• Jerald Sadoff, Glenda Gray, An Vandebosch, Vicky Cárdenas, Georgi Shukarev, Beatriz Grinsztejn, Paul A Goepfert, Carla Truyers, Ilse Van Dromme, Bart Spiessens, Johan Vingerhoets, Jerome Custers, Gert Scheper, Merlin L Robb, John Treanor, Martin F Ryser, Dan H Barouch, Edith Swann, Mary A Marovich, Kathleen M Neuzil, Lawrence Corey, Jeffrey Stoddard, Karin Hardt, Javier Ruiz-Guiñazú, Mathieu Le Gars, Hanneke Schuitemaker, Johan Van Hoof, Frank Struyf, Macaya Douoguih, and ENSEMBLE Study Group.
• From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J.R.-G., F.S.); Janssen Research and Development, Spring House, PA (V.C.); Evandro Chagas National Institute of Infectious Diseases-Fiocruz, Rio de Janeiro (B.G.); the University of Alabama at Birmingham, Birmingham (P.A.G.); Walter Reed Army Institute of Research, Silver Spring (M.L.R.), the National Institute of Allergy and Infectious Diseases, Rockville (E.S., M.A.M.), and the Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore (K.M.N.) - all in Maryland; the Biomedical Advanced Research and Development Authority, Washington, DC (J.T.); the Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston (D.H.B.); the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle (L.C.); and Janssen Research and Development, Raritan, NJ (J. Stoddard).
• N. Engl. J. Med. 2022 Mar 3; 386 (9): 847860847-860.

BackgroundThe Ad26.COV2.S vaccine was highly effective against severe-critical coronavirus disease 2019 (Covid-19), hospitalization, and death in the primary phase 3 efficacy analysis.MethodsWe conducted the final analysis in the double-blind phase of our multinational, randomized, placebo-controlled trial, in which adults were assigned in a 1:1 ratio to receive single-dose Ad26.COV2.S (5×1010 viral particles) or placebo. The primary end points were vaccine efficacy against moderate to severe-critical Covid-19 with onset at least 14 days after administration and at least 28 days after administration in the per-protocol population. Safety and key secondary and exploratory end points were also assessed.ResultsMedian follow-up in this analysis was 4 months; 8940 participants had at least 6 months of follow-up. In the per-protocol population (39,185 participants), vaccine efficacy against moderate to severe-critical Covid-19 at least 14 days after administration was 56.3% (95% confidence interval [CI], 51.3 to 60.8; 484 cases in the vaccine group vs. 1067 in the placebo group); at least 28 days after administration, vaccine efficacy was 52.9% (95% CI, 47.1 to 58.1; 433 cases in the vaccine group vs. 883 in the placebo group). Efficacy in the United States, primarily against the reference strain (B.1.D614G) and the B.1.1.7 (alpha) variant, was 69.7% (95% CI, 60.7 to 76.9); efficacy was reduced elsewhere against the P.1 (gamma), C.37 (lambda), and B.1.621 (mu) variants. Efficacy was 74.6% (95% CI, 64.7 to 82.1) against severe-critical Covid-19 (with only 4 severe-critical cases caused by the B.1.617.2 [delta] variant), 75.6% (95% CI, 54.3 to 88.0) against Covid-19 leading to medical intervention (including hospitalization), and 82.8% (95% CI, 40.5 to 96.8) against Covid-19-related death, with protection lasting 6 months or longer. Efficacy against any severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection was 41.7% (95% CI, 36.3 to 46.7). Ad26.COV2.S was associated with mainly mild-to-moderate adverse events, and no new safety concerns were identified.ConclusionsA single dose of Ad26.COV2.S provided 52.9% protection against moderate to severe-critical Covid-19. Protection varied according to variant; higher protection was observed against severe Covid-19, medical intervention, and death than against other end points and lasted for 6 months or longer. (Funded by Janssen Research and Development and others; ENSEMBLE ClinicalTrials.gov number, NCT04505722.).Copyright © 2022 Massachusetts Medical Society.

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