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 The FDA, which gave the two-dose vaccine emergency-use authorization
in December, provided its full approval for use in people age 16 and
older based on updated data from the companies' clinical trial and
manufacturing review. Public health officials hope the action will
convince unvaccinated Americans that Pfizer's shot is safe and
effective.
There is entrenched vaccine skepticism among some Americans,
particularly conservatives. COVID-19 cases, driven by the highly
infectious Delta variant, have surged in parts of the United States
with lower vaccination levels.
Speaking at the White House, Biden called the FDA approval "an
important moment in our fight against the pandemic" and urged more
private businesses to require employees to be vaccinated.
"If you're one of the millions of Americans who said that they will
not get the shot until it has full and final approval of the FDA, it
has now happened," Biden said.
"It's time for you to go get your vaccination. Get it today," Biden
added. "... There is no time to waste."
The Pentagon said it is preparing to make the vaccine mandatory for
military personnel.
U.S. health officials expect that the FDA's action also will prompt
more state and local governments, as well as private employers, to
impose vaccine mandates. New York City said https://www.reuters.com/world/us/new-york-city-mandates-covid-19-vaccine-public-school-teachers-staff-mayor-2021-08-23
it will require vaccines for public-school teachers, while New
Jersey announced that all state workers must get vaccinated by
mid-October or agree to regular COVID-19 tests.
"While millions of people have already safely received COVID-19
vaccines, we recognize that for some, the FDA approval of a vaccine
may now instill additional confidence to get vaccinated," said Janet
Woodcock, the FDA's acting commissioner.
More than 204 million people in the United States have received the
Pfizer vaccine. The FDA's approval extends the shelf life of Pfizer
shots from six months to nine months. It also confirms that the
vaccine increases risk of heart inflammation, particularly among
young men in the week following their second shot.
The approval makes it easier for doctors to prescribe a third dose
of Pfizer's vaccine off-label for people who may benefit from
additional protection against COVID-19.
Pfizer shares closed up around 2.5% and BioNTech shares gained more
than 9.5%.
The two other COVID-19 vaccines given emergency-use authorization -
made by Moderna Inc and Johnson & Johnson - have not yet received
full FDA approval.
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 The FDA gave emergency-use
authorization to Pfizer's vaccine for people age
16 and older in December - the first shot to
gain such backing in the United States - and
provided further emergency-use authorization for
people age 12 and up in May.
SHOTS FOR CHILDREN
Pfizer and BioNTech said they plan to apply for
full approval in children ages 12 to 15 as soon
as required data is available.
Woodcock said the FDA is not recommending that
children under age 12 get the vaccine now
because it needs to ensure it is safe for them,
telling reporters it "would be a great concern
if people vaccinate children because we don't
have the proper data."
 Pfizer is
expected to submit data this fall to support the shot's
emergency-use authorization for children under 12 based on smaller
doses.
The American Academy of Pediatrics, representing children's doctors,
discouraged having children under 12 receive the vaccine.
Pfizer's shot has received conditional regulatory approval elsewhere
including Britain and the European Union.
The United States leads the world in reported COVID-19 cases and
deaths. More than 625,000 Americans have died, including an average
of more than 600 daily in recent weeks.
According to the Centers for Disease Control and Prevention (CDC),
71% of Americans age 12 and older - the population eligible to
receive COVID-19 vaccines - have gotten at least one dose and 60.2%
are fully vaccinated. For the entire population, including children
up to age 11 for whom no vaccines are yet approved, 60.7% of
Americans have received at least one dose, with 51.5% fully
vaccinated.
Pfizer CEO Albert Bourla said in a statement the FDA's approval
"affirms the efficacy and safety profile of our vaccine at a time
when it is urgently needed." In Pfizer's clinical trial,
approximately 12,000 recipients of the vaccine have been followed
for at least six months. The vaccine will now be marketed under the
name Comirnaty.
The FDA on Aug. 13 authorized a third dose of the Pfizer and Moderna
vaccines for people with compromised immune systems. Pfizer's shot
has not yet been authorized for more widespread use as a booster.
(Reporting by Carl O'Donnell in New York and Manas Mishra in
Bangalore; Additional reporting by Julie Steenhuysen in Chicago and
Michael Erman in New Jersey; Editing by Will Dunham and Sriraj
Kalluvila)
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