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The United States Food and Drug Administration on Wednesday authorized a booster dose of the Pfizer and BioNTech Covid-19 vaccine for people 65 years of age and older and some high-risk Americans, paving the way for rapid vaccine deployment.
The booster dose must be given at least six months after the end of the second dose, and the authorization would include people most at risk of serious illness and those in jobs that put them at risk, the FDA said.
A U.S. Centers for Disease Control and Prevention (CDC) advisory group may vote on the use of a third vaccine injection on Thursday, an agency official said at a public meeting for the group on Wednesday.
Joe Biden announced in August the government’s intention to roll out booster shots for people aged 16 and older this week, pending FDA and CDC approval.
FDA advisers voted on Friday to recommend booster shots of the Covid-19 vaccine for Americans 65 and older and those at high risk of serious illness, after overwhelmingly rejecting a call for broader approval.
The advisory committee said there was not enough evidence to support booster injections for all those 16 and older who had received a second dose at least six months earlier and also called for more data on the security.
The agency may revisit the issue of additional shots for broader clearance in the future. Leading members of the FDA have been divided over the need for boosters for the general population, with acting backing from Janet Woodcock and some of the agency’s top scientists arguing that the current evidence does not support them.
Johnson & Johnson said on Tuesday that a second injection of its Covid-19 vaccine increased its effectiveness in the United States against moderate to severe forms of the disease.
Moderna’s vaccine data on booster doses are only a few weeks away, Biden’s chief medical adviser Dr Anthony Fauci said on Sunday.
Some countries, including Israel and Britain, have already launched recall campaigns. The United States authorized additional injections for people with weakened immune systems last month and more than 2 million people had already received a third injection, according to CDC data.
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