In a move poised to bring a second COVID-19 vaccine to the market for US kids, the Food and Drug Administration (FDA) advisory committee today approved the Moderna vaccine for children ages 6 through 17 years.The vote by the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) today precedes its deliberations tomorrow on EUA modifications for Moderna and Pfizer-BioNTech mRNA vaccines for the youngest children yet to receive vaccine eligibility, those ages 6 months to age 5.
If approved, nearly all Americans would finally be eligible for COVID-19 vaccination.The votes this week come as more parts of the country move into the high community-transmission category and more transmissible BA.4 and BA.5 Omicron subvariants expand their reach.Concerns about Omicron protectionDuring today's discussions, VRBPAC weighed the benefits and risks of the two-shot vaccine series at a dose based on age: the 100-micogram adult dose for adolescents ages 12 through 17 and a 50-microgram dose for children ages 6 through 11.
The votes passed unanimously for use of the vaccine in both age groups.During the discussions, many members said they were comfortable with the data on the vaccine, and that approval of a second mRNA vaccine for kids provides parents another choice and greater access.
They raised concerns about very rare myocarditis complications associated with mRNA vaccines, but said so far, they appear to be less common in adolescent males than in adult males.However, some members raised concerns about how well a two-dose series will protect against Omicron, though a third dose wasn't an official part of the discussion.Paul Offit, MD, professor of pediatrics at the Children's Hospital of Philadelphia, said with the