Pfizer-BioNTech Covid-19 Vaccine 100% Effective in Study of 12- to 15-Year-Olds, Companies Say--2nd Update
March 31 2021 - 5:10PM
Dow Jones News
By Jared S. Hopkins
The Covid-19 vaccine from Pfizer Inc. and BioNTech SE safely
protects kids 12 years and older, the companies said, results
likely to lead to inoculating children before this summer.
The vaccine was 100% effective in protecting against symptomatic
disease in a study of more than 2,200 children, the companies said
Wednesday. Researchers also didn't find any safety concerns.
The findings, though expected, were much anticipated by parents,
health authorities and school officials. They have been waiting for
signs on when vaccines that adults have been getting could also be
made available to children.
Like other authorized vaccines, the Pfizer-BioNTech shot hasn't
yet been cleared for use in adolescents. Health experts say
children will need to be vaccinated for a population to move past
pandemic restrictions, like masking and physical distancing.
Given the Pfizer-BioNTech results, adolescents in the U.S., at
least, could start getting vaccinated as early as May, which would
mean many would have the protection in time for attending camps and
engaging in other summer activities.
Pfizer said it would ask U.S. health regulators in the coming
weeks to expand use of the shots to 12- to 15-year-olds.
The U.S. Food and Drug Administration could grant Pfizer and
BioNTech the additional authorization two to four weeks after
receiving the application, making it possible for vaccinations to
begin in May, according to a person familiar with the matter.
Pfizer and BioNTech said they would seek clearance in other
countries, too, but didn't give a timetable.
The vaccine was authorized for use in people 16 years and older
in the U.S. in December, after a pivotal trial in 44,000
subjects.
Pfizer last week started testing the vaccine in children ages 6
months to 11 years.
"We share the urgency to expand the authorization of our vaccine
to use in younger populations and are encouraged by the clinical
trial data from adolescents between the ages of 12 and 15," said
Pfizer Chief Executive Albert Bourla.
Covid-19 vaccination efforts in the U.S. and overseas have
focused on protecting older adults who are at higher risk of severe
disease caused by the coronavirus.
Children are at lower risk of contracting the coronavirus than
adults. When they are infected, they tend to experience milder
symptoms. Some can get seriously ill, however, and some can also
spread the virus.
Health authorities say it will be important to vaccinate
children, not only to protect them from the virus but also to help
reach the communitywide immunity needed to move past the
pandemic.
Children make up about 13% of Covid-19 cases in the U.S.,
according to the American Academy of Pediatrics.
The Pfizer-BioNTech vaccine is given in two doses three weeks
apart. It is among three Covid-19 shots authorized for use in the
U.S., along with ones from Moderna Inc. and Johnson &
Johnson.
The vaccines from Moderna and Johnson & Johnson are
authorized in the U.S. for use in adults 18 years and older.
Moderna also is testing its vaccine in 12- to 15-year-olds and said
its trial is fully enrolled.
In the Pfizer-BioNTech study of younger adolescents, 1,131 of
the subjects received the vaccine, while the rest got a placebo.
The volunteers who got the vaccine received the same dose that
older people get.
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, Pfizer
said. Researchers didn't see any severe cases, deaths or
hospitalizations, the company also said.
Researchers also said an unspecified number of vaccinated
children had more neutralizing antibodies a month after receiving
their second dose than subjects 16 to 25 years of age had in the
vaccine's pivotal trial.
Neutralizing antibodies prevent the virus from entering cells
and replicating and play an important part of the immune system's
defense against viruses.
Children in the study reported side effects like fatigue and
headaches that were consistent with those reported by young adults
in the vaccine's larger pivotal trial, Pfizer said.
To further study the safety of the vaccine, researchers plan to
follow the child subjects for two years after their second dose,
according to Pfizer.
Thomas M. Burton contributed to this article.
Write to Jared S. Hopkins at jared.hopkins@wsj.com
(END) Dow Jones Newswires
March 31, 2021 16:55 ET (20:55 GMT)
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