US FDA authorises third dose of Pfizer COVID-19 vaccine for older Americans

The US Food and Drug Administration (FDA) recently authorised a booster dose of the Pfizer and BioNTech COVID-19 vaccine for those aged 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 authorisation would include people most susceptible to severe disease and those in jobs that left them at risk, the FDA said.

A US Centers for Disease Control and Prevention (CDC) advisery panel could vote on the use of a third shot of the vaccine, an agency official said at a public meeting of the panel.

Joe Biden, President, the US, 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 last week to recommend COVID-19 vaccine booster shots for Americans aged 65 years and older, and those at a high risk of severe illness, after overwhelmingly rejecting a call for broader approval.

The advisery 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 sought more safety data.

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 interim head Janet Woodcock backing them and some of the agency’s senior scientists arguing current evidence does not support them.

Johnson & Johnson had said recently  a second shot of its COVID-19 vaccine increased its effectiveness in the US against moderate-to-severe forms of the disease.