The Food and Drug Administration on Monday approved reformulated COVID-19 vaccines from Pfizer Inc. and Moderna Inc., clearing the way for a fall booster campaign amid an increase in infections and a worrying new subvariant.
But the agency deferred an expected emergency authorization for Novavax Inc.’s vaccine, the only traditional protein-based alternative to the mRNA shots from Pfizer and Moderna.
“Novavax is currently responding to the FDA’s requests to facilitate final review, and timing is ultimately at the discretion of the FDA,” the company said in a statement.
Specifically, the FDA fully approved Pfizer and Moderna vaccines as a single shot for individuals 12 years and older.
The agency granted emergency authorizations for use in children between 6 months and 11 years old. Children aged 5 years and older are eligible for one shot, while children aged 6 months to 4 years are eligible for one or two shots depending on which vaccine they received previously.
Unvaccinated children between the ages of 6 months and 4 years are eligible for either two doses of the new Moderna shot or three doses of the new Pfizer shot.
“We expect this season’s vaccine to be available in the coming days, pending recommendation from public health authorities, so people can ask their doctor about receiving their COVID-19 vaccine during the same appointment as their annual flu shot, saving time now and helping to prevent severe disease later when respiratory viruses are at their peak,” Pfizer CEO Albert Bourla said in a statement.
Advisers to the Centers for Disease Control and Prevention are scheduled to discuss on Tuesday recommendations for who should receive the vaccines and when, with CDC Director Mandy Cohen expected to sign off shortly thereafter.
Drugmakers say they’re ready to begin shipping the shots immediately in accordance with the CDC’s pending guidelines.
Cases and hospitalizations have steadily increased in recent weeks, although hospitalizations are still far below levels this time last year. Hospitalizations reached 17,418 in the week ending Aug. 26, compared to 36,922 in the week ending Aug. 27, 2022.
The new shots target the XBB.1.5 subvariant, a descendant of omicron that dominated the COVID-19 landscape this spring but is now being edged out by close relatives EG.5 and FL.1.5.1. The vaccines are expected to work relatively well against the latest two subvariants — with all three drugmakers recently reporting positive results against EG.5.
Another omicron subvariant, BA.2.86, also known as Pirola, concerns many experts because of the number of mutations allowing it to evade existing immune defenses. But the subvariant is not yet widespread in the U.S., and more recent data suggest it may not be as evasive as initially suspected.
“If BA.2.86 takes off, it will be a real test of how good our T-cell response can rev up to meet the challenge,” Scripps Research Translational Institute Director Eric Topol wrote on Substack late last month.
Moderna, for its part, said its shot generates an 8.7 to 11-fold increase in antibodies across the three new subvariants, including the worrisome BA.2.86.
The next hurdle is uptake — just 17 percent of Americans received the last booster, and just 43 percent of people 65 and older are up-to-date on their COVID-19 vaccinations.
Access could also be an issue. The end of the public health emergency in May led the federal government to transition vaccine distribution to the commercial market, and a $1.1 billion public-private partnership to offer free vaccines to the uninsured has not yet launched.
Politics has also already resurfaced. GOP lawmakers and state officials are playing offense against the potential return of COVID-19 restrictions, as some schools implement mask mandates for returning students.
Sen. Rand Paul, R-Ky., on Thursday attempted to reverse vaccine mandates for Senate pages, pointing to the fact that oft-elderly senators themselves are not required to receive the shots.
And Select Subcommittee on the Coronavirus Pandemic Chairman Brad Wenstrup, R-Ohio, recently launched an investigation into the CDC’s 2021 decision to override an advisory board recommendation excluding workers in high-risk occupations from boosters.
On Wednesday, Wenstrup wrote to Cohen requesting details of the agency’s decision under former Director Rochelle Walensky, suggesting that politics had already tainted the CDC’s upcoming decision on the new boosters.
“The CDC must follow medical science, not political science,” he wrote.