Moderna seeks FDA OK for COVID vaccine in 6 month to under 6 year olds

Moderna has submitted a request for emergency use authorization for its COVID-19 vaccine for children 6 months through 5 years old, the company announced Thursday morning.

In the company’s study of 6,700 kids in the 6-month to under 6-year age group, researchers found after receiving two 25–microgram doses of the vaccine they developed levels of virus-fighting antibodies comparable to young adults who received two doses of the full-strength 100 microgram shot.

In the Phase 3 study, which took place during the omicron wave, researchers found the vaccine was 51% effective among children 6 months to under 2, and 37% effective among children 2 to under 6.

The company’s chief medical officer Dr. Paul Burton told USA TODAY effectiveness may be less in the older group because of their changing immune systems.

“Fifty-one percent, while less than what we are used to seeing … is a level that says you certainly have great protection against severe disease and hospitalization,” he said. “The antibody result that we have is what we saw in the 12- to 24-year-olds, and we know in that group we have a strong protection against severe disease.”

While other countries already allow Moderna’s vaccine to be used in children as young as 6, the U.S. has limited the company’s shot to adults. Only Pfizer-BioNTech’s COVID-19 vaccine is allowed in the U.S. for use in teens and children as young as 5.

Moderna has requests pending with the FDA for emergency use authorization for 6- to 11-year-olds, and 12- to 17-year-olds.

The request to expand its shots to the adolescent group has been stalled since June because of agency concern about a possible, very rare heart inflammation side effect. Moderna says its original adult dose is safe and effective for this age group and recently submitted a follow-up of its clinical safety and efficacy data at the FDA’s request, which is being reviewed.

Burton said no cases of the rare condition were reported among the young children in the recent trial.

“Omicron, BA.2, all these other subvariants are really starting to tick up and these little kids have no other protection or vaccine available for them,” he said about the 6-months to 2-year-olds. “They have no options right now so this has been our highest priority.”

Competitor Pfizer currently offers kid-size doses for school-age children and full-strength shots for those 12 and older. The company is testing even smaller doses for children under 5 but had to add a third shot to its study when two injections didn’t prove strong enough. Those new results have yet to be released.

Moderna has also recently released data showing a booster shot that includes the original vaccine plus one directed at the beta variant produced two times more antibodies against the beta, delta and omicron variant one month after their shot compared to people who received the original vaccine.

The company said it is currently studying booster doses for the two oldest pediatric age groups and is designing a study to evaluate the potential for boosters in those aged 6 months to under 6 years.

“We believe mRNA-1273 will be able to safely protect these children against SARS-CoV-2, which is so important in our continued fight against COVID-19, and will be especially welcomed by parents and caregivers,” said Stéphane Bancel, Chief Executive Officer of Moderna.

Follow Adrianna Rodriguez on Twitter: @AdriannaUSAT.

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.