As the SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) pandemic persists across the US and the world, the spotlight on vaccine science has never been more intense. Researchers across the globe are working rapidly to produce a potential vaccine, and 7 candidates are already in clinical trials.1 Operation Warp Speed, the vaccine development project announced by President Trump, has advocated for a vaccine to be made available in the US by the beginning of 2021.1 But for scientists and physicians, the term “warp speed” should trigger concern. Good science requires rigor, discipline, and deliberate caution. Any medical therapy approved for public use in the absence of extensive safeguards has the potential to cause harm, not only for COVID-19 prevention efforts and vaccine recipients, but also for public trust in vaccination efforts worldwide.
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CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.
Corresponding Author: Brit Trogen, MD, MS, 15J-1510 Lexington Ave, New York, NY 10029 (firstname.lastname@example.org).
Published Online: May 26, 2020. doi:10.1001/jama.2020.8917
Conflict of Interest Disclosures: Dr Caplan reported serving as the unpaid chair of the Compassionate Use Advisory Committees (CompAC), independent panels of internationally recognized medical experts, bioethicists, and patient representatives formed by NYU School of Medicine in collaboration with Janssen. CompAC advises Janssen about requests for compassionate use of its investigational medicines. NYU receives administrative funding from Janssen to facilitate the CompAC committees. Dr Caplan reports discussing emerging issues in research ethics with Western IRB Inc/WIRB-Copernicus Group (WIRB/WCG) leadership, giving lectures on research ethics topics to WIRB/WCG staff and fellows, and that the Division of Medical Ethics has a grant from WIRB/WCG to provide education as part of an annual international research ethics fellows educational program held at NYU. Dr Caplan also reports consulting in 2017-2019 for Sangamo, Boehringer, Sanofi, Novartis (all compassionate use, unpaid), FNIH (unpaid), CSL, Glaxo, Fox Chase Cancer Center, Abeona, Genae/Cardialen-DSMB, Parker Waichman LLP, Nelson Mullins Riley & Scarborough LLP, UroGen Pharma Inc, Otsuka, and Cabaletta Bio. No other disclosures were reported.
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