|
 The panel also recommended that the FDA include healthcare workers
and others at high risk of occupational exposure to the virus that
causes COVID-19, such as teachers.
Despite the narrowed scope of the proposed authorization, the
panel's recommendation would cover most Americans who got their
shots in the earliest stages of the U.S. vaccination campaign.
"Today was an important step forward in providing better protection
to Americans from COVID-19," White House spokesperson Kevin Munoz
said. "We stand ready to provide booster shots to eligible Americans
once the process concludes at the end of next week," he said.
The FDA is expected to make its decision on the third round of shots
soon. It is not bound by the panel's recommendation but will take it
into consideration.
Dr. Paul Offit, an infectious disease expert at the University of
Pennsylvania and a member of the panel, said the recommendation was
"a step back" from the Biden administration's recommendation of
widespread boosters starting Sept. 20.
"That is not this. This is: 'We're going to test the water, one foot
at a time,'" said Offit, who voted "no" on the initial question of
widespread use of boosters and "yes" on the more modest offering of
vaccines for those at higher risk.
By a vote of 16 to 2, members of the FDA's Vaccines and Related
Biological Products Advisory Committee declined to recommend a third
dose of the Pfizer/BioNTech vaccine to anyone age 16 and older who
received their second shot at least six months earlier.
The panelists suggested the evidence supporting broad approval was
inadequate, and they wanted to see more safety data, especially
concerning the risk of heart inflammation in younger people after
vaccination.
The panel members then unanimously approved the recommendation for a
third shot for older and other high risk Americans, convinced by
evidence showing they were at higher risk of severe COVID-19 and may
be more likely to have waning immunity after the first rounds of
shots.
[to top of second column] |
 Advisers to the U.S. Centers
for Disease Control and Prevention (CDC) are
scheduled to meet on Sept. 22 and 23 to discuss
further recommendations for who will be eligible
for the shots. "We wonder how
well this restriction can be managed in real-world or how to stop
people, but the point is - it will be available for those that need
it," said Jefferies analyst Michael Yee.
Pfizer could still come back with more data to support a wider
authorization or approval.
The drugmaker said it "will work with the FDA following today’s
meeting to address the committee’s questions, as we continue to
believe in the benefits of a booster dose for a broader population."
Pfizer shares closed down 1.3%, while BioNTech's U.S.-traded shares
finished the day 3.6% lower.
Some countries, including Israel and the UK, have already begun
COVID-19 booster campaigns. The United States authorized extra shots
for people with compromised immune systems last month and some 2
million people had already received a third shot, according to the
CDC.
President Joe Biden has pushed for the additional shots in the face
of surging hospitalizations and deaths caused by the highly
contagious Delta variant of the coronavirus, mostly among the
unvaccinated, and rising cases of breakthrough infections among
fully vaccinated Americans.
Recent polls have shown that most vaccinated Americans want a
booster shot to enhance their immunity.
(Reporting by Manojna Maddipatla and Ankur Banerjee in Bengaluru,
Mike Erman in New York and Julie Steenhuysen in Chicago; Editing by
Caroline Humer, Bill Berkrot and Sonya Hepinstall)
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