FDA Rejects Covid-19 Booster Shot for Americans, Cites Rare Cases of Heart Problems

Ololade Adeyanju/

Scientific advisers to the US Food and Drug Administration (FDA) have voted overwhelmingly against Pfizer’s application to offer a third shot of its Covid-19 vaccine to everyone over 16.

Members of the FDA’s vaccine advisory committee voted 16-2 today 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.

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.

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

“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.

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 also 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.

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