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
I am concerned that panic in the WH is leading to bad decision making
Vaccination is great, but you want to maximize the benefit & minimize the harms
Simple actions have not been taken, for .e.g
The USA should ban Moderna in men < 40, as other nations had
We took way to long to fix J&J recommendations due to VITT
Boosting young men is a live issue
Observational data has scant events at these ages to show benefit of boosting
Harms from D3 are not negligible for young men
Omicron has introduced substantial uncertainty into value of boosting
A VE of 37% would not have led to FDA EUA in fall of 2020-- for an older frail population where there was more to gain
Now it is used to make recommendations in Jan 2022, in a young healthy population
It is bizarre vaccine regulation, and would not have happened if Gruber and Krause had not resigned
This is madness. In the video he asserts that if you've been vaccinated with two doses and had COVID, you should get a booster. But he himself knows there is no evidence to support that claim. He could have demanded it from the company. But did not 1/3
But perhaps the worst argument comes in the beginning of the video where he says if you've had COVID long ago, you've been exposed to an older ancestral strain. Therefore you should get the booster. However, the booster is a construct made of... Older ancestral strain 2/3
FDA had the ability to ask companies to run robust randomized control trials powered for clinical endpoints for boosters. They have abdicated that responsibility. And now engage in low levels of evidence aka storytelling to change the public's behavior. It's sad to watch. 3/3
Dear Journalists,
There is a story here π 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.