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

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

doi:10.1016/S0140-6736(20)32661-1

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

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

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

Abstract / Description of output

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; p_interaction=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.

Original language	English
Pages (from-to)	99-111
Number of pages	13
Journal	The Lancet
Volume	397
Issue number	10269
Early online date	8 Dec 2020
DOIs	https://doi.org/10.1016/S0140-6736(20)32661-1
Publication status	Published - 9 Jan 2021

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Oxford COVID Vaccine Trial Group, Voysey, M., Clemens, S. A. C., Madhi, S. A., Weckx, L. Y., Folegatti, P. M., Aley, P. K., Angus, B., Baillie, V. L., Barnabas, S. L., Bhorat, Q. E., Bibi, S., Briner, C., Cicconi, P., Collins, A. M., Colin-Jones, R., Cutland, C. L., Darton, T. C., Dheda, K., ... Pollard, A. J. (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. https://doi.org/10.1016/S0140-6736(20)32661-1

@article{9169345061574ae7a725fde4b2114af3,

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",

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.",

author = "{Oxford COVID Vaccine Trial Group} and Merryn Voysey and Clemens, {Sue Ann Costa} and Madhi, {Shabir A.} and Weckx, {Lily Y.} and Folegatti, {Pedro M.} and Aley, {Parvinder K.} and Brian Angus and Baillie, {Vicky L.} and Barnabas, {Shaun L.} and Bhorat, {Qasim E.} and Sagida Bibi and Carmen Briner and Paola Cicconi and Collins, {Andrea M.} and Rachel Colin-Jones and Cutland, {Clare L.} and Darton, {Thomas C.} and Keertan Dheda and Duncan, {Christopher J.A.} and Emary, {Katherine R.W.} and Ewer, {Katie J.} and Lee Fairlie and Faust, {Saul N.} and Shuo Feng and Ferreira, {Daniela M.} and Adam Finn and Goodman, {Anna L.} and Green, {Catherine M.} and Green, {Christopher A.} and Heath, {Paul T.} and Catherine Hill and Helen Hill and Ian Hirsch and Hodgson, {Susanne H.C.} and Alane Izu and Susan Jackson and Daniel Jenkin and Joe, {Carina C.D.} and Simon Kerridge and Anthonet Koen and Gaurav Kwatra and Rajeka Lazarus and Lawrie, {Alison M.} and Alice Lelliott and Vincenzo Libri and Lillie, {Patrick J.} and Raburn Mallory and Mendes, {Ana V.A.} and Milan, {Eveline P.} and Minassian, {Angela M.} and Alastair McGregor and Hazel Morrison and Mujadidi, {Yama F.} and Anusha Nana and O'Reilly, {Peter J.} and Padayachee, {Sherman D.} and Ana Pittella and Emma Plested and Pollock, {Katrina M.} and Ramasamy, {Maheshi N.} and Sarah Rhead and Schwarzbold, {Alexandre V.} and Nisha Singh and Andrew Smith and Rinn Song and Snape, {Matthew D.} and Eduardo Sprinz and Sutherland, {Rebecca K.} and Richard Tarrant and Thomson, {Emma C.} and T{\"o}r{\"o}k, {M. Est{\'e}e} and Mark Toshner and Turner, {David P.J.} and Johan Vekemans and Villafana, {Tonya L.} and Watson, {Marion E.E.} and Williams, {Christopher J.} and Douglas, {Alexander D.} and Hill, {Adrian V.S.} and Teresa Lambe and Gilbert, {Sarah C.} and Pollard, {Andrew J.} and Marites Aban and Fatola Abayomi and Kushala Abeyskera and Jeremy Aboagye and Matthew Adam and Kirsty Adams and James Adamson and Adelaja, {Yemi A.} and Gbadebo Adewetan and Syed Adlou and Khatija Ahmed and Yasmeen Akhalwaya and Saajida Akhalwaya and Andrew Alcock and Aabidah Ali and Allen, {Elizabeth R.} and Lauren Allen and Almeida, {Thamires C.D.S.C.} and Alves, {Mariana P.S.} and Fabio Amorim and Foteini Andritsou and Rachel Anslow and Matthew Appleby and Arbe-Barnes, {Edward H.} and Ariaans, {Mark P.} and Beatriz Arns and Laiana Arruda and Paula Azi and Lorena Azi and Gavin Babbage and Catherine Bailey and Baker, {Kenneth F.} and Megan Baker and Natalie Baker and Philip Baker and Lisa Baldwin and Ioana Baleanu and Danieli Bandeira and Anna Bara and Barbosa, {Marcella A.S.} and Debbie Barker and Barlow, {Gavin D.} and Eleanor Barnes and Barr, {Andrew S.} and Barrett, {Jordan R.} and Jessica Barrett and Louise Bates and Alexander Batten and Kirsten Beadon and Emily Beales and Rebecca Beckley and Sandra Belij-Rammerstorfer and Jonathan Bell and Duncan Bellamy and Nancy Bellei and Sue Belton and Adam Berg and Laura Bermejo and Eleanor Berrie and Lisa Berry and Daniella Berzenyi and Amy Beveridge and Bewley, {Kevin R.