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2.
Nat Med ; 27(2): 270-278, 2021 02.
Article in English | MEDLINE | ID: covidwho-1065916

ABSTRACT

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of Coronavirus Disease 2019 (COVID-19), has caused a global pandemic, and safe, effective vaccines are urgently needed1. Strong, Th1-skewed T cell responses can drive protective humoral and cell-mediated immune responses2 and might reduce the potential for disease enhancement3. Cytotoxic T cells clear virus-infected host cells and contribute to control of infection4. Studies of patients infected with SARS-CoV-2 have suggested a protective role for both humoral and cell-mediated immune responses in recovery from COVID-19 (refs. 5,6). ChAdOx1 nCoV-19 (AZD1222) is a candidate SARS-CoV-2 vaccine comprising a replication-deficient simian adenovirus expressing full-length SARS-CoV-2 spike protein. We recently reported preliminary safety and immunogenicity data from a phase 1/2 trial of the ChAdOx1 nCoV-19 vaccine (NCT04400838)7 given as either a one- or two-dose regimen. The vaccine was tolerated, with induction of neutralizing antibodies and antigen-specific T cells against the SARS-CoV-2 spike protein. Here we describe, in detail, exploratory analyses of the immune responses in adults, aged 18-55 years, up to 8 weeks after vaccination with a single dose of ChAdOx1 nCoV-19 in this trial, demonstrating an induction of a Th1-biased response characterized by interferon-γ and tumor necrosis factor-α cytokine secretion by CD4+ T cells and antibody production predominantly of IgG1 and IgG3 subclasses. CD8+ T cells, of monofunctional, polyfunctional and cytotoxic phenotypes, were also induced. Taken together, these results suggest a favorable immune profile induced by ChAdOx1 nCoV-19 vaccine, supporting the progression of this vaccine candidate to ongoing phase 2/3 trials to assess vaccine efficacy.


Subject(s)
Antibody Formation/immunology , COVID-19 Vaccines/immunology , T-Lymphocytes/immunology , Adolescent , CD4-Positive T-Lymphocytes/immunology , CD8-Positive T-Lymphocytes/immunology , COVID-19/immunology , COVID-19/virology , Dose-Response Relationship, Immunologic , Female , Humans , Immunity, Cellular , Immunity, Humoral , Immunoglobulin A/immunology , Immunoglobulin M/immunology , Interferon-gamma/metabolism , Lymphocyte Activation/immunology , Male , Middle Aged , Protein Subunits/immunology , SARS-CoV-2/immunology , Spike Glycoprotein, Coronavirus/immunology , Vaccination , Young Adult
3.
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, Plested, 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, M. 