This Friday, the U.S. Food and Drug Administration The FDA has authorized emergency use of the Moderna vaccine and the Pfizer-BioNTech vaccine for children 6 months to 4 years of age to prevent COVID-19 disease.
For the Moderna COVID-19 vaccine, the FDA amended the emergency use authorization (EUA) to include use of the vaccine in individuals 6 months to 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, the FDA amended the EUA to authorize use of the vaccine in people 6 months to 4 years of age. It has already been authorized for use in people 5 years of age and older.
The agency determined that the known and potential benefits of the Moderna and Pfizer-BioNTech COVID-19 vaccines outweigh the known and potential risks in the pediatric populations authorized for use with each vaccine.
Prior to the decision to authorize these vaccines for the respective pediatric populations, the FDA's Vaccines and Related Biological Products Advisory Committee was consulted and voted in favor of the authorizations.