Moderna seeks COVID jab EUA for young kids

March 24, 2022

Moderna is trying to be the first to get its COVID-19 vaccine approved for children six months to six years old. The company has asked the U.S. FDA to authorize the drug for emergency use after releasing data from clinical trials.

Data from the phase 2/3 KidCOVE study of the Moderna vaccine showed the drug worked safely in young children and generated an immune response likely to cause protection for the kids, the company announced.

However, data showed the vaccine trials in children didn’t quite hit the same benchmarks as in previous trials of the Moderna vaccine. In phase 3 of the study, the vaccine was about 43% effective at preventing infection in children six months to two years old and about 37% effective at preventing infection in children two to 6 years old.

These numbers fall slightly below the FDA’s previous guidance, which requested vaccines that would cut the risk of COVID-19 infection by at least 50%. However, Moderna’s trials for the vaccine efficacy in young children reflect the influence of the omicron variant, which has shown increased resistance against immunity from vaccines and prior infections.

One option, said Luciana Borio, a former FDA acting chief scientist, would be to authorize the vaccine for high-risk individuals, like children with underlying medical conditions, who would benefit greatly from vaccine authorization.

Moderna will also study the possibility of a booster in children under six, like it is currently doing for older populations. Additionally, after consulting with the FDA, the drugmaker submitted for emergency use authorization of its vaccine in children ages 6 to 11 years old.

No adverse events or safety concerns were identified in Moderna’s KidCOVE trials. There were no cases of myocarditis or pericarditis, or inflammation of the heart or the tissue surrounding it, nor were there any deaths during the trials, according to the company.