Moderna's Covid-19 Vaccine Seeks FDA Authorization for Use in Adolescents
June 10 2021 - 11:44AM
Dow Jones News
By Peter Loftus
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 Stephane Bancel said.
The FDA could make a decision on Moderna's request by early July
if it follows the same kind of timetable if took with the Covid-19
vaccine from Pfizer Inc. and BioNTech SE.
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 does
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.
(END) Dow Jones Newswires
June 10, 2021 11:35 ET (15:35 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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