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Chairman Clyburn Highlights Need for Science-Based Review to Ensure a Safe and Effective Coronavirus Vaccine

September 8, 2020

Washington, D.C. (September 8, 2020) — Today Rep. James E. Clyburn, Chair of the Select Subcommittee on the Coronavirus Crisis, issued the following statement in response to a pledge from chief executives of nine drug companies not to seek regulatory approval for experimental coronavirus vaccines until they have demonstrated safety and efficacy in Phase 3 clinical trials:

"I applaud the commitment of these pharmaceutical companies to only seek FDA approval or emergency use authorization for coronavirus vaccines that have demonstrated ‘safety and efficacy through a Phase 3 clinical study.' But Americans should not have to rely on this voluntary commitment from for-profit companies to ensure a vaccine is safe and effective. Congress directed the Food and Drug Administration to protect Americans by conducting rigorous scientific reviews of vaccines. The Trump Administration must commit to ending its inappropriate political meddling at the FDA so all Americans can trust the agency's decisions on a coronavirus vaccine will be based on science—not politics.

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