FDA panel endorses Pfizer booster shot for those 65 or older

WASHINGTON • A key advisory panel to the US Food and Drug Administration (FDA) has overwhelmingly rejected recommending Pfizer booster shots for most recipients of the coronavirus vaccine.

Instead, it has endorsed the jabs only for people who are 65 or older or at high risk of severe Covid-19 symptoms and received their second dose at least six months ago.

The vote - the first on boosters in the United States - is a blow to the Biden administration's strategy to make extra shots available to most fully vaccinated adults in the US eight months after they received their second dose.

The broader roll-out was to start this week.

Committee members appeared dismissive of the argument that the general population needed booster shots, saying the data from Pfizer and elsewhere still seemed to show two shots protected against severe disease or hospitalisation and did not prove a third shot would stem the spread of infection.

Some also criticised a lack of data that an additional injection would be safe for younger people.

"It's unclear that everyone needs to be boosted, other than a subset of the population that clearly would be at high risk for serious disease," said Dr Michael Kurilla, a committee member and official at the National Institutes of Health.

But the panel's final recommendation left some room for the White House to argue that the core of its booster strategy remained intact.

Depending on how "at high risk" is defined, tens of millions of Americans could conceivably wind up being eligible for additional shots of the Pfizer vaccine.

The committee of largely outside experts voted 16-2 against a Pfizer booster for people aged 16 and older after a tense day-long public discussion that put divisions in the agency and the administration on public display.

Officials from the Centres for Disease Control and Prevention (CDC) and the National Institutes of Health joined infectious disease experts and doctors in voting against additional shots for such a broad swathe of the population.

Dr Paul Offit, a committee member and director of the Vaccine Education Centre at the Children's Hospital of Philadelphia, questioned whether extra shots would do much at all to change the arc of the pandemic. "We all agree that if we really want to impact this pandemic, we need to vaccinate the unvaccinated," he said.

But the panel unanimously embraced a fallback position to limit additional shots to older adults and others at high risk of severe Covid-19 illness.

The FDA has the final word on vaccine approvals, and while it is not obliged to follow the committee's recommendations, it typically does.

The agency is likely to issue a decision by early this week.

An advisory committee of the CDC is scheduled to meet on Wednesday and Thursday to discuss booster shots before that agency, which sets vaccine policy, issues recommendations on who should receive them.

In a statement about Friday's vote, Dr Kathrin Jansen, senior vice-president and head of vaccine research and development at Pfizer, said: "We thank the committee for their thoughtful review of the data and will work with the FDA following today's meeting to address the committee's questions, as we continue to believe in the benefits of a booster dose for a broader population."

The committee's rejection of boosters for everyone older than 16 is the latest setback for the plan that President Joe Biden announced a month ago.

The announcement prompted weeks of criticism from public health experts, who accused the administration of trying to set booster policy before FDA and CDC clearance.

Regulators were forced to try to gather and analyse data at top speed, aiming to meet a deadline of this week that they had not set.

NYTIMES