All 21 members of an FDA committee voted to urge development of an XBB-targeted COVID-19 vaccine during a June 15 panel.
The committee cited that the update is necessary since the XBB strain continues to be the dominant version of the virus in transmission throughout the U.S. Its decision also follows a May 18 recommendation from the World Health Organization regarding COVID-19 vaccine updates, which noted that the XBB strain continues to be the most widely circulated strain worldwide.
A decision about the composition of the vaccines and which lineage of the XBB strain they should target has not yet been made, but director of the FDA's Center for Biologics Evaluation and Research Peter Marks, MD, PhD, said the panel did hear the preference for an XBB 1.5 vaccine, and plans to make a decision regarding specifics related to vaccine composition quickly.
"We anticipate the manufacturers will be moving forward with manufacturing and then obtaining the data and filings needed to inform our ultimate FDA actions in order to have vaccines evaluated with our safety and effectiveness standards for availability in the September timeframe," Dr. Marks stated.