Breaking News: FDA Panel Unanimously Endorses COVID-19 Vaccine EUA for Children Under 5 – Drug Topics

The ACIP is expected to meet this weekend.

All 21 members of the FDA Vaccine and Related Biological Products Advisory Committee (VRBPAC) have unanimously voted to recommend emergency use authorizations (EUA) for the Moderna and Pfizer-BioNTech mRNA COVID-19 vaccines for young children, bringing access one step closer to the only remaining group ineligible for a vaccine.¹

The 3-dose Pfizer-BioNTech vaccine is for children aged 6 months to 4 years, while the 2-dose Moderna shot is for those between 6 months and age 5, an age group that includes approximately 18 million children.²

Following the committee’s vote, the FDA is expected to quickly authorize the vaccines; the CDC Advisory Committee on Immunization Practices is scheduled to meet on Friday and Saturday. The entire process, including sign-off by CDC Director Rochelle Walensky, MD, is expected to be complete by next Tuesday.