Key clinical point: A two-dose regimen of the BNT162b2 mRNA SARS-CoV-2 vaccine was 95% effective in preventing COVID-19. Major finding: BNT162b2 demonstrated 95.0% vaccine efficacy against COVID-19 (95% credible interval, 90.3%-97.6%). The incidence of serious adverse events was low and similar in the vaccine (0.6%) and placebo (0.5%) arms. Study details: An ongoing global phase 2/3 trial evaluating the safety and efficacy of BNT162b2 in 43,448 persons aged at least 16 years. Disclosures: This study was supported by BioNTech and Pfizer. Several authors disclosed financial relationships with Pfizer and other pharmaceutical companies outside the submitted work.