Update on vaccines for children

And, other key FDA review dates on boosters

There’s a lot of quick-moving news stories about vaccines for children and the FDA’s review of Moderna and J&J boosters. Whew, the FDA is busy (thank you!). Let me help give you a quick summary of what’s going on and what to expect. I’m breaking this post down by vaccine type and in order of potential roll-out (if approved).

Pfizer

Pfizer announced today they formally filed for emergency use authorization for their COVID vaccine in children 5-11. Key things to keep in mind:

• The FDA will meet to discuss and vote on this on October 26th.

• The data has not officially been released for any of us to look at yet. But, we do know that the Pfizer trial among 5-11 year olds included 2,269 children. There were no serious side effects.

• This is still a 2-dose regimen, similar to 12+ kids and adults. The major change is that younger kids received a third of the dose of everyone else (10 micrograms compared to 30 micrograms for older adolescents and adults). (Of note, younger children less than 5 years received a much smaller dose of 3 micrograms. This data will not be reviewed at the October 26th meeting, but I wanted to let you all know as an FYI for those of you with < 5 year olds.)

• Pfizer said the antibody levels shown after the 2nd dose among the 5-11 year olds were just as strong as older kids and adults who received the full-strength doses. Yeehaw, friends.

Moderna

Moderna began enrolling children (6 months to 12 years) in their clinical trials in March, 2021. They expect to enroll over 13,000, beginning with 6-12 year olds, then 2-6 year olds, and then the youngest age group of 6 months to 2 years. This is a 2-dose regimen, similar to adults who receiving Moderna. It’s a bit unclear about the dosing for Moderna among children and if that differs depending on the age.

Johnson & Johnson

It’s hard to find information on J&J’s vaccine for children. They are planning these based on some press releases, but no formal data or announcements that I’ve seen yet. They are conducting a trial among 12-17 years olds in their current clinical trial.

Lots to follow and I hope this helps with timelines! Pfizer is up first for review and voting at the FDA on October 26th, then it will go to the CDC for review/vote. If all goes well, kids 5-11 could start getting their first dose around Halloween. Cue the candy… As always, I’ll keep you posted on these meetings and data.

Other key dates to keep in mind:

• October 14 - FDA reviews the Moderna booster

• October 15 - FDA reviews J&J booster

Lastly, as a gentle reminder. I only read and respond to comments or messages posted here on Substack through paid subscriptions. So, if you’ve sent me a comment or email outside of Substack, my apologies for not responding. There’s just a lot to keep up with (read=100s of messages and comments on social media/emails) and not enough time. =) I’m happy to respond via Substack which is much more manageable. You can become a paid subscriber here or send me an email if finances are a barrier. I’ll happily send you a gift subscription. I also am not able to respond to individual-type questions (like should you go to a BBQ with XYZ, etc) or clinical-type questions as an epidemiologist. Thanks for your understanding and support!

-In solidarity,

FNE