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A federal advisory panel on Tuesday recommended updating COVID-19 booster vaccines in the United States to include an Omicron component, while urging 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 of the US Food and Drug Administration (FDA) voted 19-2 in favor of a new formulation.
The panelists voted after being presented earlier in the day with new information from the Centers for Disease Control and Prevention showing that two highly infectious Omicron subvariants, BA.4 and BA.5, now make up more than half the number of new COVID cases in the United States.
“With the waning vaccine efficacy and the confluence of risk this fall, we need to make a move sooner rather than later and direct our sponsors in the proper direction,” said FDA panelist Michael Nelson, MD, PhD, University of Virginia, Charlottesville, before the vote.
Peter W. Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and 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.
Kerry Dooley Young is a freelance journalist based in Miami Beach, Florida. She is the core topic leader on patient safety issues for the Association of Health Care Journalists. Young earlier covered health policy and the federal budget for Congressional Quarterly/CQ Roll Call and the pharmaceutical industry and the Food and Drug Administration for Bloomberg. Follow her on Twitter at @kdooleyyoung.
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