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6. Vaccine effectiveness against hospitalisation estimated using a test-negative case-control study design, and comparative odds of hospital admission and severe outcomes with COVID-19 sub-lineages BQ.1, CH.1.1. and XBB.1.5 in England

Author

Kirsebom, Freja Cordelia Møller, Harman, Katie, Lunt, Rachel Jayne, Andrews, Nick, Groves, Natalie, Abdul Aziz, Nurin, Hope, Russell, Stowe, Julia, Chand, Meera, Ramsay, Mary, Dabrera, Gavin, Kall, Meaghan, and Bernal, Jamie Lopez

Published
2023
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12. COVID‐19 Vaccine Safety in Pregnancy, A Nested Case–Control Study in Births From April 2021 to March 2022, England.

Author

Mensah, Anna A., Stowe, Julia, Jardine, Jennifer E., Kirsebom, Freja C. M., Clare, Tom, Kall, Meaghan, Campbell, Helen, Lopez‐Bernal, Jamie, and Andrews, Nick

Subjects
*PREGNANT women, *PREGNANCY outcomes, *MEDICAL personnel, *VACCINE safety, *MATERNAL mortality
Abstract

Objective: Assessment of COVID‐19 vaccine safety in pregnancy using population‐based data. Design: Matched case–control study nested in a retrospective cohort. Setting: April 2021–March 2022, England. Population or Sample: All pregnant individuals aged between 18 and 50 years with valid health records. Methods: Individuals identified from the national Maternity Services Data Set (MSDS) had their records linked to hospital admission, national COVID‐19 vaccine and COVID‐19 testing databases. Matching included participant's age and estimated week of conception. We compared outcomes across multiple COVID‐19 vaccine exposures using conditional multivariable logistic regression, adjusting for demographic and health characteristics. Main Outcome Measures: Adverse pregnancy, maternal and neonatal outcomes. Results: 514 013 individuals were included. We found lower odds of giving birth to a baby who was low birthweight (aOR = 0.86, 95% CI: 0.79–0.93), preterm (aOR = 0.89, 95% CI: 0.85–0.92) or who had an Apgar score < 7 at 5 min of age (aOR = 0.89, 95% CI: 0.80–0.98) for individuals who received at least one dose of COVID‐19 vaccine during pregnancy. The odds of admission to intensive care unit during pregnancy were lower in those vaccinated (aOR = 0.85, 95% CI: 0.76–0.95). There was no association between vaccination in pregnancy and stillbirth, neonatal death, perinatal death and maternal venous thromboembolism in pregnancy. Conclusions: COVID‐19 vaccines are safe to use in pregnancy. Our findings generated important information to communicate to pregnant individuals and health professionals to support COVID‐19 maternal vaccination programmes. [ABSTRACT FROM AUTHOR]

Published
2024
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17. Author Correction: Serological responses and vaccine effectiveness for extended COVID-19 vaccine schedules in England

Author

Amirthalingam, Gayatri, Bernal, Jamie Lopez, Andrews, Nick J., Whitaker, Heather, Gower, Charlotte, Stowe, Julia, Tessier, Elise, Subbarao, Sathyavani, Ireland, Georgina, Baawuah, Frances, Linley, Ezra, Warrener, Lenesha, O’Brien, Michelle, Whillock, Corinne, Moss, Paul, Ladhani, Shamez N., Brown, Kevin E., and Ramsay, Mary E.

Published
2022
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19. Risk of myocarditis and pericarditis after a COVID-19 mRNA vaccine booster and after COVID-19 in those with and without prior SARS-CoV-2 infection: A self-controlled case series analysis in England

Author

Stowe, Julia, Miller, Elizabeth, Andrews, Nick, and Whitaker, Heather J.

