There is a tension with an agency that explicitly said they would not approve a vaccine with a VE <50%, now advising a booster with a VE<50%, while simultaneously freeing the company of the obligation to test the booster in rigorous RCTs
Dear Journalists,
There is a story here 👇 Phil Krause and Marion Gruber #2  at FDA vax have resigned over white house pressure on boosters.
Now FDA pushes this without advisory committee & with uncertain safety in boys.
The fact nearly no one would say that the AAP and CDC were off their rocker to defy the World Health Organization and UNICEF to push this foolish recommendation down to 2 will be a shameful blemish on their reputations, I doubt they will recover in next 25 yrs.
Data from Spain, of regression discontinuity design, showed it did not work months ago. Sadly CDC pushed embarrassingly flawed studies in MMWR to defend their failed policy instead.