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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
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:
https://clinicaltrials.gov/ct2/show/NCT04400838?term=vaccine&recrs=adf&type=Intr&cond=COVID&cntry=GB&phase=2&draw=2&rank=1
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
https://clinicaltrials.gov/ct2/show/NCT04400838?term=vaccine&recrs=adf&type=Intr&cond=COVID&cntry=GB&phase=2&draw=2&rank=1
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:
https://clinicaltrials.gov/ct2/show/NCT04470427?term=vaccine&recrs=adf&type=Intr&cond=COVID&cntry=US&phase=2&draw=2&rank=2
Pfizer Clinical Trials Link:
https://clinicaltrials.gov/ct2/show/NCT04368728?term=vaccine&recrs=adf&type=Intr&cond=COVID&cntry=US&phase=2&draw=2&rank=3
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.
Moderna Clinical Trials Link:
https://clinicaltrials.gov/ct2/show/NCT04470427?term=vaccine&recrs=adf&type=Intr&cond=COVID&cntry=US&phase=2&draw=2&rank=2
Pfizer Clinical Trials Link:
https://clinicaltrials.gov/ct2/show/NCT04368728?term=vaccine&recrs=adf&type=Intr&cond=COVID&cntry=US&phase=2&draw=2&rank=3
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. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4944327/
It may be that ACIP ( https://www.cdc.gov/vaccines/acip/index.html) 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.
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
And would be more challenging conversation than for previous vaccines given 1) unproven technologies 2) limited data in kids