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.; Pollard, Andrew J.; Aban, Marites, Abayomi, Fatola, Abeyskera, Kushala, Aboagye, Jeremy, Adam, Matthew, Adams, Kirsty, Adamson, James, Adelaja, Yemi A.; Adlou, Syed, Ahmed, Khatija, Akhalwaya, Yasmeen, Akhalwaya, Saajida, Alcock, Andrew, Ali, Aabidah, Allen, Elizabeth R.; Allen, Lauren, Almeida, Thamires C. D. S. C.; Alves, Mariana P. S.; Amorim, Fabio, Andritsou, Foteini, Anslow, Rachel, Appleby, Matthew, Arbe-Barnes, Edward H.; Ariaans, Mark P.; Arns, Beatriz, Arruda, Laiana, Awedetan, Gbadebo, Azi, Paula, Azi, Lorena, Babbage, Gavin, Bailey, Catherine, Baker, Kenneth F.; Baker, Megan, Baker, Natalie, Baker, Philip, Baldwin, Lisa, Baleanu, Ioana, Bandeira, Danieli, Bara, Anna, Barbosa, Marcella A. S.; Barker, Debbie, Barlow, Gavin D.; Barnes, Eleanor, Barr, Andrew S.; Barrett, Jordan R.; Barrett, Jessica, Bates, Louise, Batten, Alexander, Beadon, Kirsten, Beales, Emily, Beckley, Rebecca, Belij-Rammerstorfer, Sandra, Bell, Jonathan, Bellamy, Duncan, Bellei, Nancy, Belton, Sue, Berg, Adam, Bermejo, Laura, Berrie, Eleanor, Berry, Lisa, Berzenyi, Daniella, Beveridge, Amy, Bewley, Kevin R.; Bexhell, Helen, Bhikha, Sutika, Bhorat, Asad E.; Bhorat, Zaheda E.; Bijker, Else, Birch, Geeta, Birch, Sarah, Bird, Adam, Bird, Olivia, Bisnauthsing, Karen, Bittaye, Mustapha, Blackstone, Katherine, Blackwell, Luke, Bletchly, Heather, Blundell, Caitlin L.; Blundell, Susannah R.; Bodalia, Pritesh, Boettger, Bruno C.; Bolam, Emma, Boland, Elena, Bormans, Daan, Borthwick, Nicola, Bowring, Francesca, Boyd, Amy, Bradley, Penny, Brenner, Tanja, Brown, Phillip, Brown, Claire, Brown-O'Sullivan, Charlie, Bruce, Scott, Brunt, Emily, Buchan, Ruaridh, Budd, William, Bulbulia, Yusuf A.; Bull, Melanie, Burbage, Jamie, Burhan, Hassan, Burn, Aileen, Buttigieg, Karen R.; Byard, Nicholas, Cabera Puig, Ingrid, Calderon, Gloria, Calvert, Anna, Camara, Susana, Cao, Michelangelo, Cappuccini, Federica, Cardoso, João R.; Carr, Melanie, Carroll, Miles W.; Carson-Stevens, Andrew, Carvalho, Yasmin de M.; Carvalho, José A. M.; Casey, Helen R.; Cashen, Paul, Castro, Thais, Castro, Lucia Carratala, Cathie, Katrina, Cavey, Ana, Cerbino-Neto, José, Chadwick, Jim, Chapman, David, Charlton, Sue, Chelysheva, Irina, Chester, Oliver, Chita, Sunder, Cho, Jee-Sun, Cifuentes, Liliana, Clark, Elizabeth, Clark, Matthew, Clarke, Andrea, Clutterbuck, Elizabeth A.; Collins, Sarah L. K.; Conlon, Christopher P.; Connarty, Sean, Coombes, Naomi, Cooper, Cushla, Cooper, Rachel, Cornelissen, Lynne, Corrah, Tumena, Cosgrove, Catherine, Cox, Tony, Crocker, Wendy E. M.; Crosbie, Sarah, Cullen, Lorraine, Cullen, Dan, Cunha, Debora R. M. F.; Cunningham, Christina, Cuthbertson, Fiona C.; Da Guarda, Suzete N. Farias, da Silva, Larissa P.; Damratoski, Brad E.; Danos, Zsofia, Dantas, Maria T. D. C.; Darroch, Paula, Datoo, Mehreen S.; Datta, Chandrabali, Davids, Malika, Davies, Sarah L.; Davies, Hannah, Davis, Elizabeth, Davis, Judith, Davis, John, De Nobrega, Maristela M. D.; De Oliveira Kalid, Lis Moreno, Dearlove, David, Demissie, Tesfaye, Desai, Amisha, Di Marco, Stefania, Di Maso, Claudio, Dinelli, Maria I. S.; Dinesh, Tanya, Docksey, Claire, Dold, Christina, Dong, Tao, Donnellan, Francesca R.; Dos Santos, Tannyth, dos Santos, Thainá G.; Dos Santos, Erika