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

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Scientific advisers to the US Food and Drug Administration have voted overwhelmingly not to recommend approving 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 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 then 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. If US regulators give the final go-ahead on that basis, it would mark a significant scaling back of the plans announced last month by the administration to carry out a booster programme for all adults.

Several committee members said they were concerned 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 member of the committee, said during a debate ahead of the vote.

Hayley Gans, professor for paediatric infectious diseases at Stanford University, said: “I am struck by the FDA asking us to look at the totality of evidence when there’s several key points I think that we’re lacking right now. One of them is the very strong safety data that we could have actually with all the third doses that have been given.”

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.”

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 senior vice-president and head of vaccine research and development.

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

Earlier this week Pfizer and Moderna both 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 either Moderna or 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.

Sara Oliver, a scientist at the CDC’s division of viral diseases, noted that while protection against infection has decreased in recent months, it was unclear whether it was because of a natural erosion of protection over time or because of the more contagious Delta variant.

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.

The FDA has already authorised booster shots of mRNA vaccines for people with weakened immune systems. But allowing booster shots more broadly is controversial, both because of the limited data available about the vaccines’ long-term effectiveness, and because many countries are still struggling to secure initial supplies.

In a report published on Wednesday, FDA staff said the data were not conclusive on whether the vaccine’s ability to stop symptomatic infection declined significantly over time, a sign of internal frictions within the regulator about whether boosters were needed.

Others argue that US regulators should act quickly to stem the recent rise in coronavirus cases. Ali Mokdad, professor of global health at University of Washington, said: “We need to get a booster for everyone and to move on. Once we have boosters out then we can donate vaccines.”

In an open letter published on Thursday ahead of the FDA meeting, Pfizer’s chief executive Albert Bourla said allowing people in rich countries to get boosters would not divert supplies from those in need: “If the data demonstrates their need, safety and efficacy then they should be approved.”

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.