The CDC’s Advisory Committee on Immunization Practices (ACIP) voted 13 to 1 in favor of recommending updated, monovalent, XBB-targeting COVID-19 shots for everyone age 6 months and up.
Specifically, the language in the recommendation supports the “2023-2024” vaccines as authorized or approved by the FDA — in order to cover the recently green-lighted mRNA shots, as well as the Novavax protein subunit vaccine should that be okayed by the agency.
Demetre Daskalakis, MD, MPH, acting director of CDC’s National Center for Immunization and Respiratory Diseases (NCIRD), said that the voting language was made to be “inclusive” for vaccines authorized in the coming months, so that ACIP won’t have to reconvene.
Not long after the meeting concluded, CDC accepted ACIP’s recommendation, and said updated vaccines from Pfizer and Moderna will be available later this week.
ACIP Chair Grace Lee, MD, MPH, of Stanford University in Palo Alto, California, said the risk-benefit balance was greatest for infants and people above 65, but was concerned that making a nuanced recommendation would likely add to existing inequities.
“I’m astonished at the number of people who have not been vaccinated, so we need to make the recommendation as clear as possible,” said ACIP member Camille Kotton, MD, of Massachusetts General Hospital in Boston. “Shared clinical decision-making will result in major problems with equity.”
Pablo Sanchez, MD, of Nationwide Children’s Hospital in Columbus, Ohio, cast the lone dissenting vote, mainly because of a lack of data supporting use of the updated vaccine in children.
“I would recommend it for the elderly, and for certain risk groups, including the immune-compromised, and during pregnancy. But I think we need to let the public know the data on children are not there,” Sanchez said, raising particular concerns about myocarditis risk, which was highest for boys ages 12 to 17, according to data presented at the meeting.
“I want to be clear, I am not against this vaccine,” he added. “The limited data that are available do look great,” he said. “I hesitate to make a universal recommendation even though I support vaccination.”
Vaccine makers noted that existing data using the same underlying platforms in children show safety and efficacy for their vaccines in pediatric populations. Moderna, for instance, said it has data on 16,000 kids in its earlier clinical trials, and that it would expect the safety and efficacy of this latest version to be similar.