Pachecho, Douglas, Naomi, Downing, Charlotte, Drake, Jonathan, Drake-Brockman, Rachael, Driver, Kimberley, Drury, Ruth, Dunachie, Susanna J.; Durham, Benjamin S.; Dutra, Lidiana, Easom, Nicholas J. W.; van Eck, Samual, Edwards, Mandy, Edwards, Nick J.; El Muhanna, Omar M.; Elias, Sean C.; Elmore, Mike, English, Marcus, Esmail, Alisgair, Essack, Yakub Moosa, Farmer, Eoghan, Farooq, Mutjaba, Farrar, Madi, Farrugia, Leonard, Faulkner, Beverley, Fedosyuk, Sofiya, Felle, Sally, Feng, Shuo, Ferreira Da Silva, Carla, Field, Samantha, Fisher, Richard, Flaxman, Amy, Fletcher, James, Fofie, Hazel, Fok, Henry, Ford, Karen J.; Fowler, Jamie, Fraiman, Pedro H. A.; Francis, Emma, Franco, Marilia M.; Frater, John, Freire, Marilúcia S. M.; Fry, Samantha H.; Fudge, Sabrina, Furze, Julie, Fuskova, Michelle, Galian-Rubio, Pablo, Galiza, Eva, Garlant, Harriet, Gavrila, Madita, Geddes, Ailsa, Gibbons, Karyna A.; Gilbride, Ciaran, Gill, Hardeep, Glynn, Sharon, Godwin, Kerry, Gokani, Karishma, Goldoni, Ursula Carvalho, Goncalves, Maria, Gonzalez, Isabela G. S.; Goodwin, Jayne, Goondiwala, Amina, Gordon-Quayle, Katherine, Gorini, Giacomo, Grab, Janet, Gracie, Lara, Greenland, Melanie, Greenwood, Nicola, Greffrath, Johann, Groenewald, Marisa M.; Grossi, Leonardo, Gupta, Gaurav, Hackett, Mark, Hallis, Bassam, Hamaluba, Mainga, Hamilton, Elizabeth, Hammersley, Daniel, Hanrath, Aidan T.; Hanumunthadu, Brama, Harris, Stephanie A.; Harris, Clair, Harris, Tara, Harrison, Thomas D.; Harrison, Daisy, Hart, Thomas C.; Hartnell, Birgit, Hassan, Shadin, Haughney, John, Hawkins, Sophia, Hay, Jodie, Head, Ian, Henry, John, Hermosin Herrera, Macarena, Hettle, David B.; Hill, Jennifer, Hodges, Gina, Horne, Elizea, Hou, Mimi M.; Houlihan, Catherine, Howe, Elizabeth, Howell, Nicola, Humphreys, Jonathan, Humphries, Holly E.; Hurley, Katrina, Huson, Claire, Hyder-Wright, Angela, Hyamns, Catherine, Ikram, Sabina, Ishwarbhai, Alka, Ivan, Monica, Iveson, Poppy, Iyer, Vidyashankara, Jackson, Frederic, De Jager, Jeanne, Jaumdally, Shameem, Jeffers, Helen, Jesudason, Natasha, Jones, Bryony, Jones, Kathryn, Jones, Elizabeth, Jones, Christopher, Jorge, Marianna Rocha, Jose, Aylin, Joshi, Amar, Júnior, Eduardo A. M. S.; Kadziola, Joanne, Kailath, Reshma, Kana, Faeeza, Karampatsas, Konstantinos, Kasanyinga, Mwila, Keen, Jade, Kelly, Elizabeth J.; Kelly, Dearbhla M.; Kelly, Debbie, Kelly, Sarah, Kerr, David, Kfouri, Renato de Ávila, Khan, Liaquat, Khozoee, Baktash, Kidd, Sarah, Killen, Annabel, Kinch, Jasmin, Kinch, Patrick, King, Lloyd D. W.; King, Thomas B.; Kingham, Lucy, Klenerman, Paul, Knapper, Francesca, Knight, Julian C.; Knott, Daniel, Koleva, Stanislava, Lang, Matilda, Lang, Gail, Larkworthy, Colin W.; Larwood, Jessica P. J.; Law, Rebecca, Lazarus, Erica M.; Leach, Amanda, Lees, Emily A.; Lemm, Nana-Marie, Lessa, Alvaro, Leung, Stephanie, Li, Yuanyuan, Lias, Amelia M.; Liatsikos, Kostas, Linder, Aline, Lipworth, Samuel, Liu, Shuchang, Liu, Xinxue, Lloyd, Adam, Lloyd, Stephanie, Loew, Lisa, Lopez Ramon, Raquel, Lora, Leandro, Lowthorpe, Vicki, Luz, Kleber, MacDonald, Jonathan