FDA Expert Panel to Reviews Moderna, J&J Boosters and Vaccinations for Children

An FDA vaccines advisory committee will meet Oct. 14-15 to consider whether to recommend booster doses of Moderna’s and Johnson & Johnson’s (J&J) COVID-19 vaccines for adults 18 years and older, including assessing whether to support a mix-and-match approach using different jabs.

“The available data make clear that protection against symptomatic COVID-19 in certain populations begins to decrease over time, so it’s important to evaluate the information on the use of booster doses in various populations,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research in announcing the meeting of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC).

On Oct. 15, the National Institutes of Health will present data on mixing and matching different shots of the Pfizer/BioNTech, Moderna and J&J vaccines.

The expert panel will meet again on Oct. 26 to assess whether to support Pfizer’s request for an updated Emergency Use Authorization (EUA), covering use of its COVID-19 vaccine in children aged five to 11.

FDA Acting Commissioner Janet Woodcock said the agency will conduct a “comprehensive evaluation” of the available clinical trial data for this group, who “may need a different dosage or formulation from that used in an older pediatric population or adults.”

Last month, VRBPAC rejected recommending full approval of Pfizer’s COVID-19 booster in the general population but voted unanimously in favor of an updated EUA for boosters in people 65 years and older as well as those at high-risk of progressing to severe disease (DID, Sept. 20). ― Jason Scott