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BIO Chairman: FDA Vaccine Reviews Too Complex and Costly for States to Replicate

November 10, 2020

Via: BioSpace

Several states have pledged to review COVID-19 vaccines themselves, after U.S. Food and Drug Administration (FDA) Emergency Use Authorizations EUA), to ensure safety and efficacy. A robust review, however, is unlikely. In reality, if state reviews go forward, they most likely will be cursory.

“To replicate an FDA equivalent review in any state would be extremely challenging and costly,” Jeremy M. Levin, D.Phil., chairman of BIO, told BioSpace. The FDA employs some 17,000 people, “and replicating that in the states seems an extraordinary and unnecessary burden for taxpayers.”

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