Pfizer has requested the FDA grant EUA for a 4th dose of the original mRNA vax for 65 years and up; Moderna has made the same request for 18 and up. Wow!
The only way to know for sure that a 4th dose improves outcomes for people who already had 3 doses is to do a very large randomized trial. Antibody titers cannot be the endpoint— b/c those will definitely be higher. Even mild disease — a scratchy throat— and a positive test result is not enough to justify widespread authorization of the vaccine. You simply don’t know from that endpoint that benefits > risks.
In fact, to persuade anyone of a 4th dose, you must show in an RCT, a reduction in hospitalization (from covid) and/or death (from covid) AND you have to prove that this is also true for 20 year olds, and not driven by 70++ year olds. This is a high bar that I have not seen the companies have cleared.
Walid Gelad puts it this way:
Will the FDA grant EUA without these data?
I worry the answer is yes
Will hospitals mandate a 4th dose to young employees without these data?
I worry the answer is yes
Is this good regulatory policy?
I know the answer is no
The FDA continues its downward slide towards less and less evidence being used to support costly products given to tens of millions. More is at stake than the current moment. We risk becoming a further medicalized population used to drive corporate profits, while no relevant evidence is generated to guide our actions, and we are along for the ride.
I just listened to a friend of mine (a 50 year old woman double vaxxed and boosted) who has been diagnosed (Cleveland Clinic) with Pericarditis. The Drs at the clinic told her that there was virtually no national coordination for reporting, treating and monitoring of vaccine related pericarditis. Given this, how can we place any trust in statements by government public health officials about anything. Her Drs told her it is much more common than reported.
I've been trying to stay rational about this stuff but shit I think Alex Berenson, bad cattitude and eugyppius have been right all along.
I don't know many many things; but considering that roughly 1/4-1/3 of FDA approved drugs (one source: https://www.cnn.com/2017/05/09/health/fda-approval-drug-events-study/index.html) subsequently have major problems and/or lose that approval: haven't we been on the Healthcare Industrial Complex of Corrupt Corporatism "ride" for decades?
Keep up the great work Dr Prasad!