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
This is a bigger deal than Exondys and Aducanumab
This means there is no need for any data for FDA regulatory action
The future will be bleak
Obviously, this will change existing booster mandates for Moderna recipients to move them up to month 5 or people will be fired.
No safety or efficacy data will support that mandate
amazing
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Great article, but I fear the CDC director is doomed. Here's why.
In the next few months, we will have to accept the inevitable, that all people will be infected with the virus at some point in the future. Better to be vaccinated/ or have nat immunity when you meet it...🧵
Draconian mitigation efforts to delay the time to meet the virus make no sense.
Makes no sense for a vaccinated person to wear an n95 or equivalent. Certainly makes no sense, and is borderline insane, to make a child wear such a mask.
It is also borderline insane to make college students who have already had multiple vaccines keep getting more, or sit all day in their dorm room to avoid meeting it.
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