[packagingguy]

Thanks for posting. It is quite confusing why a letter was issued extending the EUA then a separate document was for clearance of the vaccine. Both dated August 23, 2021.

When I searched the FDA website the only thing that came up under my search was the letter I referred to above. Strange.

[fruser1]

Yeah, I had to go to the news release and there's a link at the bottom. Then, the link at the bottom of that page. Sheesh.

https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine

https://www.fda.gov/vaccines-blood-biologics/comirnaty

A significant note is that the approval is given with the caveat that post marketing testing must be done because of the possible problem with myocarditis associated with this stuff.

What it comes down to is that they see enough red flags to warrant further study, but not enough to put a warning on the bottle.