Subjects
Myocarditis -- Risk factors -- Prevention, Pericarditis -- Risk factors -- Prevention, Biological sciences
Abstract

Background An increased risk of myocarditis or pericarditis after priming with mRNA Coronavirus Disease 2019 (COVID-19) vaccines has been shown but information on the risk post-booster is limited. With the now high prevalence of prior Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection, we assessed the effect of prior infection on the vaccine risk and the risk from COVID-19 reinfection. Methods and findings We conducted a self-controlled case series analysis of hospital admissions for myocarditis or pericarditis in England between 22 February 2021 and 6 February 2022 in the 50 million individuals eligible to receive the adenovirus-vectored vaccine (ChAdOx1-S) for priming or an mRNA vaccine (BNT162b2 or mRNA-1273) for priming or boosting. Myocarditis and pericarditis admissions were extracted from the Secondary Uses Service (SUS) database in England and vaccination histories from the National Immunisation Management System (NIMS); prior infections were obtained from the UK Health Security Agency's Second-Generation Surveillance Systems. The relative incidence (RI) of admission within 0 to 6 and 7 to 14 days of vaccination compared with periods outside these risk windows stratified by age, dose, and prior SARS-CoV-2 infection for individuals aged 12 to 101 years was estimated. The RI within 27 days of an infection was assessed in the same model. There were 2,284 admissions for myocarditis and 1,651 for pericarditis in the study period. Elevated RIs were only observed in 16- to 39-year-olds 0 to 6 days postvaccination, mainly in males for myocarditis. Both mRNA vaccines showed elevated RIs after first, second, and third doses with the highest RIs after a second dose 5.34 (95% confidence interval (CI) [3.81, 7.48]; p < 0.001) for BNT162b2 and 56.48 (95% CI [33.95, 93.97]; p < 0.001) for mRNA-1273 compared with 4.38 (95% CI [2.59, 7.38]; p < 0.001) and 7.88 (95% CI [4.02, 15.44]; p < 0.001), respectively, after a third dose. For ChAdOx1-S, an elevated RI was only observed after a first dose, RI 5.23 (95% CI [2.48, 11.01]; p < 0.001). An elevated risk of admission for pericarditis was only observed 0 to 6 days after a second dose of mRNA-1273 vaccine in 16 to 39 year olds, RI 4.84 (95% CI [1.62, 14.01]; p = 0.004). RIs were lower in those with a prior SARS-CoV-2 infection than in those without, 2.47 (95% CI [1.32,4.63]; p = 0.005) versus 4.45 (95% [3.12, 6.34]; p = 0.001) after a second BNT162b2 dose, and 19.07 (95% CI [8.62, 42.19]; p < 0.001) versus 37.2 (95% CI [22.18, 62.38]; p < 0.001) for mRNA-1273 (myocarditis and pericarditis outcomes combined). RIs 1 to 27 days postinfection were elevated in all ages and were marginally lower for breakthrough infections, 2.33 (95% CI [1.96, 2.76]; p < 0.001) compared with 3.32 (95% CI [2.54, 4.33]; p < 0.001) in vaccine-naïve individuals respectively. Conclusions We observed an increased risk of myocarditis within the first week after priming and booster doses of mRNA vaccines, predominantly in males under 40 years with the highest risks after a second dose. The risk difference between the second and the third doses was particularly marked for the mRNA-1273 vaccine that contains half the amount of mRNA when used for boosting than priming. The lower risk in those with prior SARS-CoV-2 infection, and lack of an enhanced effect post-booster, does not suggest a spike-directed immune mechanism. Research to understand the mechanism of vaccine-associated myocarditis and to document the risk with bivalent mRNA vaccines is warranted., Author(s): Julia Stowe 1, Elizabeth Miller 2,*, Nick Andrews 1, Heather J. Whitaker 1 Introduction The rapid development and global deployment of Coronavirus Disease 2019 (COVID-19) vaccines based on mRNA [...]

Published
2023
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20. COVID-19 vaccine coverage in health-care workers in England and effectiveness of BNT162b2 mRNA vaccine against infection (SIREN): a prospective, multicentre, cohort study

