COVID Transmissions for 2-2-2022

FDA will consider Pfizer vaccine for children 6 months to 4 years of age

Greetings from an undisclosed location in my apartment. Welcome to COVID Transmissions.

It has been 778 days since the first documented human case of COVID-19. In 778, Charlemagne invaded Iberia, a literally storied war campaign because it is the subject of the 11th century epic The Song of Roland, essential reading in the history of French literature because it is considered the beginning of that history.

In what marks another beginning, the FDA has begun to consider data from Pfizer on a pediatric vaccine. They have also elected to fully license Moderna’s vaccine. Implications of both are covered today.

Ongoing subscription offer:

THANK YOU to everyone who subscribed using this offer since last issue. The numbers are up, and I hope if they continue to rise I can outrank the misinfo newsletters that are ahead of me!

I’ve added some weekly paid content to the newsletter, and am running a subscription offer. Here’s the short explanation—the fuller explanation is in

• This newsletter is the #5 result for “covid” on Substack

• There are newsletters ahead of it that contain substantial misinformation

• Part of the reason it is not the #1 result is that I have made a lot of content free, and Substack cares about how many paid subscribers you have, not how many total subscribers

I am pretty annoyed to be ranked behind misinformation newsletters, and I want to fix that. Which means I need to encourage and reward paid subscription, and I’m adding a paid-only weekly section discussing more general virology. However, I also believe strongly that essential COVID-19 information should be free, so everything related to COVID-19 in this newsletter will still be free. I’m also doing a 50% discount on new paid annual subscriptions until the end of February.

The offer can be found here:

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SPIKEVAX now fully licensed (aka “approved”) by the US FDA

The FDA has given licensure—the term used for full approval of a vaccine product—to Moderna for their SPIKEVAX vaccine against COVID-19 in adults: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-key-action-approving-second-covid-19-vaccine

Until now, this vaccine had been under Emergency Use Authorization (EUA) in the US.

The major problem with the EUA status was that antivaccine conspiracy theorists used this to claim it was somehow “experimental.” This was, of course, a lie, but that’s what they did anyway. The idea that these vaccines are “experimental”—again, they are not—is now deeply engrained in antivax messaging.

It would be great if that lie went away now, but I doubt it will.

The other problem with EUA status is that it left practitioners much more limited in terms of their ability to use these products off-label. When we’ve talked about deviations from the standard 2-dose protocol in the past year—like booster doses, mixed-brand vaccination, and anything else that isn’t in the label—these things have been done either at legal risk to the providers doing them, or with the express recommendation of both the FDA and the CDC. That’s the nature of working with EUA products.

When the Pfizer vaccine, COMIRNATY, was formally licensed only a few months ago,¹ this opened up the opportunity for healthcare providers to use more flexible clinical judgment in administration. Deviating from the schedule in ways that make sense for individual patients became a more reasonable possibility—without needing the FDA to weigh in.

The same is now true for SPIKEVAX, which means in particular that schedules combining these vaccines will be off-label uses of approved vaccines. That could make it simpler for people to construct, in collaboration with their doctors, a mixed-brand vaccination schedule that agrees with their understanding of the available evidence.

FDA requests data from Pfizer-BioNTech on pediatric vaccine

I’m surprised to be writing this. Some months ago, we heard the bad news that 2 doses of the 3 microgram pediatric version of Pfizer’s COVID-19 vaccine, for use in children 2 to 5 years old, were not sufficiently immunogenic for the scientific standards that the company set. They were going back to the trial design to add a third dose and see if that helped.

In the meantime, they noted that the vaccine was well-tolerated and without serious safety events.

I kind of thought this meant we would be waiting a lot longer for a pediatric vaccine, but it appears that the FDA has asked Pfizer to provide its data anyway, and will be considering an EUA for 2 vaccine doses later this month. You can read about this in a press release from Pfizer: https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-initiate-rolling-submission-emergency

This is, apparently, motivated by a surge in cases in this age group. Quoting the press release:

Since the pandemic began, more than 10.6 million children have tested positive for COVID-19 in the U.S., with children under 4 accounting for more than 1.6 million of those cases. Further, reported COVID-19 cases and related hospitalization among children have spiked dramatically across the United States during the Omicron variant surge. For the week ending January 22, children under 4 accounted for 3.2% of the total hospitalizations due to COVID-19.

That is pretty serious. It appears the FDA has chosen to take action in light of this, initiating a “rolling submission” for an EUA of this vaccine formulation in children 6 months to 4 years of age (inclusive).

