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Adverse Consequences of Rushing a SARS-CoV-2 VaccineImplications for Public Trust

Educational Objective
To understand the importance of adhering to scientific principles in the development of a SARS-CoV-2 Vaccine

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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Article Information

Corresponding Author: Brit Trogen, MD, MS, 15J-1510 Lexington Ave, New York, NY 10029 (brit.trogen@nyulangone.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.

References
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Sanger  DE , Kirkpatrick  DD , Zimmer  C , Thomas  K , Wee  SL . Profits and pride at stake, the race for a vaccine intensifies. New York Times. Published May 2, 2020. Accessed May 19, 2020. https://www.nytimes.com/2020/05/02/us/politics/vaccines-coronavirus-research.html
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Dubé  E , Vivion  M , MacDonald  NE .  Vaccine hesitancy, vaccine refusal and the anti-vaccine movement: influence, impact and implications.   Expert Rev Vaccines. 2015;14(1):99-117. doi:10.1586/14760584.2015.964212PubMedGoogle ScholarCrossref
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World Health Organization. Ten threats to global health in 2019. Published September 2019. Accessed May 4, 2020. https://www.who.int/news-room/feature-stories/ten-threats-to-global-health-in-2019
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Hotez  P .  America and Europe’s new normal: the return of vaccine-preventable diseases.   Pediatr Res. 2019;85(7):912-914. doi:10.1038/s41390-019-0354-3PubMedGoogle ScholarCrossref
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Oshinsky  D .  Polio: An American Story. Oxford University Press; 2005.
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Offit  P .  The Cutter Incident: How America’s First Polio Vaccine Led to the Growing Vaccine Crisis. Yale University Press; 2005.
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Sencer  DJ , Millar  JD .  Reflections on the 1976 swine flu vaccination program.   Emerg Infect Dis. 2006;12(1):29-33. doi:10.3201/eid1201.051007PubMedGoogle ScholarCrossref
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Plotkin  SA , Caplan  A .  Extraordinary diseases require extraordinary solutions.   Vaccine. 2020;38(24):3987-3988. doi:10.1016/j.vaccine.2020.04.039PubMedGoogle ScholarCrossref
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Credit Designation Statement: The American Medical Association designates this Journal-based CME activity activity for a maximum of 1.00  AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to:

  • 1.00 Medical Knowledge MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program;;
  • 1.00 Self-Assessment points in the American Board of Otolaryngology – Head and Neck Surgery’s (ABOHNS) Continuing Certification program;
  • 1.00 MOC points in the American Board of Pediatrics’ (ABP) Maintenance of Certification (MOC) program;
  • 1.00 Lifelong Learning points in the American Board of Pathology’s (ABPath) Continuing Certification program; and
  • 1.00 CME points in the American Board of Surgery’s (ABS) Continuing Certification program

It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting MOC credit.

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