Author

Andrews, N, Atti, A, Aziz, H, Brooks, T, Brown, CS, Camero, D, Carr, C, Chand, MA, Charlett, A, Crawford, H, Cole, M, Conneely, J, D'Arcangelo, S, Ellis, J, Evans, S, Foulkes, S, Gillson, N, Gopal, R, Hall, L, Hall, VJ, Harrington, P, Hopkins, S, Hewson, J, Hoschler, K, Ironmonger, D, Islam, J, Kall, M, Karagiannis, I, Kay, O, Khawam, J, King, E, Kirwan, P, Kyffin, R, Lackenby, A, Lattimore, M, Linley, E, Lopez-Bernal, J, Mabey, L, McGregor, R, Miah, S, Monk, EJM, Munro, K, Naheed, Z, Nissr, A, O'Connell, AM, Oguti, B, Okafor, H, Organ, S, Osbourne, J, Otter, A, Patel, M, Platt, S, Pople, D, Potts, K, Ramsay, M, Robotham, J, Rokadiya, S, Rowe, C, Saei, A, Sebbage, G, Semper, A, Shrotri, M, Simmons, R, Soriano, A, Staves, P, Taylor, S, Taylor, A, Tengbe, A, Tonge, S, Vusirikala, A, Wallace, S, Wellington, E, Zambon, M, Corrigan, D, Sartaj, M, Cromey, L, Campbell, S, Braithwaite, K, Price, L, Haahr, L, Stewart, S, Lacey, ED, Partridge, L, Stevens, G, Ellis, Y, Hodgson, H, Norman, C, Larru, B, Mcwilliam, S, Roynon, A, Northfield, J, Winchester, S, Cieciwa, P, Pai, A, Bakker, P, Loughrey, C, Watt, A, Adair, F, Hawkins, A, Grant, A, Temple-Purcell, R, Howard, J, Slawson, N, Subudhi, C, Davies, S, Bexley, A, Penn, R, Wong, N, Boyd, G, Rajgopal, A, Arenas-Pinto, A, Matthews, R, Whileman, A, Laugharne, R, Ledger, J, Barnes, T, Jones, C, Osuji, N, Chitalia, N, Bailey, T, Akhtar, S, Harrison, G, Horne, S, Walker, N, Agwuh, K, Maxwell, V, Graves, J, Williams, S, O'Kelly, A, Ridley, P, Cowley, A, Johnstone, H, Swift, P, Democratis, J, Meda, M, Brake, S, Gunn, J, Selassi, A, Hams, S, Irvine, V, Chandrasekaran, B, Forsyth, C, Radmore, J, Thomas, C, Brown, K, Roberts, S, Burns, P, Gajee, K, Lewis, T, Byrne, TM, Sanderson, F, Knight, S, Macnaughton, E, Burton, BJL, Smith, H, Chaudhuri, R, Aeron-Thomas, J, Hollinshead, K, Shorten, RJ, Swan, A, Favager, C, Murira, J, Baillon, S, Hamer, S, Shah, A, Russell, J, Brennan, D, Dave, A, Chawla, A, Westwell, F, Adeboyeku, D, Papineni, P, Pegg, C, Williams, M, Ahmad, S, Horsley, A, Gabriel, C, Pagget, K, Maloney, G, Ashcroft, J, Del Rosario, I, Crosby-Nwaobi, R, Flanagan, D, Dhasmana, D, Fowler, S, Cameron, E, Prentice, L, Sinclair, C, Bateman, V, McLelland-Brooks, K, Ho, A, Murphy, M, Cochrane, A, Gibson, A, Black, K, Tempeton, K, Donaldson, S, Coke, L, Elumogo, N, Elliott, J, Padgett, D, Cross, A, Mirfenderesky, M, Joyce, S, Sinanovic, I, Howard, M, Cowling, P, Brazil, M, Hanna, E, Abdelrazik, A, Brand, S, Sheridan, EA, Wadams, B, Lloyd, A, Mouland, J, Giles, J, Pottinger, G, Coles, H, Joseph, M, Lee, M, Orr, S, Chenoweth, H, Browne, D, Auckland, C, Lear, R, Mahungu, T, Rodger, A, Warren, S, Brooking, D, Pai, S, Druyeh, R, Smith, E, Stone, S, Meisner, S, Delgado, D, Underhill, E, Keen, L, Aga, M, Domingos, P, Gormley, S, Kerrison, C, Birch, S, DeSilva, T, Allsop, L, Ambalkar, S, Beekes, M, Jose, S, Tomlinson, J, Painter, Sharen, Price, C, Pepperell, J, James, K, Trinick, T, Moore, L, Day, J, Boulos, A, Knox, I, Defever, E, McCracken, D, Gray, K, Houston, A, Planche, T, Pritchard Jones, R, Wycherley, Diane, Bennett, S, Marrs, J, Nimako, K, Stewart, B, Bain, SC, Kalakonda, N, Khanduri, S, Ashby, A, Holden, M, Mahabir, N, Harwood, J, Payne, B, Court, K, White, N, Longfellow, R, Hughes, LE, Green, ME, Halkes, M, Mercer, P, Roebuck, A, Wilson-Davies, E, Gallego, L, Lazarus, R, Aldridge, N, Berry, L, Game, F, Reynolds, T, Holmes, C, Wiselka, M, Higham, A, Booth, M, Duff, C, Alderton, J, Hilton, D, Powell, J, Jackson, A, Plant, AJ, Ahmed, N, Chin, T, Qazzafi, MZ, Moody, AM, Tilley, RE, Donaghy, T, O'Kane, M, Shipman, K, Sierra, R, Parmar, C, Mills, G, Harvey, D, Huang, YWJ, Birch, J, Robinson, L, Board, S, Broadley, A, Laven, C, Todd, N, Eyre, DW, Jeffery, K, Dunachie, S, Duncan, C, Klenerman, P, Turtle, L, Baxendale, H, Heeney, JL, Hall, Victoria Jane, Foulkes, Sarah, Saei, Ayoub, Andrews, Nick, Oguti, Blanche, Charlett, Andre, Wellington, Edgar, Stowe, Julia, Gillson, Natalie, Atti, Ana, Islam, Jasmin, Karagiannis, Ioannis, Munro, Katie, Khawam, Jameel, Chand, Meera A, Brown, Colin S, Ramsay, Mary, Lopez-Bernal, Jamie, and Hopkins, Susan

