Moderna on March 23 said it plans to submit a request to the FDA "in the coming weeks" for authorization of a low-dose COVID-19 vaccine for children 6 months to under 6 years.
The request is for a two-dose primary vaccination series, with each dose containing 25 micrograms — a quarter of the dose given to adults.
Moderna's request is based on interim trial results in which two doses of vaccine were administered among healthy children 28 days apart. The trial enrolled about 4,200 children aged 2 to under 6, and 2,500 children 6 months to under 2.
The "interim analysis showed a robust neutralizing antibody response in both age groups" and "a favorable safety profile," Moderna said, adding the pediatric doses provided similar protection to that of the primary series for adults. The company said lower efficacy against COVID-19 infection was expected, consistent with data from adult studies, as the trial took place during omicron's dominance. Among children 6 months to 2 years, vaccine efficacy was about 44 percent, and about 38 percent for the 2 to under 6 cohort. The majority of infections after vaccination were mild, with no cases of severe illness, hospitalization or death.
"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," Moderna's CEO Stephane Bancel said. He also announced the company has initiated an emergency use authorization submission of its vaccine for children aged 6-11 and is updating its submission to the FDA for authorization in adolescents aged 12-17.
Pfizer-BioNTech's COVID-19 vaccine is currently the only one authorized for people under 18. No vaccine has been authorized yet for children under 5. Pfizer-BioNTech in early February submitted an authorization request for a two-dose vaccine regimen for children under 5, despite trial results from December indicating the regimen didn't generate a strong immune response in 2- to 4-year-olds. On Feb. 11, they postponed their rolling FDA submission to wait for data on a three-dose regimen for young children. At the time, the drugmakers said they expect to have data on the three-dose regimen ready by early April.