Moderna to Ask FDA to Authorize Vaccine for Children as Young as 6 Months

Effectiveness lower than threshold deemed acceptable by FDA, WHO

A health worker administers a dose of a Moderna COVID-19 vaccine during a vaccination clinic at the Norristown Public Health Center in Norristown, Pa., on Dec. 7, 2021. Matt Rourke/AP Photo

Moderna on March 23 said its clinical trial for its COVID-19 vaccine in children aged 6 months to 5 years old successfully met its primary endpoint, and plans to ask the Food and Drug Administration (FDA) to grant emergency use authorization for the age group, even as the estimated effectiveness is lower than the bar set by the FDA and the World Health Organization.

Moderna, a Massachusetts-based biotechnology firm, said the phase 2/3 trial showed the safety profile in young children was similar to that seen in adults and older kids, with no cases of post-vaccination heart inflammation recorded.