Published
2021
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21. Methodological challenges in post-licensure vaccine safety studies using large routinely collected datasets

Author

Toffa-Stowe, Julia Margaret

Subjects
362.1
Abstract

Robust and responsive epidemiological post-licensure vaccine safety studies are the backbone to having confidence in a vaccination programme. Consideration must be given to the unique methodological challenges inherent when assessing a potential causal association between a vaccine and the condition of interest; these can be present from setting up the study through to communicating the results. Public Health England (PHE) has addressed a number of vaccine safety concerns since the 1990's using routinely collected healthcare data and methods specific to the disease and vaccine under scrutiny. This thesis comprises of seven published post-licensure vaccine safety studies which were carried out in response to a number of different pertinent safety concerns relevant to the UK's immunisation schedule. As a background to these studies the history of routinely collected data is examined in the context of how we use the data today along with a description of the pre and post-licensure vaccine safety activities which often precede the epidemiological studies. By bringing together the methodological issues of these seven studies and demonstrating the different ways in which these issues have been handled it has created a blueprint for addressing vaccine safety concerns in the future. The seven studies are i) Intussusception and Rotavirus vaccination ii) Narcolepsy in adults and Pandemic Influenza vaccine iii) Convulsions and Pandemic and Seasonal Influenza vaccine iv) Bacterial and Viral Infections and Measles Mumps and Rubella vaccine v) Guillain-Barré syndrome and Seasonal Influenza vaccine vi) Idiopathic Thrombocytopenic Purpura and the second dose of Measles Mumps and Rubella vaccine vii) Bell's Palsy and Seasonal Influenza vaccine. In conclusion the methodological approaches employed in these studies can be used in the future to assess potential adverse events and the access to routinely collected health data is an essential element of this.

Published
2017

22. Interim 2023/2024 Season Influenza Vaccine Effectiveness in Primary and Secondary Care in the United Kingdom

Author

Whitaker, Heather, primary, Findlay, Beth, additional, Zitha, Jana, additional, Goudie, Rosalind, additional, Hassell, Katie, additional, Evans, Josie, additional, Kalapotharakou, Panoraia, additional, Agrawal, Utkarsh, additional, Kele, Beatrix, additional, Hamilton, Mark, additional, Moore, Catherine, additional, Byford, Rachel, additional, Stowe, Julia, additional, Robertson, Chris, additional, Couzens, Anastasia, additional, Jamie, Gavin, additional, Hoschler, Katja, additional, Pheasant, Kathleen, additional, Button, Elizabeth, additional, Quinot, Catherine, additional, Jones, Tim, additional, Anand, Sneha, additional, Watson, Conall, additional, Andrews, Nick, additional, de Lusignan, Simon, additional, Zambon, Maria, additional, Williams, Christopher, additional, Cottrell, Simon, additional, Marsh, Kimberly, additional, McMenamin, Jim, additional, and Lopez Bernal, Jamie, additional

