FDA’s reliance on animal-tested data ahead of a planned Fall 2022 booster rollout is nothing short of cutting corners.
To this end, U.S. regulators have optedof their U.K. counterparts. Instead, in June 2022, the FDA asked drug makers to develop multivariant booster vaccines, i.e., ones that protect against multiple variants at once, including the most recent BA.4 and BA.5 subvariants. Drug makers often find themselves in a race against time to tailor vaccines to the latest variants and obtain regulatory acceptance.
Second, substituting the efficacy data in mice, or any artificial animal model, for human data is extraordinary under any circumstances. It is not a secret that scientific findings in animals often fail to translate to medical discoveries in humans. In fact, 90 percent of experimental drugs tested on animals do not work in humans due to either safety or efficacy issues. In most contexts, animal data used to inform clinical applications need to be met with the utmost skepticism.
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