} and Helen Bexhell and Sutika Bhikha and Bhorat, {Asad E.} and Bhorat, {Zaheda E.} and Else Bijker and Geeta Birch and Sarah Birch and Adam Bird and Olivia Bird and Karen Bisnauthsing and Mustapha Bittaye and Katherine Blackstone and Luke Blackwell and Heather Bletchly and Blundell, {Caitlin L.} and Blundell, {Susannah R.} and Pritesh Bodalia and Boettger, {Bruno C.} and Emma Bolam and Elena Boland and Daan Bormans and Nicola Borthwick and Francesca Bowring and Amy Boyd and Penny Bradley and Tanja Brenner and Phillip Brown and Claire Brown and Charlie Brown-O'Sullivan and Scott Bruce and Emily Brunt and Ruaridh Buchan and William Budd and Bulbulia, {Yusuf A.} and Melanie Bull and Jamie Burbage and Hassan Burhan and Aileen Burn and Buttigieg, {Karen R.} and Nicholas Byard and {Cabera Puig}, Ingrid and Gloria Calderon and Anna Calvert and Susana Camara and Michelangelo Cao and Federica Cappuccini and Cardoso, {Jo{\~a}o R.} and Melanie Carr and Carroll, {Miles W.} and Andrew Carson-Stevens and Carvalho, {Yasmin de M.} and Carvalho, {Jos{\'e} A.M.} and Casey, {Helen R.} and Paul Cashen and Thais Castro and Castro, {Lucia Carratala} and Katrina Cathie and Ana Cavey and Jos{\'e} Cerbino-Neto and Jim Chadwick and David Chapman and Sue Charlton and Irina Chelysheva and Oliver Chester and Sunder Chita and Cho, {Jee Sun} and Liliana Cifuentes and Elizabeth Clark and Matthew Clark and Andrea Clarke and Clutterbuck, {Elizabeth A.} and Collins, {Sarah L.K.} and Conlon, {Christopher P.} and Sean Connarty and Naomi Coombes and Cushla Cooper and Rachel Cooper and Lynne Cornelissen and Tumena Corrah and Catherine Cosgrove and Tony Cox and Crocker, {Wendy E.M.} and Sarah Crosbie and Lorraine Cullen and Dan Cullen and Cunha, {Debora R.M.F.} and Christina Cunningham and Cuthbertson, {Fiona C.} and {Da Guarda}, {Suzete N.Farias} and {da Silva}, {Larissa P.} and Damratoski, {Brad E.} and Zsofia Danos and Dantas, {Maria T.D.C.} and Paula Darroch and Datoo, {Mehreen S.} and Chandrabali Datta and Malika Davids and Davies, {Sarah L.} and Hannah Davies and Elizabeth Davis and Judith Davis and John Davis and {De Nobrega}, {Maristela M.D.} and {De Oliveira Kalid}, {Lis Moreno} and David Dearlove and Tesfaye Demissie and Amisha Desai and {Di Marco}, Stefania and {Di Maso}, Claudio and Dinelli, {Maria I.S.} and Tanya Dinesh and Claire Docksey and Christina Dold and Tao Dong and Donnellan, {Francesca R.} and {Dos Santos}, Tannyth and {dos Santos}, {Thain{\'a} G.} and {Dos Santos}, {Erika Pachecho} and Naomi Douglas and Charlotte Downing and Jonathan Drake and Rachael Drake-Brockman and Kimberley Driver and Ruth Drury and Dunachie, {Susanna J.} and Durham, {Benjamin S.} and Lidiana Dutra and Easom, {Nicholas J.W.} and {van Eck}, Samual and Mandy Edwards and Edwards, {Nick J.} and {El Muhanna}, {Omar M.} and Elias, {Sean C.} and Mike Elmore and Marcus English and Alisgair Esmail and Essack, {Yakub Moosa} and Eoghan Farmer and Mutjaba Farooq and Madi Farrar and Leonard Farrugia and Beverley Faulkner and Sofiya Fedosyuk and Sally Felle and {Ferreira Da Silva}, Carla and Samantha Field and Richard Fisher and Amy Flaxman and James Fletcher and Hazel Fofie and Henry Fok and Ford, {Karen J.} and Jamie Fowler and Fraiman, {Pedro H.A.} and Emma Francis and Franco, {Marilia M.} and John Frater and Freire, {Maril{\'u}cia S.M.} and Fry, {Samantha H.} and Sabrina Fudge and Julie Furze and Michelle Fuskova and Pablo Galian-Rubio and Eva Galiza and Harriet Garlant and Madita Gavrila and Ailsa Geddes and Gibbons, {Karyna A.} and Ciaran Gilbride and Hardeep Gill and Sharon Glynn and Kerry Godwin and Karishma Gokani and Goldoni, {Ursula Carvalho} and Maria Goncalves and Gonzalez, {Isabela G.S.} and Jayne Goodwin and Amina Goondiwala and Katherine Gordon-Quayle and Giacomo Gorini and Janet Grab and Lara Gracie and Melanie Greenland and Nicola Greenwood and Johann Greffrath and Groenewald, {Marisa M.} and Leonardo Grossi and Gaurav Gupta and Mark Hackett and Bassam Hallis and Mainga Hamaluba and Elizabeth Hamilton and Joseph Hamlyn and Daniel Hammersley and Hanrath, {Aidan T.} and Brama Hanumunthadu and Harris, {Stephanie A.} and Clair Harris and Tara Harris and Harrison, {Thomas D.