(Bloomberg) -- Outside advisers to the U.S. Food and Drug Administration tentatively plan to meet in June to discuss Covid-19 vaccines for younger kids.
The FDA said Friday that it has held the dates of June 8, June 21 and June 22 for potential meetings of its Vaccines and Related Biological Products Advisory Committee to discuss pediatric use of vaccines made by Moderna Inc. and the partnership of Pfizer Inc. and BioNTech SE.
The news comes one day after Moderna said it had applied for emergency authorization for its shot in young kids. There is tremendous pressure on the FDA to authorize one or more Covid vaccines in children under 5 years old. More than 900 doctors sent a letter Wednesday to FDA Commissioner Robert Califf asking for a quick review of a Covid vaccine for young children.
“It is important to note that the dates below are tentative as none of the submissions are complete,”the FDA said in its announcement. “The agency understands the urgency to authorize a vaccine for age groups who are not currently eligible for vaccination and will work diligently to complete our evaluation of the data.”
Moderna's two-dose vaccine in the youngest kids uses a quarter of the adult dose. In a trial, it produced immune responses that matched those in younger adults. Moderna's vaccine is currently only cleared for adults in the U.S. The company plans to complete its FDA application for the youngest kids next week.
Pfizer is waiting for data on three doses of its vaccine in kids under 5 before it completes its submission to the agency. The shot is already cleared in the U.S. for kids ages 5 and older, but two doses in younger kids didn't produce the immune responses that the company had hoped for. The data on three doses are due soon. In the youngest kids, Pfizer is using one-tenth of the adult dose in each shot.
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