FDA Panel Suggest Including Omicron Component in COVID Boosters

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.

Reason for New Suggestion

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 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.

Source: Medindia

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