Fri 2022-Feb-11

FDA VRBPAC To Consider Pfizer COVID-19 Vaccine for Kids 6mo - 4yr

Tagged: COVID / PharmaAndBiotech / Statistics

On Monday 2022-Feb-15 the FDA’s VRBPAC will meet to consider Pfizer’s COVID-19 vaccine for ages 6mo - 2yr. It worked for 6mo - 2yr, but not for 2yr - 4yr. A 3rd dose is being tested for 2yr - 4yr, but the FDA invited this application so parents can get their kids started on the first 2 doses while waiting for data on the 3rd. Unusual? Very!

Meeting Materials

Honestly, I just dunno what’s going on any more. The FDA practically never invites applications, especially before the trial data is in. But… here we are:

  • A vaccine that works in kids over age 5 and adults,
  • And for which a trial says it works in age 6mos - 2yr,
  • But for which it didn’t work in ages 2yr - 5yr.

Rather than go back to the drawing board or try another dose, the FDA and Pfizer decided maybe it was a 3-shot vaccine after all for ages 2yr - 5yr, and are doing an extension of the trial to test that.

But that 3rd dose trial is not yet finished!

And yet, here we are. The best rationalization I’ve heard is that parents want to “get started”, since they’ll have to wait 6mos for the 3rd shot. I mean, it sort of makes sense… but I’ve never seen anything like it before.

FDA VRBPAC: Pfizer age 6mos - 4yr meeting announcement & materials If you want to read ahead, the meeting materials will start appearing online at the VRBPAC’s page for this meeting. [1] Right now, the only thing there is some financial disclosure stuff.

More will appear today & over the weekend. Somehow the VRBPAC members are supposed to read it all before the meeting, which makes it awkward that it’s not there now. But that’s probably the least awkward fact about this whole little circus.

Addendum 2022-Feb-11, late night:

“Curiouser and curiouser!” said Alice.

Gary Cornell just emailed me to note that Pfizer had withdrawn its application! If you go to the page in the References below, you now see this bit of clickbait:

FDA VRBPAC: Pfizer meeting postponed?!

If you follow the link, because ‘clickbait’, you find a page chock full of catnip like this as the lead-off graf:

The U.S. Food and Drug Administration has been notified by Pfizer that new data have recently emerged regarding its emergency use authorization request for the use of the Pfizer-BioNTech COVID-19 Vaccine in children 6 months through 4 years of age. As part of its rolling submission, the company recently notified the agency of additional findings from its ongoing clinical trial. Based on the agency’s preliminary assessment, and to allow more time to evaluate additional data, we believe additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization.

So let’s summarize:

  1. Everybody agrees we want to be able to vax kids.
  2. Pfizer’s been doing age-deescalation trials, where you start with adults and work your way down. They’re now working on 6 months - 4 years; everybody above that has a vaccine EUA’d or even approved for them.
  3. The trial of 2 shots worked for 6 months - 2 years, but failed for 2 years - 4 years. This is a problem, because you don’t get to skip an age group in an age-deescalation trial. They don’t want to approve something for little kiddles who will then, in the natural course of things, age into the danger group.
  4. Rather than go back to the drawing board completely, Pfizer & the FDA agreed to try a 3rd shot and see if that got enough immune response in the 2yr -4yr tranche.
  5. That data is not yet in, but the FDA invited submission anyway, and that was what was going to happen on Monday. The whisper network says they wanted parents to “get kids started” on the timeline to getting the 3rd shot.
  6. Now Pfizer pulled the emergency brake line, saying in effect: “Hold on, we got data. Let’s have a think before we meet.” Which is… the first sensible thing in this list.

So I guess it’s sack-of-hammers weird that the FDA invited an application before the trial data was in, possibly attempting to move faster than usual. But then somebody at Pfizer maybe burnt the midnight oil and produced data at the last minute?

It’ll take them a couple weeks to argue about the data, and produce the usual duelling slide decks. Maybe sometime by the end of February we’ll know what’s going on.

Honestly, I’ve just never seen anything like this. I see the ripples on the water and conclude there are big things swimming below the surface; I decline to swim in the waters to find out the details.

ϜΤΦ, indeed.

Addendum 2022-Feb-12: STAT News doesn’t know, either

STAT News: A few details on Pfizer/FDA postponement There’s an article up at STAT News by Herper, Florko, and Branswell. [2] I haven’t much experience with Florko, but Herper and Bransewell have been extraordinarily reliable.

While there’s some detail in the article, most of it amounts to “we don’t really know what’s going on, so we have to wait for the fuller dataset to be submitted and analyzed before anybody will talk.” The FDA quote above implies that they’ve already received some new data; this article implies they’re waiting for the data from the completion of the 3rd shot trial.

As John Bogle was told at the start of his investing career: “Nobody knows nothin’.”

Notes & References

1: FDA VRBPAC Staff, “Vaccines and Related Biological Products Advisory Committee February 15, 2022 Meeting Announcement”, US FDA Vaccines and Related Biologic Products Advisory Committee, 2022-Feb-15.

Retrieved 2022-Feb-11 ahead of the meeting. Links to event materials are at the bottom of the page.

2: M Herper, N Florko, & H Branswell, “Pfizer and FDA pull back from plan to expedite review of Covid-19 vaccine in young children”, STAT News, 2022-Feb-11.

Published Fri 2022-Feb-11

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