Thread by @ASlavitt

COVID Update: The FDA is meeting on boosters.

There are a lot of moving pieces. We are monitoring & the head of the FDA is coming on @inthebubblepod Monday.

Follow here if interested today for updates & explanation of what to expect. 1/

As background, the FDA meeting starts today and will hopefully end today.

The CDC will then meet to make recommendations on: age, time, mix-match recommendations, nursing homes, and more. I will address each of these.

It could be a full week before all that is ironed out. 2/

Let me start with where there is certainty & likelihood.

Americans over 65: the evidence says 3 things.
-Booster is safe
-Booster dramatically increases immune response, symptom reduction, hospitalization#
-Seniors have lower levels of immunity after 2nd dose

A no brainer. 3/

Here’s what’s less certain, but possible:

-there is less evidence but still suggestive that people 40 & over will benefit similar to people over 65
-18-40 is both a tougher case & also farther out in the future
-what to say to people in these age groups who have taken Moderna 4

-what to say to people who have taken J&J
-handling nursing home vaccine administration
-should we allow physician discretion to administer Pfizer
-calling out of special groups (health care workers, etc)

So far 18 countries have approved vaccine boosters for those over 65.

So while that seems reasonably solid, let me handicap the rest of it. 6/

1- I suspect between the FDA review, the CDC recommendations & the final CDC decision, there will be a fair amount of dissenting opinion.

That’s ok. This is decision making w uncertainty. But that means it could be end of next week, not the beginning before things are final.7/

Pfizer? Moderna? J&J?

Since this is a Pfizer review & since there is still only the beginnings of data on mix & match, the real question is when will they have an answer for others & what to do in the meantime.

Here’s how I see it. 8/

People with Pfizer (over the age recommendation) will get a Pfizer boost.

For others, the best way it could play out is if the FDA were silent on the label & the CDC deferred to physicians. Because Pfizer is fully approved & can be prescribed, unless prohibited docs can Rx it.9/

Here’s how: a 75 woman on Moderna wants a Pfizer boost because she doesn’t want to wait the time (weeks) to get Moderna approved. The doc can weigh the side effect risk (low but not 0) against the benefit (high) & prescribe it.

CVS, et al can then administer it. 10/

I’m nursing homes mixing & matching is likely to be allowable and it should work the same way among the rest of the population.

Those at higher risk (older, pre-existing conditions, etc) can get a boost if warranted. Those at lower risk, their doc may recommend waiting. 11/

When considering the question of what’s the right age cut off— 18, 40, 65– or some number in between, the question should revolve around what we want to solve for: hospitalizations, infections, or transmissions. 12/

If all we care about is hospitalization, that argues for a higher age cut off. The benefit & the time lag at lower age groups will be lower & of course as time passes those groups can be added.

But there is much more to solve for than preventing hospitalization. 13/

To minimize the pandemic & reduce the impact on kids & the economy, we need to reduce transmissions & case rates.

That would argue for a much lower age limit. If you vaccinate parents of young kids & young teachers & younger workers, there are significant benefits. 14:

You don’t need to reach full immunity to save a lot of lives. 15/

Thought about another way— if we tolerate 150,000 cases/day— and people quarantine for 10 days, within a week 10.5 million days of work are missed before you account for contacts of theirs.

Most of those people work by the hour. Many are teachers. This could be crippling. 15/

There is some good data which show that boosters reduce transmission of the virus— a reduction in upper respiratory symptoms— too.

If we want schools & the economy to benefit, focusing on hospitalizations alone won’t get there. This argues for a lower age cutoff. 16/

INTERRUPTION: The FDA panel is about to vote. Will keep you posted here. 17/

^The question on the table for voting:

Do you support the booster dose to be administered 6 months after the 2nd dose in those 16 years and older?

BREAKING: 19 voters: 84% vote no on boosters.

The question is whether they will now vote on whether to approve boosters above a higher age. Where the cutoff would be made is a matter of judgment.

https://twitter.com/aslavitt/status/1438948553976528897