Infectious Disease

FDA authorizes COVID-19 vaccines for youngest children

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Califf and Marks report no relevant financial disclosures.

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The FDA announced Friday that it authorized the emergency use of Moderna and Pfizer-BioNTech’s COVID-19 vaccines for children as young as 6 months old.

The announcement comes after two back-to-back meetings of the Vaccines and Related Biological Products Advisory Committee (VRBPAC), which recommended on Wednesday that Moderna’s emergency use authorization (EUA) be amended so that children aged 6 months through 5 years can receive a two-dose series, at 25 g per dose, and that Pfizer-BioNTech’s EUA be amended to allow infants and children aged 6 months through 4 years to receive a three-dose series, at 3 g per dose. In both cases, the committee voted 21-0 that the benefits of the vaccines outweighed the risks.

Child getting COVID vaccine

Because of the FDA’s decision today, COVID-19 vaccines will be available for everyone aged 6 months and older. Source: Adobe Stock

Additionally, on Tuesday, the committee unanimously agreed to back Moderna’s two-dose series for adolescents aged 12 through 17 years at 100 g per dose, and a two-dose series at 50 g per dose for children aged 6 through 11 years, both of which were also authorized today.

Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, addressed the EUA in a statement.

“As with all vaccines for any population, when authorizing COVID-19 vaccines intended for pediatric age groups, the FDA ensures that our evaluation and analysis of the data [are] rigorously and thoroughly,” Marks said. “In addition to making certain the data for these vaccines met FDA’s rigorous standards, the agency’s convening of an advisory committee was part of a transparent process to help the public have a clear understanding of the safety and effectiveness data supporting the authorization of these two vaccines for pediatric populations.”

The CDC’s Advisory Committee on Immunization Practices is already scheduled to vote on clinical recommendations for the vaccines this weekend.

Moderna asked the FDA to authorize its vaccine for younger children in April, citing data from the phase 2/3 KidCOVE study, in which young children in two age groups — 6 months to younger than 2 years and 2 years to younger than 6 years — received the vaccine and had an immune response against the virus that was consistent with those seen in older children and adults.

According to the FDA’s briefing documents for Wednesday’s meeting, the vaccine’s efficacy among children aged 2 to 5 years was 36.8% based on a CDC definition and 46.4% based on a Moderna study’s definition.

Other briefing documents compiled by the FDA reported that the efficacy of Pfizer-BioNTech’s three-dose series — calculated during the omicron wave — was 80.4%, based on three cases of COVD-19 that occurred in the study’s vaccine group and seven in its placebo poor. According to the documents, efficacy was far lower (28.3%) when calculated after the second dose but before the third.

Pfizer and BioNTech announced last December that they were evaluating the addition of a third 3 µg dose — one-tenth the size of an adult dose — after a two-dose series failed to produce the expected level of protection in young children.

Moderna and Pfizer’s vaccines are already approved for adults.

“Many parents, caregivers and clinicians have been waiting for a vaccine for younger children, and this action will help protect those down to 6 months of age,” FDA Commissioner Robert M. Califf, MD, said in a statement. “As we have seen with older age groups, we expect that the vaccines for younger children will provide protection from the most severe outcomes of COVID-19, such as hospitalization and death. Those trusted with the care of children can have confidence in the safety and effectiveness of these COVID-19 vaccines and can be assured that the agency was thorough in its evaluation of the data.”

According to the AAP, more than 87,644 new pediatric COVID-19 cases were reported in the United States during the week ending June 9, out of 635,980 weekly reported cases.

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