id author title date pages extension mime words sentences flesch summary cache txt cord-271090-91lzr4tz Edwards, Kathryn M. Anticipating SARS-CoV-2 Vaccine Testing, Licensure, and Recommendations for Use 2020-06-19 .txt text/plain 2694 142 47 Because of concerns raised about enhanced disease after wild virus infection in animal studies following vaccination against severe acute respiratory syndrome coronavirus 1 (SARS-CoV-1) and Middle East respiratory syndromecoronavirus (MERS-CoV) (9, 10), experts have met and proposed immunologic criteria to be evaluated in animals and humans to detect and consequently reduce the risk of enhanced disease (11) . Some of the Phase 1 studies evaluating SARS-CoV-2 vaccines have also included individuals >65 years of age to assess safety and immunogenicity in this population, which is at greater risk for severe COVID-19 disease. With SARS-CoV-2 vaccines, Phase 2 studies are planned to expand the safety profile and to assess immune responses in larger numbers of subjects. The Phase 3 efficacy trials planned for SARS-CoV-2 vaccines in the United States are expected to enroll 20,000 to 30,000 individuals, the numbers projected to be necessary to determine whether the vaccines will prevent significant disease over a period of 6 months follow-up. ./cache/cord-271090-91lzr4tz.txt ./txt/cord-271090-91lzr4tz.txt