By Jared S. Hopkins
Pharmaceutical companies and health officials are homing in on a
key sector of the population that has been largely left out of
planning for Covid-19 vaccines: children.
Pfizer Inc. and BioNTech SE, whose jointly developed vaccine is
now being rolled out in the U.K., became the first Covid-19 vaccine
developers to include children in U.S. trials in September. Moderna
Inc., whose vaccine has also shown to be effective in adults, said
Thursday it began a trial for children 12 to 17 years old.
AstraZeneca PLC also plans a U.S. trial for children.
The omission of children in U.S. vaccine trials so far worries
public-health experts, who say they don't know whether the vaccines
are safe for children or need changes to dosage levels. While
children are less likely than adults to fall gravely ill or die
because of Covid-19, researchers say, vaccinating them will help
prevent the spread of the virus and achieve herd immunity.
Yet some experts don't expect a children's vaccine will be ready
by the 2021 school year because of how long trials take, even on
the accelerated timeline for Covid-19 vaccines. "I'm pretty worried
that the window's closing if it hasn't already closed," said Evan
Anderson, a pediatrics professor at the Emory University School of
Medicine. "The timing then becomes a challenge in order to achieve
enough data such that you've had a vaccine fully tested and
evaluated over the spring and summer."
The American Academy of Pediatrics recently sent a letter to
federal officials urging children to be included in clinical
studies. In the letter, AAP noted that more than two-thirds of the
children who died from Covid-19 infections were Black or
Latino.
The first vaccine shots in the U.S. are expected to go to
high-risk populations such as long-term-care residents and
health-care workers. A National Academy of Medicine panel that
crafted a plan for prioritizing vaccine distribution included
children in its third of four phases, after essential workers such
as teachers but before most of the general population.
The Food and Drug Administration has said it is important for
drugmakers to test their shots in children. It has provided few
details about how to do so and hasn't said whether vaccine makers
must collect results from thousands of children or merely
hundreds.
Matthew Huang, a 15-year-old from Cleveland's suburbs who
attends school virtually, jumped at the opportunity in October to
enroll in Pfizer's trial when his doctor's office asked for
volunteers. Unable to play cello or piano with friends for months
because of the virus, he wanted to help researchers find a solution
to the pandemic.
"I was like, yes, immediately," said Matthew, an aspiring
physical therapist whose 8th-grade school project last year was on
vaccine safety. "Participating in this is really important to help
others."
The fear that children would transmit Covid-19 was initially
central in the debate on how to operate schools without them
becoming hot spots for the virus. But transmission rates within
schools that have reopened since the fall have been much lower than
those in the wider population. The coronavirus also appears to
cause less harmful effects in children. Through July, just 121 of
the approximate 190,000 deaths in the U.S. at the time for
Covid-19-related reasons included children under the age of 21,
according to the CDC.
Still, more than one million children in the U.S. have become
infected, according to the AAP, and research shows children are
more likely to be asymptomatic or have milder symptoms than adults.
Health experts note that the number of Covid-related deaths among
children has almost surpassed the range of flu-related deaths for
children, which has ranged from 37 to 188 since the 2004-05 flu
season, according to the CDC.
"I know there's a perception that kids are just running around
asymptomatic, but there are kids who get really sick from this,"
said Grace Lee, a Stanford University professor of pediatrics who
sits on the Centers for Disease Control and Prevention's Advisory
Committee on Immunization Practices. "We want to be able to protect
as much of the population as possible. Only protecting adults
doesn't make sense as a public-health intervention."
Pediatricians and health experts say studies on children should
begin because there is sufficient safety data on the most advanced
shots. They also point to how childhood vaccines that proved to be
effective for measles and polio didn't have to show efficacy in
adults first.
"For most vaccines there is not much of a reason to think that
if they are safe in adults, they wouldn't be safe in children,"
said Sean O'Leary, a professor of pediatrics at the University of
Colorado School of Medicine and vice chairman of the American
Academy of Pediatrics' committee on infectious diseases.
Vaccines are proven to save children's lives. About 21 million
hospitalizations and 732,000 deaths were prevented among children
born during a 20-year-period because of vaccines, according to the
CDC.
Vaccine experts say pediatric trials could start with older
children before gradually moving down to younger groups and
adjusting dosage levels.
Pfizer, whose vaccine was 95% effective in its late-stage trial,
began enrolling children as young as 16 years old in September, and
12 and up the next month, after internal discussions over the
challenge education officials faced with school openings, said
Kathrin Jansen, who leads Pfizer's vaccine R&D. Pfizer's
analysis for emergency authorization included some data on 100
children between 12 and 15, and no serious safety concerns arose. A
pediatric trial is planned, Pfizer says.
The vaccine from the University of Oxford and AstraZeneca, which
has shown to work in adults, is slated to be tested in children in
the U.S., according to the drugmaker. Johnson & Johnson, which
hasn't released data for its vaccine yet, plans to start a trial
for children 12 to 18 once regulators sign off, and eventually
younger children, too, according to the company.
Matthew, who enrolled at Senders Pediatrics in South Euclid,
Ohio, said he experienced mild side effects after both doses, such
as a fever, but he recovered in about two days. He said he hasn't
really changed his behavior, although his mother, Molly, said the
family now relies on him to buy groceries since they are convinced
he got the vaccine and not a placebo.
"We give him a list, and we park at the grocery store," she
said. "We let him go in and pick up the groceries instead of
me."
Write to Jared S. Hopkins at jared.hopkins@wsj.com
(END) Dow Jones Newswires
December 11, 2020 07:14 ET (12:14 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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