Phase 3 Safety and Efficacy of AZD1222 (ChAdOx1 nCoV-19) Covid-19 Vaccine
Author
Falsey, Ann RSobieszczyk, Magdalena E
Hirsch, Ian
Sproule, Stephanie
Robb, Merlin L
Corey, Lawrence
Neuzil, Kathleen M
Hahn, William
Hunt, Julie
Mulligan, Mark J
McEvoy, Charlene
DeJesus, Edwin
Hassman, Michael
Little, Susan J
Pahud, Barbara A
Durbin, Anna
Pickrell, Paul
Daar, Eric S
Bush, Larry
Solis, Joel
Carr, Quito Osuna
Oyedele, Temitope
Buchbinder, Susan
Cowden, Jessica
Vargas, Sergio L
Benavides, Alfredo Guerreros
Call, Robert
Keefer, Michael C
Kirkpatrick, Beth D
Pullman, John
Tong, Tina
Isaacs, Margaret Brewinski
Benkeser, David
Janes, Holly E
Nason, Martha C
Green, Justin A
Kelly, Elizabeth J
Maaske, Jill
Mueller, Nancy
Shoemaker, Kathryn
Takas, Therese
Marshall, Richard P
Pangalos, Menelas N
Villafana, Tonya
Gonzalez-Lopez, Antonio
Date
2021-09-29Journal
New England Journal of MedicinePublisher
Massachusetts Medical SocietyType
Article
Metadata
Show full item recordAbstract
Background: The safety and efficacy of the AZD1222 (ChAdOx1 nCoV-19) vaccine in a large, diverse population at increased risk for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in the United States, Chile, and Peru has not been known. Methods: In this ongoing, double-blind, randomized, placebo-controlled, phase 3 clinical trial, we investigated the safety, vaccine efficacy, and immunogenicity of two doses of AZD1222 as compared with placebo in preventing the onset of symptomatic and severe coronavirus disease 2019 (Covid-19) 15 days or more after the second dose in adults, including older adults, in the United States, Chile, and Peru. Results: A total of 32,451 participants underwent randomization, in a 2:1 ratio, to receive AZD1222 (21,635 participants) or placebo (10,816 participants). AZD1222 was safe, with low incidences of serious and medically attended adverse events and adverse events of special interest; the incidences were similar to those observed in the placebo group. Solicited local and systemic reactions were generally mild or moderate in both groups. Overall estimated vaccine efficacy was 74.0% (95% confidence interval [CI], 65.3 to 80.5; P<0.001) and estimated vaccine efficacy was 83.5% (95% CI, 54.2 to 94.1) in participants 65 years of age or older. High vaccine efficacy was consistent across a range of demographic subgroups. In the fully vaccinated analysis subgroup, no severe or critical symptomatic Covid-19 cases were observed among the 17,662 participants in the AZD1222 group; 8 cases were noted among the 8550 participants in the placebo group (<0.1%). The estimated vaccine efficacy for preventing SARS-CoV-2 infection (nucleocapsid antibody seroconversion) was 64.3% (95% CI, 56.1 to 71.0; P<0.001). SARS-CoV-2 spike protein binding and neutralizing antibodies increased after the first dose and increased further when measured 28 days after the second dose. Conclusions: AZD1222 was safe and efficacious in preventing symptomatic and severe Covid-19 across diverse populations that included older adults. (Funded by AstraZeneca and others; ClinicalTrials.gov number, NCT04516746.).Rights/Terms
Copyright © 2021 Massachusetts Medical Society.Identifier to cite or link to this item
http://hdl.handle.net/10713/16909ae974a485f413a2113503eed53cd6c53
10.1056/NEJMoa2105290
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