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Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK

The Lancet (British edition), 2021-01, Vol.397 (10269), p.99-111 [Peer Reviewed Journal]

2021 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license ;Copyright © 2021 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved. ;2021. The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. This work is published under https://creativecommons.org/licenses/by/3.0/ (theLicense”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. ;2021 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license 2021 ;ISSN: 0140-6736 ;EISSN: 1474-547X ;DOI: 10.1016/S0140-6736(20)32661-1 ;PMID: 33306989

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Title:
Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK
Author: Voysey, Merryn ; Weckx, Lily Y ; Collins, Andrea M ; Hill, Helen ; Lazarus, Rajeka ; Lawrie, Alison M ; McGregor, Alastair ; Villafana, Tonya L ; Gilbert, Sarah C ; Aban, Marites ; Aboagye, Jeremy ; Adam, Matthew ; Adams, Kirsty ; Alves, Mariana P.S. ; Barnes, Eleanor ; Berrie, Eleanor ; Bewley, Kevin R. ; Bletchly, Heather ; Borthwick, Nicola ; Brown, Phillip ; Buttigieg, Karen R. ; Cashen, Paul ; Castro, Lucia Carratala ; Chadwick, Jim ; Chapman, David ; Charlton, Sue ; Clark, Matthew ; Clutterbuck, Elizabeth A. ; Cooper, Cushla ; Cooper, Rachel ; Darroch, Paula ; Dearlove, David ; Drake-Brockman, Rachael ; van Eck, Samual ; Farrar, Madi ; Fraiman, Pedro H.A. ; Gracie, Lara ; Grossi, Leonardo ; Hanrath, Aidan T. ; Harris, Tara ; Hassan, Shadin ; Hay, Jodie ; Head, Ian ; Hodges, Gina ; Horne, Elizea ; Hou, Mimi M. ; Humphries, Holly E. ; Hyder-Wright, Angela ; Jeffers, Helen ; Karampatsas, Konstantinos ; Keen, Jade ; Khan, Liaquat ; King, Thomas B. ; Klenerman, Paul ; Lees, Emily A. ; Li, Yuanyuan ; Loew, Lisa ; Marques, Gabriela N. ; Masilela, Mduduzi ; Mathew, Moncy ; Meijs, Wilma ; Morris, Susan ; Mpelembue, Mushiya ; Noal, Helena ; Nugent, Fay L. ; O'Connor, Daniel ; Olchawski, Victoria ; O'Reilly, Paula ; Phillips, Daniel J. ; Pickup, Lorinda ; Du Plessis, Joan ; Pollard, Samuel ; Poulton, Ian ; Pulido, David ; Reiné, Jesús ; Resuello-Dauti, Mila ; Richter, Alex ; Roche, Sophie ; Rollier, Christine ; Ruiz, Sarah ; Sala, Claudia ; Sanchez-Gonzalez, Amada ; Sharpe, Hannah E. ; Smith, Daniel C. ; Smith, Holly E. ; Soares, Tiago ; Souza, Cinthia M.C.D.L. ; Spina, Fernanda ; Steven, Jill ; Stockdale, Lisa ; Stockwell, Lisa V. ; Sturdy, Ann ; Tarr, Alexander W. ; Taylor, Ursula ; Themistocleous, Andreas ; Tsheko, Betty Lebogang ; Turabi, Aadil ; Waddington, Claire S. ; Wallis, Erica ; Webb, Stewart
Subjects: Adolescent ; Adult ; Adverse events ; Aged ; Brazil ; ChAdOx1 nCoV-19 ; Charities ; Clinical trials ; Coronaviruses ; COVID-19 ; COVID-19 - prevention & control ; COVID-19 vaccines ; COVID-19 Vaccines - adverse effects ; Double-Blind Method ; Epidemics ; Female ; Humans ; Innovations ; Male ; Middle Aged ; Nucleic acids ; Older people ; Pandemics ; Regression analysis ; Regression models ; Regulatory agencies ; Research facilities ; Robustness (mathematics) ; Safety ; Severe acute respiratory syndrome ; Severe acute respiratory syndrome coronavirus 2 ; Single-Blind Method ; South Africa ; Statistical analysis ; Treatment Outcome ; United Kingdom ; Vaccine efficacy ; Vaccines ; Viral diseases ; Young Adult
Is Part Of: The Lancet (British edition), 2021-01, Vol.397 (10269), p.99-111
Description: 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. We evaluated the safety and efficacy of the ChAdOx1 nCoV-19 vaccine in a pooled interim analysis of four trials. This analysis includes data from four ongoing blinded, randomised, controlled trials done across the UK, Brazil, and South Africa. 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). Participants in the ChAdOx1 nCoV-19 group received two doses containing 5 × 1010 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). 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 were analysed according to treatment received, with data cutoff on Nov 4, 2020. Vaccine efficacy was calculated as 1 - relative risk derived from a robust Poisson regression model adjusted for age. Studies are registered at ISRCTN89951424 and ClinicalTrials.gov, NCT04324606, NCT04400838, and NCT04444674. Between 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. In participants who received two standard doses, vaccine efficacy was 62·1% (95% CI 41·0–75·7; 27 [0·6%] of 4440 in the ChAdOx1 nCoV-19 group vs71 [1·6%] of 4455 in the control group) and in participants who received a low dose followed by a standard dose, efficacy was 90·0% (67·4–97·0; three [0·2%] of 1367 vs 30 [2·2%] of 1374; pinteraction=0·010). Overall vaccine efficacy across both groups was 70·4% (95·8% CI 54·8–80·6; 30 [0·5%] of 5807 vs 101 [1·7%] of 5829). 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. There were 74 341 person-months of safety follow-up (median 3·4 months, IQR 1·3–4·8): 175 severe adverse events occurred in 168 participants, 84 events in the ChAdOx1 nCoV-19 group and 91 in the control group. 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. ChAdOx1 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. 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.
Publisher: England: Elsevier Ltd
Language: English
Identifier: ISSN: 0140-6736
EISSN: 1474-547X
DOI: 10.1016/S0140-6736(20)32661-1
PMID: 33306989
Source: ProQuest One Psychology
AUTh Library subscriptions: ProQuest Central
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Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK

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