Moderna seeks FDA Emergency Authorization for Children Under 6

March 23, 2022

Moderna touts new data supporting the use of its COVID-19 vaccine Spikevax in children under 6 as it prepares to ask the FDA and EMA to grant emergency authorization (EA) for low-dose vaccines for younger children. In doing so, it has delayed its filing to the FDA for an EA for Spikevax in children 6-11 years of age. Although the vaccine has demonstrated a marked antibody response, the efficacy in children is significantly less than adults.

According to Angus Liu of Fierce News, “In a phase 2/3 trial dubbed KidCOVE, two doses of 25-microgram Spikevax showed “a robust neutralizing antibody response” in two age subgroups, along with a “favorable” safety profile, Moderna said. In both children 6 months to 2 years old and those between 2 and 6, Spikevax elicited anti-coronavirus immune responses that were “similar to” the high dose in adults, the company said. The trial therefore met its primary goal in these age groups.”