United states

The Biden administration plans to offer updated booster shots in September

WASHINGTON — The Biden administration now expects to launch a booster campaign against Covid-19 with revamped vaccines in September, as Pfizer and Moderna have promised they can supply doses by then, according to people familiar with the discussions.

With updated wording apparently on the horizon, federal officials decided not to expand eligibility for second boosters of existing vaccines this summer. The new versions are expected to perform better against the now-dominant Omicron BA.5 sub-variant, although the data available so far is still preliminary.

At this time, only Americans over age 50 and those over age 12 with certain immune deficiencies are eligible for second booster doses. Although some federal officials have pushed to boost protections for younger Americans now, officials agreed on a goal of boosting everyone’s immunity in the fall with what is hoped to be a more effective booster before a possible winter surge in the virus.

In internal discussions, some senior health officials have argued that eligibility for a second booster should be widened before the reformulated version is ready as coronavirus infections rise again. Dr. Anthony S. Fauci, the president’s chief medical adviser, and Dr. Ashish K. Jha, the White House pandemic response coordinator, advocated this position.

“I think there should be flexibility and permissiveness at least in allowing” a second booster for younger Americans, Dr. Fauci said in an interview this month. One alternative discussed was offering the vaccines only to a subset of younger, at-risk individuals, such as pregnant women.

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But officials from the Food and Drug Administration and the Centers for Disease Control and Prevention argued that the government should focus instead on the fall campaign with updated doses — if the campaign can start soon enough. After Pfizer and Moderna recently assured the FDA that they could ship millions of doses by mid-September, regulators decided it was better to wait for those pictures.

All adults are expected to be eligible for the updated booster shots. Children could also qualify, according to people familiar with the discussions.

The federal government also plans to continue stressing that anyone eligible for additional vaccines should get them now, not until the fall. As of midweek, health officials were still developing their specific advice on the reformulated shots.

One concern was making sure people didn’t get a booster now, followed by another with the updated formula too soon after. Officials worry that, especially in young men, two booster shots in close succession may increase the risk of a rare heart-related side effect, myocarditis, which has been linked to both Pfizer’s and Moderna’s vaccines.

For other reasons, immunologists caution against giving booster shots at short intervals.

“You can’t get vaccinated on Aug. 1 and get another vaccine on Sept. 15 and expect the second vaccine to do anything,” said Shane Crotty, a virologist at the La Jolla Institute of Immunology. “You have so many antibodies lying around that if you get another dose it won’t do anything.”

“The antibodies stop the next dose from working” if the next dose is given too early, he added — a model that also applies to other vaccines, such as tetanus or flu shots.

Federal officials were also concerned about the public’s patience with additional photos. The number of recipients decreases with each new dose offered. While nearly half of those eligible for the first booster chose to receive it, for example, less than 30 percent of eligible Americans chose to receive the second booster — their fourth injection overall.

The Biden administration was busy contracting for the newly developed doses. The Department of Health and Human Services recently made an advance purchase of 105 million doses of Pfizer-BioNTech’s $3.2 billion vaccine, scheduled for possible rollout in the fall. The administration on Friday said it had secured 66 million doses of Moderna’s candidate.

The government’s decision comes as cases of the highly contagious BA.5 variant remain high across the country. Deaths and hospitalizations have increased in recent weeks. The number of new cases announced each day hovers near 130,000 — likely a significantly lower number because of the number of home tests that go unreported — and President Biden just had his own battle with the variant.

Deaths from Covid-19 are still heavily concentrated among older age groups, while hospitalizations remain well below the peak of last winter’s Omicron wave.

At a late June meeting of an FDA advisory committee, independent vaccine experts largely agreed on the need to update coronavirus vaccines because the virus is now more adept at evading their protection. But both Pfizer and Moderna were reluctant to commit to shipping doses with a revised formula in early fall.

Catherine Jansen, head of vaccine research for Pfizer, told the meeting that her company is ready to deliver doses by early October. Dr. Steven Hoge, Moderna’s president, said his company would not be able to ship reformulated injections until late October or early November.

But both companies recently assured federal officials they could accelerate their schedules and be ready by early September, according to people familiar with the discussions.