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FDA sets June dates to meet on Covid vaccine for young kids

The agency's advisory committee has been asked to convene to make recommendations on Moderna and Pfizer's vaccines for the youngest age group.
A child receives a COVID test in New York on Dec. 23, 2021. (Anna Watts/The New York Times)
A child receives a Covid test in New York on Dec. 23, 2021.Anna Watts / The New York Times / Redux

The Food and Drug Administration said Friday it plans to convene its vaccine advisory committee over several days in June to discuss authorization of the Covid-19 vaccines for the nation's youngest children.

The FDA has set aside the dates of June 8, June 21 and June 22 for the Vaccines and Related Biological Products Advisory Committee to review Moderna and Pfizer-BioNTech's vaccines for young kids, the agency said in a statement.

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The meeting dates are tentative, meaning they are subject to change. Once the FDA has finalized the dates, it intends to make additional materials available to the public.

Still, the tentative dates are important because they can help gauge when the FDA could make a final decision on the vaccines. The agency typically waits for a recommendation from its committee before making a decision, and usually follows that recommendation.

Parents have been eagerly awaiting news on Covid vaccines for young kids. Children under 5 are the only group in the United States unable to get the shots.

On Thursday, Moderna asked the FDA to authorize a lower dose of its two-dose Covid vaccine for children ages 6 months to 5 years.

Shortly after, the American Academy of Pediatrics released a statement urging the FDA to review Moderna's vaccine as soon as possible, noting that Covid cases in kids have started to rise again in the U.S. after a decline following the omicron variant surge.

Pfizer hasn't yet submitted an application to the FDA on its three-dose vaccine for kids under 5, but it's expected to do so in the coming weeks.

The FDA also said Friday it plans to convene its advisers on June 7 to discuss Novavax's application for its Covid vaccine for adults.

The vaccine, which uses proteins to kick-start the body’s immune system, is already available for use in at least 170 countries, but if cleared for emergency use in the U.S., it would provide an alternative to the popular mRNA-based shots from Pfizer and Moderna.

The agency is also planning a June 28 meeting to discuss what virus strain or strains should be included in Covid booster shots for this coming fall.

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