By Jared S. Hopkins, Thomas M. Burton and Jennifer Calfas
U.S. health regulators have for the first time cleared a
Covid-19 vaccine's use in children, paving the way for many to be
immunized before summer camps and the start of the next school
Millions of people ages 16 years and older have taken the shot
from Pfizer Inc. and partner BioNTech SE. The U.S. Food and Drug
Administration's decision Monday widens the vaccine's use to
children as young as 12.
The move comes after a study of 2,260 adolescents found the
two-dose shot worked safely in that age group.
Its expanded use is expected to boost a vaccination campaign
seeking to immunize as many people as possible before dangerous
variants able to elude shots emerge. Wider use of the vaccines also
could permit easing of pandemic measures.
The expansion "is a significant step in the fight against the
Covid-19 pandemic," said Acting FDA Commissioner Janet Woodcock.
"Today's action allows for a younger population to be protected
from Covid-19, bringing us closer to returning to a sense of
normalcy and to ending the pandemic.
Dr. Woodcock said the agency made its decision after a rigorous
and thorough review of data on the vaccine's safety and
effectiveness in the adolescents.
The authorization could also bolster schools' efforts to open
classrooms full-time to middle and high-school students for five
days a week, superintendents and education leaders said. Many
districts have already announced full-time reopening plans for this
fall, though uncertainty around when children could get vaccinated,
for instance, could upset preparations.
"The vaccination is the ticket for the most normal school year
possible next year," said Fairfax County, Va., Public Schools
Superintendent Scott Brabrand, whose district plans to offer
in-person instruction full-time this fall.
More than 114 million Americans have been fully vaccinated,
mostly adults, according to the U.S. Centers for Disease Control
and Prevention. Health experts say children will need to be
inoculated to reach the communitywide immunity necessary to drop
pandemic precautions fully. About one-quarter of the U.S.
population is under 18 years old.
"We're saving children from ending up sick and going to the
hospital," said William Gruber, a pediatrician and senior vice
president of Pfizer's vaccine clinical research. "We're also
expanding on that herd immunity protection that is going to be so
critical for us to resume our normal lives."
Pfizer Chief Executive Albert Bourla expressed thanks to the
children and their families who volunteered to study the vaccine's
Since adolescents will take the same shot older people get,
inoculations in the younger group could start in pharmacies and
mass-vaccination sites as soon as states deem them eligible.
Expanded eligibility could come as early as this week, according to
Some adolescents would be fully vaccinated before they head off
to summer camps, according to health experts, and many would be
protected against the symptomatic disease by the time their next
school year starts.
First, a committee of experts advising the U.S. Centers for
Disease Control and Prevention is tentatively scheduled to meet
Wednesday to review the study data and decide whether to recommend
giving the shots to youths, a CDC spokeswoman said.
The federal government is working with states, pharmacy chains,
pediatricians and other groups to determine the logistics of
administering the shots to children, the spokeswoman said.
Surveys suggest that some parents will seek to get their
adolescent children vaccinated as soon as possible while other
parents want to wait, with some hesitant to get their children
vaccinated. Some public-school systems are planning to encourage
families to get their children immunized and to offer shots at
vaccination sites in schools and elsewhere.
The School District of Philadelphia is working with the local
health department and the Children's Hospital of Philadelphia to
help students reach vaccines, Superintendent William Hite said.
"Every step we take toward getting more people in our
communities vaccinated is a step closer to putting all of this
behind us," said Tulsa, Okla., Public Schools Superintendent
Deborah Gist. The Tulsa system, she said, is looking into
vaccinating students over the final weeks of the school year and
during a new summer learning program.
Districts generally require students be vaccinated against
infectious diseases like measles and mumps. Several school
superintendents of larger districts said they probably wouldn't
immediately require students to be inoculated against Covid-19 for
in-person learning because the vaccine is authorized for emergency
use rather than fully approved.
Los Angeles Unified Superintendent Austin Beutner said the
district would await further guidance from federal authorities to
determine whether Covid-19 vaccinations would be required.
"Down the road, one might have that expectation," he said. "But
we'll wait for health authorities first to tell us it's
appropriate, and I expect that to come in the weeks and months
White House press secretary Jen Psaki has said the federal
government wouldn't require schools and districts to mandate
Canadian health regulators cleared the vaccine for children 12
years and older last week. Pfizer and BioNTech also have asked
European regulators to authorize the two-dose shot for children 12
years and older.
Covid-19 vaccines for children under 12 years may be available
in the U.S. by the end of the year. Pfizer recently said it
anticipates asking the FDA in September to authorize its vaccine's
use in children 2 to 11 years should ongoing studies prove
Children are at lower risk of Covid-19 infection than adults,
according to health experts, and when they are infected they tend
to experience milder symptoms. Yet some can become seriously ill
and some can spread the virus.
"We're going to have a lot of parents anxious to get their kids
vaccinated, not only for summer because it gives them breathing
room to travel, but also for school reasons," said Dr. Yvonne
Maldonado, a professor of global health and infectious diseases at
During a recent gathering hosted by the American Academy of
Pediatrics about 20% of pediatricians attending said they were
already giving vaccinations to people at least 16 years old, while
60% had enrolled with their state as a vaccinator, according to the
The Pfizer-BioNTech vaccine is among three authorized for use in
the U.S., along with shots from Moderna Inc. and Johnson &
The U.S. authorized the Pfizer-BioNTech shot in December for use
in people 16 years and older after a trial involving 44,000
To limit risks to children, drug researchers usually first test
experimental medicines in adults. During the pandemic, health
authorities gave priority to inoculating those most vulnerable to
serious cases, including the elderly.
The Moderna and Johnson & Johnson vaccines are authorized in
the U.S. for adults 18 years and older. Moderna is studying its
vaccine in children and J&J has said it is in discussion with
regulators to do so.
Some students have returned to in-person instruction in
classrooms in many school systems when the option became available,
though some families haven't sent their children back, partly out
of concern that unvaccinated classmates could spread the virus,
according to superintendents and education leaders. Expanding
eligibility for Covid-19 vaccines to children might ease concerns,
the leaders said, prompting some families to allow their children
to return to classrooms.
Studies have found limited Covid-19 spread in school buildings
that follow safety recommendations like mask-wearing and
distancing, though public-health and school officials have reported
cases linked to youth and school sports.
Studies have found that teachers were more likely than students
to transmit the virus to other students. Recent surveys from the
American Federation of Teachers and the National Education
Association, two of the country's largest teachers unions, show a
large majority of members have been either vaccinated or plan to
get their shots.
--Bojan Pancevski contributed to this article.
Write to Jared S. Hopkins at firstname.lastname@example.org, Thomas M.
Burton at email@example.com and Jennifer Calfas at
(END) Dow Jones Newswires
May 10, 2021 18:00 ET (22:00 GMT)
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