To explain this, I have to draw on my experience as a pharmaceutical executive rather than a virologist—as it turns out, I end up using both of these skillsets quite frequently in writing about COVID-19. The “rolling” nature of the submission means that Pfizer will send in the data that it has now, and will continue to provide additional data as their trial continues out to the follow up from three doses.

It appears that despite Pfizer’s decision not to pursue an application initially, the FDA felt that they’d like the right to decide for themselves whether or not an EUA is appropriate.

This displays a pragmatism and flexibility that we’ve not seen from the FDA so far during the pandemic. They recognize that if this vaccine formulation is safe in children—which Pfizer has claimed, and will have data to back up—then it would not be harmful to get the vaccine on the market now, for two doses, so that it can immediately go to three doses when new data are available.

If ultimately a vaccine is authorized based on this process that can be used in children, we are looking at the prospect of a full-lifetime immunization continuity for COVID-19, like so:

• 0-6 months: reliance upon passive transfer of antibodies from parent, which has been observed

• 6 months to 4 years: 3 microgram vaccination being evaluated

• 5 years to 12 years: 10 microgram vaccination authorized

• 12 to 16 years: 30 microgram vaccination authorized

• 16 and older: 30 microgram vaccination fully licensed, plus two other authorized vaccines

Until now we have always had at least one segment of the population who cannot get a vaccine even if that’s what they or their caregivers want. If this is authorized, that situation will end, and thus leave us with the opportunity to really protect as many people as possible.

On the other hand, the vaccine has to be safe, and ultimately, there needs to be data that support it being effective too. I expect both of those things, but it isn’t a done deal here, and as always, I want to see the data.

Image is a picture of Lt Commander Data from Star Trek, sitting on the bridge of the Enterprise, with Dr. Crusher and Counselor Troi behind him and out of focus over his left and right shoulder, respectively. Text on the image reads, “show me the data.”

The data will be made available to the public and discussed publicly—as is done for all FDA evaluations. This is described in FDA’s press release announcing the advisory committee meeting they have scheduled for this product on February 15th: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-advisory-committee-meeting-discuss-request-authorization-pfizer

You’ll hear my take on that meeting in this newsletter on the morning of February 16th. Stay tuned.

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Part of science is identifying and correcting errors. If you find a mistake, please tell me about it.

Though I can’t correct the emailed version after it has been sent, I do update the online post of the newsletter every time a mistake is brought to my attention.

Correction: last issue, I referred to the third dose of an mRNA vaccine in immunocompromised individuals as a “booster.” This is a situation where terminology is an issue; technically every dose after the first (“prime”) dose is a boost. However, the US CDC—and other organizations elsewhere in the world—consider 3 doses to be part of the “primary series” for initial vaccination, and so the 4th dose would be considered a “booster” under this regime. Sorry if this created any confusion.

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What am I doing to cope with the pandemic? This:

Mixing seasonings and spices

Really a very minor update, but I tried mixing a curry spice blend with Trader Joe’s “Everything But the Bagel” seasoning on some roast chicken tonight, and it turned out to be a really tasty combination. Both are staples in my kitchen, but not usually combined. Try it out if you’re interested.

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Reader Lisa Hertel, and a few others privately, pointed out the following on the last issue:

The paywall also hid the footnotes.

Sorry about that! That’s a frustrating behavior. I am going to reach out to Substack about that. Until I hear it is fixed, I will comment the footnotes onto the newsletter on days when there is a paid section, so that everyone can see them in the comments thread.

Reader Brock shared their experience as a participant in a Pfizer vaccine trial, which is really interesting! See here:

I'm participating in Pfizer's vaccine trial, so there is a 50% chance that I will receive the new Omicron-specific booster tomorrow. If I'm in the control group, I'll receive a fourth dose of the original vaccine.

I asked for more details, which Brock kindly provided:

The experience has been very positive. I enrolled in Fall of 2020, and received two doses of what turned out in retrospect to be the placebo, and went in once to let them draw some blood. When the vaccine was approved and the study was unblinded, I received the real thing from Pfizer's study partner, and I also received the booster from them in October.

I check in once a week on a mobile app to say if I'm experiencing any symptoms, and if I do I'm expected to swab myself and send them the sample.

When the reports of vaccine side-effects were released in early December 2020, I was fairly sure I was in the placebo group. Since the control group is receiving a real vaccine this time and not saline, I will have no evidence this time which group I'm in.

If there are future vaccine studies for which I qualify, I would not hesitate about volunteering again.

You might have some questions or comments! Join the conversation, and what you say will impact what I talk about in the next issue. You can also email me if you have a comment that you don’t want to share with the whole group, or if you are unable to comment due to the paywall in today’s issue.

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Always,

JS

1. Feels like it has been a century, right?