October 6, 2020, Vol 324, No. 13, Pages 1261-1362
Regulatory Decision-making on COVID-19 Vaccines During a Public Health Emergency
Jerry Avorn, MD; Aaron Kesselheim, MD, JD, MPH
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JAMA. 2020;324(13):1284-1285. doi:10.1001/jama.2020.17101
This Viewpoint reviews the enormous political and public pressures the FDA is likely to be under in fall 2020 to provide emergency authorization or approval of candidate COVID-19 vaccines, and urges adherence to existing science-based protocols for approval to ensure vaccine safety and acceptance and thus protect the public’s health.