Johnson & Johnson single-shot COVID-19 vaccine phase III data published in New England Journal of Medicine

Johnson & Johnson announced publication in the New England Journal of Medicine of primary data from the Phase III ENSEMBLE clinical trial for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen).

The publication of the primary analysis follows the topline efficacy and safety data announced in January, showing the trial met all primary and key secondary endpoints, and found that the Johnson & Johnson single-dose COVID-19 vaccine prevented hospitalization and death across all study participants 28 days after vaccination. These data demonstrated that, despite the high prevalence of emerging SARS-CoV-2 variants among COVID-19 cases in the study, including the South African variant of the B.1.351 lineage and the P2 lineage variant found in Brazil, vaccine efficacy was consistent against symptomatic infection, and the vaccine showed protection against COVID-19-related hospitalization and death as of 28 days after vaccination.

The ENSEMBLE data demonstrated that Johnson & Johnson’s single-dose COVID-19 vaccine was 85 percent effective against severe/critical disease. Additionally, the trial met its co-primary endpoints of protecting against moderate to severe COVID-19 at 14 and 28 days after vaccination, achieving 67 percent efficacy at 14 days after vaccination; and 66 percent efficacy at 28 days after vaccination, with prevention against COVID-19-related hospitalization and death across all participants (N=44,325). Protection was generally consistent across race, age groups, including adults over 60 years of age (N=14,672), and those with and without comorbidities.

See-“Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19”- Jerald Sadoff, M.D., Glenda Gray, M.B., B.Ch., An Vandebosch, Ph.D., Vicky Cárdenas, Ph.D.,, et al., for the ENSEMBLE study group.-April 21, 2021. DOI: 10.1056/NEJMoa2101544.