This is an OpEd from the British Journal of Medicine regarding the FDA's approval of the vaccine.
Does the FDA think these data justify the first full approval of a covid-19 vaccine? - The BMJ
Apparently the data cited in the approval was old...from the initial trial published last spring.
The waning effect/loss of efficacy isn't addressed.
i made it seven minutes and forty eight seconds. if i didn't have any clue whatsoever about how fda approval works it would be easy to go 'hey, yeah - that seems pretty off.'
but i know more than i'd probably like to about filings and approvals and what he seems to be complaining about is just how the process works. to me, he sounds like someone completely ignorant of hockey questioning players' competence for leaving the offensive zone just because the puck went just a little over that blue line.
approvals usually take months. there are procedural hurdles. lots of them. unless something in the original data triggers specific questions from the agency, the clinical data is not just updated along the way - the approval is based on the original clinical data. this approval is for covid. it is not for a specific variant. and at this point there may not be enough controlled variant specific data anyway. the data that cutoff at march 13th included six months of data. the fda, and the manufacturer know that things will change. it's not like there is one flu vaccine that was approved and no others came along to try to do better against varying flu strains. they state efficacy drops (which is the case with pretty much all vaccines), give the info from the original data, and call it a day. if they were crazy and filing for approval while making a claim like "85% effective for a full year" then they'd be boned (also, they wouldn't even have enough data to file yet). but there is no claim like that.
basically, the part of this video i watched looked like someone creating great content for those who want to complain that the fda was wrong to give approval - especially because approval makes mandates much easier.
or, it is just brits trying to get back at the fda for making them look stupid in the whole thalidomide thing 60ish years ago. (in spite of what your aunt's facebook may say, the fda didn't approve thalidomide until the 90s under specific conditions. less than twenty flipper babies were born in the US, and half of those got their thalidomide outside the country. the rest were in clinical trials.)
