Moderna asks FDA to clear COVID-19 vaccine for adolescents
Moderna on Thursday said it has filed a request with the Food and Drug Administration (FDA) to use its coronavirus vaccine in adolescents as young as 12 years old.
The emergency use authorization is expected to be granted, and would greatly expand the amount of vaccines available for students in middle and high school ahead of classes resuming in the fall. Pfizer and BioNTech received FDA authorization for the same age group last month.
Moderna announced late last month that its two-dose vaccine was 100 percent effective among the nearly 2,500 adolescents who received it as part of a study in which more than 3,700 people were enrolled.
No cases of COVID-19 were observed in participants who received two doses of the vaccine, while four cases were observed in the placebo group, the company said.
No significant safety concerns have been identified to date, the company added, and the majority of side effects were mild or moderate in severity.
The FDA examined the data from Pfizer-BioNTech for a little more than a month before granting the authorization, so Moderna is likely operating under the same timeline.
Children need to be vaccinated in order to raise the overall level of immunity in the country. While herd immunity may not be within reach, getting more people vaccinated will lower the numbers of COVID-19 infections, hospitalizations and deaths.
The nationwide vaccination push has resulted in more than 304 million doses administered, enough to get almost 64 percent of the adult population at least one dose. But the American public’s enthusiasm for taking a coronavirus vaccine has dropped off, and the pace of vaccinations has slowed to a crawl.
At the same time, companies are pushing ahead to make sure the youngest children can be vaccinated safely. Moderna said last month that it began testing the shots on children aged 6 months to 12 years old.
— Updated at 9:04 a.m.