} and Daisy Harrison and Hart, {Thomas C.} and Birgit Hartnell and Shadin Hassan and John Haughney and Sophia Hawkins and Jodie Hay and Ian Head and John Henry and {Hermosin Herrera}, Macarena and Hettle, {David B.} and Jennifer Hill and Gina Hodges and Elizea Horne and Hou, {Mimi M.} and Catherine Houlihan and Elizabeth Howe and Nicola Howell and Jonathan Humphreys and Humphries, {Holly E.} and Katrina Hurley and Claire Huson and Angela Hyder-Wright and Catherine Hyams and Sabina Ikram and Alka Ishwarbhai and Monica Ivan and Poppy Iveson and Vidyashankara Iyer and Frederic Jackson and {De Jager}, Jeanne and Shameem Jaumdally and Helen Jeffers and Natasha Jesudason and Bryony Jones and Kathryn Jones and Elizabeth Jones and Christopher Jones and Jorge, {Marianna Rocha} and Aylin Jose and Amar Joshi and J{\'u}nior, {Eduardo A.M.S.} and Joanne Kadziola and Reshma Kailath and Faeeza Kana and Konstantinos Karampatsas and Mwila Kasanyinga and Jade Keen and Kelly, {Elizabeth J.} and Kelly, {Dearbhla M.} and Debbie Kelly and Sarah Kelly and David Kerr and Kfouri, {Renato de {\'A}vila} and Liaquat Khan and Baktash Khozoee and Sarah Kidd and Annabel Killen and Jasmin Kinch and Patrick Kinch and King, {Lloyd D.W.} and King, {Thomas B.} and Lucy Kingham and Paul Klenerman and Francesca Knapper and Knight, {Julian C.} and Daniel Knott and Stanislava Koleva and Matilda Lang and Gail Lang and Larkworthy, {Colin W.} and Larwood, {Jessica P.J.} and Rebecca Law and Lazarus, {Erica M.} and Amanda Leach and Lees, {Emily A.} and Lemm, {Nana Marie} and Alvaro Lessa and Stephanie Leung and Yuanyuan Li and Lias, {Amelia M.} and Kostas Liatsikos and Aline Linder and Samuel Lipworth and Shuchang Liu and Xinxue Liu and Adam Lloyd and Stephanie Lloyd and Lisa Loew and {Lopez Ramon}, Raquel and Leandro Lora and Vicki Lowthorpe and Kleber Luz and MacDonald, {Jonathan C.} and Gordon MacGregor and Meera Madhavan and Mainwaring, {David O.} and Edson Makambwa and Rebecca Makinson and Mookho Malahleha and Ross Malamatsho and Garry Mallett and Kushal Mansatta and Takalani Maoko and Katlego Mapetla and Marchevsky, {Natalie G.} and Spyridoula Marinou and Emma Marlow and Marques, {Gabriela N.} and Paula Marriott and Marshall, {Richard P.} and Marshall, {Julia L.} and Martins, {Fl{\'a}via J.} and Masebole Masenya and Mduduzi Masilela and Masters, {Shauna K.} and Moncy Mathew and Hosea Matlebjane and Kedidimetse Matshidiso and Olga Mazur and Andrea Mazzella and Hugh McCaughan and Joanne McEwan and Joanna McGlashan and Lorna McInroy and Zoe McIntyre and Daniela McLenaghan and Nicky McRobert and Steve McSwiggan and Clare Megson and Savviz Mehdipour and Wilma Meijs and Mendon{\c c}a, {Renata N.{\'A}.} and Mentzer, {Alexander J.} and Neginsadat Mirtorabi and Celia Mitton and Sibusiso Mnyakeni and Fiona Moghaddas and Kgaogelo Molapo and Mapule Moloi and Maria Moore and Moraes-Pinto, {M. Isabel} and Marni Moran and Ella Morey and R{\'o}is{\'i}n Morgans and Susan Morris and Sheila Morris and Morris, {Helen C.} and Franca Morselli and Gertraud Morshead and Richard Morter and Lynelle Mottal and Andrew Moultrie and Nathifa Moya and Mushiya Mpelembue and Sibekezelo Msomi and Yvonne Mugodi and Ekta Mukhopadhyay and Jilly Muller and Alasdair Munro and Claire Munro and Sarah Murphy and Philomena Mweu and Myasaki, {Celia Hatsuko} and Gurudutt Naik and Kush Naker and Eleni Nastouli and Abida Nazir and Bongani Ndlovu and Fabio Neffa and Cecilia Njenga and Helena Noal and Andr{\'e}s No{\'e} and Gabrielle Novaes and Nugent, {Fay L.} and G{\'e}ssika Nunes and Katie O'Brien and Daniel O'Connor and Miranda Odam and Suzette Oelofse and Blanche Oguti and Victoria Olchawski and Oldfield, {Neil J.} and Oliveira, {Marianne G.} and Catarina Oliveira and Angela Oosthuizen and Paula O'Reilly and Piper Osborne and Owen, {David R.J.} and Lydia Owen and Daniel Owens and Nelly Owino and Mihaela Pacurar and Paiva, {Brenda V.B.} and Palhares, {Edna M.F.} and Susan Palmer and Sivapriyai Parkinson and Parracho, {Helena M.R.T.} and Karen Parsons and Dipak Patel and Bhumika Patel and Faeezah Patel and Kelly Patel and Maia Patrick-Smith and Payne, {Ruth O.} and Yanchun Peng and Penn, {Elizabeth J.} and Anna Pennington and {Peralta Alvarez}, {Marco Polo} and James Perring and Nicola Perry and Rubeshan Perumal and Sahir Petkar and Tricia Philip and Phillips, {Daniel J.