Wednesday brought some potentially positive news for the parents and caregivers of young children who have endured an agonizing wait for an effective COVID-19 vaccine. Moderna announced Wednesday that its two-dose vaccine for children ages 6 months to under 6 years appeared safe and produced strong antibody levels that correlate with effectiveness in adults. The company plans to ask the Food and Drug Administration to authorize the vaccine in the coming weeks.
The trial, a randomized, observer-blind, placebo-controlled study called KidCOVE, involved 6, 700 children under 6 years old (4, 200 children six months to 2 years and 2, 500 children two years to under 6 years). Vaccinated children received two 25-microgram doses of vaccine—a quarter of the adult dose—which were given 28 days apart. Neutralizing antibody levels in the vaccinated children met or exceeded those seen in adults ages 18 to 25, for which shot is already approved.
Though the primary objective of the test was to reach those antibody levels seen in adults—a process called an immunobridging study—the demo also looked at efficacy against infection and severe disease amid the wave of omicron coronavirus variant infections. Phase III tryout data indicated that the injection was about 44 percent effective at preventing an omicron infection in children ages 6 weeks to 2 years and 37. 5 percent effective against an omicron infection in children ages 2 years to under six years.