Brwned
Have you ever been in love before?
- Joined
- Apr 18, 2008
- Messages
- 50,946
What’s with the attitude? He’s reading the same thing I’m reading at least…
And you’re yet to provide what I’ve requested (unless again it was posted and I missed it in which case apologies but do please point me that way if it is the case)
The FDA fully approved the Pfizer vaccine in August 2021. That's their press release on it. That approval applies for anyone over 16 and following the two-dose regimen, i.e. aligning with the primary population and regimen of the trial.
Until that point it was operating under an EUA for that same population in December 2020. They have separately given new EUAs for a booser dose, and for children, i.e. a secondary population or a different regimen to the trial.
The FDA draws a very clear distinction betwen Pfizer's status and other vaccine statuses in that press release, and if you read through it explains the distinction between the two.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said Acting FDA Commissioner Janet Woodcock, M.D.
“While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
...
For Comirnaty, the BLA builds on the extensive data and information previously submitted that supported the EUA, such as preclinical and clinical data and information, as well as details of the manufacturing process, vaccine testing results to ensure vaccine quality, and inspections of the sites where the vaccine is made.
It's mostly about the breadth of data supplied to meet specific requirements. Pfizer have supplied it. They are unequivocally fully approved for that two-dose regimen in people over 16, the EUA has been superseded. Anyone telling you otherwise genuinely does not have sufficient knowledge of the facts freely available on the subject.