FDA advisory committee backs Moderna vaccine for kids 6 and older
A key FDA advisory committee on Tuesday voted to recommend Moderna's COVID vaccine receive emergency use authorization for kids six and older.
Why it matters: If Moderna ultimately receives emergency use authorization and a CDC recommendation, it would create a second option for a COVID-19 vaccine for older children in the U.S.
- The committee's recommendation comes a day before the same group weighs the risks and benefits of both Moderna and Pfizer's COVID shots for kids younger than six years old and five years old, respectively.
"I'd like to give parents as many choices as possible," said Arthur Reingold from the University of California, Berkeley, one of the FDA's advisers, during the meeting.
The big picture: The committee zeroed in on whether the benefits of the vaccine's protection outweighed the risks of not getting it, and potentially getting severe COVID infection.
Yes, but: The incidence of myocarditis remains a lingering concern — as does the concern that the EUA would approve the primary series as two shots even though several members said it's become clear under Omicron that three doses are necessary to achieve protection against severe disease.
"The benefits outweigh the risks," said Paul Offit, a member of the FDA committee and director of the Vaccine Education Center at Children's Hospital of Philadelphia.
- "But we're not at the same point in this pandemic," Offit said, adding he believes a third shot shouldn't be considered a "booster" but part of the primary series.
Both Moderna and Pfizer's vaccine received emergency use authorization for adults in the U.S. in last 2020. Pfizer's vaccine got the OK for use in kids. Pfizer's vaccine was authorized by the FDA for kids 12- to 15-years-old in May 2021 and for kids 5- to 11-years-old in October 2021.