Pfizer Covid-19 booster for sixty-five and up is rejected by US FDA panel

A panel of expert advisers to the US Food and Drug Administration, rejecting a demand for wider distribution, said the Covid-19 vaccine booster shot proposed by Pfizer Inc. and BioNTech SE should be offered to the elderly Americaans and to those at high risk.

Whilst the recommendation is not binding, it is a blow to Biden’s plans to provide all American adults with third doses in the coming weeks to stabilise the spread of the virus. In the next few days, the FDA will have to decide to follow or overrule their trusted scientific counsellors and carry out a broader booster licence.

Initially, Pfizer had proposed that everyone 16 years and older should approve a booster shot. However, the consultants reject the idea because the data supported by such a widespread application is thin and there may be risks for young people in particular.

“It’s not clear to me that the data we’re seeing right now is applicable or necessary for the general population,” said National Institutes of Health scientist Michael Kurilla. Another panelist, Paul Offit of the Children’s Hospital of Philadelphia, said he wanted to see more data on the risk of heart inflammation in younger men.

Instead, the panel voted 18-0 in favor of an emergency-use authorization — a more limited clearance than a full approval — for people 65 and older or individuals at high risk of severe Covid-19. The vote didn’t specify what was meant by “high risk,” though panelists later agreed the authorization could include people who may be exposed to Covid-19 because of their jobs, such as health-care workers.

‘We Can Tweak’

The move is a setback to a sweeping plan from the Biden administration to roll out booster shots to a broad population next week. In August, the president had said everyone who’d been vaccinated would be able to receive a third dose at least eight months after their most recent dose.

Still, the administration called it “an important step” toward its fight against the pandemic. “We stand ready to provide booster shots to eligible Americans once the process concludes at the end of next week,” White House spokesman Kevin Munoz said.

Peter Marks, head of the FDA’s vaccine program, made clear to panelists Friday that the agency will make its own decision.

“We are not bound at FDA by your vote, just so you understand that,” he said. “We can tweak this as need be.”

Pfizer said it 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.”

If the FDA follows the advisers’ recommendation, U.S. health officials would still be able to target third doses at people at highest risk of getting seriously ill or dying from Covid-19 — at least those who took Pfizer’s vaccine. Moderna has also applied to the FDA for emergency authorization of a third dose booster, while the agency is still waiting for data backing an additional dose from Johnson & Johnson.

The FDA may make its decision on Pfizer in the coming days. An outside advisory panel to the Centers for Disease Control and Prevention will also make detailed recommendations for the use of the booster shot at a meeting next week.

Shares of Pfizer declined 1.3% at the close in New York, and BioNTech shares were down 3.6%. Shares of Moderna Inc., maker of a similar Covid vaccine, were down 2.4%.

Changing Data

Arnold Monto, acting chair of the advisory committee, also left the door open for the group to recommend emergency use authorization for boosters in younger people later, when more information becomes available about potential side effects and effectiveness.

“That’s the beauty of an EUA,” he said. “It can be changed based on changing data.”