Moderna to seek FDA authorization of COVID-19 vaccine for children ages 6 months to 6 years

Drugmaker Moderna said Wednesday it will seek emergency authorization of a COVID-19 vaccine for children under 6 years old, touting preliminary data showing it produced an immune response similar to that of larger doses for young adults.

The Massachusetts-based company said its two-dose regimen was 44% effective in preventing symptomatic illness among those 6 months to 2 years old, and 37% effective in 2- to 5-year-olds during the omicron wave.

However, vaccine makers say that those percentages are better than nothing and that they think a booster will be necessary to thwart the variant in children, as it is in adults.

The Food and Drug Administration had pushed a rival drugmaker, Pfizer-BioNTech, to seek approval of its two-dose regimen to get a jump-start on the vaccine rollout for young children, only to backtrack and wait for data on a third dose by April.

Moderna said it will submit its two-dose data to the FDA as it prepares to evaluate the impact of a booster on ages 6 months to 6 years, older children and adolescents. The company will also seek the authorization of its vaccine for 6- to 11-year-olds.

Right now, the Pfizer-BioNTech vaccine is available to kids 5 years old and older.

“We now have clinical data on the performance of our vaccine from infants 6 months of age through older adults,” Moderna CEO Stéphane 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.”

The authorization of a vaccine for even younger kids would be a major step in the COVID-19 fight. Some parents and policymakers are clamoring for the shots so that basically everyone in their communities has the chance to seek protection from COVID-19 vaccines as society tries to pivot back to normal. As it stands, roughly 18 million Americans under age 5 are ineligible for COVID-19 vaccines.

Polls suggest only a third of parents would get their young children vaccinated right away, however, given the relatively low rates of severe disease and death from COVID-19 in children versus older persons.

Moderna said its vaccine regimen for those 6 months to 5 years old consists of two shots of a 25-microgram dose of messenger-RNA, a groundbreaking platform that teaches the body to recognize the virus and attack it. The shots for adults hold 50 micrograms.

Moderna’s senior vice president for infectious diseases, Dr. Jacqueline Miller, told The New York Times that it was important to begin offering some protection to children even if omicron is somewhat able to chip away at the efficacy of a primary vaccine series.

“What I will say is 37.5% and 43.7% are higher than zero,” Dr. Miller said. “If I were the parent of a young child, I would want there to be some protection on board, especially if we see another wave of infections.”

Moderna said 6,700 participants ages 6 months to 6 years were enrolled in the study. Some children recorded a fever after the second dose, but there were no major safety concerns or reports of inflammation of the heart muscle, or myocarditis, that had been reported in young adults amid the COVID-19 vaccine drive.

For more information, visit The Washington Times COVID-19 resource page.