Please use this identifier to cite or link to this item: https://www.arca.fiocruz.br/handle/icict/52662
Title: Final Analysis of Efficacy and Safety of Single-Dose Ad26.COV2.S
Authors: Sadoff, Jerald
Gray, Glenda
Vandebosch, An
Cárdenas, Vicky
Shukarev, Georgi
Grinsztejn, Beatriz
Goepfert, Paul A.
Truyers, Carla
Dromme, Ilse Van
Spiessens, Bart
Vingerhoets, Johan
Custers, Jerome
Scheper, Gert
Robb, Merlin L.
Treanor, John
Ryser, Martin F.
Barouch, Dan H.
Swann, Edith
Marovich, Mary A.
Neuzil, Kathleen M.
Corey, Lawrence
Stoddard, Jeffrey
Hardt, Karin
Ruiz-Guiñazú, Javier
Le Gars, Mathieu
Schuitemaker, Hanneke
Hoof, Johan Van
Struyf, Frank
Douoguih, Macaya
ENSEMBLE Study Group
Affilliation: Múltiplas - Ver em Notas.
Abstract: Background: The 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. Methods: We 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. Results: Median 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. Conclusions: A 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 longe
Keywords: COVID-19
SARS-CoV-2
Vaccine
Ad26.COV2.S
Efficacy
Safety
Issue Date: 2022
Publisher: Massachusetts Medical Society
Citation: SADOFF, Jerald et al. Final Analysis of Efficacy and Safety of Single-Dose Ad26.COV2.S. The New England journal of medicine, v. 386, n. 9, p. 847-860, 2022
Description: Beatriz Grinsztejn - Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil. 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).
DOI: 10.1056/NEJMoa2117608
ISSN: 1533-4406
Copyright: open access
Appears in Collections:INI - Artigos de Periódicos
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