Thread by @ASlavitt

NEW: Pfizer files for approval of vaccines for kids 0-5.

There is more to this story and for people paying attention, I will add more info here soon. 1/

The last group of people to get approved for vaccinations also live under the most stringent rules, they have broad exposure & themselves can be highly infectious.

Leaving parents often with few good choices. 2/

In all likelihood only a small portion of the public will vaccinate their youngest kids.

For all the talk of politics driving vaccine decisions, it’s really age. 9 of 10 85 year olds are vaccinated & close to 9 in 10 10 year olds are not.3/

But for all those who do want to vaccinate their infants & toddlers, the process has been endless & they have been compromising their lives significantly.

Days and weeks are valuable.

So enter the unusual situation with vaccines for younger kids. 4/

Pfizer submitted data a few weeks ago for a micro dose that wasn’t all that promising for what can be accomplished clinically with 2 doses. They now believe a third dose will be effective and are testing it now. 5/

For the FDA and advisory committee to approve 2 doses of the vaccine under EUA, they would first and foremost need to find the doses safe— which so far the data shows.

If it continues to, the only question is how big a dose it would take to be clinically effective. 6/

Given the weeks it takes between doses & given the sense of urgency among the parents who want it, this presents a compelling case for approving 2 doses today so parents can begin the process as we wait to see how many additional doses are needed. 7/

The ACIP which reviews the data Feb 15 could decide to wait for more data before approving the first 2 doses.

That would be a typical and traditional response. Wait for all the evidence. Don’t get accused of going off half baked with children involved. 8/

But if it turns out that 3 doses are what it takes to be effective, as the company seems to think, parents would rightfully ask “why didn’t we start with the first two doses before?” 9/

There might be a legitimate answer to that question but parents have reason to be critical of excess conservatism if smarter approaches are available.

@Bob_Wachter has pointed this out and others who see this as a common sense approach agree. 10/

Recommending approval would simply allow parents & pediatricians to make an individual decision. If kids are in a broad day care setting or have at risk family members at home, they can opt to start their doses.

Those that prefer to wait for more data can. 11/

For the last 2 years, we have press led our agencies to move faster, to expedite solutions, to think out of the box.

FDA faced serious criticism for not more rapidly approving at home tests. Many had a mixed track record or no data. 12/

Too slow or too fast. FDA will always have critics. Their goal should not be to be popular but to use science to protect the public.

They may get criticized no matter what they do. But if the data shows it safe, FDA has a chance to make things better for kids faster./end

One more fact I left out. There is no question thee vaccines work. The question is only the dosage. Kids under 2 did receive an effective response with 2 doses.

Kids 2-5 did not.

If the FDA took this approach, some kids would clearly see a benefit even without a boost. /endend

To the thread that won’t end, I will add this.

The biggest risk among kids may in fact be MIS-C. And vaccines have been shown to reduce long COVID/MIS-C. This may be reason enough to alter the endpoint in the midst of the Omicron wave to get vaccines in little arms./reallytheend