Question: I haven’t been keeping track.  When are we expecting vaccines for under-5s?

Answer: Pfizer expects to have data on the efficacy of its 3-dose series for children ages 6 months through 4 years in early April.  If the data are positive– e.g. no safety profile concerns and the 3 doses elicit ample antibody response and/or the 3 doses show effectiveness against infection*– then Pfizer will submit an application for emergency use authorization to the FDA.  As described in our Q&A of 12/6/21, if the process follows a similar timeline as the process for 5-11 year olds, Pfizer could submit data to the FDA one week after initial results are announced.  It would take another ~4 weeks for FDA to review and meet and another ~1 week for CDC’s ACIP to meet and make its recommendation (i.e. recommendation could come in late-May).  Of course, there are no guarantees here.

*If you’re interested in reading more about the clinical trials outcomes of interest, check out the detailed information shared on clinicaltrials.gov.  And if you’re interested in reading more about the recent pull back of FDA’s plan to expedite review of Pfizer’s COVID-19 vaccine in young children data, this STATNews article gives a solid overview.