M and P have filed for full FDA approval. FDA需要数月审核

本帖于 2021-06-11 06:36:50 时间, 由普通用户 fuz 编辑

(按FDA规则,需要二个月的临试三期数据才能获得EUA,而正式批准至少要六个月以上的数据。)

 

https://www.nbcchicago.com/news/coronavirus/covid-vaccine-fda-approval-heres-how-the-process-works/2529706/

So far, Moderna and Pfizer have both filed for full FDA approval, however.

FDA approval of a drug, which requires a rigorous and structured process, means that data on the drug’s effects have been reviewed by the Center for Drug Evaluation and Research, which rules on whether the drug's provided benefits "outweigh its known and potential risks for the intended population," according to the agency's website.

Moderna announced earlier this month that it had begun a “rolling submission” to the FDA of data from its studies of the two-dose mRNA vaccine.

“We are pleased to announce this important step in the U.S. regulatory process for a Biologics License Application (BLA) of our COVID-19 vaccine,” Moderna CEO Stephane Bancel said in a press release. “We look forward to working with the FDA and will continue to submit data from our Phase 3 study and complete the rolling submission.”

Large-scale studies of the shots continued after Moderna’s emergency authorization. The FDA will scrutinize the information to see if the vaccine meets stringent criteria for full licensure.

 

 

https://abcnews.go.com/Health/full-fda-approval-drive-covid-19-vaccinations-experts/story?id=78048166

 

Both authorization and approval are rigorous processes that look at the safety and efficacy of a vaccine, Moss said. A key difference between the two is that at least two months of follow-up data from phase 3 clinical trials are considered for authorization, versus at least six months for approval.

The FDA will take several months to review the full set of data before granting approval, which several experts told ABC News was very likely. For Moss, with nearly 300 million doses administered in the U.S., "there's nothing about that review process that's going to reveal anything we don't know."

 

所有跟帖: 

如果数月后FDA不批,就悲剧了:( -Wendy2014- 给 Wendy2014 发送悄悄话 (0 bytes) () 06/11/2021 postreply 09:02:31

你是那种glass half empty类人。lol -山水一程歌- 给 山水一程歌 发送悄悄话 (0 bytes) () 06/11/2021 postreply 09:11:21

一句话就给定性了LOL, 有点道理 -Wendy2014- 给 Wendy2014 发送悄悄话 (0 bytes) () 06/11/2021 postreply 09:43:43

很小机率不批,目前的数据太给力了。尽管有些副作用,但仍然是有史以来最好的疫苗。 -fuz- 给 fuz 发送悄悄话 fuz 的博客首页 (464 bytes) () 06/11/2021 postreply 10:35:16

那就完美了。夫子对Biogen的新批的alzheimer's drug药怎末看。 -Wendy2014- 给 Wendy2014 发送悄悄话 (0 bytes) () 06/11/2021 postreply 11:06:09

鸡肋 -fuz- 给 fuz 发送悄悄话 fuz 的博客首页 (0 bytes) () 06/11/2021 postreply 12:04:25

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