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Booster shots against the coronavirus vaccine for people younger than 50 are on hold as the Biden administration tries to speed up a fall vaccination campaign using reformulated shots that target the now-dominant omicron subvariants, according to federal health officials.
Officials hope that the vaccine makers, Moderna and Pfizer and their German partner, BioNTech, can make the updated vaccines available as early as mid-September instead of later in the fall, three officials said who spoke on condition of anonymity because they were not authorized to speak on the subject.
The retrofitted boosters will contain components from the omicron BA.4 and BA.5 subvariants, 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 redesigned boosters will be more effective in dealing with an evolving virus.
In late June, FDA advisers recommended including an omicron component in retrofitted boosters, and the agency ordered manufacturers to do so. The companies indicated they would likely deliver the new plugs in October. But since then, officials have urged the companies to move faster on shot production. If the new boosters are available in early to mid-September, officials said, the administration is unlikely to authorize a second dose of the current boosters for people under 50.
A final decision has not been made; Officials are awaiting information from manufacturers on whether there would be an adequate supply of reformulated shots if the fall campaign starts earlier than planned. A decision is expected in a few days.
The FDA said it is evaluating the current situation, including data showing increased hospitalizations, and will make decisions about reinforcements based on all available evidence.
Moderna spokesman Chris Ridley said the company is committed to accelerating the supply of its reformulated vaccines “to meet the needs of regulators and public health demands worldwide.” Pfizer declined to comment on the administration’s vaccine decisions.
Currently, the only groups eligible for a second coronavirus booster are people aged 50 and over and people aged 12 and over with compromised immune systems.
Earlier this month, administration officials said they were weighing a plan to allow all adults to receive a second booster to stem a surge in the virus fueled by increasingly contagious omicron subvariants like BA. 5 that bypass some immune protections and have increased the risk of reinfections.
Ashish Jha, the White House’s coronavirus coordinator, and Anthony S. Fauci, the White House’s chief medical adviser, both favored making booster shots more widely available this summer and called for a quick decision. But Peter Marks, the FDA’s top vaccine official, had some concerns, officials said.
As the debate dragged on until the end of July, officials became increasingly concerned that the window was closing to encourage younger adults to get a second booster shot now and then a reformulated one at the end of this year.
Rochelle Walensky, director of the Centers for Disease Control and Prevention, told Washington Post Live on Friday that her agency is talking to the FDA about a second booster for all adults, but that ultimately it’s up to the fda
“There should be action by the FDA to authorize a fourth dose for people under 50,” Walensky said. “In the meantime, another thing we’re doing is planning for the fall and understanding what the implications are and where we’re going for the fall, which is about six weeks away.”
Some outside experts endorsed the idea of allowing all adults to receive a second dose of the current booster, particularly because the protection provided by the first boosters is waning. This would also allow the Biden administration to use doses of vaccines that reach their expiration date and would otherwise be discarded.
But other experts warned that a second dose of the current booster would not provide much benefit and could do some harm. Paul A. Offit, director of the Center for Vaccine Education at the Children’s Hospital of Philadelphia and an outside advisor to the FDA, said recently that repeated administration of the same vaccine could lead to a phenomenon known as “imprinting.” in which an individual’s immune system develops. a very specific response to earlier versions of a virus and does not adapt as that virus evolves.
The federal government has agreed to buy 105 million doses of Pfizer-BioNTech’s rebooted vaccine for $3.2 billion. At $30.50 a dose, that’s a premium over the initial contracts the government made for the original vaccine in 2020, when vaccines were $19.50 a dose.
The government is expected to sign a contract with Moderna shortly.