On Tuesday, an FDA advisory group suggested that COVID-19 booster vaccinations in the United States be updated to contain an Omicron component, while also emphasizing the need for further research on how effectively these doses perform against evolving strains of the virus.
The Vaccines and Related Biological Products Advisory Committee approved the proposed formula 19-2.
The panelists voted after the CDC provided fresh data showing that two highly infectious Omicron subvariants, BA.4 and BA.5, now account for more than half of all new COVID-19 cases in the US.
With prior vaccinations losing effectiveness over time and the likelihood of a rise in cases this autumn, FDA panelist Michael Nelson, MD, PhD, of the University of Virginia, said before the vote, “we need to make a move sooner rather than later and guide our sponsors in the appropriate path.”
The FDA’s Center for Biologics Evaluation & Research director, Peter W. Marks, MD, PhD, observed that this is a difficult issue since no one has a “crystal ball” to predict how the Omicron virus, which he described as “crafty,” would evolve.
“We’re trying to harness every single ounce of what we can from predictive modelling and new data to attempt to move ahead,” he added.
The vaccinations would ideally be available in the autumn, but issues regarding the appropriate formulation remain. The panel’s vote is the first stage in a multi-step procedure that must occur before any new vaccine may be used. The new vaccination combination would be considered authorized if the government followed the committee’s suggestion. However, the CDC’s own panel of specialists, as well as Director Rochelle Walensky, MD, must approve it before patients may receive it.