Pfizer, BioNTech Asks FDA to Expand Use of Their Covid-19 Vaccine to Adolescents
10 April 2021 - 5:13AM
Dow Jones News
By Jared S. Hopkins
Pfizer Inc. and BioNTech SE asked U.S. health regulators to
allow their Covid-19 vaccine to be given to adolescents, which
could make the shots available to kids in the coming weeks.
The companies said Friday that they asked the U.S. Food and Drug
Administration to extend their shot's use to children 12 years and
older. The companies also said they planned to make similar
requests to regulators in other countries.
The Pfizer-BioNTech vaccine is currently authorized in the U.S.
for people 16 years and older. Shots from Moderna Inc. and Johnson
& Johnson are authorized in the U.S. for use in adults 18 years
and older.
The FDA expects to take a few weeks to review the request, a
person familiar with the matter said. The agency doesn't plan, the
person said, to ask a panel of outside experts to review the
submission, as the agency did before first authorizing the shot in
December.
Health authorities say it will be important to vaccinate
children to protect them from the virus and help reach the
communitywide immunity needed to move past the pandemic, known as
herd immunity.
Children are at lower risk of becoming infected with the
coronavirus than adults and when they become sick tend to
experience milder symptoms. Some can get seriously ill, and some
can also spread the virus.
The vaccine from Pfizer and BioNTech was 100% effective in
protecting against symptomatic disease in a study of more than
2,200 kids 12 years and older, the companies said last month. There
weren't any safety concerns.
Researchers found the shot to be 100% effective after observing
18 cases of Covid-19 in children who had received a placebo,
compared with no cases in the group that got vaccinated.
Researchers added they didn't see any severe cases, deaths or
hospitalizations.
Researchers also said vaccinated youths generated high levels of
antibodies, which play a key role in the immune response, similar
to those seen in subjects 16 to 25 years of age in the vaccine's
pivotal trial.
The Pfizer-BioNTech vaccine is given in two doses three weeks
apart. Children 12 to 15 years received the same dosage as
adults.
The companies recently began testing the vaccine in children
ages 6 months to 11 years.
Moderna started a study of its vaccine in 12- to 17-year-olds
last year and expects results sometime this spring. The company in
March started a separate trial of the vaccine in children under
12.
Early this month, Johnson & Johnson said it began testing
its Covid-19 vaccine in youths 12 to 17 years.
Thomas M. Burton and Peter Loftus contributed to this
article.
https://www.wsj.com/articles/pfizer-covid-19-vaccine-100-effective-in-study-of-12-to-15-year-olds-company-says-11617187500
https://www.wsj.com/articles/moderna-is-testing-its-covid-19-vaccine-on-young-children-11615892416
https://www.wsj.com/articles/pfizer-covid-19-vaccine-starts-testing-in-young-children-11616689800?mod=article_inline
https://www.wsj.com/articles/covid-19-shots-for-children-hold-key-to-herd-immunity-11616923801
Write to Jared S. Hopkins at jared.hopkins@wsj.com
(END) Dow Jones Newswires
April 09, 2021 14:58 ET (18:58 GMT)
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