The FDA advisory panel's recommendation is a win for Covid vaccine makers Pfizer, Moderna and Novavax, which will race to deliver updated shots for the fall.
But Dr. Peter Marks, head of the FDA's vaccine division, said the agency is concerned that the U.S. will have another Covid wave "during a time when the virus has further evolved, immunity of the population has waned further and we move indoors for wintertime."
More than 40% of adults 65 and older have been boosted with those shots, while the rate among younger adults and children ranges between 18% and 20%. She added that clinical trial data on more than 100 people similarly demonstrates that the monovalent XBB.1.5 vaccine produces protective antibodies against all XBB variants. All trial participants had previously received four Covid vaccine doses.
That means the immune response an updated shot produces against XBB variants will likely be similar, regardless of which specific variant it targets, Edwards said. Pfizer will be able to deliver a monovalent shot targeting XBB.1.5 by July and a jab targeting XBB.1.16 by August, according to Kena Swanson, the company's senior principal scientist.
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