Published
2024
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31. Increased reports of severe myocarditis associated with enterovirus infection in neonates, United Kingdom, 27 June 2022 to 26 April 2023

Author

Singanayagam, Anika, primary, Moore, Catherine, additional, Froude, Susannah, additional, Celma, Cristina, additional, Stowe, Julia, additional, Hani, Erjola, additional, Ng, Khuen Foong, additional, Muir, Peter, additional, Roderick, Marion, additional, Cottrell, Simon, additional, Bibby, David F., additional, Vipond, Barry, additional, Gillett, Sophie, additional, Davis, Peter J., additional, Gibb, Jack, additional, Barry, Mai, additional, Harris, Phillippa, additional, Rowley, Frances, additional, Song, Jiao, additional, Shankar, Ananda Giri, additional, McMichael, Danielle, additional, Cohen, Jonathan M., additional, Manian, Abirami, additional, Harvey, Ciaran, additional, Primrose, Louise Shaw, additional, Wilson, Stefanie, additional, Bradley, Declan T., additional, Paranthaman, Karthik, additional, Beard, Stuart, additional, Zambon, Maria, additional, Ramsay, Mary, additional, Saliba, Vanessa, additional, Ladhani, Shamez, additional, and Williams, Christopher, additional

Published
2023
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34. Vaccine effectiveness against hospitalisation and comparative odds of hospital admission and severe outcomes with BQ.1, CH.1.1. and XBB.1.5 in England.

Author

Kirsebom, Freja C M, primary, Harman, Katie, additional, Lunt, Rachel J, additional, Andrews, Nick, additional, Groves, Natalie, additional, Aziz, Nurin Iwani Binti Abdul, additional, Hope, Russell, additional, Stowe, Julia, additional, Chand, Meera, additional, Ramsay, Mary, additional, Dabrera, Gavin, additional, Kall, Meaghan, additional, and Lopez Bernal, Jamie, additional

Published
2023
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44. Protection against symptomatic infection with delta (B.1.617.2) and omicron (B.1.1.529) BA.1 and BA.2 SARS-CoV-2 variants after previous infection and vaccination in adolescents in England, August, 2021–March, 2022: a national, observational, test-negative, case-control study

Author

Powell, Annabel A, primary, Kirsebom, Freja, additional, Stowe, Julia, additional, Ramsay, Mary E, additional, Lopez-Bernal, Jamie, additional, Andrews, Nick, additional, and Ladhani, Shamez N, additional

Published
2022
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47. Guillain-Barré syndrome following SARS-CoV-2 vaccination in the UK: a prospective surveillance study

Author

Tamborska, Arina A, Singh, Bhagteshwar, Leonhard, Sonja E, Hodel, Eva Maria, Stowe, Julia, Watson-Fargie, Taylor, Fernandes, Peter M, Themistocleous, Andreas C, Roelofs, Jacob, Brennan, Kathryn, Morrice, Caroline, Michael, Benedict D, Jacobs, Bart C, McDonald, Helen, Solomon, Tom, and UK Covid Vaccine GBS Study Group

Abstract

Objective: To investigate features of Guillain-Barré syndrome (GBS) following SARS-CoV-2 vaccines and evaluate for a causal link between the two. Methods: We captured cases of GBS after SARS-CoV-2 vaccination through a national, open-access, online surveillance system. For each case, the certainty of GBS was graded using the Brighton criteria, and the relationship to the vaccine was examined using modified WHO Causality Assessment criteria. We compared age distribution of cases with that of prepandemic GBS cases and clinical features with the International GBS Outcome Study (IGOS). Results: Between 1 January and 30 June 2021, we received 67 reports of GBS following the ChAdOx1 vaccine (65 first doses) and three reports following the BNT162b2 vaccine (all first doses). The causal association with the vaccine was classified as probable for 56 (80%, all ChAdOx1), possible for 12 (17%, 10 ChAdOx1) and unlikely for two (3%, 1 ChAdOx1). A greater proportion of cases occurred in the 50-59 age group in comparison with prepandemic GBS. Most common clinical variants were sensorimotor GBS (n=55; 79%) and facial diplegia with paraesthesias (n=10; 14%). 10% (n=7/69) of patients reported an antecedent infection, compared with 77% (n=502/652) of the IGOS cohort (p

Published
2022

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