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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

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
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

Background: 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.

Methods: 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.

Findings: 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.

Interpretation: 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.

Funding: 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.

Adolescent, Adult, Aged, Brazil, COVID-19/prevention & control, COVID-19 Vaccines/adverse effects, Double-Blind Method, Female, Humans, Male, Middle Aged, Single-Blind Method, South Africa, Treatment Outcome, United Kingdom, Young Adult
0140-6736
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Voysey, Merryn, Clemens, Sue Ann Costa, Madhi, Shabir A., Weckx, Lily Y., Folegatti, Pedro M., Aley, Parvinder K., Angus, Brian, Baillie, Vicky L., Barnabas, Shaun L., Bhorat, Qasim E., Bibi, Sagida, Briner, Carmen, Cicconi, Paola, Collins, Andrea M., Colin-Jones, Rachel, Cutland, Clare L., Darton, Thomas C., Dheda, Keertan, Duncan, Christopher J.A., Emary, Katherine R.W., Ewer, Katie J., Fairlie, Lee, Faust, Saul N., Feng, Shuo, Ferreira, Daniela M., Finn, Adam, Goodman, Anna L., Green, Catherine M., Green, Christopher A., Heath, Paul T., Hill, Catherine, Hill, Helen, Hirsch, Ian, Hodgson, Susanne H.C., Izu, Alane, Jackson, Susan, Jenkin, Daniel, Joe, Carina C.D., Kerridge, Simon, Koen, Anthonet, Kwatra, Gaurav, Lazarus, Rajeka, Lawrie, Alison M., Lelliott, Alice, Libri, Vincenzo, Lillie, Patrick J., Mallory, Raburn, Mendes, Ana V.A., Milan, Eveline P., Minassian, Angela M., McGregor, Alastair, Morrison, Hazel, Mujadidi, Yama F., Nana, Anusha, O’Reilly, Peter J., Padayachee, Sherman D., Pittella, Ana, Plesteda, Emma, Pollock, Katrina M., Ramasamy, Maheshi N., Rhead, Sarah, Schwarzbold, Alexandre V., Singh, Nisha, Smith, Andrew, Song, Rinn, Snape, Matthew D., Sprinz, Eduardo, Sutherland, Rebecca K., Tarrant, Richard, Thomson, Emma C., Török, Estée, Toshner, Mark, Turner, David P.J., Vekemans, Johan, Villafana, Tonya L., Watson, Marion E.E., Williams, Christopher J., Douglas, Alexander D., Hill, Adrian V.S., Lambe, Teresa, Gilbert, Sarah C. and Pollard, Andrew J. , Oxford COVID Vaccine Trial Group (2021) 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, 397 (10269), 99-111. (doi:10.1016/S0140-6736(20)32661-1).

Record type: Article

Abstract

Background: 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.

Methods: 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.

Findings: 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.

Interpretation: 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.

Funding: 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.

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Accepted/In Press date: 1 January 2020
e-pub ahead of print date: 8 December 2020
Published date: 9 January 2021
Keywords: Adolescent, Adult, Aged, Brazil, COVID-19/prevention & control, COVID-19 Vaccines/adverse effects, Double-Blind Method, Female, Humans, Male, Middle Aged, Single-Blind Method, South Africa, Treatment Outcome, United Kingdom, Young Adult

Identifiers

Local EPrints ID: 446188
URI: http://eprints.soton.ac.uk/id/eprint/446188
ISSN: 0140-6736
PURE UUID: 0f6c3d7c-d31a-4970-8fd2-ff0d6f4c73af
ORCID for Saul N. Faust: ORCID iD orcid.org/0000-0003-3410-7642

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Date deposited: 27 Jan 2021 17:30
Last modified: 26 Nov 2021 02:50

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Contributors

Author: Merryn Voysey
Author: Sue Ann Costa Clemens
Author: Shabir A. Madhi
Author: Lily Y. Weckx
Author: Pedro M. Folegatti
Author: Parvinder K. Aley
Author: Brian Angus
Author: Vicky L. Baillie
Author: Shaun L. Barnabas
Author: Qasim E. Bhorat
Author: Sagida Bibi
Author: Carmen Briner
Author: Paola Cicconi
Author: Andrea M. Collins
Author: Rachel Colin-Jones
Author: Clare L. Cutland
Author: Thomas C. Darton
Author: Keertan Dheda
Author: Christopher J.A. Duncan
Author: Katherine R.W. Emary
Author: Katie J. Ewer
Author: Lee Fairlie
Author: Saul N. Faust ORCID iD
Author: Shuo Feng
Author: Daniela M. Ferreira
Author: Adam Finn
Author: Anna L. Goodman
Author: Catherine M. Green
Author: Christopher A. Green
Author: Paul T. Heath
Author: Catherine Hill
Author: Helen Hill
Author: Ian Hirsch
Author: Susanne H.C. Hodgson
Author: Alane Izu
Author: Susan Jackson
Author: Daniel Jenkin
Author: Carina C.D. Joe
Author: Simon Kerridge
Author: Anthonet Koen
Author: Gaurav Kwatra
Author: Rajeka Lazarus
Author: Alison M. Lawrie
Author: Alice Lelliott
Author: Vincenzo Libri
Author: Patrick J. Lillie
Author: Raburn Mallory
Author: Ana V.A. Mendes
Author: Eveline P. Milan
Author: Angela M. Minassian
Author: Alastair McGregor
Author: Hazel Morrison
Author: Yama F. Mujadidi
Author: Anusha Nana
Author: Peter J. O’Reilly
Author: Sherman D. Padayachee
Author: Ana Pittella
Author: Emma Plesteda
Author: Katrina M. Pollock
Author: Maheshi N. Ramasamy
Author: Sarah Rhead
Author: Alexandre V. Schwarzbold
Author: Nisha Singh
Author: Andrew Smith
Author: Rinn Song
Author: Matthew D. Snape
Author: Eduardo Sprinz
Author: Rebecca K. Sutherland
Author: Richard Tarrant
Author: Emma C. Thomson
Author: Estée Török
Author: Mark Toshner
Author: David P.J. Turner
Author: Johan Vekemans
Author: Tonya L. Villafana
Author: Marion E.E. Watson
Author: Christopher J. Williams
Author: Alexander D. Douglas
Author: Adrian V.S. Hill
Author: Teresa Lambe
Author: Sarah C. Gilbert
Author: Andrew J. Pollard
Corporate Author: Oxford COVID Vaccine Trial Group

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