} and Jennifer Phillips and Phohu, {Mary Kgomotso} and Lorinda Pickup and Sonja Pieterse and Jo Piper and Dimitra Pipini and Mary Plank and {Du Plessis}, Joan and Samuel Pollard and Jennifer Pooley and Anil Pooran and Ian Poulton and Claire Powers and Presa, {Fernando B.} and Price, {David A.} and Vivien Price and Marcelo Primeira and Proud, {Pamela C.} and Samuel Provstgaard-Morys and Sophie Pueschel and David Pulido and Sheena Quaid and Ria Rabara and Alexandra Radford and Kajal Radia and Durga Rajapaska and Thurkka Rajeswaran and Ramos, {Alberto San Francisco} and {Ramos Lopez}, Fernando and Tommy Rampling and Jade Rand and Helen Ratcliffe and Tom Rawlinson and David Rea and Byron Rees and Jes{\'u}s Rein{\'e} and Mila Resuello-Dauti and {Reyes Pabon}, Emilia and Ribiero, {Carla M.} and Marivic Ricamara and Alex Richter and Neil Ritchie and Ritchie, {Adam J.} and Robbins, {Alexander J.} and Hannah Roberts and Robinson, {Ryan E.} and Hannah Robinson and Rocchetti, {Talita T.} and Rocha, {Beatriz Pinho} and Sophie Roche and Christine Rollier and Louisa Rose and {Ross Russell}, {Amy L.} and Lindie Rossouw and Simon Royal and Indra Rudiansyah and Sarah Ruiz and Stephen Saich and Claudia Sala and Jessica Sale and Salman, {Ahmed M.} and Natalia Salvador and Stephannie Salvador and Milla Sampaio and Samson, {Annette D.} and Amada Sanchez-Gonzalez and Helen Sanders and Katherine Sanders and Erika Santos and {Santos Guerra}, {Mayara F.S.} and Iman Satti and Saunders, {Jack E.} and Caroline Saunders and Aakifah Sayed and {Schim van der Loeff}, Ina and Schmid, {Annina B.} and Ella Schofield and Gavin Screaton and Samiullah Seddiqi and Segireddy, {Rameswara R.} and Roberta Senger and Sonia Serrano and Rajiv Shah and Imam Shaik and Sharpe, {Hannah E.} and Katherine Sharrocks and Robert Shaw and Adam Shea and Amy Shepherd and Shepherd, {James G.} and Farah Shiham and Emad Sidhom and Silk, {Sarah E.} and {da Silva Moraes}, {Antonio Carlos} and Gilberto Silva-Junior and Laura Silva-Reyes and Silveira, {Anderson D.} and Silveira, {Mariana B.V.} and Jaisi Sinha and Skelly, {Donal T.} and Smith, {Daniel C.} and Nick Smith and Smith, {Holly E.} and Smith, {David J.} and Smith, {Catherine C.} and Airanu{\'e}dida Soares and Tiago Soares and Carla Sol{\'o}rzano and Sorio, {Guilherme L.} and Kim Sorley and Tiffany Sosa-Rodriguez and Souza, {Cinthia M.C.D.L.} and Souza, {Bruno S.D.F.} and Souza, {Alessandra R.} and Spencer, {Alexandra J.} and Fernanda Spina and Louise Spoors and Lizzie Stafford and Imogen Stamford and Igor Starinskij and Ricardo Stein and Jill Steven and Lisa Stockdale and Stockwell, {Lisa V.} and Strickland, {Louise H.} and Stuart, {Arabella C.} and Ann Sturdy and Natalina Sutton and Anna Szigeti and Abdessamad Tahiri-Alaoui and Rachel Tanner and Carol Taoushanis and Tarr, {Alexander W.} and Keja Taylor and Ursula Taylor and Taylor, {Iona Jennifer} and Justin Taylor and {te Water Naude}, Rebecca and Yrene Themistocleous and Andreas Themistocleous and Merin Thomas and Kelly Thomas and Thomas, {Tonia M.} and Asha Thombrayil and Fawziyah Thompson and Amber Thompson and Kevin Thompson and Ameeka Thompson and Julia Thomson and Viv Thornton-Jones and Tighe, {Patrick J.} and Tinoco, {Lygia Accioly} and Gerlynn Tiongson and Bonolo Tladinyane and Michele Tomasicchio and Adriana Tomic and Susan Tonks and James Towner and Nguyen Tran and Julia Tree and Gerry Trillana and Charlotte Trinham and Rose Trivett and Adam Truby and Tsheko, {Betty Lebogang} and Aadil Turabi and Richard Turner and Cheryl Turner and Marta Ulaszewska and Underwood, {Benjamin R.} and Rachel Varughese and Dennis Verbart and Marije Verheul and Iason Vichos and Taiane Vieira and Waddington, {Claire S.} and Laura Walker and Erica Wallis and Matthew Wand and Deborah Warbick and Theresa Wardell and George Warimwe and Warren, {Sarah C.} and Bridget Watkins and Ekaterina Watson and Stewart Webb and Alice Webb-Bridges and Angela Webster and Jessica Welch and Jeanette Wells and Alison West and Caroline White and Rachel White and Paul Williams and Williams, {Rachel L.} and Rebecca Winslow and Mark Woodyer and Worth, {Andrew T.} and Danny Wright and Marzena Wroblewska and Andy Yao and Rafael Zimmer and Dalila Zizi and Peter Zuidewind",

