USA – FDA authorizes Pfizer, Moderna vaccines for youngest children

The US Food and Drug Administration (FDA) on Friday authorized the emergency use of Moderna and Pfizer-BioNTech’s COVID-19 vaccines for children as young as 6 months of age, asserting that the benefits of the vaccines outweigh the risks.

This action comes two days after the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted to support expanding the emergency use authorizations (EUAs). (RELATED: VRPAC recommends Pfizer, Moderna COVID vaccines for youngest children, Regulatory Focus 15 June 2022)

Moderna’s vaccine was authorized in children 6 months through 17 years of age; the vaccine was previously authorized, and later approved, for use in adults 18 years of age and older. Pfizer’s vaccine was expanded to allow its use in children 6 months through four years of age. Previously, the vaccine was authorized in children five years of age and older as a two dose series. The Pfizer-BioNTech vaccine is approved as a two-dose series in individuals 16 years of age and older.

FDA authorized the Moderna’s vaccine as a two-dose series to be administered one month apart and allows a third dose one month following the second dose for children who are immunocompromised. Pfizer-BioNTech’s vaccine was authorized as a three dose series; the initial two doses are administered three weeks apart, followed by a third dose eight weeks after the second…