With updated formulations apparently close, federal officials decided against expanding eligibility for second boosters of existing vaccines this summer. The new versions are expected to outperform the now-dominant Omicron BA.5 sub-variant, although the data available so far is still preliminary. At that point, only Americans over age 50 and those over age 12 with certain immune deficiencies were eligible for second booster doses. Although some federal officials have now pushed to boost protection for younger Americans, officials agreed on the goal of boosting everyone’s immunity in the fall with what is expected to be a more effective booster, ahead of a possible winter surge in the virus. In internal discussions, some senior health officials have argued that eligibility for a second recall should be widened before the reformulated version is ready because coronavirus infections are rising again. Dr. Anthony S. Fauci, the president’s chief medical adviser, and Dr. Ashish K. Jha, the White House pandemic response coordinator, both supported that position. “I think there should be flexibility and permissiveness in at least allowing” a second boost for younger Americans, Dr. Fauci said in an interview this month. An alternative discussed was offering the shots only to a subset of younger people at risk, 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 administration should focus on the fall campaign with updated doses — if the campaign could begin soon enough. After both 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 shots. All adults are expected to be eligible for the updated booster shots. Children could also be eligible, according to people familiar with the deliberations. The federal government also plans to continue to stress that anyone who is eligible for additional shots should get them now and not wait until the fall. As of midweek, health officials were still working out their specific advice on the reformulated shots. One concern was making sure people didn’t get one booster now followed by another with the updated formulation too soon after. Officials worry that, especially for young men, two back-to-back boosters 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 receiving booster shots at short intervals. “You can’t give a vaccine on August 1st and give another vaccine on September 15th and expect the second vaccine to do anything,” said Shane Crotty, a virologist at the La Jolla Institute for Immunology. “You have so many antibodies lying around, if you take another dose, it won’t do anything.” “The antibodies stop working that next dose” if the next dose is given too early, he added — a pattern that holds true for other vaccines, such as tetanus or flu shots. Federal officials also worried about the public’s patience with additional shootings. The number of recipients decreases with each new installment offered. While nearly half of those eligible for the first booster chose to get it, for example, less than 30 percent of eligible Americans chose to get the second booster — their fourth shot overall. The Biden administration has been busy contracting for the newly designed installments. The Department of Health and Human Services recently advanced 105 million doses of Pfizer-BioNTech’s vaccine for $3.2 billion, with a timeline for possible deployment in the fall. Management said on Friday that it had secured 66 million shares 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 reported each day hovers near 130,000 — likely a significant undercount due to the number of home tests that go unreported — and President Biden has just had his own battle with the strain. Deaths from Covid-19 are still heavily concentrated in 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 panel, independent vaccine experts overwhelmingly 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 administering doses with a revised formulation in early fall. Kathryn Jansen, head of vaccine research for Pfizer, told the meeting that her company was ready to deliver doses by early October. Dr. Stephen Hoge, Moderna’s president, said his company would only be able to perform reconstituted shots until late October or early November. But more recently, both companies assured federal officials they could accelerate their timelines and be ready by early September, according to people familiar with the discussions.
