FDA Vaccine Committee Recommends Moderna Vaccine for Two Pediatric Age Groups

The FDA’s Vaccines and Related Biological Products Advisory Committee voted unanimously, 22-0, yesterday to recommend FDA authorization of Moderna’s two-dose primary series of its COVID-19 vaccine for children between the ages of 12 and 17 and between six and 11.

Although every panelist voted in favor of the vaccine for pediatric use, several expressed reservations.

Paul A. Offit, director of the vaccine education center at Children’s Hospital in Philadelphia noted that children getting the two-dose primary series cannot be considered fully vaccinated in light of the Omicron variant and subvariants. He suggested that a three-dose series would be needed in order for the vaccine to be fully effective.

H. Cody Meissner of Tufts Children’s Hospital noted that the risk of myocarditis while taking the Moderna vaccine was not properly addressed by the panel.

Michael R. Nelson, professor of medicine at the University of Virginia, also pointed out the limitations of the currently available data, including for children with weakened immune systems.

But Ofer Levy, director of the precision vaccines program at Boston Children’s Hospital, said the committee’s endorsement would help “vulnerable populations who merit protection against the SARS-CoV-2 virus.”

The advisory committee is reconvening today to consider amending the Emergency Use Authorization (EUA) for the Moderna vaccine to include the prevention of COVID-19 in infants and children six months through five years. It will also discuss amending the EUA for the Pfizer-BioNTech vaccine to include the prevention of COVID-19 in infants and children six months through four years. — Selma Khenissi