Stefan Baral Profile picture
🇨🇦🇸🇪,MD,MPH FRCPC & CCFP, 🏳️‍🌈 ally Jew No $ COI Papers: https://t.co/FQjCu7BsNE Free Course: https://t.co/yLabiMSsvj COVID Talk: https://t.co/u1t1lAc0vT

Sep 15, 2020, 6 tweets

Are we testing #COVID19 vaccines for kids?

I often see an assumption that the COVID vaccines being trialed will be available for kids at the same time as adults assuming efficacy. And that's a big (HUGE) assumption.

Let's take a look at the Oxford, Moderna, and Pfizer trials

Oxford Clinical Trials Link:
clinicaltrials.gov/ct2/show/NCT04…

Two things:
1) Efficacy doesn't appear to be primary outcome for kids as they are only getting one dose
2) Where are the 13-17 yo kids

If I am missing something, happy to be corrected

The two mRNA candidates:
Moderna Clinical Trials Link:
clinicaltrials.gov/ct2/show/NCT04…

Pfizer Clinical Trials Link:
clinicaltrials.gov/ct2/show/NCT04…

These trials are easier as are both 18+ so no inclusion of kids. The others including the NA-831 adjuvant for OPV also focused on adults.

Pre-COVID, if we only had data on adults, we would do step-down studies to test for safety in adolescents, kids, etc. Now, exclusion of 13-17 yo in Oxford might be a mistake in clinical trials registration, but mRNA studies seem to be adults only.
ncbi.nlm.nih.gov/pmc/articles/P…

It may be that ACIP (cdc.gov/vaccines/acip/…) approves for kids anyways but I think that this would be uncommon without more data on safety in kids.

All to say, assuming these vaccines work, I don't think we will have efficacy and safety data for kids for quite some time.

If regulatory bodies do approve for kids, I think 50% of parents will sign up right away, 25% will want to talk about it for an hour, and 25% will refuse.

And would be more challenging conversation than for previous vaccines given 1) unproven technologies 2) limited data in kids

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