C.; MacGregor, Gordon, Madhavan, Meera, Mainwaring, David O.; Makambwa, Edson, Makinson, Rebecca, Malahleha, Mookho, Malamatsho, Ross, Mallett, Garry, Mansatta, Kushal, Maoko, Takalani, Mapetla, Katlego, Marchevsky, Natalie G.; Marinou, Spyridoula, Marlow, Emma, Marques, Gabriela N.; Marriott, Paula, Marshall, Richard P.; Marshall, Julia L.; Martins, Flávia J.; Masenya, Masebole, Masilela, Mduduzi, Masters, Shauna K.; Mathew, Moncy, Matlebjane, Hosea, Matshidiso, Kedidimetse, Mazur, Olga, Mazzella, Andrea, McCaughan, Hugh, McEwan, Joanne, McGlashan, Joanna, McInroy, Lorna, McIntyre, Zoe, McLenaghan, Daniela, McRobert, Nicky, McSwiggan, Steve, Megson, Clare, Mehdipour, Savviz, Meijs, Wilma, Mendonça, Renata N. Á, Mentzer, Alexander J.; Mirtorabi, Neginsadat, Mitton, Celia, Mnyakeni, Sibusiso, Moghaddas, Fiona, Molapo, Kgaogelo, Moloi, Mapule, Moore, Maria, Moraes-Pinto, M. Isabel, Moran, Marni, Morey, Ella, Morgans, Róisín, Morris, Susan, Morris, Sheila, Morris, Helen C.; Morselli, Franca, Morshead, Gertraud, Morter, Richard, Mottal, Lynelle, Moultrie, Andrew, Moya, Nathifa, Mpelembue, Mushiya, Msomi, Sibekezelo, Mugodi, Yvonne, Mukhopadhyay, Ekta, Muller, Jilly, Munro, Alasdair, Munro, Claire, Murphy, Sarah, Mweu, Philomena, Myasaki, Celia Hatsuko, Naik, Gurudutt, Naker, Kush, Nastouli, Eleni, Nazir, Abida, Ndlovu, Bongani, Neffa, Fabio, Njenga, Cecilia, Noal, Helena, Noé, Andrés, Novaes, Gabrielle, Nugent, Fay L.; Nunes, Géssika, O'Brien, Katie, O'Connor, Daniel, Odam, Miranda, Oelofse, Suzette, Oguti, Blanche, Olchawski, Victoria, Oldfield, Neil J.; Oliveira, Marianne G.; Oliveira, Catarina, Oosthuizen, Angela, O'Reilly, Paula, Osborne, Piper, Owen, David R. J.; Owen, Lydia, Owens, Daniel, Owino, Nelly, Pacurar, Mihaela, Paiva, Brenda V. B.; Palhares, Edna M. F.; Palmer, Susan, Parkinson, Sivapriyai, Parracho, Helena M. R. T.; Parsons, Karen, Patel, Dipak, Patel, Bhumika, Patel, Faeezah, Patel, Kelly, Patrick-Smith, Maia, Payne, Ruth O.; Peng, Yanchun, Penn, Elizabeth J.; Pennington, Anna, Peralta Alvarez, Marco Polo, Perring, James, Perry, Nicola, Perumal, Rubeshan, Petkar, Sahir, Philip, Tricia, Phillips, Daniel J.; Phillips, Jennifer, Phohu, Mary Kgomotso, Pickup, Lorinda, Pieterse, Sonja, Piper, Jo, Pipini, Dimitra, Plank, Mary, Du Plessis, Joan, Pollard, Samuel, Pooley, Jennifer, Pooran, Anil, Poulton, Ian, Powers, Claire, Presa, Fernando B.; Price, David A.; Price, Vivien, Primeira, Marcelo, Proud, Pamela C.; Provstgaard-Morys, Samuel, Pueschel, Sophie, Pulido, David, Quaid, Sheena, Rabara, Ria, Radford, Alexandra, Radia, Kajal, Rajapaska, Durga, Rajeswaran, Thurkka, Ramos, Alberto San Francisco, Ramos Lopez, Fernando, Rampling, Tommy, Rand, Jade, Ratcliffe, Helen, Rawlinson, Tom, Rea, David, Rees, Byron, Reiné, Jesús, Resuello-Dauti, Mila, Reyes Pabon, Emilia, Ribiero, Carla M.; Ricamara, Marivic, Richter, Alex, Ritchie, Neil, Ritchie, Adam J.; Robbins, Alexander J.; Roberts, Hannah, Robinson, Ryan E.; Robinson, Hannah, Rocchetti, Talita