US FDA releasing millions of Moderna boosters as some states report shortages

The federal government is releasing millions of Moderna booster shots that were delayed by the Food and Drug Administration as a result of a safety inspection at an Indiana packaging plant, even as states report shortages and encourage people to get Pfizer boosters instead.

The release of the withheld doses, which has not previously been reported, represents the latest wrinkle in the Biden administration’s fall booster campaign, with officials confronting slow uptake of the redesigned shots even before President Biden’s recent comment that the “pandemic is over.” Only 34.9 percent of eligible Americans ages 5 and older have received a booster shot since the first batch was made available last year, according to federal data, and the White House has been encouraging Americans to seek out the updated Moderna and Pfizer shots that are targeting omicron and its subvariants.

The FDA’s inspection was focused on production issues at a plant in Bloomington, Ind., operated by Catalent, which is helping to bottle and package Moderna’s vaccine. Inspectors last month began raising concerns that the facility was not sufficiently sterile and started checking whether vials packaged there might have been contaminated, as part of routine safety reviews, said people with knowledge of the inspection. FDA inspectors concluded that there were no problems with Moderna’s vaccine, and the agency is set to soon release more than 10 million doses that had been held back.