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The US Food and Drug Administration (FDA) will likely issue emergency use authorizations for 2 vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), one developed jointly by Pfizer and BioNTech and the other by Moderna. According to company press releases and data made available by the FDA,1 both vaccines have shown approximately 95% efficacy in preventing symptomatic COVID-19 infections in phase 3 trials, without significant safety concerns that might hinder authorization by the FDA. Additional phase 3 trials of vaccines manufactured by Janssen and AstraZeneca are underway; with rapidly rising case counts in the US, initial results from those trials may not be far behind. All of these trials compare the incidence of symptomatic infection among vaccine recipients with that among a placebo control group. However, once authorized vaccines become widely available, conducting placebo-controlled trials of subsequent vaccine candidates may become challenging.2 Alternative strategies to evaluate those vaccines, and to compare their safety and efficacy with those of authorized products, are needed.
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Joffe S. Evaluating SARS-CoV-2 Vaccines After Emergency Use Authorization or Licensing of Initial Candidate Vaccines. JAMA. 2021;325(3):221–222. doi:10.1001/jama.2020.25127
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