Moderna asks FDA to authorize COVID-19 vaccine in young children
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Moderna announced today that it has submitted a request to the FDA to authorize its COVID-19 vaccine in children aged as young as 6 months.
The company announced its plans to do so back in March.
Moderna asked the FDA to authorize a two-dose series of its COVID-19 vaccine for children aged 6 months to under 6 years. Source: Adobe Stock
The data are based on Moderna’s phase 2/3 KidCOVE study, in which young children in two age groups — 6 months to less than 2 years and 2 years to less than 6 years — received the vaccine and had an immune response against the virus that was consistent with those seen in older children and adults. The requests for both age groups are based on a 25 mg, two-dose series of the vaccine, the company said.
In a press release, the company said that in both groups, two doses of vaccine at 25 µg provided similar immunogenicity to the 100 µg two-dose primary series in adults aged 18 to 25 years, meeting the study’s noninferiority criteria. Compared with young adults, the SARS-CoV-2 neutralizing antibody geometric mean ratio (GMR) in children aged 6 months to younger than 2 years was 1.3 (95% Cl, 1.1-1.5), and the GMR was 1 (95% Cl, 0.9-1.2) for children aged 2 years to younger than 6 years.
Stéphane Bancel, chief executive officer of Moderna, said in the statement that the results represented “good news for parents.”
“We now have clinical data on the performance of our vaccine from infants 6 months of age through older adults," Bancel said. "Given the need for a vaccine against COVID-19 in infants and young children, we are working with the U.S. FDA and regulators globally to submit these data as soon as possible. Additionally, after consultation with the U.S. FDA, we have initiated a submission for emergency use authorization of our COVID-19 vaccine in children ages 6 to 11 years old and are updating our submission to the FDA for emergency use authorization of mRNA-1273 in adolescents ages 12 to 17 years with additional follow-up data. We remain committed to helping to end the COVID-19 pandemic with a vaccine for children of all ages."
Although Moderna’s vaccine is authorized for use in adults, the FDA delayed its review of the vaccine in adolescents aged 12 to 17 years to evaluate heart risks. Moderna said at the time that it was also delaying an EUA submission for a half-dose for children aged 6 to 11 years.
Moderna’s announcement is one of several recent developments regarding COVID-19 vaccines for children. On Tuesday, Pfizer and BioNTech asked the FDA to authorize a booster dose — or third dose — of its COVID-19 vaccine for children aged 5 to 11 years who completed the two-dose series.