FDA lays out annual COVID shot plan similar to the flu

Americans will get a clearer idea of how often they’ll roll up their sleeves for COVID-19 shots when advisers to U.S. regulators meet Thursday to discuss an immunization schedule that looks more like the one used for flu. The plan would have health officials meet each June to review which strains of the virus should be included in COVID shots to be deployed no later than September of the same year, according to documents released by the U.S. Food and Drug Administration ahead of the Jan. 26 meeting. Moderna Inc. and the partnership of Pfizer Inc. and BioNTech SE are the biggest makers of doses for the U.S. Experts from around the world convene annually to make predictions about which flu strains will dominate during the upcoming season and should be targeted by shots. The FDA is looking for a similar coordinated effort to take place at least as often for COVID shots, one of several moves the agency hopes might help simplify the immunization process and encourage more Americans to stay up to date. Waning immunity from vaccinations and the emergence of new variants every few months has led regulators to recommend variant-targeted boosters, a tactic that so far has been unpopular among Americans and has even split some health experts on costs and benefits. Just weeks after rolling out the updated BA.4 and BA.5 boosters in September, new mutations were rampant. Now, even as the U.S. sees the rise of an immune-evasive variant called XBB.1.5, booster uptake is hovering at about 15%. “We are working on potential updates against multiple strains, including XBB.1.5, and will be ready to deliver if an update is requested by regulators,” Moderna spokesperson Christopher Ridley said in an email. Pfizer didn’t immediately respond to a request for comment. Moderna’s stock was up 1.9% as of 11:27 a.m. in New York, while Pfizer’s gained 0.3%. “Although the use of the bivalent mRNA boosters is supported by the available evidence, their deployment has been associated with significant implementation complexities,” the FDA said. Switching to one composition for both primary shots and boosters will help streamline the process, according to the agency documents.