Safety and utilisation of AZD1222 (ChAdOx1 nCoV-19) COVID-19 vaccine: a UK post-authorisation active surveillance study
Objectives To monitor the safety and utilisation of AZD1222 under real-world use in the UK.Design A non-interventional post-authorisation active surveillance study.Setting Vaccination sites in the UK.Participants A total of 17 945 participants were eligible and provided consent to participate in the...
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BMJ Publishing Group
2025-05-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/15/5/e093366.full |
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| author | Miranda Davies Debabrata Roy Sandeep Dhanda Saad Shakir Alison Evans Samantha Lane Denise Morris Taylor Aurelius Catherine Fry |
| author_facet | Miranda Davies Debabrata Roy Sandeep Dhanda Saad Shakir Alison Evans Samantha Lane Denise Morris Taylor Aurelius Catherine Fry |
| author_sort | Miranda Davies |
| collection | DOAJ |
| description | Objectives To monitor the safety and utilisation of AZD1222 under real-world use in the UK.Design A non-interventional post-authorisation active surveillance study.Setting Vaccination sites in the UK.Participants A total of 17 945 participants were eligible and provided consent to participate in the study between 1 March 2021 and 6 April 2023. Participants were followed up at weeks 1, 4 and 14 and at months 6, 9, 12 and 18 after the first dose of AZD1222 vaccination and prompted to complete electronic data capture forms. A total of 11 219 participants submitted a Follow-Up 1 form and 5189 participants submitted a Follow-Up 7 form (at 18 months).Primary and secondary outcome measures The safety of AZD1222, including the identification, assessment and quantification of serious adverse events (SAEs) and adverse events of special interest (AESI), was examined. The utilisation of AZD1222 was described and characterised, including populations with missing information.Results The majority of participants were women (n=10 845; 60.4%) and the median age (IQR) was 50 (43, 62) years. Most participants were from white ethnic groups (n=13 112; 73.1%). Headache and fatigue had the highest reported incidence rate (421.28 cases per 1000 person years and 386.00 cases per 1000 person years, respectively). The most frequently reported AESI was anosmia (6.25 cases per 1000 person years). An increased Observed versus Expected (O:E) ratio was seen for anaphylaxis (O:E 7.38 (95% CI 2.80 to 11.95); based on 10 observed cases (expected cases: 1.36)) and anosmia and/or ageusia (O:E 39.23 (95% CI 29.13 to 49.32), based on 58 observed cases (expected cases: 1.48)).Conclusions The most frequent vaccinee-reported adverse events (AEs) were headache and fatigue. An increased O:E ratio was seen for the AEs of anaphylaxis and anosmia and/or ageusia. No safety signals were identified throughout the course of this study.Trial registration number This study is registered with the HMA-EMA Catalogue of RWD studies (EUPAS44035). |
| format | Article |
| id | doaj-art-c4dba797dc4c441fb81943b281101663 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-05-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-c4dba797dc4c441fb81943b2811016632025-08-20T02:28:27ZengBMJ Publishing GroupBMJ Open2044-60552025-05-0115510.1136/bmjopen-2024-093366Safety and utilisation of AZD1222 (ChAdOx1 nCoV-19) COVID-19 vaccine: a UK post-authorisation active surveillance studyMiranda Davies0Debabrata Roy1Sandeep Dhanda2Saad Shakir3Alison Evans4Samantha Lane5Denise Morris6Taylor Aurelius7Catherine Fry8Nuffield Trust, London, UK1 Drug Safety Research Unit, Southampton, UKSchool of Pharmacy and Biomedical Sciences, University of Portsmouth, Portsmouth, Hampshire, UK2 University of Portsmouth, Portsmouth, UK4 Kennedy Institute of Rheumatology, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UKDrug Safety Research Unit, Southampton, UK1 Drug Safety Research Unit, Southampton, UK1 Drug Safety Research Unit, Southampton, UK1 Drug Safety Research Unit, Southampton, UKObjectives To monitor the safety and utilisation of AZD1222 under real-world use in the UK.Design A non-interventional post-authorisation active surveillance study.Setting Vaccination sites in the UK.Participants A total of 17 945 participants were eligible and provided consent to participate in the study between 1 March 2021 and 6 April 2023. Participants were followed up at weeks 1, 4 and 14 and at months 6, 9, 12 and 18 after the first dose of AZD1222 vaccination and prompted to complete electronic data capture forms. A total of 11 219 participants submitted a Follow-Up 1 form and 5189 participants submitted a Follow-Up 7 form (at 18 months).Primary and secondary outcome measures The safety of AZD1222, including the identification, assessment and quantification of serious adverse events (SAEs) and adverse events of special interest (AESI), was examined. The utilisation of AZD1222 was described and characterised, including populations with missing information.Results The majority of participants were women (n=10 845; 60.4%) and the median age (IQR) was 50 (43, 62) years. Most participants were from white ethnic groups (n=13 112; 73.1%). Headache and fatigue had the highest reported incidence rate (421.28 cases per 1000 person years and 386.00 cases per 1000 person years, respectively). The most frequently reported AESI was anosmia (6.25 cases per 1000 person years). An increased Observed versus Expected (O:E) ratio was seen for anaphylaxis (O:E 7.38 (95% CI 2.80 to 11.95); based on 10 observed cases (expected cases: 1.36)) and anosmia and/or ageusia (O:E 39.23 (95% CI 29.13 to 49.32), based on 58 observed cases (expected cases: 1.48)).Conclusions The most frequent vaccinee-reported adverse events (AEs) were headache and fatigue. An increased O:E ratio was seen for the AEs of anaphylaxis and anosmia and/or ageusia. No safety signals were identified throughout the course of this study.Trial registration number This study is registered with the HMA-EMA Catalogue of RWD studies (EUPAS44035).https://bmjopen.bmj.com/content/15/5/e093366.full |
| spellingShingle | Miranda Davies Debabrata Roy Sandeep Dhanda Saad Shakir Alison Evans Samantha Lane Denise Morris Taylor Aurelius Catherine Fry Safety and utilisation of AZD1222 (ChAdOx1 nCoV-19) COVID-19 vaccine: a UK post-authorisation active surveillance study BMJ Open |
| title | Safety and utilisation of AZD1222 (ChAdOx1 nCoV-19) COVID-19 vaccine: a UK post-authorisation active surveillance study |
| title_full | Safety and utilisation of AZD1222 (ChAdOx1 nCoV-19) COVID-19 vaccine: a UK post-authorisation active surveillance study |
| title_fullStr | Safety and utilisation of AZD1222 (ChAdOx1 nCoV-19) COVID-19 vaccine: a UK post-authorisation active surveillance study |
| title_full_unstemmed | Safety and utilisation of AZD1222 (ChAdOx1 nCoV-19) COVID-19 vaccine: a UK post-authorisation active surveillance study |
| title_short | Safety and utilisation of AZD1222 (ChAdOx1 nCoV-19) COVID-19 vaccine: a UK post-authorisation active surveillance study |
| title_sort | safety and utilisation of azd1222 chadox1 ncov 19 covid 19 vaccine a uk post authorisation active surveillance study |
| url | https://bmjopen.bmj.com/content/15/5/e093366.full |
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