note = "Funding Information: This Article was funded by UK Research and Innovation, NIHR, Coalition for Epidemic Preparedness Innovations, the Bill & Melinda Gates Foundation, the Lemann Foundation, Rede D'Or, the Brava and Telles Foundation, NIHR Oxford Biomedical Research Centre, Thames Valley and South Midland's NIHR Clinical Research Network, and AstraZeneca. The authors dedicate this paper to the many healthcare workers who have lost their lives during the pandemic. This report is independent research funded by the UK National Institute for Health Research, UK Research and Innovation, the Bill & Melinda Gates Foundation, the Lemann Foundation, Rede D'OR, the Brava and Telles Foundation, and the South African Medical Research Council. We are grateful to the NIHR infrastructure provided through the NIHR Biomedical Research Centres and the NIHR Clinical Research Network at the UK study sites. The views expressed in this publication are those of the author(s) and not necessarily those of the National Institute for Health Research or the Department of Health and Social Care. PMF received funding from the Coordenacao de Aperfeicoamento de Pessoal de Nivel Superior, Brazil (finance code 001). The authors are grateful to the volunteers who participated in this study. The authors are grateful to the senior management at AstraZeneca for facilitating and funding the manufacture of the AZD1222 vaccine candidate and for financial support for expansion of the Oxford sponsored clinical trials in Brazil. AstraZeneca reviewed the data from the study and the final manuscript prior to submission, but the authors retained editorial control. Funding Information: This Article was funded by UK Research and Innovation, NIHR, Coalition for Epidemic Preparedness Innovations, the Bill & Melinda Gates Foundation, the Lemann Foundation, Rede D{\textquoteright}Or, the Brava and Telles Foundation, NIHR Oxford Biomedical Research Centre, Thames Valley and South Midland's NIHR Clinical Research Network, and AstraZeneca. The authors dedicate this paper to the many healthcare workers who have lost their lives during the pandemic. This report is independent research funded by the UK National Institute for Health Research, UK Research and Innovation, the Bill & Melinda Gates Foundation, the Lemann Foundation, Rede D{\textquoteright}OR, the Brava and Telles Foundation, and the South African Medical Research Council. We are grateful to the NIHR infrastructure provided through the NIHR Biomedical Research Centres and the NIHR Clinical Research Network at the UK study sites. The views expressed in this publication are those of the author(s) and not necessarily those of the National Institute for Health Research or the Department of Health and Social Care. PMF received funding from the Coordenacao de Aperfeicoamento de Pessoal de Nivel Superior, Brazil (finance code 001). The authors are grateful to the volunteers who participated in this study. The authors are grateful to the senior management at AstraZeneca for facilitating and funding the manufacture of the AZD1222 vaccine candidate and for financial support for expansion of the Oxford sponsored clinical trials in Brazil. AstraZeneca reviewed the data from the study and the final manuscript prior to submission, but the authors retained editorial control. Publisher Copyright: {\textcopyright} 2021 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license",

