FDA Advisors Back Moderna Shot for Older Children, Teens

WEDNESDAY, June 15, 2022 — The U.S. Food and Drug Administration’s vaccine advisory panel voted unanimously on Tuesday to recommend the agency approve the emergency use of Moderna’s COVID-19 vaccine in children aged 6 to 17.

Despite the unanimous support, some panel members worried that trials of the vaccine were conducted before the emergence of the omicron variant. They noted the vaccine would likely help prevent serious illness but not be as good at blocking mild infections, The Washington Post reported.

“We crossed a line,” when omicron and its subvariants surfaced because now a third dose is needed for full protection, said panel member Paul Offit, M.D., of the Children’s Hospital of Philadelphia. Offit supported authorization — as long as a third Moderna dose is on the way. “We’re at a different part in this pandemic,” Offit added. “I think the benefits clearly outweigh the risks, but I say that with the comfort being provided that there will be a third dose.”

Moderna told the panel it is testing a booster shot for the 6-through-17 age groups and could seek FDA authorization as early as July.

In coming to its decision, the FDA panel analyzed Moderna’s two-dose vaccine for children aged 6 to 11 at half the strength of the adult shot, and for youth aged 12 to 17 at the adult dose. Typically, the FDA follows the recommendations of its expert panels. Once the FDA has authorized the shots, as expected, expert advisers to the U.S. Centers for Disease Control and Prevention will discuss the best use of the Moderna vaccine in older children and teens this weekend.

In a second meeting on Wednesday, the same FDA panel will weigh Moderna’s vaccine for children under 6 and Pfizer’s vaccine for children under 5. There are about 18 million children under 5 in the United States and they are the only age group in the country not yet eligible for any COVID-19 vaccines, The Post reported.

The Washington Post Article

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