Moderna's dose is 100, 100, and 50 for booster;
Pfizer is 30, 30, 30
Moderna has WAY more myocarditis
it is NOT REASONABLE to make a Moderna determination from Pfizer data
FDA has never, to my knowledge, changed a label for 1 product based on data from a completely different product, given at a different dose, with different rates of adverse events
I sit down with @LeslieBienen, OHSU-PSU Public Health Faculty & author of dozens of op-eds & we talk about poor data to support masking kids, boosting, & college madness etc.
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
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