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COVID Vaccine for Small Kids OK'd by FDA, Awaits CDC Approval

A two-dose COVID-19 vaccine for children ages 6 months to five years was approved by the Federal Drug Administration yesterday. If CDC advisers give it the greenlight, vaccinations could start June 21.

FDA sign with seal
A Food and Drug Administration panel has given its support to Moderna Inc.'s COVID-19 vaccine for infants and toddlers.
Sarah Silbiger/TNS
(TNS) — Moderna Inc.’s COVID-19 vaccine for infants and toddlers won the support of a panel of U.S. regulatory advisers, putting parents one step closer to being able to protect their youngest against COVID-19 for the first time.

The 21-member committee advising the Food and Drug Administration voted unanimously in favor of Moderna’s two-dose vaccine for youngsters ages six months through 5 years. The panel will vote on Pfizer’s three-dose vaccine for children six months through 4 years later Wednesday. The FDA doesn’t have to follow the recommendations of its advisory panels, but it usually does.

An authorized vaccine for this age group would be welcome news for parents whose youngsters are the last remaining age group with no cleared vaccine. While children are less likely than adults to experience the worst outcomes of COVID-19, the FDA warned that the rate of hospitalization for children, particularly during the omicron wave, has been “quite troubling.”

The youngest population “has been much less affected than the older populations, particularly the oldest population, but nonetheless has also been affected,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in the meeting. “Each child that’s lost essentially fractures a family.”

The U.S. government has already secured a supply of 10 million doses from Pfizer and Moderna to vaccinate children under 5 as soon as the FDA and the Centers for Disease Control and Prevention give the green light. The vaccines for the youngest of kids are expected to be rolled out as early as June 21, the Biden administration said earlier this month.

Advisers to the CDC will hold a two-day meeting later this week to discuss the shots for kids. The panel of outside experts, the Advisory Committee on Immunization Practices, advises the CDC on how best to administer new vaccines. CDC Director Rochelle Walensky will need to sign off on any recommendations before vaccines can begin to be administered.

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