The US Food and Drug Administration on Wednesday authorized a booster dose of the Pfizer-BioNTech COVID-19 vaccine for those 65 and older and some high-risk Americans, paving the way for an accelerated rollout of the shots.
The booster dose is to be given at least six months after the completion of the second dose, and authorization will include those susceptible to serious illness and those who put them at risk, the FDA said.
The US Centers for Disease Control and Prevention advisory panel could vote on Thursday on the use of a third shot of the vaccine, an agency official said at a public meeting of the panel on Wednesday.
President Joe Biden announced in August that the government intended to roll out booster shots to people 16 and older this week, pending approval by the FDA and CDC.
FDA advisers to recommend COVID-19 vaccine booster shots for Americans 65 and older and those at high risk of serious illness, after overwhelmingly rejected calls for broader approval Voted on Friday.
The advisory panel said there was not enough evidence to support booster shots for all those 16 and older who had received a second dose at least six months earlier, and also asked for more safety data.
The agency may revisit the issue of additional shots for wider authorization in the future. Top FDA members are divided on the need for boosters for the general population, with interim chief Janet Woodcock backing them and some senior agency scientists arguing that the current evidence does not support them.
Johnson & Johnson said Tuesday that a second shot of its COVID-19 vaccine has boosted its effectiveness against moderate to severe forms of the disease in the United States.
President Joe Biden’s chief medical adviser, Dr. Anthony Fauci, said on Sunday that information on a booster dose of Moderna Inc.’s COVID-19 vaccine is just weeks away.
Some countries, including Israel and the UK, have already started COVID-19 booster campaigns. The United States last month authorized additional shots for people with compromised immune systems, data from the CDC shows, and more than 2 million people have already received a third shot.