Moderna Inc. said Thursday it has asked U.S. health regulators to authorize the use of its Covid-19 shot in adolescents ages 12 to 17, setting up the potential availability of a second vaccine option for adolescents.
The application means Moderna’s vaccine could be cleared for use in the older children this summer.
Moderna is seeking authorization from the U.S. Food and Drug Administration after releasing results of a study in May showing that the vaccine safely induced immune response in adolescents and appeared to be protective against Covid-19 disease.
“We are encouraged that the Moderna Covid-19 vaccine was highly effective at preventing Covid-19 and SARS-CoV-2 infection in adolescents,” Moderna Chief Executive Stéphane Bancel said.
The FDA could make a decision on Moderna’s request by early July if it follows the same kind of timetable it took with the Covid-19 vaccine from Pfizer Inc. and BioNTech SE. BNTX -0.69%
The agency took about a month to clear Pfizer’s request for use of its Covid-19 vaccine in 12- to 15-year-olds in May.
Moderna’s vaccine is currently authorized for use in adults ages 18 and older, as is one from Johnson & Johnson. Pfizer’s vaccine was initially cleared in people 16 years and older before the FDA expanded use.
Pfizer and Moderna also are studying their shots in children younger than age 12. The companies said this week initial results from that testing could be available by the fall.
Positive results could clear the way for regulators to authorize use of the shots in younger children before the end of the year.
Moderna’s request is part of a wider push to expand the mass vaccination campaign to children, after initially focusing on adults.
Though children have lower risk than adults of severe complications from Covid-19, infectious-disease specialists say some can develop serious illness. They say it’s important to vaccinate children to protect them individually, as well as build herd immunity that can allow everyone to return to a more normal life.
About seven million adolescents have received at least one dose of a Covid-19 vaccine in the U.S., according to the U.S. Centers for Disease Control and Prevention.
Moderna earlier this week requested authorization of use of its vaccine in adolescents in Canada and the European Union.
Moderna conducted a Phase 2/3 study of its Covid-19 vaccine in about 3,700 adolescents. The study found that their immune responses were comparable with those from adults who had participated in a separate Phase 3 study of the vaccine in adults. The adult study had shown that the vaccine was 94.1% effective at preventing symptomatic Covid-19.
The Cambridge, Mass., company said the most common side effects among adolescents included injection-site pain, headache and fatigue.
Write to Peter Loftus at [email protected]
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Appeared in the June 11, 2021, print edition as ‘Moderna Asks FDA To Let Adolescents Receive Its Shot.’
