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The Development of COVID-19 VaccinesSafeguards Needed

Educational Objective
To understand the risks and challenges of developing a COVID-19 vaccine
1 Credit CME

A safe and effective vaccine against coronavirus disease 2019 (COVID-19) is the best way to control and ultimately end the pandemic. Vaccine development is moving at unprecedented speed, with more than 200 candidates, billions of dollars committed, and manufacturing often proceeding before even knowing whether a given vaccine candidate will succeed. To date, the US federal government has rapidly advanced 5 vaccine candidates through Operation Warp Speed.1 At the same time, a growing movement of skeptics has raised doubt about future COVID-19 vaccines.2 A poll of 1056 individuals in the US found that only 49% reported that they currently are planning to receive a COVID-19 vaccine; 31% are uncertain, and 20% are not, with safety a major concern.3

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Article Information

Corresponding Author: Nicole Lurie, MD, MSPH, Coalition for Epidemic Preparedness Innovations (CEPI), 1900 Pennsylvania Ave NW, Washington, DC 20006 (nicole.lurie@cepi.net).

Published Online: July 6, 2020. doi:10.1001/jama.2020.12461

Conflict of Interest Disclosures: Dr Sharfstein reported that he served as Principal Deputy Commissioner of FDA from March 2009 to January 2011. Dr Goodman reported that he served as the Chief Scientist of the FDA from January 2009 to March 2014. No other disclosures were reported.

Disclaimer: The views expressed herein are solely those of the authors, and do not necessarily represent the views of any organizations with which they are affiliated.

References
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Weiland  N , Sanger  DE . Trump administration selects five coronavirus vaccine candidates as finalists. New York Times. June 2, 2020. Updated June 15, 2020. Accessed June 30, 2020. https://www.nytimes.com/2020/06/03/us/politics/coronavirus-vaccine-trump-moderna.html
2.
Zhang  S . We don’t even have a COVID-19 vaccine, and yet the conspiracies are here. The Atlantic. May 24, 2020. Accessed June 30, 2020. https://www.theatlantic.com/science/archive/2020/05/covid-19-vaccine-skeptics-conspiracies/611998/
3.
Expectations for a COVID-19 vaccine. Associated Press-NORC Center for Public Affairs. May 2020. Accessed June 30, 2020. http://www.apnorc.org/projects/Pages/Expectations-for-a-COVID-19-Vaccine.aspx
4.
Goodman  JL , Borio  L .  Finding effective treatments for covid-19: scientific integrity and public confidence in a time of crisis.   JAMA. 2020;323(19):1899-1900. doi:10.1001/jama.2020.6434PubMedGoogle ScholarCrossref
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Emanuel  EJ , Offit  PA . Could Trump turn a vaccine into a campaign stunt. New York Times. June 8, 2020. Accessed June xx, 2020. https://www.nytimes.com/2020/06/08/opinion/trump-coronavirus-vaccine.html
6.
Lambert  PH , Ambrosino  DM , Andersen  SR ,  et al.  Consensus summary report for CEPI/BC March 12-13, 2020 meeting: assessment of risk of disease enhancement with COVID-19 vaccines.   Vaccine. 2020;38(31):4783-4791. doi:10.1016/j.vaccine.2020.05.064PubMedGoogle ScholarCrossref
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Ison  MG , Wolfe  C , Boucher  HW .  Emergency use authorization of remdesivir: the need for a transparent distribution process.   JAMA. 2020;323(23):2365-2366. doi:10.1001/jama.2020.8863PubMedGoogle Scholar
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Salmon  DA , Akhtar  A , Mergler  MJ ,  et al; H1N1 Working Group of Federal Immunization Safety Task Force.  Immunization-safety monitoring systems for the 2009 H1N1 monovalent influenza vaccination program.   Pediatrics. 2011;127(suppl 1):S78-S86. doi:10.1542/peds.2010-1722LPubMedGoogle ScholarCrossref
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Neustadt  RE , Fineberg  HV .  The Swine Flu Affair: Decision-making on a Slippery Disease. National Academies Press; 1978.
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