Biden administration plans to offer updated booster shots in September

WASHINGTON — The Biden administration now plans to launch a Covid-19 booster campaign with revamped vaccines in September, as Pfizer and Moderna promised they could deliver doses by then, according to people familiar with the deliberations.

With updated formulations seemingly at hand, federal officials have 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 sub-variant BA.5, although the data available so far is still preliminary.

At this point, only Americans over 50 and those over 12 with certain immune deficiencies were eligible for a second booster dose. Although some federal officials have pushed for stronger protections for young Americans now, officials have agreed on the goal of boosting everyone’s immunity in the fall with what is hoped to be a stronger reminder. effective, before a possible winter outbreak of the virus.

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

“I think there should be flexibility and permissiveness to at least allow” a second booster for young Americans, Dr. Fauci said in an interview this month. An alternative discussed was to offer the injections only to a subset of younger, at-risk people, such as pregnant women.

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

All adults should be eligible for updated booster shots. Children could also be eligible, according to people familiar with the deliberations.

The federal government also plans to continue to insist that anyone eligible for additional injections should get them now and not wait until the fall. As of midweek, health officials were still working on their specific advice regarding reformulated injections.

One of the concerns was making sure people didn’t get a reminder now followed by another with the updated wording too soon after. Officials were concerned that, especially for young men, two booster shots in quick succession could increase the risk of a rare heart-related side effect, myocarditis, which has been linked to vaccines from Pfizer and Moderna.

For other reasons, immunologists warn against receive booster shots at short intervals.

“You can’t get vaccinated on August 1 and get another vaccine on September 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 around that if you get another dose, it won’t do anything.”

“Antibodies prevent the next dose from working” if the next dose is given too soon, he added – a pattern that also applies to other vaccines, such as tetanus or influenza.

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

The Biden administration has been busy closing deals for the newly designed doses. The Department of Health and Social Services recently pre-purchased 105 million doses Pfizer-BioNTech’s $3.2 billion vaccine, scheduled for possible rollout in the fall. The administration said on Friday that 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 increased those last weeks. The number of new cases announced each day has hovered around 130,000 — likely a significant undercount due to the number of home tests going unreported — and President Biden just had his own fight with the variant.

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

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

Kathrin Jansen, head of vaccine research at Pfizer, told the meeting that her company was ready to deliver doses in early October. Dr. Stephen Hoge, president of Moderna, said his company wouldn’t be able to provide restated plans until late October or early November.

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