FDA panel votes against Pfizer’s Covid-19 booster jab application

Covid-19 vaccines updates

Scientific advisers to the US Food and Drug Administration have voted overwhelmingly against Pfizer’s application to offer a third shot of its Covid-19 vaccine to everyone over 16, dealing a serious blow to the Biden administration’s plans for a widespread booster programme.

Members of the regulator’s vaccine advisory committee voted 16-2 on Friday against endorsing a booster of the two-dose BioNTech/Pfizer vaccine for Americans aged 16 or older at least six months after receiving their second shot.

They subsequently voted unanimously to authorise a third shot only for over-65s, anyone at high risk of contracting severe Covid-19, and people whose jobs expose them to the virus, such as healthcare workers.

The vote poses a dilemma for US regulators, who are not bound by the recommendation. The FDA could still approve Pfizer’s application for widespread boosters but may ask the company to resubmit a new application within the limits suggested by the committee.

Pfizer said it would work with the vaccines committee to address its questions and that it continued to believe in the benefits of boosters for a broader population.

“These data, and the larger body of scientific evidence presented at the meeting, underscore our belief that boosters will be a critical tool in the ongoing effort to control the spread of this virus,” said Kathrin Jansen, Pfizer’s head of vaccine research and development.

The FDA did not immediately respond to the vote, but the agency is already split on the issue of whether to authorise a large-scale booster programme. Two senior FDA scientists who are both leaving the regulator helped write an academic article published this week arguing against such a plan.

“Really big decisions like this should not be rushed, and this felt rushed,” said Walid Gellad, associate professor of medicine at the University of Pittsburgh.

Several committee members expressed concern during the meeting about approving a booster dose for everyone aged 16 and over, given reports of rare cases of heart problems suffered by young people following the two-dose regimen.

“Given the risk of breakthrough infection in that younger population is much lower than it is in other parts of the population, recommending a third dose for younger people is just not something I’d be comfortable with at this point,” Melinda Wharton, a senior official at the Centers for Disease Control and Prevention and a member of the committee, said during a debate ahead of the vote.

Paul Offit, director of the Vaccine Education Center in Philadelphia, said: “While I would probably support a three-dose recommendation for those over 60 or 65, I really have trouble supporting this as written for people greater than or equal to 16.”

The vote is a setback for Pfizer and Moderna. Tens of millions of Americans have been vaccinated with mRNA vaccines so far, and analysts had forecast both companies would generate billions of dollars from the proposed US booster programme.

Earlier this week, Pfizer and Moderna released data suggesting the effectiveness of their messenger-RNA vaccines can decline within months after a second shot.

As the FDA committee discussed the issue, the CDC released results from a study showing the efficacy of the Pfizer vaccine appeared to drop more sharply over time than jabs made by Moderna and Johnson & Johnson.

“There is a clear erosion of vaccine protection over time against Covid-19, and emerging data indicates a loss of protection against hospitalisation,” William Gruber, senior vice-president of vaccine clinical R&D for Pfizer, told the committee.

Data from Israel show severe Covid cases began to decline sharply about 10 days after the booster programme started. Covid cases there jumped more than 10-fold from early July to August, with 60 per cent of cases in fully vaccinated people, data from the country showed.

“If we had not started booster doses at the end of July we would have come to the capacity of the Israel hospitalisation capability and probably gone beyond it,” Sharon Elroy-Preiss, director of public health services at Israel’s health ministry, told the panel on Friday.

Ultimately, however, this evidence proved insufficient to persuade the committee that boosters are needed for most people. Archana Chatterjee, the dean of Chicago Medical School, said: “I think this should demonstrate to the public that the members of this committee are independent of the FDA.”

Pfizer’s stock closed 1.3 per cent lower on Friday, while BioNTech fell 3.6 per cent and Moderna dropped 2.4 per cent.

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