FDA Staff Makes No Recommendation on J&J Covid Shot Booster

Bloomberg2021-10-14

U.S. regulators didn’t make a recommendation on whether recipients of theJohnson & Johnson Covid-19 vaccine should receive a booster, ahead of a closely watched meeting where scientific experts will ...

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mseokt
2021-10-14
mseokt
Selling mode??
SaveHK
2021-10-14
SaveHK
Oh so sell on News
jerryang17
2021-10-14
jerryang17
Like please.
- Pplymm:
  Done. Pls like back

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In a 54-page report released Wednesday in preparation, the agency’s staff didn’t make a formal recommendation for the panel.\nFDA personnel don’t always make a recommendation to the advisory committee. The staff also declined to make a recommendation regarding booster shots from both Moderna Inc.and the Pfizer Inc.-BioNTech SE partnership.\nOn Friday, the FDA’s advisers will discuss potential time intervals for the booster to be given. While J&J has recommended a booster at six months or more after the initial shot, it said it may also be administered as early as two months, based on the strength of the immune response.\nJ&J’s two-dose results are somewhat complicated because it originally studied the vaccine as a single-dose inoculation. It then conducted a large trial examining the efficacy of two doses given two months apart.\nSeparately, the company ran a much smaller trial looking at whether giving a second shot six months after the first raised neutralizing antibodies. 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The staff also noted that the margin of error between one- and two-dose efficacy rates overlapped.\nJ&J hasn’t reported how a booster delivered six months following the initial dose impacts efficacy against Covid, although it has said a booster at that interval led to a rapid andstrong increase in antibodies.\nU.S. regulators added in their Wednesday report that some data showed that a longer interval between the initial dose and the booster may result in a stronger response in protective neutralizing antibodies.\nIn particular, the staff said, there were too few cases of the delta variant in the the two-month interval trial to make any conclusions about efficacy against the strain. However, the two-shot trial results didn’t identify any new safety concerns, the agency said.\nThe single-shot vaccine continues to afford protection against severe Covid-19 disease and death in the U.S., the FDA staff report said. And it was still less effective than messenger RNA shots developed from Moderna and the Pfizer-BioNTech team, the staff said.","kind":"news","is_publish_news":true,"is_publish_highlight":true,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1},"commentList":[{"id":825919513,"gmtCreate":1634188502287,"gmtModify":1634188502361,"author":{"id":"3577447162748311","authorId":"3577447162748311","name":"mseokt","avatar":"https://static.laohu8.com/default-avatar.jpg","vip":1,"crmLevel":2,"crmLevelSwitch":0,"idStr":"3577447162748311","authorIdStr":"3577447162748311"},"htmlText":"Selling mode??","listText":"Selling mode??","text":"Selling mode??","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":1,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/825919513","repostId":1100517973,"repostType":4,"isVote":1,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"tweetType":1,"langContent":"CN"},{"id":825994825,"gmtCreate":1634186712561,"gmtModify":1634186712957,"author":{"id":"3570678493691973","authorId":"3570678493691973","name":"SaveHK","avatar":"https://static.tigerbbs.com/89b74f5799a23844400ed6de94296d38","vip":1,"crmLevel":4,"crmLevelSwitch":0,"idStr":"3570678493691973","authorIdStr":"3570678493691973"},"htmlText":"Oh so sell on News","listText":"Oh so sell on News","text":"Oh so sell on News","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":2,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/825994825","repostId":1100517973,"repostType":4,"isVote":1,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"tweetType":1,"langContent":"CN"},{"id":825996899,"gmtCreate":1634186221802,"gmtModify":1634186221802,"author":{"id":"4092410761566010","authorId":"4092410761566010","name":"jerryang17","avatar":"https://static.tigerbbs.com/1eb61373cf0be973dd9dc7f072c54352","vip":1,"crmLevel":5,"crmLevelSwitch":0,"idStr":"4092410761566010","authorIdStr":"4092410761566010"},"htmlText":"Like please.&nbsp;","listText":"Like please.&nbsp;","text":"Like please.","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":4,"commentSize":1,"repostSize":0,"link":"https://laohu8.com/post/825996899","repostId":1100517973,"repostType":4,"isVote":1,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"tweetType":1,"comments":[{"id":6193555,"gmtCreate":1634187382735,"gmtModify":1634636152673,"authorId":3582681835792049,"author":{"id":3582681835792049,"idStr":"3582681835792049","authorId":3582681835792049,"name":"Pplymm","avatar":"https://static.laohu8.com/default-avatar.jpg","vip":1,"crmLevel":2,"crmLevelSwitch":0,"individualDisplayBadges":[]},"repliedAuthorId":0,"objectId":825996899,"type":1,"supId":0,"prevId":0,"content":"Done. 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