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June 28, 2022 — A FDA advisory panel on Tuesday recommended updating COVID-19 booster vaccines in the United States to include an Omicron component, while also stressing the need for more information on how well these shots work on emerging strains of the virus.
The Vaccines and Related Biological Products Advisory Committee voted 19-2 in favor of the new formula. formulation.
The panelists voted after the CDC presented new information that showed two highly infectious Omicron subvariants, BA.4 and BA.5, now make up more than half the number of new COVID-19 cases in the United States.
With earlier vaccines loosing effectiveness over time, and the risk of an increase in cases this fall, “we need to make a move sooner rather than later and direct our sponsors in the proper direction,” FDA panelist Michael Nelson, MD, PhD, of the University of Virginia, said before the vote.
Peter W. Marks, MD, PhD, the director of the FDA’s Center for Biologics Evaluation & Research, noted that this is a challenging decision, as no one has a “crystal ball” to tell how the virus – which he called “crafty” — will evolve.
“We are trying to use every last ounce of what we can from predictive modeling and from the data that we have that’s emerging to try to get ahead,” he said.
The vaccines would ideally be rolled out in the fall, but there are still questions to be answered about the best formulation. The panel’s vote is the first in a multi-step process before any new vaccine is put to use. If the agency itself follows the committee’s recommendation, the new vaccine cocktail would be considered authorized. But the CDC’s own panel of experts, and Director Rochelle Walensky, MD, must sign off before patients can receive it.