In unanimous decision FDA approves Moderna’s Covid-19 vaccine for children and teens ages 6 to 17

INDIANA – In a unanimous decision on Tuesday, US Food and Drug Administration advisers voted in favor of authorizing Moderna’s Covid-19 vaccine for children and teens ages 6 to 17.

All 22 members of the FDA’s Vaccines and Related Biological Products Advisory Committee voted “yes” in response to two questions of whether the benefits of the vaccine – when given as two 100-microgram doses for ages 12 to 17 and two 50-microgram doses for ages 6 to 11 – outweigh its risks, based on the available scientific evidence.

The FDA, which typically follows the committee’s decisions, will now decide whether to authorize the vaccine for emergency use in these age groups. 

However, shots can’t be given until the US Centers for Disease Control and Prevention’s own vaccine advisers have voted on whether to recommend them and CDC Director Dr. Rochelle Walensky has signed off on the recommendation.

Moderna’s vaccine has been estimated to be 93.3% effective against symptomatic Covid-19 among adolescents ages 12 to 17 when the original coronavirus and the Alpha variant were dominant, according to an FDA briefing document.

The vaccine was estimated to be 76.8% effective against symptomatic Covid-19 for children ages 6 to 11 when the Delta variant was dominant. Pfizer/BioNTech’s Covid-19 vaccine is approved for people 16 and older, and it’s authorized for use in children as young as 5.