Discover more from Vinay Prasad's Observations and Thoughts
FDA wants to push a yearly shot on 6 year old girls & 20 year old men without RCTs proving reduction in severe disease
This Week's Meeting Shows the Full Failure of this FDA
The FDA has posted briefing documents from VRBPAC— the vaccine advisory meeting coming this week. Conspicuously absent is information about subclinical myocarditis. Remember Pfizer was legally obligated to study troponin elevations in young men who got the shot. This is different that clinical myocarditis— this is heart damage that these young healthy men may not feel or may ignore, and is much more common.
To date, available data suggests it might be as much as 100 times more common (Thailand/ Swiss data). Yet strangely, these data are missing from the FDA briefing document. It’s sad the FDA once again neglects its duty to generate confirmatory data.
Instead we get this proposal for yearly shots:
The average American will now only be tasked with getting a yearly unproven booster, and the primary series will be ignored. Kids and older Americans will have to get 2 doses of the bivalent shot and then placed on the perpetual booster train. Pfizer will keep earning billions.
There is no talk of:
Running randomized trials to ensure annual boosters actually lower severe disease in healthy young adults and kids
The risks of myocarditis from a perpetual booster strategy, which are disproportionately faced by young men who have the least (perhaps nothing) to gain
The fact that these vaccines will always be chasing the last variant
The fact these vaccines provide no benefit to others because they cannot stop spread
If one zooms out on all of human existence (8 billion people and 1 trillion human interactions a day) any and all vaccine programs cannot even slow spread.
Eric Rubin of NEJM fame says exactly my position:
And strangely NPR found a quote that is correct (for once).
Although this administration claims to follow the science, they instead follow the Bourla. Their policies have been dictated to them by Pfizer, and work to keep Pfizer shareholders rich. I fear that many of the key players here— Marks, Jha, Walensky and Califf— will go to work for Pfizer at the end of their term; just as Scott Gottlieb former FDA commish has.
We have to be very careful that the fear and panic of the pandemic do not turn young American into perpetual pin cushions without evidence that all those shots improve important health outcomes. This meeting should be watched carefully.