The vaccine made by Pfizer and its German partner BioNTech
already is available for anyone 12 and older. But with kids now back in school
and the extra-contagious delta variant causing a huge jump in pediatric
infections, many parents are anxiously awaiting vaccinations for their younger
children.
"Over the past nine months, hundreds of millions of
people ages 12 and older from around the world have received our COVID-19
vaccine. We are eager to extend the protection afforded by the vaccine to this
younger population, subject to regulatory authorization, especially as we track
the spread of the Delta variant and the substantial threat it poses to children,"
said Pfizer CEO Albert Bourla.
For elementary school-aged kids, Pfizer tested a much lower
dose -- a third of the amount that’s in each shot given now. Yet after their
second dose, children ages 5 to 11 developed coronavirus-fighting antibody
levels just as strong as teenagers and young adults, Dr. Bill Gruber, a Pfizer
senior vice president, told The Associated Press.
"The safety profile and immunogenicity data in children
aged 5 to 11 years vaccinated at a lower dose are consistent with those we have
observed with our vaccine in other older populations at a higher dose,"
said Dr. Ugur Sahin, CEO and co-founder of BioNTech.
While kids are at lower risk of severe illness or death than
older people, more than 5 million children in the U.S. have tested positive for
COVID-19 since the pandemic began and at least 460 have died, according to the
American Academy of Pediatrics. Cases in children have risen dramatically as
the delta variant swept through the country.
Pfizer said it studied the lower dose in 2,268
kindergartners and elementary school-aged kids. The FDA required what is called
an immune "bridging" study: evidence that the younger children
developed antibody levels already proven to be protective in teens and adults.
That's what Pfizer reported Monday in a press release, not a scientific
publication. The study still is ongoing, and there haven't yet been enough
COVID-19 cases to compare rates between the vaccinated and those given a
placebo — something that might offer additional evidence.
The study isn’t large enough to detect any extremely rare
side effects, such as the heart inflammation that sometimes occurs after the
second dose, mostly in young men. The FDA’s Marks said the pediatric studies
should be large enough to rule out any higher risk to young children. Pfizer’s
Gruber said once the vaccine is authorized for younger children, they’ll be
carefully monitored for rare risks just like everyone else.
A second U.S. vaccine maker, Moderna, also is studying its
shots in elementary school-aged children. Pfizer and Moderna are studying even
younger tots as well, down to 6-month-olds. Results are expected later in the
year.
The news comes days after a U.S. Food and Drug
Administration (FDA) advisory panel on Friday endorsed emergency approval for
the Pfizer-BioNTech COVID-19 vaccine booster shot at least six months following
the second dose among people ages 65 and older and those at high risk of
occupational exposure and severe COVID-19.
The vote was 18-0. The vote will now go before the FDA to
issue a final decision.
The panel earlier Friday afternoon voted to reject licensure
of Pfizer's booster vaccine in people ages 16 and older, at a vote of 2-16.
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