The U.S. Food and Drug Administration issued an emergency use authorization (EUA) 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 6 months of age.
For the Moderna COVID-19 Vaccine, the FDA amended the EUA to include use of the vaccine in individuals 6 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, the FDA amended the EUA to include use of the vaccine in individuals 6 months through 4 years of age. The vaccine had been authorized for use in individuals 5 years of age and older.
The FDA’s evaluation and analysis of the safety, effectiveness and manufacturing data of these vaccines was rigorous and comprehensive, supporting the EUAs.
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 for each vaccine.
Prior to making the decision to authorize these vaccines for the respective pediatric populations, the FDA’s independent Vaccines and Related Biological Products Advisory Committee was consulted and voted in support of the authorizations.
“Many parents, caregivers and clinicians have been waiting for a vaccine for younger children and this action will help protect those down to 6 months of age. As we have seen with older age groups, we expect that the vaccines for younger children will provide protection from the most severe outcomes of COVID-19, such as hospitalization and death,” said FDA Commissioner Robert M. Califf, MD “Those trusted with the care of children can have confidence in the safety and effectiveness of these COVID-19 vaccines and can be assured that the agency was thorough in its evaluation of the data.”
The Moderna COVID-19 Vaccine is administered as a primary series of two doses, one month apart, to individuals 6 months through 17 years of age. The vaccine is also authorized to provide a third primary series dose at least one month following the second dose for individuals in this age group who have been determined to have certain kinds of immunocompromise.
The Pfizer-BioNTech COVID-19 Vaccine is administered as a primary series of three doses in which the initial two doses are administered three weeks apart followed by a third dose administered at least eight weeks after the second dose in individuals 6 months through 4 years of age.
“As with all vaccines for any population, when authorizing COVID-19 vaccines intended for pediatric age groups, the FDA ensures that our evaluation and analysis of the data is rigorous and thorough,” said Peter Marks, MD, PhD, Director of the FDA’s Center for Biologics Evaluation and Research. “In addition to making certain the data for these vaccines met FDA’s rigorous standards, the agency’s convening of an advisory committee was part of a transparent process to help the public have a clear understanding of the safety and effectiveness data supporting the authorization of these two vaccines for pediatric populations.”