Moderna files for U.S. authorization of COVID shot for children under 6

NEW YORK — According to published reports, Moderna said on Thursday it asked U.S. regulators to authorize its COVID-19 vaccine for children under the age of 6. This move would make it the first shot against the coronavirus available for those under 5-years-old.

The COVID-19 vaccine from Pfizer Inc and BioNTech SE is authorized for children 5 and older. But their trial results for 2- to 4-year-olds showed a weaker immune response than in adults, forcing the study to be extended to test a third dose. Pfizer has said that data would come in April.

“This does represent an important area of unmet need,” Moderna chief medical officer Paul Burton said in an interview.

“There’s no other vaccine, no other therapy, that these little kids can have,” Burton said. “If they do judge the data to be sufficient, I think from a public health perspective, offering it to these children as quickly as possible is the best thing.”

Moderna released trial data in March showing that its vaccine was safe and generated a similar immune response in young children as for adults, which was the goal of the study.

The Omicron variant of the coronavirus, which has been shown to evade vaccine immunity compared with earlier versions, was predominant during the pediatric trial. The drugmaker said two doses were around 37% effective in preventing infections in 2- to 5-year-olds and 51% effective for children ages 6 months to 2 years.

Burton did not give a time frame for when the U.S. Food and Drug Administration was expected to consider the authorization request.