The recombined boosters will contain components from the omicron sub-variants BA.4 and BA.5 in addition to the original formula, which was Based on the version of the virus that went global in early 2020. The hope is that the redesigned boosters will be more effective in dealing with an evolving virus.
In late June, FDA advisors recommended the inclusion of the Omicron component in recombinant boosters, and the agency directed manufacturers to do so. The companies have indicated that they will likely deliver the new shots in October. But since then, officials have urged companies to move faster in producing the shots. If the new boosters are available by early and mid-September, officials said, the administration is unlikely to allow a second dose of the current boosters for people under 50 years old.
no final decision has been made; Officials are awaiting information from manufacturers about whether there will be an adequate supply of reworked shots if the fall campaign begins earlier than expected. A decision is expected within days.
The FDA said it is assessing the current situation, including data showing an increase in hospitalizations, and will make decisions about boosters based on all available evidence.
Moderna’s spokesperson, Chris Ridley, said the company is committed to expediting the supply of reformulated vaccines “to meet the needs of regulators and public health requirements around the world.” Pfizer declined to comment on vaccine administration decisions.
Currently, the only groups eligible for a second booster dose of coronavirus are people 50 years of age or older and those 12 or older who have compromised immune systems.
Earlier this month, administration officials said they were studying a plan to allow all adults to have a second booster to curb the surge of viruses fueled by more infectious omicron sub-variants such as BA. 5 that avoid certain immune protections and increase the risk of re-infection.
Ashish Jha, the White House coronavirus coordinator, and Anthony S. Fauci, the White House’s chief medical advisor, preferred to make the booster vaccines more widely available this summer and call for a quick decision. But officials said Peter Marks, the Food and Drug Administration’s chief vaccine officer, had some concerns.
As the debate continued in late July, officials became increasingly concerned about closing the window to encourage younger adults to take a second booster dose now and then and recasting the shot later this year.
Rochelle Wallinsky, director of the Centers for Disease Control and Prevention, said Friday in the Washington Post Live that her agency is talking to the FDA about a second booster for all adults, but that’s ultimately the FDA’s decision.
“There should be action by the Food and Drug Administration to allow a fourth dose for those under 50,” Walinsky said. “In the meantime, another thing we’re doing is planning for fall and understanding the implications of it, and where we’re headed for fall, which is only six weeks away.”
Some outside experts have supported the idea of allowing all adults to get a second dose of the current booster—particularly as the protection provided by the first boosters is diminished. This would also allow the Biden administration to use vaccine doses that have reached their expiration dates and that would have otherwise been discarded.
But other experts caution that a second dose of the current booster will not provide much benefit and may cause some harm. said Paul A. Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and an outside advisor to the Food and Drug Administration, recently said that repeatedly giving the same vaccine can lead to a phenomenon known as “imprinting,” in which an individual’s immune system grows. A highly targeted response to previous versions of the virus and a failure to adapt to the evolution of this virus.
The federal government has agreed to purchase 105 million doses of a rebooted Pfizer-BioNTech vaccine for $3.2 billion. At $30.50 a dose, that’s a premium on the initial contracts the government made for the original vaccine in 2020, when the vaccines were $19.50 a dose.
The government is expected to sign a contract with Moderna soon.