":1,"supId":5631466,"prevId":0,"content":"Definitely!&nbsp; 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