U.S. Food and Drug Administration Using New Method to Test COVID Boosters

Monday, August 22nd, 2022 -- 11:00 AM

(Rob Stein, Wisconsin Public Radio) The U.S. Food and Drug Administration is using a controversial strategy to evaluate the next generation of COVID-19 boosters.

According to Rob Stein with the Wisconsin Public Radio, the approach is stirring debate as the agency works to make new, hopefully improved, boosters available in September to help prevent severe disease and save lives in the fall and winter.

For the first time, the FDA is planning to base its decision about whether to authorize new boosters on studies involving mice instead of humans. "For the FDA to rely on mouse data is just bizarre, in my opinion," says John Moore, an immunologist at Weill Cornell Medicine in New York. "Mouse data are not going to be predictive in any way of what you would see in humans."

But others defend the approach, arguing that the country has had enough experience with the vaccines at this point to be confident the shots are safe and that there's not enough time to wait for data from human studies.

"We have 500 people a day dying of coronavirus right now. Those numbers sadly might very well rise in the fall and the winter. The question is: 'Can we do something better?'" says Dr. Ofer Levy, a pediatrics and infectious disease researcher at Harvard Medical School who also advises the FDA. "And I think the answer is: 'We can, by implementing this approach.'"

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