FDA Advisory Panel Recommends Moderna and Pfizer Vaccines for Children Six Months and Older

June 16, 2022

The FDA’s Vaccines and Related Biological Products Advisory Committee voted unanimously, 21-0, yesterday in favor of FDA emergency authorization for Moderna’s two-dose COVID-19 vaccine series in children between age six months and five years and Pfizer’s three-dose COVID-19 vaccine series in children between age six months and four years.

Emergency Use Authorization by the agency will mean that “the country has reached the milestone where virtually anyone in the U.S. can choose to receive a COVID-19 vaccine,” said Arnold S. Monto, professor at the University of Michigan’s School of Public Health, who is acting chair of the committee.

Hayley Gans, Clinical Professor at Stanford, said her yes vote on the Moderna vaccine reflects how significant COVID-19 is as a pediatric disease. “Prevention is the way to go,” she said.

James E.K. Hildreth of Meharry Medical College said that the vaccines will give parents a choice, especially those with children who have underlying conditions.

Ofer Levy from Boston Children’s Hospital and Archana Chatterjee from Rosalind Franklin University both said, however, that in spite of reaching this point, much more work needs to be done post-authorization, especially for safety monitoring.

In a closing statement, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER), promised that the agency would continue to monitor the vaccines’ safety and effectiveness. — Selma Khenissi