Alliance for Pandemic Preparedness

January 29, 2021

Johnson & Johnson Announces Single-Shot Janssen COVID-19 Vaccine Candidate Met Primary Endpoints in Interim Analysis of its Phase 3 ENSEMBLE Trial

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[Press release, not peer-reviewed] The Johnson and Johnson single-dose COVID-19 candidate vaccine had 66% efficacy against moderate to severe COVID-19, based on a press release describing the phase 3 clinical trial results from the ENSEMBLE trial. Among all participants including those infected with an emerging viral variant the vaccine prevented moderate to severe COVID-19 28 days after vaccination with the first evidence of protection observed as early as day 14. The level of protection against moderate to severe COVID-19 infection was 72% in the United States, 66% in Latin America, and 57% in South Africa 28 days post-vaccination. 

Johnson & Johnson (Jan 29, 2021). Johnson & Johnson Announces Single-Shot Janssen COVID-19 Vaccine Candidate Met Primary Endpoints in Interim Analysis of its Phase 3 ENSEMBLE Trial. Press release downloaded Jan 29 from https://www.jnj.com/johnson-johnson-announces-single-shot-janssen-covid-19-vaccine-candidate-met-primary-endpoints-in-interim-analysis-of-its-phase-3-ensemble-trial