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8. Vaccines

Author

Hahné, Susan, primary, Bollaerts, Kaatje, additional, and Farrington, Paddy, additional

Published
2021
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12. Vaccine safety

Author

Hahné, Susan, primary, Bollaerts, Kaatje, additional, and Farrington, Paddy, additional

Published
2021
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16. Introduction

Author

Hahné, Susan, primary, Bollaerts, Kaatje, additional, and Farrington, Paddy, additional

Published
2021
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20. Cumulative incidence of cardiac surgery associated with exposure to benfluorex: A retrospective analysis based on compensation claims data.

Author

Farrington, Paddy and Lellinger, Solène

Subjects
*CARDIAC surgery, *HEART valve diseases, *DRUGS, *HEART valves, *RETROSPECTIVE studies
Abstract

Data on retrospective compensation claims for injuries caused by pharmaceutical drugs are prone to selection and reporting biases. Nevertheless, this case study of the antidiabetic drug benfluorex shows that such data can be used to estimate the cumulative incidence of drug‐related injury, and to provide insights into its epidemiology. To this end, we develop a modelling framework for under‐reporting of retrospective claims for compensation arising from drug damage. The model involves a longitudinal component related to attrition of cases over time, and a cross‐sectional component related to incomplete reporting. We apply this model to cardiac valve surgery necessitated by exposure to benfluorex. Benfluorex was marketed in France between 1976 and 2009, when it was withdrawn because it caused valvular heart disease. A scandal erupted in 2010 over the scale of the damage caused by the drug. Since then, no further estimates of cumulative incidence have been published, though thousands of claims for compensation have been processed. The analysis combines compensation claims data and sociological survey data on benfluorex users, together with data on benfluorex sales and duration of treatment. We find a threshold of toxicity at about 6 months' exposure, and that at least 1690 individuals (95% CI 1290 to 2320) needed heart surgery to replace or repair valves damaged by exposure to benfluorex in France: a cumulative incidence of 3.68 per 10,000 (95% CI 2.68 to 5.34) benfluorex users or 3.22 per 10,000 (95% CI 2.48 to 4.39) person‐years at risk above the exposure threshold. While these findings are tentative, they are consistent with those obtained previously using very different methods. [ABSTRACT FROM AUTHOR]

Published
2024
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28. Further SCCS models

Author

Farrington, Paddy, primary, Whitaker, Heather, additional, and Weldeselassie, Yonas Ghebremichael, additional

Published
2018
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29. Introduction

Author

Farrington, Paddy, primary, Whitaker, Heather, additional, and Weldeselassie, Yonas Ghebremichael, additional

Published
2018
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31. The SCCS likelihood

Author

Farrington, Paddy, primary, Whitaker, Heather, additional, and Weldeselassie, Yonas Ghebremichael, additional

Published
2018
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35. Quadrivalent human papillomavirus vaccination in girls and the risk of autoimmune disorders: the Ontario Grade 8 HPV Vaccine Cohort Study

Author

Liu, Erin Y., Smith, Leah M., Ellis, Anne K., Whitaker, Heather, Law, Barbara, Kwong, Jeffrey C., Farrington, Paddy, and Levesque, Linda E.

Subjects
Complications and side effects, Research, Risk factors, Safety and security measures, Autoimmune diseases -- Risk factors, Papillomavirus vaccines -- Complications and side effects -- Safety and security measures -- Research, Vaccination -- Safety and security measures -- Research
Abstract

Human papillomavirus (HPV) is the most common sexually transmitted infection globally, (1) affecting 50%-75% of sexually active individuals. (2,3) The quadrivalent HPV (HPV4) vaccine protects against 2 oncogenic strains of [...], BACKGROUND: Despite demonstrated effectiveness in real-world settings, concerns persist regarding the safety of the quadrivalent human papillomavirus (HPV4) vaccine. We sought to assess the risk of autoimmune disorders following HPV4 vaccination among grade 8 girls eligible for Ontario's school-based HPV vaccination program. METHODS: We undertook a population-based retrospective cohort study using Ontario's administrative health and vaccination databases from 2007 to 2013. The self-controlled case series method was used to compare the rate of a composite end point of autoimmune disorders diagnosed during days 7-60 post vaccination ("exposed" follow-up) to that at any other time ("unexposed"). The analysis was repeated to assess the effect of a history of immune-mediated diseases and time since vaccination. We also conducted an exploratory analysis of individual autoimmune disorders. Rate ratios and 95% confidence intervals (CIs) were estimated using conditional Poisson regression, adjusted for age, seasonality, concomitant vaccinations and infections. RESULTS: The study cohort consisted of 290939 girls aged 12-17 years who were eligible for vaccination between 2007 and 2013. There was no significant risk for developing an autoimmune disorder following HPV4 vaccination (n = 681; rate ratio 1.12, 95% CI 0.85-1.47), and the association was unchanged by a history of immune-mediated disorders and time since vaccination. Exploratory analyses of individual autoimmune disorders found no significant risks, including for Bell palsy (n = 65; rate ratio 1.73, 95% CI 0.77-3.89), optic neuritis (n = 67; rate ratio 1.57, 95% CI 0.74-3.33) and Graves disease (n = 47; rate ratio 1.55, 95% CI 0.92-2.63). INTERPRETATION: We did not observe an increased risk of autoimmune disorders following HPV4 vaccination among teenaged girls. These findings should reassure parents and health care providers.

