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
Would like to understand the 1/3 dose versus the full dose, after you see the data. My son (who will likely be 11.5 by the time the vaccine for children is released and weighs the same as some adults) might only receive 1/3 the vaccine while a 12 year old will receive a full vaccine. Should that cause worry? Do you think they will be able to show the effectiveness of 5 versus 11 year olds? I know something is better than nothing but wondering about the value of waiting a few months. Would love to hear your thoughts after you see the data...
Any thoughts on the Pfizer shot for kids who meet the 5+ age requirement, but are very small in stature? For instance, is it okay for a 5-year-old to get the 10-microgram dose even though their size is more in line with a 3-4 year old who will be getting a 3-microgram dose eventually?