The FDA cleared kid-size doses — just a third of the amount
given to teens and adults — for emergency use, and up to 28 million more American
children could be eligible for vaccinations as early as next week.
One more regulatory hurdle remains: On Tuesday, advisers to
the Centers for Disease Control and Prevention will make more detailed
recommendations on which youngsters should get vaccinated, with a final
decision by the agency's director expected shortly afterwards.
"With this vaccine kids can go back to something that's
better than being locked at home on remote schooling, not being able to see
their friends," said Dr. Kawsar Talaat of Johns Hopkins University.
"The vaccine will protect them and also protect our communities."
A few countries have begun using other COVID-19 vaccines in
children under 12, including China, which just began vaccinations for
3-year-olds. But many that use the vaccine made by Pfizer and its partner
BioNTech are watching the U.S. decision, and European regulators just began
considering the companies' kid-size doses.
With FDA's action, Pfizer plans to begin shipping millions
of vials of the pediatric vaccine — in orange caps to avoid mix-ups with the
purple-capped doses for everyone else — to doctors' offices, pharmacies and
other vaccination sites. Kids will get two shots, three weeks apart.
While children are at lower risk of severe illness or death
from COVID-19 than older people, 5- to 11-year-olds still have been seriously
affected — including over 8,300 hospitalizations, about a third requiring
intensive care, and nearly 100 deaths since the start of the coronavirus
pandemic, according to the FDA.
And with the extra-contagious delta variant circulating, the
government has counted more than 2,000 coronavirus-related school closings just
since the start of the school year, affecting more than a million children.
Earlier this week, FDA's independent scientific advisers
voted that the pediatric vaccine's promised benefits outweigh any risks. But
several panelists said not all youngsters will need to be vaccinated, and that
they preferred the shots be targeted to those at higher risk from the virus.
Nearly 70% of 5- to 11-year-olds hospitalized for COVID-19
in the U.S. have other serious medical conditions, including asthma and
obesity, according to federal tracking. Additionally, more than two-thirds of
youngsters hospitalized are Black or Hispanic, mirroring long-standing
disparities in the disease's impact.
The question of how broadly Pfizer's vaccine should be used
will be a key consideration for the CDC and its advisers, who set formal
recommendations for pediatricians and other medical professionals.
A Pfizer study of 2,268 schoolchildren found the vaccine was
nearly 91% effective at preventing symptomatic COVID-19 infections, based on 16
cases of COVID-19 among kids given dummy shots compared to just three who got
vaccinated.
The kid dosage also proved safe, with similar or fewer
temporary reactions — such as sore arms, fever or achiness — that teens experience.
But the study wasn't large enough to detect any extremely
rare side effects, such as the heart inflammation that occasionally occurs
after the second full-strength dose, mostly in young men and teen boys. It's
unclear if younger children getting a smaller dose also will face that rare
risk.
Some parents are expected to vaccinate their children ahead
of family holiday gatherings and the winter cold season.
But a recent Kaiser Family Foundation survey suggests most
parents won't rush to get the shots. About 25 percent of parents polled earlier
this month said they would get their children vaccinated "right
away." But the remaining majority of parents were roughly split between
those who said they will to wait to see how the vaccine performs and those who
said they "definitely" won't have their children vaccinated.
The similarly made Moderna vaccine also is being studied in
young children, and both Pfizer and Moderna also are testing shots for babies
and preschoolers. -AP
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