The FDA on Monday approved a new Covid vaccine booster produced by ModernaTX Inc. and Pfizer Inc. to combat emerging strains of the virus which together account for the majority of existing cases around the world.
“Consistent with the totality of the evidence and input from the FDA's expert advisors, these vaccines have been updated to include a monovalent (single) component that corresponds to the Omicron variant XBB.1.5,” a statement from the agency read.
People 12 and older can receive the new shot without restriction. It is available to children six months old through eleven years old only via emergency-use authorization. The original bivalent vaccines developed at the start of the pandemic by the two pharmaceutical giants are no longer authorized for use in the U.S. under the new update. The new vaccine is monovalent, the statement said.
"Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death," Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in the statement Monday. "The public can be assured that these updated vaccines have met the agency's rigorous scientific standards for safety, effectiveness, and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated."
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