FDA Grants EUA to Moderna’s COVID-19 Vaccine for Children and Updates Pfizer Vaccine EUA

On the heels of unanimous recommendations last week by its vaccines advisory committee, the FDA granted Emergency Use Authorization (EUA) on Friday for Moderna’s COVID-19 vaccine for children between six months and 17 years and for Pfizer-BioNTech’s COVID-19 vaccine for children between six months and four years.

The agency made its announcement ahead of a June 17-18 meeting by a Centers for Disease Control and Prevention (CDC) advisory committee on the pediatric vaccines, but said its own evaluation of the vaccines was rigorous.

“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, director of the FDA’s Center for Biologics Evaluation and Research.

And FDA Commissioner Robert Califf emphasized that “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 FDA’s Vaccines and Related Biological Products Advisory Committee voted overwhelmingly in favor of the two COVID-19 vaccines being administered to young children (DID, June 16). — Selma Khenissi