FDA Panel Recommendation to Include Omicron Component in COVID Booster Kit

Panelists voted after the CDC presented new information showing that two highly infectious Omicron sub-variants, BA.4 and BA.5, now account for more than half of new COVID-19 cases in USA.

Reason for New Proposal

With previous vaccines losing effectiveness over time and the risk of cases increasing this fall, “we need to act sooner rather than later and direct our donors to in the appropriate direction,” said FDA panelist Michael Nelson at the University of Virginia, before voting.


Peter W. Marks, MD, PhD, director of the FDA’s Center for Biological Evaluation & Research, notes that this is a challenging decision, as no one has a “crystal ball” for knowing the virus, which he called “tricky”. will develop.

“We’re trying to use every bit of what we can from predictive modeling and from the data we have to try to get ahead,” he said.

Ideally, the vaccine would be released in the fall, but many questions remain to be answered about the best formulation. The panel vote is the first in a multi-step process before any new vaccines are put into use.

If the agency itself follows the committee’s recommendation, then the new vaccine will be considered authoritative. But the CDC expert panel and Director Rochelle Walensky, MD, must sign it before patients can receive it.

Source: Medindia

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