FDA authorized, not approved, Pfizer for youth
November 11, 2021
To The Eagle:
Error on Page 6: “I think the biggest news is the Pfizer vaccine being FDA approved for 5-11 year olds,” (Chris) Bischoff said. Wrong, wrong, wrong… total misinformation.
Key: FDA did not “approve” the Pfizer BioNTech vaccine for children use. FDA did issue Emergence Use Authorization (EUA) for Pfizer vaccine use by 5-11 year olds.
FDA states: “Under an EUA, FDA may allow the use of unapproved medical products…”
Pfizer BioNTech vaccine is still not approved by FDA for adults or children. It has only been FDA authorized meaning allowed to be used by adults and children who volunteer to receive it. HHS still requires by federal regulation (CFR) 100% optional use by those wanting any EUA (authorized) vaccination products.
Why anyone in authority would continually confuse “FDA authorized” with “FDA approved” is troubling. After two years of this problem, no wonder the public is confused. This is a case of “truthiness” or stating a fact, the way you wish it was, instead of how it factually is.
As of October 29, FDA only “authorized” use of non-approved BioNTech vaccine by children. Not a rocket science concept to understand, yet the error continues in media (by design?). There is a legal difference between BioNTech and Comirnaty vaccine.
Sidebar: FDA did “approve” Comirnaty vaccine for use by those 16 and older. The label must say “Comirnaty” on it, or it is not legally approved by FDA. Devil is in the details as they say.