year = "2021",

month = jan,

day = "9",

doi = "10.1016/S0140-6736(20)32661-1",

language = "English",

volume = "397",

pages = "99--111",

journal = "The Lancet",

issn = "0140-6736",

publisher = "Elsevier",

number = "10269",

}

Oxford COVID Vaccine Trial Group, Voysey, M, Clemens, SAC, Madhi, SA, Weckx, LY, Folegatti, PM, Aley, PK, Angus, B, Baillie, VL, Barnabas, SL, Bhorat, QE, Bibi, S, Briner, C, Cicconi, P, Collins, AM, Colin-Jones, R, Cutland, CL, Darton, TC, Dheda, K, Duncan, CJA, Emary, KRW, Ewer, KJ, Fairlie, L, Faust, SN, Feng, S, Ferreira, DM, Finn, A, Goodman, AL, Green, CM, Green, CA, Heath, PT, Hill, C, Hill, H, Hirsch, I, Hodgson, SHC, Izu, A, Jackson, S, Jenkin, D, Joe, CCD, Kerridge, S, Koen, A, Kwatra, G, Lazarus, R, Lawrie, AM, Lelliott, A, Libri, V, Lillie, PJ, Mallory, R, Mendes, AVA, Milan, EP, Minassian, AM, McGregor, A, Morrison, H, Mujadidi, YF, Nana, A, O'Reilly, PJ, Padayachee, SD, Pittella, A, Plested, E, Pollock, KM, Ramasamy, MN, Rhead, S, Schwarzbold, AV, Singh, N, Smith, A, Song, R, Snape, MD, Sprinz, E, Sutherland, RK, Tarrant, R, Thomson, EC, Török, ME, Toshner, M, Turner, DPJ, Vekemans, J, Villafana, TL, Watson, MEE, Williams, CJ, Douglas, AD, Hill, AVS, Lambe, T, Gilbert, SC & Pollard, AJ 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, vol. 397, no. 10269, pp. 99-111. https://doi.org/10.1016/S0140-6736(20)32661-1

