CDC recommends bivalent COVID-19 boosters
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The CDC’s vaccine advisory committee on Thursday voted to recommend the bivalent COVID-19 booster vaccines authorized this week by the FDA that also target the omicron variant of SARS-CoV-2.
In two separate votes, the Advisory Committee on Immunization Practices voted 13-1 to recommend the bivalent boosters made by Moderna and Pfizer-BioNTech, and to appeal previous recommendations for their monovalent booster shots.
Specifically, the recommendations say people aged 12 years or older can receive the Pfizer-BioNTech booster and adults aged 18 years or older can receive the Moderna booster, as long as it has been at least 2 months since they completed their primary series or received their most recent booster shot.
CDC Director Rochelle P. Walensky, MD, MPH, later signed off on the recommendations, making them official.
Both of the messenger RNA vaccines combine the companies' original vaccines with another component targeting the omicron BA.4 and BA.5 subvariants — which the FDA noted on Wednesday is expected to circulate this fall and already accounts for all but 0.2% of new infections in the U.S, according to the CDC.
Numerous ACIP members voiced concern about voting on the bivalent boosters without any available human clinical data. Although studies on the bivalent boosters are underway, the data presented during Thursday’s ACIP meeting were from research that used mice and studies of different bivalent vaccines containing earlier omicron subvariants.
Both “no” votes were made by Pablo J. Sánchez, MD, a physician and professor of pediatrics at The Ohio State University and Nationwide Children’s Hospital, who said he thought the votes were “a bit premature” given the lack of human clinical trial data.
“It’s a new vaccine, it’s a new platform. There’s a lot of hesitancy already. We need the human data,” Sánchez said. “Having said that, I’m comfortable that the vaccine(s) will be safe like the others.”
Sarah S. Long, MD, professor of pediatrics at Drexel University College of Medicine in Philadelphia, said she voted to recommend the bivalent boosters “considering and hoping that the advantages will outweigh any risks that we do not yet anticipate.”
This vote came 1 day after the FDA authorized the bivalent boosters for emergency use in the United States and roughly 2 months after the FDA voted in favor of adding an omicron component to COVID-19 boosters.
“With FDA’s regulatory action approving the bivalent booster yesterday, we have an opportunity to update and simplify our recommendations for vaccine use,” Melinda Wharton, MD, MPH, associate director for vaccine policy at the CDC’s National Center for Immunization and Respiratory Diseases, said during Thursdays ACIP meeting.
She added that updating the recommendations will be a transition and that “there will be some bumps in the road,” but that it is an important move toward simpler recommendations and an updated vaccine that she expects will provide broader protection.
Sara Oliver, MD, MPH, head of the ACIP’s COVID-19 vaccines work group and medical officer in the in the Division of Viral Diseases, summarized data from Pfizer-BioNTech and Moderna showing that bivalent boosters appear to provide protection from omicron sublineages, provide a more diverse response overall and could likely improve the response to future variants.
Oliver presented positive data from Pfizer and Moderna studies on their bivalent booster shots containing an omicron BA.1 component that showed the boosters increased immune responses in people who had completed a primary series and received a previous booster.
Oliver added, however, that there is still a lot to learn about the bivalent vaccines, including rates of myocarditis following vaccination, although she said it is unlikely that the inclusion of an omicron component would increase myocarditis rates.
In a presentation, Elisha Hall, PhD, the CDC’s clinical guidelines lead, said providers should offer all available vaccines — including influenza vaccines and COVID-19 boosters — to eligible patients during the same visit.
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ACIP Meeting.
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