Re-equiped boosters will contain components from the omicron BA.4 and BA.5 sub-variants as well as the original formula, which was based on the version of the virus that spread around the world 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 retooled boosters, and the agency ordered manufacturers to do so. The companies said they would likely deliver the new snaps in October. But since then, officials have urged companies to speed up production of the snaps. If the new boosters are available in early to mid-September, officials said, the administration is unlikely to allow a second dose of the current boosters for people under age 50.
A final decision has not been made; officials are awaiting information from manufacturers on whether there would be an adequate supply of reformulated vaccines if the fall campaign begins earlier than expected. A decision is expected in a few days.
The FDA said it is evaluating the current situation, including data showing an increase in hospitalizations, and will make recall decisions 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 around the world.” Pfizer declined to comment on vaccine administration decisions.
Currently, the only groups eligible for a second coronavirus booster are people 50 and older and those 12 and older with compromised immune systems.
Earlier this month, administration officials said they were considering a plan to allow all adults to receive a second booster to mitigate a virus surge fueled by growing omicron subvariants. more contagious such as BA. 5 which escape certain immune protections and have increased the risk of reinfection.
Ashish Jha, the White House coronavirus coordinator, and Anthony S. Fauci, the White House chief medical adviser, preferred to make booster shots more widely available this summer and call for a quick decision. But Peter Marks, the FDA’s top vaccine official, had some concerns, officials said.
As the debate dragged on into late July, officials grew increasingly concerned that the window was closing to encourage young adults to get a second booster shot now and then, and then a reformulated shot later this year.
Rochelle Walensky, director of the Centers for Disease Control and Prevention, told Washington Post Live Friday that her agency was discussing with the FDA a second booster for all adults, but that was ultimately the FDA’s decision.
“The FDA would need to act 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 have endorsed the idea of allowing all adults to receive a second dose of the current booster, particularly because the protection offered by the first boosters is diminishing. It would also allow the Biden administration to use vaccine doses that reach their expiration date and would otherwise be thrown away.
But other experts have warned that a second dose of the current booster will not provide much benefit and could do harm. Paul A. Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and an outside adviser to the FDA, said recently that repeated administration of the same vaccine could lead to a phenomenon known as “fingerprinting.” , in which an individual’s immune system develops. a highly targeted response to earlier versions of a virus and fails to adapt as that virus evolves.
The federal government has agreed to buy 105 million doses of the restarted vaccine from Pfizer-BioNTech 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 the shots cost $19.50 a dose.
The government is expected to sign a contract with Moderna soon.