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. / Oxford COVID Vaccine Trial Group; Voysey, Merryn; Clemens, Sue Ann Costa et al.
In: The Lancet, Vol. 397, No. 10269, 09.01.2021, p. 99-111.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2

T2 - an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK

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AU - Weckx, Lily Y.

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AU - Sprinz, Eduardo

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AU - Alcock, Andrew

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AU - Mweu, Philomena

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AU - Naker, Kush

AU - Nastouli, Eleni

AU - Nazir, Abida

AU - Ndlovu, Bongani

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AU - Schofield, Ella

AU - Screaton, Gavin

AU - Seddiqi, Samiullah

AU - Segireddy, Rameswara R.

AU - Senger, Roberta

AU - Serrano, Sonia

AU - Shah, Rajiv

AU - Shaik, Imam

AU - Sharpe, Hannah E.

AU - Sharrocks, Katherine

AU - Shaw, Robert

AU - Shea, Adam

AU - Shepherd, Amy

AU - Shepherd, James G.

AU - Shiham, Farah

AU - Sidhom, Emad

AU - Silk, Sarah E.

AU - da Silva Moraes, Antonio Carlos

AU - Silva-Junior, Gilberto

AU - Silva-Reyes, Laura

AU - Silveira, Anderson D.

AU - Silveira, Mariana B.V.

AU - Sinha, Jaisi

AU - Skelly, Donal T.

AU - Smith, Daniel C.

AU - Smith, Nick

AU - Smith, Holly E.

AU - Smith, David J.

AU - Smith, Catherine C.

AU - Soares, Airanuédida

AU - Soares, Tiago

AU - Solórzano, Carla

AU - Sorio, Guilherme L.

AU - Sorley, Kim

AU - Sosa-Rodriguez, Tiffany

AU - Souza, Cinthia M.C.D.L.

AU - Souza, Bruno S.D.F.

AU - Souza, Alessandra R.

AU - Spencer, Alexandra J.

AU - Spina, Fernanda

AU - Spoors, Louise

AU - Stafford, Lizzie

AU - Stamford, Imogen

AU - Starinskij, Igor

AU - Stein, Ricardo

AU - Steven, Jill

AU - Stockdale, Lisa

AU - Stockwell, Lisa V.

AU - Strickland, Louise H.

AU - Stuart, Arabella C.

AU - Sturdy, Ann

AU - Sutton, Natalina

AU - Szigeti, Anna

AU - Tahiri-Alaoui, Abdessamad

AU - Tanner, Rachel

AU - Taoushanis, Carol

AU - Tarr, Alexander W.

AU - Taylor, Keja

AU - Taylor, Ursula

AU - Taylor, Iona Jennifer

AU - Taylor, Justin

AU - te Water Naude, Rebecca

AU - Themistocleous, Yrene

AU - Themistocleous, Andreas

AU - Thomas, Merin

AU - Thomas, Kelly

AU - Thomas, Tonia M.

AU - Thombrayil, Asha

AU - Thompson, Fawziyah

AU - Thompson, Amber

AU - Thompson, Kevin

AU - Thompson, Ameeka

AU - Thomson, Julia

AU - Thornton-Jones, Viv

AU - Tighe, Patrick J.

AU - Tinoco, Lygia Accioly

AU - Tiongson, Gerlynn

AU - Tladinyane, Bonolo

AU - Tomasicchio, Michele

AU - Tomic, Adriana

AU - Tonks, Susan

AU - Towner, James

AU - Tran, Nguyen

AU - Tree, Julia

AU - Trillana, Gerry

AU - Trinham, Charlotte

AU - Trivett, Rose

AU - Truby, Adam

AU - Tsheko, Betty Lebogang

AU - Turabi, Aadil

AU - Turner, Richard

AU - Turner, Cheryl

AU - Ulaszewska, Marta

AU - Underwood, Benjamin R.

