This is an Open Access article under the CC BY 4.0 license. UK Research and Innovation, National Institutes for Health Research (NIHR), Coalition for Epidemic Preparedness Innovations, Bill & Melinda Gates Foundation, Lemann Foundation, Rede D'Or, Brava and Telles Foundation, NIHR Oxford Biomedical Research Centre, Thames Valley and South Midland's NIHR Clinical Research Network, and AstraZeneca.Ĭopyright © 2021 The Author(s). Three events were classified as possibly related to a vaccine: one in the ChAdOx1 nCoV-19 group, one in the control group, and one in a participant who remains masked to group allocation.ĬhAdOx1 nCoV-19 has an acceptable safety profile and has been found to be efficacious against symptomatic COVID-19 in this interim analysis of ongoing clinical trials. There were 74 341 person-months of safety follow-up (median 3♴ months, IQR 1♳-4♸): 175 severe adverse events occurred in 168 participants, 84 events in the ChAdOx1 nCoV-19 group and 91 in the control group. From 21 days after the first dose, there were ten cases hospitalised for COVID-19, all in the control arm two were classified as severe COVID-19, including one death. In participants who received two standard doses, vaccine efficacy was 62♱% (95% CI 41♰-75♷ 27 of 4440 in the ChAdOx1 nCoV-19 group vs71 of 4455 in the control group) and in participants who received a low dose followed by a standard dose, efficacy was 90♰% (67♴-97♰ three of 1367 vs 30 of 1374 p interaction=0♰10). Studies are registered at ISRCTN89951424 and, NCT04324606, NCT04400838, and NCT04444674.īetween April 23 and Nov 4, 2020, 23 848 participants were enrolled and 11 636 participants (7548 in the UK, 4088 in Brazil) were included in the interim primary efficacy analysis. Vaccine efficacy was calculated as 1 - relative risk derived from a robust Poisson regression model adjusted for age. Participants were analysed according to treatment received, with data cutoff on Nov 4, 2020. The primary efficacy analysis included symptomatic COVID-19 in seronegative participants with a nucleic acid amplification test-positive swab more than 14 days after a second dose of vaccine. Participants in the ChAdOx1 nCoV-19 group received two doses containing 5 × 10 10 viral particles (standard dose SD/SD cohort) a subset in the UK trial received a half dose as their first dose (low dose) and a standard dose as their second dose (LD/SD cohort). Participants aged 18 years and older were randomly assigned (1:1) to ChAdOx1 nCoV-19 vaccine or control (meningococcal group A, C, W, and Y conjugate vaccine or saline). This analysis includes data from four ongoing blinded, randomised, controlled trials done across the UK, Brazil, and South Africa. We evaluated the safety and efficacy of the ChAdOx1 nCoV-19 vaccine in a pooled interim analysis of four trials. A safe and efficacious vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), if deployed with high coverage, could contribute to the control of the COVID-19 pandemic.
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