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 The decision paves the way for a quick rollout of the booster shots
as soon as this week for millions of people who had their second
dose of the vaccine at least six months ago.
The change to the vaccine's emergency use authorization will allow
boosters for groups such as health-care workers, teachers and day
care staff, grocery workers and those in homeless shelters or
prisons, FDA acting Commissioner Janet Woodcock said in a statement.
Pfizer had asked the FDA to expand its vaccine approval to include
boosters for all people aged 16 and older and presented data last
week to an outside FDA panel of advisers that it said showed waning
immunity over time.
The panel voted against the proposition that boosters were needed by
everyone but said evidence showed they were helpful to older people
and those at high risk.
Dr. William Schaffner, medical director of the National Foundation
for Infectious Diseases (NFID), said the FDA's statement was more
expansive in who it included as eligible for boosters when compared
to the panel's recommendation.
"Very broad indeed, especially that 'among others.' That could
essentially give the green light for giving boosters to a very
substantial proportion of the previously vaccinated adult
population," said Schaffner, who serves as the NFID's liaison to the
Advisory Committee on Immunization Practices (ACIP) at the U.S.
Centers for Disease Control and Prevention (CDC).
ACIP could vote Thursday on the use of a third shot of the vaccine,
an agency official said at a public meeting of the panel on
Wednesday.
"Tomorrow's ACIP meeting at the CDC will be focused on turning this
into an official recommendation for implementation," said Dr. Amesh
Adalja, senior scholar at the Johns Hopkins University Center for
Health Security.
The FDA authorization was "generally in line" with the advisory
panel vote, said Dr. Jesse Goodman, an infectious disease expert at
Georgetown University in Washington and former chief scientist at
the FDA.
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 "These are pretty broad
categories that give a fair amount of latitude
to the judgment of healthcare providers and
people providing immunizations," he added.
President Joe Biden and eight top health
officials including Woodcock announced in August
the government's intention to roll out booster
shots for people aged 16 and older this week,
pending approval by the FDA and CDC.
But the advisory panel said there was not enough evidence to support
booster shots for that population and also sought more safety data.
The FDA does not have to follow the advisory panel's recommendation,
but often does.
The agency could revisit the issue for a broader authorization in
the future.
"This first FDA authorization of a COVID-19 vaccine booster is a
critical milestone in the ongoing fight against this disease," said
Pfizer chief Albert Bourla. The company had argued that boosters are
needed for the general population.
Top FDA members have been split on the need for boosters for the
general population, with Woodcock backing them while some of the
agency's senior scientists argued that current evidence does not
support them.
Some countries, including Israel and Britain, have already rolled
out COVID-19 booster campaigns. The United States authorized extra
shots for people with compromised immune systems last month and over
2 million people have already received a third shot, CDC data
showed.
(Reporting by Ahmed Aboulenein; Additional reporting by Manas Mishra
and Bhargav Acharya in Bengaluru and Michael Erman in New Jersey;
Editing by Leslie Adler, Peter Cooney, Peter Henderson and Caroline
Humer)
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