FDA approves COVID-19 vaccines for youngest kids

Accepting a recommendation this week from its independent advisory committee, the Food and Drug Administration (FDA) today authorized emergency use of Moderna and BioNTech COVID-19 vaccines for children as young as 6 months.In global developments, World Health Organization (WHO) advisers today weighed in on the composition of modified COVID-19 vaccines, which comes as some countries are reporting case rises due to the more transmissible BA.4 and BA.5 Omicron subvariants.ACIP starts deliberating recommendationsIn its announcement today, the FDA said it amended Moderna's emergency use authorization (EUA) to include children ages 6 months through 17 years old.

The FDA amended Pfizer's EUA to include kids 6 months through 4 years of age.In two meetings this week, FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended approval Moderna for use in kids ages 6 though 17 years, then the next day recommended approval for kids as young as 6 months old for the Moderna and Pfizer-BioNTech vaccines.In a related development, the Center for Disease Control and Prevention (CDC) vaccine advisory group began discussing recommendations for use of the two vaccines in kids as young as 6 months old.

The Advisory Committee on Immunization Practices (ACIP) will vote on its recommendations tomorrow, and the CDC must formally accept them before immunization of young kids can begin.Following the FDA's approval, though, shipments are on their way to states.Robert Califf, MD, the FDA's commissioner, said in a statement, "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.