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 The Food and Drug Administration is expected to give the nod to the
shots for at least this group in the days ahead of a meeting of
advisers to the U.S. Centers for Disease Control and Prevention
scheduled for Wednesday afternoon. The CDC panel will discuss more
precise recommendations for how the shots will be administered.
On Friday, an FDA advisory committee voted to recommend emergency
authorization of the additional Pfizer shots for Americans 65 and
older and those at high risk of severe illness.
The panel had earlier decided against recommending broader approval,
saying there was not enough evidence to support broad use, and that
they wanted to see more safety data, especially concerning the risk
of heart inflammation in younger people after vaccination.
The FDA is not bound to follow the panel's recommendation but
usually does.
The agency could revisit the booster shots for a broader
authorization in the future. Top FDA members have been split on the
necessity of the boosters, with interim head Janet Woodcock backing
them and some of the agency's top scientists arguing they are not
needed yet.
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 and
whose immunity may be waning.
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 Norman Baylor, chief executive
of Biologics Consulting and former director of
FDA’s Office of Vaccines Research and Review,
said the decision gives FDA additional time to
understand what data is required to approve
booster shots broadly.
"It does give them some space," Baylor said.
Health officials signaled they expect boosters
will ultimately be recommended for a broad swath
of the population, but advised Americans not to
seek booster doses until they have the nod from
the FDA.
President Joe Biden's chief medical adviser, Dr.
Anthony Fauci, told CNN on Sunday that the data
needed to determine the advisability of booster
shots of the Moderna Inc and Johnson & Johnson
COVID-19 vaccines is just weeks away.
Some countries, including Israel and Britain,
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.
(Reporting by Michael Erman; Editing by Stephen
Coates)
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