Alliance for Pandemic Preparedness

August 20, 2020

RNA-Based COVID-19 Vaccine BNT162b2 Selected for a Pivotal Efficacy Study

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• [Preprint, not peer-reviewed] Walsh et al. report Phase 1 results of an ongoing dose-escalation clinical trial of two RNA vaccine candidates for SARS-CoV-2 (BNT162b1 and BNT162b2) among 195 healthy adults randomized into 13 groups based on age (18-55 or 65-85 years), vaccine type and vaccine dose. Participants received two injections of either vaccine or placebo 21 days apart. Results showed that the on day 28 (7 days after Dose 2) the SARS-CoV-2–neutralizing geometric mean titers were boosted in both age groups receiving the highest dose of vaccine to 2.8-3.8 times (younger age) to 1.1-1.6 times (older age) the levels present in convalescent sera.
• The authors anticipate expanding the study to up to 30,000 participants from diverse backgrounds in a global Phase 2/3 large-scale safety and efficacy evaluation.

Walsh et al. (Aug 20, 2020). RNA-Based COVID-19 Vaccine BNT162b2 Selected for a Pivotal Efficacy Study. Pre-print downloaded Aug 20 from https://doi.org/10.1101/2020.08.17.20176651