US authorizes Pfizer coronavirus vaccine for children ages 12 to 15
Move expands inoculation program as vaccination rates
slow
Edward
Helmore and agency
Mon 10 May
2021 22.30 BST
https://www.theguardian.com/world/2021/may/10/pfizer-vaccine-fda-authorized-children-12-15
US
regulators on Monday authorized Pfizer and its partner BioNTech’s Covid vaccine
for use in children as young as 12, widening the country’s inoculation program
even as vaccination rates have slowed significantly.
The vaccine
has been available under an emergency use authorization (EUA) to people as
young as 16 in the United States. Today’s decision means the FDA is amending
the EUA to include children aged 12 to 15. The vaccine makers said they had
started the process for full approval for those ages last week.
“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,” said
Janet Woodcock, the acting FDA commissioner.
“Parents
and guardians can rest assured that the agency undertook a rigorous and
thorough review of all available data, as we have with all of our Covid-19
vaccine emergency use authorizations,” Woodcock added.
According
to the FDA, about 1.5m cases have been reported to the Centers for Disease
Control and Prevention (CDC) in individuals 11 to 17 years of age between March
2020 and April this year.
Pfizer’s
vaccine is being used in multiple countries for teens as young as 16, and
Canada recently became the first to expand use to 12 and up.
While
children are far less likely than adults to get seriously ill, the age group
represents nearly 14% of coronavirus cases in the US. At least 296 have died in
the US after contracting the virus and more than 15,000 have been hospitalized,
according to the American Academy of Pediatrics (AAP).
The agency
also said “the known and potential benefits of this vaccine in individuals 12
years of age and older outweigh the known and potential risks, supporting the vaccine’s
use in this population.”
“With
science guiding our evaluation and decision-making process, the FDA can assure
the public and medical community that the available data meet our rigorous
standards to support the emergency use of this vaccine in the adolescent
population 12 years of age and older,” said Peter Marks, the director of the
FDA’s Center for Biologics Evaluation and Research.
The CDC
says unvaccinated people – including children – should continue taking
precautions such as wearing masks indoors and keeping their distance from other
unvaccinated people outside of their households.
The latest
news is welcome for many families struggling to decide what activities are safe
to resume when only the youngest family members remain unvaccinated.
For Carrie
Vittitoe, a substitute teacher in Louisville, Kentucky, who is fully
vaccinated, as are her husband and 17-year-old daughter, the FDA decision means
her 13-year-old son soon could be eligible, leaving only her 11-year-old son
who would be unvaccinated.
“I can’t
feel totally comfortable because my boys aren’t vaccinated,” Vittitoe told the
Associated Press. “We can’t really go back to normal because two-fifths of our
family don’t have protection.”
Pfizer
isn’t the only company seeking to lower the age limit for its vaccine. Moderna
recently said preliminary results from its study in 12- to 17-year-olds show
strong protection and no serious side effects.
Another US
company, Novavax, has a Covid-19 vaccine in late-stage development and just
began a study in 12- to 17-year-olds as well.
The next
hurdle is to test whether the vaccine works for even younger children. Both
Pfizer and Moderna have begun studies in children aged from 6 months to 11
years that explore whether babies, preschoolers and elementary-age kids will
need different dosages to teens and adults.
Outside of
the US, AstraZeneca is studying its vaccine among six- to 17-year-olds in
Britain. And in China, Sinovac recently announced it has submitted preliminary
data to Chinese regulators showing its vaccine is safe in children as young as
three.
The AAP
welcomed FDA’s decision.
“Our youngest generations have shouldered heavy burdens over the past year, and the vaccine is a hopeful sign that they will be able to begin to experience all the activities that are so important for their health and development,” said Dr Lee Savio Beers, the AAP president, in
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