Moderna is developing a so-called bivalent vaccine that combines an omicron-specific shot with the company’s original Covid-19 vaccine.
online to a preprint server in February, that suggested an omicron-specific booster shot may not provide any greater protection compared to the existing boosters.
In any scenario, Pfizer and Moderna would likely need a compelling case for why new shots are advantageous over the existing vaccines, backed up by robust safety and immunogenicity data, said Dr. Celine Gounder, an infectious disease specialist at NYU Langone Health in New York City. "Both Pfizer and Moderna have licensed products, so the FDA might say, 'Let's do a noninferiority study against your licensed product,'" Baylor said. A noninferiority study looks at whether a new treatment is better or worse than the active treatment to which it is being compared.
He said the company is confident it could make a compelling case to the FDA, using a wide range of data from its original vaccine, its omicron-specific shot and the bivalent vaccines it has already tested or will test.If a new booster is authorized, it's likely only some Americans would need to get the shot, said Dr. Paul Offit, a vaccine expert at Children's Hospital of Philadelphia.
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