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Moderna and Pfizer/BioNTech’s COVID-19 vaccines proved safe and effective for kids under 5 years of age, paving the way for immunization of the only age group still awaiting access, according to FDA briefing documents released ahead of 2 days of advisory meetings.

On Tuesday, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet to discuss Moderna’s request for emergency use authorization (EUA) of its COVID-19 vaccine (Spikevax) in children ages 6 years to 17 years.

And on Wednesday, the agency’s vaccine advisers will discuss whether the benefits of the mRNA COVID-19 vaccines outweigh the risks in the country’s youngest patients: those ages 6 months to 4 years for Pfizer/BioNTech’s EUA request and those ages 6 months to 5 years for Moderna’s request.

Over the 2-day session, VRBPAC will discuss whether a two-dose regimen of the Moderna mRNA vaccine is safe and effective to prevent COVID-19 in kids ages 6 months to 17 years.

Moderna’s COVID vaccine is currently approved in adults 18 and over. The company has submitted EUA requests to the FDA for three pediatric age groups: ages 12 to 17 years, ages 6 to 11 years, and ages 6 months to 5 years. The proposed two-dose primary series for each age group are 100 μg, 50 μg, and 25 μg per dose, respectively. Currently, only the Pfizer/BioNTech formula (Comirnaty) is authorized for use among children ages 5 to 17 years.

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