Moderna To Seek Authorization For COVID-19 Vaccine For Children Under Six Years Of Age
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In an announcement released by Moderna on Wednesday, the biotechnology company shared that their Phase 2/3 KidCOVE study of the COVID-19 vaccine in children aged six months to two years and two years to six years had reached a successful primary endpoint. 

In the study, statistically significant vaccine efficacy was observed during the Omicron wave and young children in two groups (six months to two years) who received the vaccine in the study had a similar immune response against the virus as seen in adults. The vaccine was only about 44 percent effective at preventing symptomatic infection in children six months to two years old, and 37 percent effective in children aged two to five.

Fortunately, no new safety concerns were observed, as the vaccine was shown to have a similar safety profile to other pediatric vaccines after two months of median safety follow-up, with safety follow-ups continuing on the study.

“We believe these latest results from the KidCOVE study are good news for parents of children under 6 years of age. We now have clinical data on the performance of our vaccine from infants six months of age through older adults,” said Stéphane Bancel, Chief Executive Officer of Moderna.

Per Moderna’s release:

The interim analysis showed a robust neutralizing antibody response after a 25 µg two-dose primary series of mRNA-1273 along with a favorable safety profile. Based on these data, Moderna will submit a request for authorization of a 25 μg two-dose primary series of mRNA-1273 for children 6 months to under 6 years of age to the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and other global regulators in the coming weeks.

Moderna has also initiated a submission to the FDA for emergency use authorization of mRNA-1273 in children six to under 12 years of age and plans to update a similar request filed in 2021 for children between 12 and 17 with additional follow-up data.

“We remain committed to helping to end the COVID-19 pandemic with a vaccine for children of all ages,” Bancel says.

According to Moderna, KidCOVE is a “randomized, observer-blind, placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of two doses of mRNA-1273 given to healthy children 28 days apart.” The study population, which has included more than 11,000 children, is divided into three age groups (six to under 12 years, two to under six years, and six months to under two years) where the efficacy could be evaluated if enough cases accrued.

While young children under the age of five remain the only group of Americans ineligible for vaccine shots, the need for this age group’s protection against contracting COVID-19 is evident with the recent lifting of mask mandates across the country. 

Due to the high need for a vaccine against the virus for babies and small children, Moderna is working with the U.S. FDA and regulators globally to submit their data “as soon as possible,” as stated in the company’s press release.