Published
2018
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39. Risks of deep vein thrombosis, pulmonary embolism, and bleeding after covid-19 : nationwide self-controlled cases series and matched cohort study

Author

Katsoularis, Ioannis, Fonseca-Rodríguez, Osvaldo, Farrington, Paddy, Jerndal, Hanna, Häggström Lundevaller, Erling, Sund, Malin, Lindmark, Krister, Fors Connolly, Anne-Marie, Katsoularis, Ioannis, Fonseca-Rodríguez, Osvaldo, Farrington, Paddy, Jerndal, Hanna, Häggström Lundevaller, Erling, Sund, Malin, Lindmark, Krister, and Fors Connolly, Anne-Marie

Abstract

OBJECTIVE: To quantify the risk of deep vein thrombosis, pulmonary embolism, and bleeding after covid-19. DESIGN: Self-controlled case series and matched cohort study. SETTING: National registries in Sweden. PARTICIPANTS: 1 057 174 people who tested positive for SARS-CoV-2 between 1 February 2020 and 25 May 2021 in Sweden, matched on age, sex, and county of residence to 4 076 342 control participants. MAIN OUTCOMES MEASURES: Self-controlled case series and conditional Poisson regression were used to determine the incidence rate ratio and risk ratio with corresponding 95% confidence intervals for a first deep vein thrombosis, pulmonary embolism, or bleeding event. In the self-controlled case series, the incidence rate ratios for first time outcomes after covid-19 were determined using set time intervals and the spline model. The risk ratios for first time and all events were determined during days 1-30 after covid-19 or index date using the matched cohort study, and adjusting for potential confounders (comorbidities, cancer, surgery, long term anticoagulation treatment, previous venous thromboembolism, or previous bleeding event). RESULTS: Compared with the control period, incidence rate ratios were significantly increased 70 days after covid-19 for deep vein thrombosis, 110 days for pulmonary embolism, and 60 days for bleeding. In particular, incidence rate ratios for a first pulmonary embolism were 36.17 (95% confidence interval 31.55 to 41.47) during the first week after covid-19 and 46.40 (40.61 to 53.02) during the second week. Incidence rate ratios during days 1-30 after covid-19 were 5.90 (5.12 to 6.80) for deep vein thrombosis, 31.59 (27.99 to 35.63) for pulmonary embolism, and 2.48 (2.30 to 2.68) for bleeding. Similarly, the risk ratios during days 1-30 after covid-19 were 4.98 (4.96 to 5.01) for deep vein thrombosis, 33.05 (32.8 to 33.3) for pulmonary embolism, and 1.88 (1.71 to 2.07) for bleeding, after adjusting for the effect of potential confounders. Th

Published
2022
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42. A modified self‐controlled case series method for event‐dependent exposures and high event‐related mortality, with application to COVID‐19 vaccine safety

Author

Ghebremichael‐Weldeselassie, Yonas, primary, Jabagi, Marie Joëlle, additional, Botton, Jérémie, additional, Bertrand, Marion, additional, Baricault, Bérangère, additional, Drouin, Jérôme, additional, Weill, Alain, additional, Zureik, Mahmoud, additional, Dray‐Spira, Rosemary, additional, and Farrington, Paddy, additional

Published
2022
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50. COVID-19 and myocardial infarction – Authors' reply

Author

Katsoularis, Ioannis, Fonseca Rodriguez, Osvaldo, Farrington, Paddy, Lindmark, Krister, Connolly-Andersen, Anne-Marie, Katsoularis, Ioannis, Fonseca Rodriguez, Osvaldo, Farrington, Paddy, Lindmark, Krister, and Connolly-Andersen, Anne-Marie

Published
2021
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