FDA is not even trying anymore;
The decision is based on PFIZER data not MODERNA data, which they acknowledge in today's letter

There is literally have NO EVIDENCE for boosting MODERNA at month 5 👇👇

Gruber & Krause resign & FDA is unhinged
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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More from @VPrasadMDMPH

8 Jan
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...🧵
.. But avoiding it is not an option

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.

It is coming for them.

They're sacrifice won't change broader dynamics.
Read 23 tweets
7 Jan
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.

See thread for a link to her op-eds

Read 8 tweets
6 Jan
If a four, five or six-year-old falls asleep wearing an n95 mask and something bad happens....

We should all be very clear on who we're going to litigate.
Read 5 tweets
6 Jan
Yes, a mask is more than the filtration properties. It's what happens to real people in the real world when you institute real mandates.

Making little kids wear these masks will not age well. It won't change pandemic dynamics, and kids will pay a price.
Given challenges with compliance, It will likely not even blunt the spread of Omicron.

Given restrictions on speech, subjective shortness of breath, exertion, it will harm children.
Fundamentalism in all its forms is wrong. This is a new fundamentalism. Don't let adult anxiety lead you to clearly mistaken policy choices.
Read 5 tweets
5 Jan
I dunno what we will tell 12 -17 yo healthy boys who develop myocarditis from D3 mandates

We had no evidence this shot would further reduce your risk of severe outcomes

We knew the booster had only a small reduction in transmission for Omicron & total spread was inevitable
At the time we made the decision, many people alerted us that the harms of this 3rd dose may exceed benefits, but we pushed mandates anyway

We made no carve-outs for 2 doses + prior infection

We failed to shield you from iatrogenic harm due to irrational policies
I suspect this episode will lead to serious reforms to FDA and CDC in the future

Checks must be placed on expert organizations which cannot rationally consider decisions
Read 4 tweets
5 Jan
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
Read 4 tweets

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