By Jared S. Hopkins and Betsy McKay
A federal advisory panel recommended that 12- to 15-year-olds
receive the Covid-19 vaccine from Pfizer Inc. and BioNTech SE, an
important step toward expanding the nation's vaccination
The Advisory Committee on Immunization Practices, or ACIP, which
advises the Centers for Disease Control and Prevention on
vaccination policy, voted to recommend the vaccine at a meeting
Wednesday after reviewing clinical trial data and other relevant
information. The vote was 14-0, with one voting member
Many parents, school officials and health authorities are eager
for children to receive vaccinations in time for summer camps and
the start of the next school year. Health authorities expect
children to be vaccinated at pharmacies, physician offices and
existing mass-vaccination sites.
Vaccinations of adolescents have already begun in some parts of
the country, but most shot providers were waiting for a formal
recommendation from ACIP. The committee recommendation would become
policy when the CDC's director, Dr. Rochelle Walensky, signs
"This is another way to get closer to ending this horrible
pandemic," said Dr. Camille Kotton, an infectious-disease
specialist at Massachusetts General Hospital in Boston and ACIP
Expanding vaccination to children is necessary to slow the
spread of Covid-19 and move the country beyond the pandemic,
allowing full returns to school, work and commerce, public-health
officials say. There are nearly 17 million children ages 12 to 15
in the U.S., according to the Kaiser Family Foundation, a health
The 15-member advisory panel consists of pediatricians,
infectious-disease doctors and other medical experts. The panel's
recommendation follows the Food and Drug Administration's
authorization Monday of the two-dose Pfizer-BioNTech shot for use
in children as young as 12 years old, the first Covid-19 vaccine
for children in the nation.
"This will provide protection for 12- to 15-year-olds," said Dr.
Henry Bernstein, a voting member of ACIP and professor of
pediatrics at Zucker School of Medicine at Hofstra/Northwell. "It
will decrease transmission within their families. It will
contribute to community immunity, and it will allow the kids to
more safely go back to camps this summer and back to in-person
Children are at lower risk of Covid-19 infection than adults,
according to health experts, and when infected tend to experience
milder symptoms. Yet some children can become seriously ill and
some can spread the virus.
At Wednesday's meeting, ACIP members discussed the results of
the Pfizer-BioNTech study of 2,260 adolescents that found the
two-dose shot was 100% effective at protecting against symptomatic
Covid-19 in 12- to 15-year-olds.
In the trial, about half of the subjects received doses of
vaccine three weeks apart, while the rest of the subjects received
placebos. The volunteers who got the vaccine received the same dose
that older people get.
Researchers found 12- to 15-year-olds who received the vaccine
generated an immune response similarly strong as in 16- to
So far, researchers haven't found evidence the vaccine poses any
additional or different risks to children versus adults. The most
common side effects of the vaccine are flulike symptoms such as
fever, muscle aches and chills, and they were at similar rates
found in 16- to 25-year-olds, according to the CDC and Pfizer.
Seven children who were vaccinated experienced swollen or
enlarged lymph nodes due to the vaccine, compared with one subject
in the placebo group, according to Pfizer and the CDC.
Five children who received the vaccine experienced serious side
effects, compared with two in the placebo group, said John Perez,
Pfizer's vice president of clinical research and development. In
the vaccinated group these included four cases of psychiatric
disorders, including depression, anxiety and suicide ideation, and
Dr. Perez said these children either had a history of depression or
were prescribed medication for related disorders before the trial.
One child in the vaccinated group also experienced stomach pain and
constipation, and nerve pain.
None of the serious side effects were found to be linked to the
vaccine, according to the CDC.
Pfizer hasn't yet analyzed the data by race or ethnicity, said
Dr. Perez. About 85% of the subjects in the trial were white.
Covid-19 cases are rising in adolescents, and as older Americans
have gotten vaccinated, adolescents make up an increasing
proportion of the overall U.S. case count, Sara Oliver, a CDC
medical officer, said. Adolescents accounted for 9% of reported
cases in April, a larger proportion than cases involving people 65
years and older as more adults have been vaccinated, she said.
More than 1.5 million children ages 12 to 17 have been diagnosed
with Covid-19 since March 2020 and more than 13,000 have been
hospitalized, CDC data show. Millions of cases go unreported,
though, Dr. Oliver said. The agency estimates that 22.2 million
children ages 5 to 17 have been infected since February 2020,
making up about 19% of all infections.
Hospitalizations among 12- to 17-year-olds are far higher for
Covid-19 than for influenza, CDC data show, and adolescents suffer
more severely from a rare Covid-19 complication known as
multisystem inflammatory syndrome in children, or MIS-C, than
younger children. Covid-19 made up 1.3% of all deaths among 12- to
17-year-olds between Jan. 1, 2020, and April 30 this year. That
level would have put it in the top 10 causes of death among
children in 2019, Dr. Oliver said.
The Pfizer-BioNTech vaccine has become the most widely used shot
in the U.S. since regulators cleared it in December for use in
people 16 years and older after a trial involving 44,000
The companies' vaccine is among three authorized for use in the
U.S., along with shots from Moderna Inc. and Johnson &
Pfizer anticipates asking the FDA in September to authorize its
vaccine's use in children 2 to 11 years old should ongoing studies
prove positive. The company said It plans to make a similar request
for children 6 months to 2 years of age in the fourth quarter.
CDC officials also said during the meeting that people could
receive Covid-19 vaccines the same day as other vaccines, or within
two weeks of another vaccine. Since authorization, the shots have
been administered to people if they weren't given other vaccines
within two weeks.
Pediatricians have been monitoring for such a change because
children may be able to get more than one vaccine when they visit
physicians. Many children fell behind on vaccinations during the
pandemic, according to federal officials.
Wednesday's recommendation is a reminder of the toll that the
pandemic has taken on America's youth, said Grace Lee, an ACIP
voting member who is a pediatric infectious-disease specialist at
Stanford University. "I think the childhood experience our kids
have gone through will have long-lasting consequences that may
extend across generations," she said. "To be honest, we don't
really fully yet understand the total physical health, mental
health and educational impact of the pandemic on our kids."
Write to Jared S. Hopkins at firstname.lastname@example.org and Betsy
McKay at email@example.com
(END) Dow Jones Newswires
May 12, 2021 17:01 ET (21:01 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.