T.; Rocha, Beatriz Pinho, Roche, Sophie, Rollier, Christine, Rose, Louisa, Ross Russell, Amy L.; Rossouw, Lindie, Royal, Simon, Rudiansyah, Indra, Ruiz, Sarah, Saich, Stephen, Sala, Claudia, Sale, Jessica, Salman, Ahmed M.; Salvador, Natalia, Salvador, Stephannie, Sampaio, Milla, Samson, Annette D.; Sanchez-Gonzalez, Amada, Sanders, Helen, Sanders, Katherine, Santos, Erika, Santos Guerra, Mayara F. S.; Satti, Iman, Saunders, Jack E.; Saunders, Caroline, Sayed, Aakifah, Schim van der Loeff, Ina, Schmid, Annina B.; Schofield, Ella, Screaton, Gavin, Seddiqi, Samiullah, Segireddy, Rameswara R.; Senger, Roberta, Serrano, Sonia, Shah, Rajiv, Shaik, Imam, Sharpe, Hannah E.; Sharrocks, Katherine, Shaw, Robert, Shea, Adam, Shepherd, Amy, Shepherd, James G.; Shiham, Farah, Sidhom, Emad, Silk, Sarah E.; da Silva Moraes, Antonio Carlos, Silva-Junior, Gilberto, Silva-Reyes, Laura, Silveira, Anderson D.; Silveira, Mariana B. V.; Sinha, Jaisi, Skelly, Donal T.; Smith, Daniel C.; Smith, Nick, Smith, Holly E.; Smith, David J.; Smith, Catherine C.; Soares, Airanuédida, Soares, Tiago, Solórzano, Carla, Sorio, Guilherme L.; Sorley, Kim, Sosa-Rodriguez, Tiffany, Souza, Cinthia M. C. D. L.; Souza, Bruno S. D. F.; Souza, Alessandra R.; Spencer, Alexandra J.; Spina, Fernanda, Spoors, Louise, Stafford, Lizzie, Stamford, Imogen, Starinskij, Igor, Stein, Ricardo, Steven, Jill, Stockdale, Lisa, Stockwell, Lisa V.; Strickland, Louise H.; Stuart, Arabella C.; Sturdy, Ann, Sutton, Natalina, Szigeti, Anna, Tahiri-Alaoui, Abdessamad, Tanner, Rachel, Taoushanis, Carol, Tarr, Alexander W.; Taylor, Keja, Taylor, Ursula, Taylor, Iona Jennifer, Taylor, Justin, te Water Naude, Rebecca, Themistocleous, Yrene, Themistocleous, Andreas, Thomas, Merin, Thomas, Kelly, Thomas, Tonia M.; Thombrayil, Asha, Thompson, Fawziyah, Thompson, Amber, Thompson, Kevin, Thompson, Ameeka, Thomson, Julia, Thornton-Jones, Viv, Tighe, Patrick J.; Tinoco, Lygia Accioly, Tiongson, Gerlynn, Tladinyane, Bonolo, Tomasicchio, Michele, Tomic, Adriana, Tonks, Susan, Tran, Nguyen, Tree, Julia, Trillana, Gerry, Trinham, Charlotte, Trivett, Rose, Truby, Adam, Tsheko, Betty Lebogang, Turabi, Aadil, Turner, Richard, Turner, Cheryl, Ulaszewska, Marta, Underwood, Benjamin R.; Varughese, Rachel, Verbart, Dennis, Verheul, Marije, Vichos, Iason, Vieira, Taiane, Waddington, Claire S.; Walker, Laura, Wallis, Erica, Wand, Matthew, Warbick, Deborah, Wardell, Theresa, Warimwe, George, Warren, Sarah C.; Watkins, Bridget, Watson, Ekaterina, Webb, Stewart, Webb-Bridges, Alice, Webster, Angela, Welch, Jessica, Wells, Jeanette, West, Alison, White, Caroline, White, Rachel, Williams, Paul, Williams, Rachel L.; Winslow, Rebecca, Woodyer, Mark, Worth, Andrew T.; Wright, Danny, Wroblewska, Marzena, Yao, Andy, Zimmer, Rafael, Zizi, Dalila, Zuidewind, Peter.
The Lancet ; 2020.
Article in English | Web of Science | ID: covidwho-969870

ABSTRACT

Summary 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

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