They are REQUIRING them to conduct several multi-year studies on what THEY, the FDA are saying are "known serious risks of myocarditis and pericarditis"
FDA "Approval" of Pfizer Injection COMIRNATY States There Were No Concerns Or Controversial Issues - Yet - Pfizer Is Required To Conduct Several Long Term Studies
https://freerepublic.com/focus/f-news/3988135/posts
The decision to grant (or not) a Biologics License Application for Pfizer's injection was due by January 2022.
Moderna's is around that timeframe as well.
Janssens expect to file for the BLA sometime later this year making any decision due by later in 2022.
https://www.fdanews.com/articles/203794-fda-reassigns-staff-to-accelerate-full-approval-for-pfizers-covid-19-vaccine
Why, with all the clear signs out there....and admission (booster shot needed) that the injection efficacy was falling....did they feel the need to rush the "approval," while also admitting they don't know the "serious" long term affects?
This was ALL about political science (i.e. politics) and NOT about science.[1][2]
Sen. Ron Johnson: 5 Questions for FDA About Pfizer Vaccine Approval
FDA to Senator Johnson .....
... crickets
Pfizer is changing the labels to say Comirnaty as fast as they can.
Leftist have no idea or are willfully ignorant the FDA ‘approval’ is for a jab not available or scarce in America.
I have some too.....
6. When will the FDA PULL the EAU for alternate manufacturers (like Maderna, J&J, etc) now that an APPROVED vaccine is available? (EAU is only lawful when other approved drugs are NOT available)
7. Is the Pfizer still experimental??? When was the last time a drug was EVER FULLY approved while it was still in an experimental phase???
8. Does Pfizer still enjoy full immunity from adverse side effects or death? If so, why?
Add asking about adjuvants to the list.
So, some of the early commenters have been proven absolutely correct when they said that Pfizer’s shot wasn’t approved and they only had the EUA extended. Interesting.
5 questions are not enough
ridiculous approval needs congressional investigation not letter writing
Even if it were approved after 5 years of rigorous testing, the committed anti vaxxers would not take it.
So why keep harping on it?
PFIZER-BIONTECH COVID-19 VACCINE COMIRNATY® RECEIVES FULL U.S. FDA APPROVAL FOR INDIVIDUALS 16 YEARS AND OLDER
Indication & Authorized Use
COMIRNATY® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech.
It is approved as a 2-dose series for prevention of COVID-19 in individuals 16 years of age and older
It is also authorized under Emergency Use Authorization (EUA) to be administered for emergency use to: prevent COVID-19 in individuals 12 through 15 years, and provide a third dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise
The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to:
prevent COVID-19 in individuals 12 years of age and older, and provide a third dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise
The FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series. An individual may be offered either COMIRNATY® (COVID-19 Vaccine, mRNA) or the Pfizer-BioNTech COVID-19 Vaccine to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2.
EUA Statement
This emergency use of the product has not been approved or licensed by FDA, but has been authorized by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older; and the emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.
Important Safety Information
Individuals should not get the Pfizer-BioNTech COVID-19 Vaccine if they:
had a severe allergic reaction after a previous dose of this vaccine
had a severe allergic reaction to any ingredient of this vaccine
Individuals should tell the vaccination provider about all of their medical conditions, including if they:
have any allergies
have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart) have a fever
have a bleeding disorder or are on a blood thinner
are immunocompromised or are on a medicine that affects the immune system
are pregnant, plan to become pregnant, or are breastfeeding have received another COVID-19 vaccine
have ever fainted in association with an injection
The vaccine may not protect everyone.
https://www.pfizer.com/news/press-release/press-release-detail/pfizer-biontech-covid-19-vaccine-comirnatyr-receives-full
My mom is at death’s door due to Pfizer. Do NOT get it.
Can’t get the general forum board to come up. 11pm central time. Any one else having this issue? Able to get into mail and pings. Thanks and blessings!