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

Covid-19 vaccine updates

U.S. Food and Drug Administration science advisers overwhelmingly voted against Pfizer’s request to offer a third injection of its Covid-19 vaccine to anyone over the age of 16, dealing a serious blow to the Biden administration’s plans for a widespread recall program.

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

They then voted unanimously to allow a third injection only for those over 65, anyone at high risk of contracting severe Covid-19, and people whose work exposes 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 request for full-scale boosters, but could ask the company to resubmit a new request within the limits suggested by the committee.

Pfizer said it will work with the Vaccines Committee to answer their questions and continue to believe in the benefits of boosters for a wider population.

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

The FDA did not immediately respond to the vote, but the agency is already divided on whether to allow a large-scale recall program. Two senior FDA scientists who are both leaving the regulator helped write an academic article published this week opposing such a plan.

“Really big decisions like this don’t have to be rushed, and it seems rushed,” said Walid Gellad, associate professor of medicine at the University of Pittsburgh.

Several committee members expressed concern at the meeting about approving a booster dose for anyone 16 years of age and older, given the reports of rare cases of heart problems experienced by young people following the diet. two doses.

“Given that the risk of breakthrough infection in this younger population is much lower than in other parts of the population, recommending a third dose for young people is just not something I would be comfortable with. ‘comfortable at this point,’ Melinda Wharton, a senior Center for Disease Control and Prevention official and committee member, 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 people over 60 or 65, I really have a hard time supporting this as it is. written for people aged 16 or over. “

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 predicted the two companies would generate billions of dollars from the proposed U.S. booster program.

Earlier this week, Pfizer and Moderna published data suggesting that the effectiveness of their messenger RNA vaccines may decline within months of a second injection.

As the FDA committee discussed the matter, the CDC released the results of a study showing that the effectiveness of the Pfizer vaccine appeared to drop more sharply over time than injections made by Moderna and Johnson & Johnson.

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

Data from Israel shows severe cases of Covid began to decline sharply around 10 days after the recall program began. Covid cases there have been multiplied by more than 10 from early July to August, with 60% of cases in fully vaccinated people, data from the country showed.

“If we had not started the booster doses at the end of July, we would have reached Israel’s hospital capacity and we would probably have exceeded it,” said Sharon Elroy-Preiss, director of public health services at the ministry. Israeli Health. Friday.

Ultimately, however, this evidence proved insufficient to persuade the committee that recalls are necessary for most people. Archana Chatterjee, Dean of Chicago Medical School, said, “I think this should demonstrate to the public that the members of this committee are independent from the FDA. “

Pfizer stock closed 1.3% lower on Friday, while BioNTech fell 3.6% and Moderna fell 2.4%.

Return to the office

We want to hear from readers about plans to return to their workplace. Are you in a hurry to get home or can’t wait to see colleagues again? Tell us about your projects through this survey.