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September 09, 2020

Health Law Daily

Nine Pharmaceutical Company CEOs Pledge To Not Seek Regulatory Approval For Coronavirus Vaccines That Have Not Been Shown To Be Safe And Effective

  • September 09, 2020

The Washington Post (9/8, Rowland) reports the CEOs of nine pharmaceutical companies with coronavirus vaccine candidates in clinical trials “pledged Tuesday not to seek regulatory approval before the safety and efficacy of their experimental coronavirus vaccines has been established in Phase 3 clinical trials, an extraordinary effort to bolster public faith in a vaccine amid President Trump’s public rush to introduce a vaccine before Election Day.” In a joint statement, the CEOs of the nine companies said, “We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which covid-19 vaccines are evaluated and may ultimately be approved.” The nine companies that signed the pledge are: AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer, and Sanofi.
      The AP (9/8, Johnson) reports the pledge “comes amid worries that the U.S. Food and Drug Administration will be under political pressure to approve a vaccine before tests to prove it is safe and effective are finished.”
      USA Today (9/8, Weintraub, Weise) reports FDA Commissioner Stephen Hahn “has repeatedly said he would not approve a vaccine until it has been shown to be safe and effective.”
      Among other news outlets providing similar coverage are: ABC News (9/8, Thorbecke), CNN (9/8, Howard, Thomas), FiercePharma (9/8, Sagonowsky), The Hill (9/8, Sullivan), NPR (9/8, Chappell), Politico (9/8, Owermohle), Reuters (9/8, Burger, Weiss, Copley), STAT (9/8, Facher), and the Wall Street Journal (9/8, Hopkins, Loftus, Subscription Publication).