AU - Varughese, Rachel

AU - Verbart, Dennis

AU - Verheul, Marije

AU - Vichos, Iason

AU - Vieira, Taiane

AU - Waddington, Claire S.

AU - Walker, Laura

AU - Wallis, Erica

AU - Wand, Matthew

AU - Warbick, Deborah

AU - Wardell, Theresa

AU - Warimwe, George

AU - Warren, Sarah C.

AU - Watkins, Bridget

AU - Watson, Ekaterina

AU - Webb, Stewart

AU - Webb-Bridges, Alice

AU - Webster, Angela

AU - Welch, Jessica

AU - Wells, Jeanette

AU - West, Alison

AU - White, Caroline

AU - White, Rachel

AU - Williams, Paul

AU - Williams, Rachel L.

AU - Winslow, Rebecca

AU - Woodyer, Mark

AU - Worth, Andrew T.

AU - Wright, Danny

AU - Wroblewska, Marzena

AU - Yao, Andy

AU - Zimmer, Rafael

AU - Zizi, Dalila

AU - Zuidewind, Peter

N1 - Funding Information: This Article was funded by UK Research and Innovation, NIHR, Coalition for Epidemic Preparedness Innovations, the Bill & Melinda Gates Foundation, the Lemann Foundation, Rede D'Or, the Brava and Telles Foundation, NIHR Oxford Biomedical Research Centre, Thames Valley and South Midland's NIHR Clinical Research Network, and AstraZeneca. The authors dedicate this paper to the many healthcare workers who have lost their lives during the pandemic. This report is independent research funded by the UK National Institute for Health Research, UK Research and Innovation, the Bill & Melinda Gates Foundation, the Lemann Foundation, Rede D'OR, the Brava and Telles Foundation, and the South African Medical Research Council. We are grateful to the NIHR infrastructure provided through the NIHR Biomedical Research Centres and the NIHR Clinical Research Network at the UK study sites. The views expressed in this publication are those of the author(s) and not necessarily those of the National Institute for Health Research or the Department of Health and Social Care. PMF received funding from the Coordenacao de Aperfeicoamento de Pessoal de Nivel Superior, Brazil (finance code 001). The authors are grateful to the volunteers who participated in this study. The authors are grateful to the senior management at AstraZeneca for facilitating and funding the manufacture of the AZD1222 vaccine candidate and for financial support for expansion of the Oxford sponsored clinical trials in Brazil. AstraZeneca reviewed the data from the study and the final manuscript prior to submission, but the authors retained editorial control. Funding Information: This Article was funded by UK Research and Innovation, NIHR, Coalition for Epidemic Preparedness Innovations, the Bill & Melinda Gates Foundation, the Lemann Foundation, Rede D’Or, the Brava and Telles Foundation, NIHR Oxford Biomedical Research Centre, Thames Valley and South Midland's NIHR Clinical Research Network, and AstraZeneca. The authors dedicate this paper to the many healthcare workers who have lost their lives during the pandemic. This report is independent research funded by the UK National Institute for Health Research, UK Research and Innovation, the Bill & Melinda Gates Foundation, the Lemann Foundation, Rede D’OR, the Brava and Telles Foundation, and the South African Medical Research Council. We are grateful to the NIHR infrastructure provided through the NIHR Biomedical Research Centres and the NIHR Clinical Research Network at the UK study sites. The views expressed in this publication are those of the author(s) and not necessarily those of the National Institute for Health Research or the Department of Health and Social Care. PMF received funding from the Coordenacao de Aperfeicoamento de Pessoal de Nivel Superior, Brazil (finance code 001). The authors are grateful to the volunteers who participated in this study. The authors are grateful to the senior management at AstraZeneca for facilitating and funding the manufacture of the AZD1222 vaccine candidate and for financial support for expansion of the Oxford sponsored clinical trials in Brazil. AstraZeneca reviewed the data from the study and the final manuscript prior to submission, but the authors retained editorial control. Publisher Copyright: © 2021 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license

PY - 2021/1/9

Y1 - 2021/1/9

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=85097463811&partnerID=8YFLogxK

U2 - 10.1016/S0140-6736(20)32661-1

DO - 10.1016/S0140-6736(20)32661-1

M3 - Article

C2 - 33306989

AN - SCOPUS:85097463811

SN - 0140-6736

VL - 397

SP - 99

EP - 111

JO - The Lancet

JF - The Lancet

IS - 10269

ER -

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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