BRIEF—FDA backs Moderna and Pfizer-BioNTech COVID-19 Vaccines for infants

17 June 2022

The US Food and Drug Administration today authorized emergency use of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include use in children down to six months of age, with the decision coming just a day after an FDA advisory panel recommended approval in this age group.

For the Moderna COVID-19 Vaccine, brand name Spikevax, the FDA amended the emergency use authorization (EUA) to include use of the vaccine in individuals six months through 17 years of age. The vaccine had been authorized for use in adults 18 years of age and older.
For the Pfizer-BioNTech COVID-19 Vaccine, trade name Comirnaty, the FDA amended the EUA to include use of the vaccine in individuals six months through four years of age. The vaccine had been authorized for use in individuals five years and older.