FDA expected to authorize new Covid boosters without data from tests in people

The updated Covid vaccine boosters, a reformulated version targeting the BA.5 omicron subvariant [will] be the first Covid shots distributed without results from human trials. Because the Biden administration has pushed for a fall booster campaign to begin in September, the mRNA vaccine-makers Pfizer-BioNTech and Moderna have only had time to test the reformulated shots in mice, not people. That means the Food and Drug Administration is relying on the mice trial data – plus human trial results from a similar vaccine that targets the original omicron strain, called BA.1 – to evaluate the new shots. Federal health officials hope that the new vaccines will provide stronger protection over the existing booster shots, which still target the original coronavirus strain. But the lack of data in humans means officials likely won’t know how much better the new shots are – if at all – until the fall booster campaign is well underway. The FDA’s decision to move forward without data from human trials is a gamble, experts say, threatening to further lower public trust in the vaccines should the new boosters not work as intended. The U.S. is still on its first iteration of the Covid vaccines, and the mRNA technology has only been in widespread use since late 2020. The agency is making “huge assumptions” in its consideration of the new Covid boosters, [Dr. Paul] Offit said, adding that it’s possible the new shots may not be any more effective than the existing vaccines.

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