FDA approves Pfizer Covid booster shot for high-risk populations

Those over 65 and people working in high-exposure settings can receive third dose

A syringe is prepared with the Pfizer Covid-19 vaccine at a clinic in Reading, Pennsylvania. AP

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The US Food and Drug Administration (FDA) on Wednesday authorised a booster dose of the Pfizer-BioNTech Covid-19 vaccine for those aged 65 and older as well as some high-risk Americans, paving the way for a quick roll-out of the shots.

The booster dose is to be administered at least six months after receiving the second dose and the authorisation includes people most susceptible to severe disease and those in jobs that put them at risk, the FDA said.

The FDA amended its emergency authorisation “for a booster dose in certain populations such as healthcare workers, teachers and day care staff, grocery workers and those in homeless shelters or prisons, among others,” said Acting FDA Commissioner Janet Woodcock.

A US Centres for Disease Control and Prevention (CDC) advisory panel could vote on Thursday on the use of a third dose of the vaccine, an agency official said at a public meeting of the panel on Wednesday.

President Joe Biden 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.

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.

The advisory panel said there was not enough evidence to support booster shots for all those aged 16 and older who had received a second dose at least six months earlier and also called for more safety data to be collected.

The agency could revisit the issue of additional shots for a broader authorisation in the future.

Top FDA members have been split on the need for boosters for the general population, with Ms Woodcock backing them and some of the agency's senior scientists arguing current evidence does not support them.

“This pandemic is dynamic and evolving, with new data about vaccine safety and effectiveness becoming available every day,” she said.

“As we learn more about the safety and effectiveness of Covid-19 vaccines, including the use of a booster dose, we will continue to evaluate the rapidly changing science and keep the public informed.”

Johnson & Johnson said on Tuesday a second shot of its Covid-19 vaccine increased effectiveness against moderate to severe forms of the disease.

Data from Moderna's Covid-19 vaccine booster doses is weeks away, Mr Biden's chief medical adviser, Dr Anthony Fauci, said on Sunday.

Some countries, including Israel and Britain, have already begun Covid-19 booster campaigns.

The US authorised extra shots for people with compromised immune systems last month and over two million people have already received a third shot, CDC data showed.