A panel of advisers to the Centers for Disease Control and Prevention voted 13-1 Tuesday to recommend updated Covid-19 booster shots for all Americans 6 months and older. CDC Director Mandy Cohen signed off on the recommendation hours later, and vaccines would be available within 48 hours.
The recommendation applies to mRNA shots from Pfizer-BioNTech and Moderna, both of which were approved by the Food and Drug Administration Monday. The FDA is still reviewing a third shot from Novavax, but officials indicated that the recommendation could also apply to the company’s protein-based shot when authorized.
Advisers were swayed by studies showing the new vaccines induced immune responses against circulating strains, as well as data indicating the virus continues to pose a threat to both high- and lower-risk groups. A CDC analysis suggested that a universal vaccine recommendation could prevent 400,000 hospitalizations and 40,000 deaths over two years.
“Knowing that there were deaths, including in children, including in those without chronic conditions — and my perception is that those deaths are vaccine-preventable,” said Matthew Daley, a senior investigator at the Institute for Health Research at Kaiser Permanente Colorado.
There was also data to suggest that previous vaccines and boosters could reduce the risk of long Covid.
“I’m fully in favor of the universal recommendation, I think the long Covid data, the [data on] post-Covid conditions is compelling,” said Oliver Brooks, chief medical officer at Watts HealthCare Corporation in Los Angeles.
The lone negative vote came from Pablo Sanchez, a professor of pediatrics at Ohio State University. He argued there weren’t enough data in children. And he worried about potential side effects, such as heart inflammation, in young adults. Although there were no data showing the variant-specific vaccines introduced last year caused myocarditis in young adults, relatively few young adults received that vaccine, and there were data suggesting previous shots might have.
He argued the committee should recommend the vaccine only for high-risk groups, such as older adults and immunocompromised people, and recommend that people in other groups talk to their doctor about the best decision for them. That recommendation would be closer to the strategy taken in the United Kingdom, where health authorities are targeting the new boosters to high-risk groups.
“I just want to be clear that I am not against this vaccine. The data do look great,” Sanchez said. “I just want to comment that we have extremely limited data for children, infants, some groups … and we do have to be concerned about potential side effects, especially in young adults.”
The new shots are specific to the XBB.1.5 version of Omicron, which was dominant when the FDA selected the strain in June. Health officials are also now monitoring a new variant, BA.2.86, which has a high number of mutations from previous strains.
That has raised concern the variant could spread widely, but it does not appear that the new strain is behind a recent uptick in cases in the U.S.
“Everything that is circulating currently, at any significant prevalence, is XBB lineage,” said Natalie Thornburg, a lead research microbiologist at the CDC.
And different analyses new shots should still provide significant protection. Thornburg pointed to lab studies suggesting that antibodies people generated against previous variants, including XBB, still neutralize BA.2.86. Pfizer also presented mouse data suggesting its vaccine induced antibodies against the new strain, and Moderna showed the same with human data from clinical trial.
The new vaccines will not be purchased by the federal government, as previous vaccines were. Moderna, Pfizer, and Novavax will charge between $120 to $130 per dose. But most insurers and Medicare will cover them. A federal “bridge program” is designed to cover the shot for the 25 to 30 million American adults under 65 who are not insured.
Although some members cautioned that they still don’t have a firm grip on SARS-CoV-2’s seasonality, the move pushes the U.S. toward once-a-year vaccination, similar to flu. People who are immunocompromised may receive an additional dose at least two months after an initial booster.
Advisers who disagreed with Sanchez noted there was extensive safety data on prior versions of the mRNA shots in children. And they argued that recommending the vaccine only to high-risk groups could further entrench health disparities, as a less forceful decision from the agency could disincentivize people to get the jab.
Still, they acknowledged that it was likely that many of the people they believed would most benefit from additional immunity may not get it, despite their recommendation.
“Universal may be the best we have, but it’s not good enough,” said Sarah Long, a professor of pediatrics at Drexel University College of Medicine. “Because I think we’ll recommend it and nobody will get it. Or the people who need it most may not get it, and especially the groups we’re more concerned about equity.”