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2021-03-22

Biomedical Ethics Unit, McGill University, Montreal, Quebec, Canada (A.M., N.H., O.S., E.O., E.F., C.O., J.S., F.A., C.W., J.K.).; Biomedical Ethics Unit, McGill University, Montreal, Quebec, Canada (A.M., N.H., O.S., E.O., E.F., C.O., J.S., F.A., C.W., J.K.).; Biomedical Ethics Unit, McGill University, Montreal, Quebec, Canada (A.M., N.H., O.S., E.O., E.F., C.O., J.S., F.A., C.W., J.K.).; Biomedical Ethics Unit, McGill University, Montreal, Quebec, Canada (A.M., N.H., O.S., E.O., E.F., C.O., J.S., F.A., C.W., J.K.).; Biomedical Ethics Unit, McGill University, Montreal, Quebec, Canada (A.M., N.H., O.S., E.O., E.F., C.O., J.S., F.A., C.W., J.K.).; Biomedical Ethics Unit, McGill University, Montreal, Quebec, Canada (A.M., N.H., O.S., E.O., E.F., C.O., J.S., F.A., C.W., J.K.).; Biomedical Ethics Unit, McGill University, Montreal, Quebec, Canada (A.M., N.H., O.S., E.O., E.F., C.O., J.S., F.A., C.W., J.K.).; Biomedical Ethics Unit, McGill University, Montreal, Quebec, Canada (A.M., N.H., O.S., E.O., E.F., C.O., J.S., F.A., C.W., J.K.).; Biomedical Ethics Unit, McGill University, Montreal, Quebec, Canada (A.M., N.H., O.S., E.O., E.F., C.O., J.S., F.A., C.W., J.K.).; McGill University, Montreal, Quebec, Canada (J.P., N.E.B.).; McGill University, Montreal, Quebec, Canada (J.P., N.E.B.).; Biomedical Ethics Unit, McGill University, Montreal, Quebec, Canada (A.M., N.H., O.S., E.O., E.F., C.O., J.S., F.A., C.W., J.K.).

BACKGROUND: Anticipated success rates and timelines for COVID-19 vaccine development vary. Recent experience with developing and testing viral vaccine candidates can inform expectations regarding the development of safe and effective vaccines. OBJECTIVE: To estimate timelines and probabilities of success for recent vaccine candidates. DESIGN: ClinicalTrials.gov was searched to identify trials testing viral vaccines that had not advanced to phase 2 before 2005, and the progress of each vaccine from phase 1 through to U.S. Food and Drug Administration (FDA) licensure was tracked. Trial characteristics were double-coded. (Registration: Open Science Framework [https://osf.io/dmuzx/]). SETTING: Trials launched between January 2005 and March 2020. PARTICIPANTS: Preventive viral vaccine candidates for 23 emerging or reemerged viral infectious diseases. MEASUREMENTS: The primary end point was the probability of vaccines advancing from launch of phase 2 to FDA licensure within 10 years.