|
 The shot will not be immediately available to the age group. The
U.S. Centers for Disease Control and Prevention still needs to
advise on how the shot should be administered, which will be decided
after a group of outside advisers discuss the plan on Tuesday.
Pfizer said it will begin shipping pediatric vials of the vaccine on
Saturday to pharmacies, pediatricians' offices and other places
where the shots may be administered.
The FDA decision is expected to make the vaccine available to 28
million American children, many of whom are back in school for
in-person learning.
It comes after a panel of advisers to the regulator voted
overwhelmingly to recommend the authorization on Tuesday.
Only a few other countries, including China, Cuba and the United
Arab Emirates, have so far cleared COVID-19 vaccines for children in
this age group and younger.
The FDA authorized a 10-microgram dose of Pfizer's vaccine in young
children, lower than the 30 micrograms in the original vaccine for
those age 12 and older.
Advisers on the FDA panel said a lower dose could help mitigate some
of the rare side effects after paying close attention to the rate of
heart inflammation, or myocarditis, that has been linked to both
Pfizer and Moderna vaccines, especially in young men.
The regulator said on Friday that known and potential benefits of
the Pfizer vaccine in individuals aged between 5 and 11 outweigh the
risks.
For the pediatric shots, the FDA has authorized a new version of the
vaccine, which uses a new buffer and allows them to be stored in
refrigerators for up to 10 weeks.
In the United States, around 58% of the population is fully
vaccinated, lagging other nations such as the UK and France. Many
adults, who have been hesitant to get a vaccine, may be more
cautious about giving the shot to their children.
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 "We certainly hope that as
people see children getting vaccinated, and
being protected and being able to participate in
activities without concern, that more people
will get their kids vaccinated," Acting FDA
Commissioner Dr. Janet Woodcock said at a press
conference.
"And as we accumulate more experience with the
vaccine, more comfort with the safety will
occur."
Pfizer and BioNTech said their vaccine showed
90.7% efficacy against the coronavirus in a
clinical trial of children aged 5 to 11.
"This is a day so many parents, eager to protect
their young children from this virus, have been
waiting for," Pfizer Chief Executive Albert
Bourla said in a statement
The United States started administering the
vaccine to teens between ages 12 and 17 in May.
Vaccination coverage among the age group is
lower than in older groups, according to the
CDC.
Pfizer's vaccine was the first to be authorized
for emergency use in the United States in
December last year for those age 16 and older
and was granted full U.S. approval in August.
Earlier this week, Moderna reported interim data
showing that its vaccine generated a strong
immune response in children ages 6 to 11 years.
It is awaiting a U.S. regulatory decision on the
authorization for children between ages 12 and
17.
(Reporting by Manas Mishra and Manojna
Maddipatla in Bengaluru and Michael Erman in New
Jersey; additional reporting by Amruta Khandekar
in Bengaluru and Ahmed Aboulenein in Washington;
Editing by Bill Berkrot, Shinjini Ganguli and
Arun Koyyur)
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