FDA set to grant approval to Pfizer vaccine without public discussion of data

FDA set to grant approval to Pfizer vaccine without public discussion of data(bmj.com)

27 points by pmcpinto 4 years ago | 5 comments

londgine 4 years ago |

did they not already approve it last week? https://www.fda.gov/news-events/press-announcements/fda-appr...

dragonwriter 4 years ago | |

This article is from 8/20, it was given full approval 8/23.

cyanydeez 4 years ago |

formal is the opperative word here. this things been discussed since it was given emergency use.

xyzzy21 4 years ago |

It's NOT a real approval:

1. It's a redundant renewal of the existing Pfizer under the exact same EUA - thus STILL NOT finished clinical efficacy and safety trials 2. It "pre-approves" a new future Pfizer vaccine that has not yet even been created nor passed even the first stage FDA efficacy and safety trials

So it's literally a bait-and-switch lie to try to get people to take the Pfizer NOW that is still under EUA (and not fully tested).

dragonwriter 4 years ago | |

> It's a redundant renewal of the existing Pfizer under the exact same EUA

No, its a full approval of the existing Pfizer vaccine for those 16+. The EUA remains in place for younger people 12+.

> It "pre-approves" a new future Pfizer vaccine

It doesn't, I guess this is a misreading of the fact that the approval of the existing Pfizer vaccine includes, as such approvals do, the marketing name of the vaccine (“Comirnaty”), but this isn't a new vaccine, just the brand name for marketing the existing one.