Johnson & Johnson Single-Shot COVID-19 Vaccine Phase 3 Data Published in New England Journal of Medicine

NEW BRUNSWICK, N.J., April 21, 2021 – Johnson &Johnson (the Company) today announced publication in the New England Journal of Medicine of primary data from the Phase 3 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.“This comprehensive evidence demonstrates that Johnson &Johnson’s single-shot COVID-19 vaccine offers protection and prevents hospitalization and death, including in countries where viral variants are highly prevalent,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson &Johnson. “Regardless of race and ethnicity, age, geographic location and c...
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