The retooled boosters will feature components from the omicron sub-variants BA.4 and BA.5, as well as the original formula that 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 retrofitted boosters, and the agency directed manufacturers to do so. The companies said they expect to ship the new recordings in October. But since then, officials have urged the companies to move faster in manufacturing the shots. If the new boosters are available in early to mid-September, officials said, it’s unlikely the government would approve a second dose of the current boosters for those under the age of 50.
A final decision has not yet been made; Officials are awaiting information from manufacturers on whether there would be an adequate supply of reformulated shots if the fall campaign started earlier than expected. A decision is expected within a few days.
The FDA said it is evaluating the current situation, including data showing an increase in hospitalizations, and will make decisions about booster shots based on all available evidence.
Moderna spokesman Chris Ridley said the company is committed to expediting shipments of its reformulated vaccines “to meet regulatory and public health needs around the world.” Pfizer declined to comment on vaccine administration decisions.
Currently, the only groups eligible for a second coronavirus booster are those aged 50 and over and those aged 12 and over with compromised immune systems.
Earlier this month, government officials said they were considering a plan that would allow all adults to receive a second booster shot in a bid to mitigate a viral surge fueled by increasingly contagious Omicron subvariants such as BA. 5 that evade some immune protection measures and have increased the risk of reinfection.
Ashish Jha, the White House coronavirus coordinator, and Anthony S. Fauci, the White House senior medical adviser, spoke out in favor of 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 into late July, officials became increasingly concerned about the window closing to encourage younger adults to have a second booster shot every now and then and a reformulated injection later this year.
Rochelle Walensky, director of the Centers for Disease Control and Prevention, told The Washington Post Live Friday that her agency is in discussions with the FDA about a second booster shot for all adults, but that it’s ultimately the FDA’s decision.
“The FDA would need to take action to allow a fourth dose for people under the age of 50,” Walensky said. “In the meantime we are also planning for the fall and understanding what the implications are and where we are going for the fall which is only about six weeks away.”
Some outside experts supported the idea of allowing all adults to get a second dose of the topical booster – particularly as the protection offered by the first boosters wears off. This would also allow the Biden administration to use vaccine doses that are approaching their expiration date and would otherwise be discarded.
However, other experts warned that a second dose of the current booster shot might not bring much benefit and might cause harm. Paul A. Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and an outside consultant to the FDA, recently said that repeated administration of the same vaccine could lead to a phenomenon known as “imprinting,” in which a person’s immune system develops a highly targeted response to previous 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 newly launched vaccine for $3.2 billion. At $30.50 per dose, this is a premium over the original contracts the government made for the original vaccine in 2020, when the vaccines cost $19.50 per dose.
The government is expected to sign a deal with Moderna shortly.