FDA accelerates booster campaign to September, emphasizes new formula

Currently, only Americans 50 and older and individuals at least 12 years old with impaired immune systems are eligible for second boosters.

The FDA, in announcing its fall strategy, said it had received assurances from the vaccine manufacturers — Moderna and Pfizer and its German partner, BioNTech — that reformulated boosters will be ready in September. Those boosters will contain components from the omicron subvariants BA.4 and BA.5 as well as the original formula, which was based on the version of the virus that spread globally in early 2020. The hope is that the bivalent shots will be more effective against a rapidly evolving virus and shield Americans from a potential fall and winter surge.

The FDA has also continued its calls for people younger than 50 to get a single booster shot, and for older Americans and people with compromised immune systems to receive two. Because coronavirus cases are increasing, it urged people to get boosters as soon as they are eligible, even as the agency prepares to launch the fall vaccination drive. They said people who get boosters now still will be eligible to get the reformulated vaccine later.

The announcement Friday ended strenuous debate among the administration’s top health officials. Ashish Jha, the White House’s coronavirus coordinator, and Anthony S. Fauci, Biden’s chief medical adviser, favored making second boosters broadly available this summer. But they said it was the FDA’s decision, and Peter Marks, the agency’s top vaccine official, had qualms. The White House referred questions about the modified boosters to the FDA.

Outside experts have differing views, too. Some doctors praised the FDA’s focus on the fall vaccine; if the government expanded eligibility for the current booster now, and then quickly introduced an updated vaccine, the result could be rampant confusion, they said. Some doctors also worried that the effectiveness of a new vaccine could be undercut if it were given too soon after a booster dose of the original formula. Others disagreed, saying millions of younger adults need stronger protection now, especially as any prior immunity wanes amid a summer wave of cases.

“I think it is probably the best strategic step to go for a new vaccine and do it sooner rather than later,” said Jeanne Marrazzo, director of the division of infectious diseases at the University of Alabama at Birmingham.

“It’s always about risk versus benefit,” Marrazzo said, noting there have been rare instances of complications such as heart…