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Experts who advise the Food and Drug Administration voted overwhelmingly on Tuesday to recommend the agency issue an emergency use authorization for Novavax’s Covid-19 vaccine — a long-awaited win for a company that has struggled to get to this point. The Vaccines and Related Biological Products Advisory Committee voted 21 to 0 to recommend that the vaccine receive an EUA, with a single abstention. The strong vote belied the tenor of much of the day’s discussion, which started with one member of the committee, Eric Rubin, editor of the New England Journal of Medicine, questioning whether additional EUAs are needed when three vaccines are already in use in the country. (Branswell, 6/7)

The committee agreed that the FDA should come to an agreement with Novavax on how the company will identify and evaluate a possible causal link between its vaccine and cases of heart inflammation. FDA reviewers said they suspect such an association based on a handful of myocarditis and pericarditis cases that arose during the clinical trial within days of immunization, though the company has argued there’s not yet enough evidence to establish a definitive link. The FDA added a warning last summer to the fact sheets for Pfizer’s and Moderna’s Covid-19 vaccines about the rare risk of developing inflammatory heart conditions. (Gardner and Foley, 6/7)

Bruce Gellin, chief of global public health strategy at the Rockefeller Foundation, abstained from voting but said he was giving the vaccine a “conditional yes.” He said the vaccine was shown to be generally safe and effective when clinical trials were conducted but that “we don’t know whether that is true today.” He said it was important to monitor the vaccine’s performance as it comes into use. (Johnson and McGinley, 6/7)

The timeline for Novavax is not clear. Novavax Chief Commercial Officer John Trizzino said the agency is still reviewing documents detailing its manufacturing processes submitted last week. "We hopefully expect to have product in the U.S. in our warehouse by the end of June," he said in an interview, adding that the company plans to ship millions of doses made by its partner, the Serum Institute of India, soon after authorization. (Erman and Mishra, 6/7)

Large studies in the U.S., Mexico and Britain found two doses of the Novavax vaccine were safe and about 90% effective at preventing symptomatic COVID-19. One complication: Those studies were done far earlier in the pandemic. Novavax chief medical officer Dr. Filip Dubovsky said tests of a booster dose revved up virus-fighting antibodies that could tackle the omicron mutant, data that FDA will have to consider later. This type of vaccine “we think generates a broad immune response against a broad array of variants,” he told the FDA advisory panel. (Neergaard, 6/7)