By Jared S. Hopkins and Betsy McKay
A federal advisory panel recommended Wednesday 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
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
Vaccinations of adolescents have already begun in some parts of
the country, but most vaccination providers were waiting for a
formal recommendation from ACIP. A committee recommendation becomes
policy when the CDC's director, Dr. Rochelle Walensky, signs
Expanding vaccination to children is necessary to slow the
spread of Covid-19 and move the country beyond the pandemic,
allowing returns to school, work and commerce, public-health
The 15-member 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 shot for use in children as
young as 12 years old, the first Covid-19 vaccine for children in
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 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 two 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, 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 experienced stomach pain and constipation, and nerve
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.
There were no deaths in the study, said Dr. Perez. There were no
severe allergic reactions or cases of Bell's palsy, which is
temporary muscle paralysis in the face that was found in a small
number of adults in Pfizer's pivotal study, according to Dr. Perez
and the CDC. There also were no cases of blood clots, which have
been found in small numbers of people who received other Covid-19
vaccines, Dr. Perez said.
Vaccinating adolescents, along with other groups of the
population, is an important step toward making it possible for the
U.S. to move beyond the pandemic, said Sara Oliver, a CDC medical
officer. Infected children, while less affected by the disease than
adults, can transmit the virus to others, studies have shown.
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, Dr. Oliver said.
Adolescents accounted for 9% of reported cases in April, a larger
proportion than those reported for 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 shot 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 subjects. More
than 1 million Americans who are under age 18 have received the
vaccine, according to the CDC.
The Pfizer-BioNTech vaccine is among three authorized for use in
the U.S., along with shots from Moderna Inc. and Johnson &
Covid-19 vaccines for children under 12 years may be available
in the U.S. by the end of the year. 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. It plans to make a
similar request for children 6 months to 2 years of age in the
fourth quarter, Pfizer said.
Write to Jared S. Hopkins at email@example.com and Betsy
McKay at firstname.lastname@example.org
(END) Dow Jones Newswires
May 12, 2021 15:31 ET (19:31 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.