The US Food and Drug Administration on Wednesday authorized a booster dose of the Pfizer and BioNTech Covid-19 vaccine for those ages 65 and older and some high-risk Americans, paving the way for a quick rollout of the shots.
The booster dose is to be administered at least six months after completion of the second dose, and the authorization would include people most susceptible to severe disease and those in jobs that left them at risk, the FDA said.
Those people include “healthcare workers, teachers and daycare staff, grocery workers and those in homeless shelters or prisons, among others,†said Janet Woodcock, acting commissioner of the FDA. “This pandemic is dynamic and evolving, with new data about vaccine safety and effectiveness becoming available every day.â€
Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said the agency will “continue to analyze data submitted to the FDA pertaining to the use of booster doses of Covid-19 vaccines and we will make further decisions as appropriate based on the dataâ€.
A US Centers for Disease Control and Prevention (CDC) 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. The CDC will have to approve any booster shot before it can be given.
Joe Biden announced in August the government’s intention to roll out booster shots for people ages 16 and older this week, pending approval by the FDA and CDC.
Advisers to the FDA voted on Friday to recommend Covid-19 vaccine booster shots for Americans 65 and older and those at high risk of severe illness, after overwhelmingly rejecting a call for broader approval. Currently, only immunocompromised people are eligible for a third dose of the Pfizer or Moderna vaccine, with more than 2 million people already taking this shot.
The advisory panel said there was not enough evidence to support booster shots for all those ages 16 and older who had received a second dose at least six months earlier and also sought more safety data.
The agency could revisit the issue of additional shots for a broader authorization in the future. Top FDA members have been split on the need for boosters for the general population, with interim head Janet Woodcock backing them and some of the agency’s senior scientists arguing that available evidence does not support them.
Johnson & Johnson said on Tuesday a second shot of its Covid-19 vaccine increased its effectiveness in the United States against moderate to severe forms of the disease.
Data from Moderna’s vaccine on booster doses is just weeks away, Biden’s chief medical adviser, Dr Anthony Fauci, said on Sunday.
Some countries, including Israel and Britain, have already introduced booster campaigns. The United States authorized extra shots for people with compromised immune systems last month and more than 2 million people had already received a third shot, CDC data showed.
