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JERALD C. SADOFF, Glenda Gray, An Vandebosch, Vicky Cárdenas, Georgi Shukarev, Beatriz Gilda Jegerhorn Grinsztejn, Paul Goepfert, Carla Truyers, Hein Fennema, Bart Spiessens and 20 more
BACKGROUND: The Ad26.COV2.S vaccine is a recombinant, replication-incompetent human adenovirus type 26 vector encoding full-length severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein in a prefusion-stabilized conformation. METHODS: viral particles) or placebo. The primary end points were vaccine efficacy against moderate to severe-critical coronavirus disease 2019 (Covid-19) with an onset at least 14 days and at least 28 days after administration among participants in the per-protocol population who had tested negative for SARS-CoV-2. Safety was also assessed. RESULTS: The per-protocol population included 19,630 SARS-CoV-2-negative participants who received Ad26.COV2.S and 19,691 who received placebo. Ad26.COV2.S protected against moderate to severe-critical Covid-19 with onset at least 14 days after administration (116 cases in the vaccine group vs. 348 in the placebo group; efficacy, 66.9%; adjusted 95% confidence interval [CI], 59.0 to 73.4) and at least 28 days after administration (66 vs. 193 cases; efficacy, 66.1%; adjusted 95% CI, 55.0 to 74.8). Vaccine efficacy was higher against severe-critical Covid-19 (76.7% [adjusted 95% CI, 54.6 to 89.1] for onset at ≥14 days and 85.4% [adjusted 95% CI, 54.2 to 96.9] for onset at ≥28 days). Despite 86 of 91 cases (94.5%) in South Africa with sequenced virus having the 20H/501Y.V2 variant, vaccine efficacy was 52.0% and 64.0% against moderate to severe-critical Covid-19 with onset at least 14 days and at least 28 days after administration, respectively, and efficacy against severe-critical Covid-19 was 73.1% and 81.7%, respectively. Reactogenicity was higher with Ad26.COV2.S than with placebo but was generally mild to moderate and transient. The incidence of serious adverse events was balanced between the two groups. Three deaths occurred in the vaccine group (none were Covid-19-related), and 16 in the placebo group (5 were Covid-19-related). CONCLUSIONS: A single dose of Ad26.COV2.S protected against symptomatic Covid-19 and asymptomatic SARS-CoV-2 infection and was effective against severe-critical disease, including hospitalization and death. Safety appeared to be similar to that in other phase 3 trials of Covid-19 vaccines. (Funded by Janssen Research and Development and others; ENSEMBLE ClinicalTrials.gov number, NCT04505722.).
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SADOFF, J. C., Gray, G., Vandebosch, A., Cárdenas, V., Shukarev, G., Grinsztejn, B. G. J., Goepfert, P., Truyers, C., Fennema, H., Spiessens, B., Offergeld, K., Scheper, G. C., Taylor, K. L., Robb, M. L., Treanor, J. J., Barouch, D. H., Stoddard, J. J., Ryser, M., Marovich, M., … Douoguih, M. (2021). Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19. New England Journal of Medicine, 384(23), 2187–2201. https://doi.org/10.1056/nejmoa2101544
SADOFF, JERALD C., et al. "Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19." New England Journal of Medicine, vol. 384, no. 23, 2021, pp. 2187–2201, https://doi.org/10.1056/nejmoa2101544.
SADOFF, JERALD C., Glenda Gray, An Vandebosch, Vicky Cárdenas, Georgi Shukarev, Beatriz Gilda Jegerhorn Grinsztejn, Paul Goepfert, et al. "Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19." New England Journal of Medicine 384, no. 23 (2021): 2187–2201. https://doi.org/10.1056/nejmoa2101544.
SADOFF J. C., Gray G., Vandebosch A. [и др.] Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19 // New England Journal of Medicine. — 2021. — Vol. 384, № 23. — P. 2187–2201. — URL: https://doi.org/10.1056/nejmoa2101544
@article{sadoff2021safety,
title = {{Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19}},
author = {JERALD C. SADOFF and Glenda Gray and An Vandebosch and Vicky Cárdenas and Georgi Shukarev and Beatriz Gilda Jegerhorn Grinsztejn and Paul Goepfert and Carla Truyers and Hein Fennema and Bart Spiessens and Kim Offergeld and Gert C. Scheper and Kimberly L. Taylor and Merlin Lee Robb and John J. Treanor and Dan H. Barouch and Jeffrey J. Stoddard and Martin Ryser and Mary Marovich and Kathleen Maletic Neuzil and Lawrence Corey and Nancy Cauwenberghs and Tamzin Tanner and Karin Hardt and Javier Ruiz‐Guiñazú and Mathieu Le Gars and Hanneke Schuitemaker and Johan Van Hoof and Frank Struyf and Macaya Douoguih},
journal = {New England Journal of Medicine},
year = {2021},
volume = {384},
number = {23},
pages = {2187--2201},
doi = {10.1056/nejmoa2101544},
url = {https://doi.org/10.1056/nejmoa2101544}
}TY - JOUR AU - SADOFF, JERALD C. AU - Gray, Glenda AU - Vandebosch, An AU - Cárdenas, Vicky AU - Shukarev, Georgi AU - Grinsztejn, Beatriz Gilda Jegerhorn AU - Goepfert, Paul AU - Truyers, Carla AU - Fennema, Hein AU - Spiessens, Bart AU - Offergeld, Kim AU - Scheper, Gert C. AU - Taylor, Kimberly L. AU - Robb, Merlin Lee AU - Treanor, John J. AU - Barouch, Dan H. AU - Stoddard, Jeffrey J. AU - Ryser, Martin AU - Marovich, Mary AU - Neuzil, Kathleen Maletic AU - Corey, Lawrence AU - Cauwenberghs, Nancy AU - Tanner, Tamzin AU - Hardt, Karin AU - Ruiz‐Guiñazú, Javier AU - Gars, Mathieu Le AU - Schuitemaker, Hanneke AU - Hoof, Johan Van AU - Struyf, Frank AU - Douoguih, Macaya TI - Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19 JO - New England Journal of Medicine VL - 384 IS - 23 SP - 2187 EP - 2201 PY - 2021 DA - 2021/04/21 DO - 10.1056/nejmoa2101544 UR - https://doi.org/10.1056/nejmoa2101544 ER -
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