Safety and utilisation of AZD1222 (ChAdOx1 nCoV-19) COVID-19 vaccine: a UK post-authorisation active surveillance study

ObjectivesTo monitor the safety and utilisation of AZD1222 under real-world use in the UK.DesignA non-interventional post-authorisation active surveillance study.SettingVaccination sites in the UK.ParticipantsA total of 17 945 participants were eligible and provided consent to participate in the stu...

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Published in:BMJ open Vol. 15; no. 5; p. e093366
Main Authors: Evans, Alison, Roy, Debabrata, Davies, Miranda, Dhanda, Sandeep, Morris, Denise, Aurelius, Taylor, Lane, Samantha, Fry, Catherine, Shakir, Saad
Format: Journal Article
Language:English
Published: England British Medical Journal Publishing Group 02.05.2025
BMJ Publishing Group LTD
BMJ Publishing Group
Subjects:
Adult
Aged
Breastfeeding & lactation
ChAdOx1 nCoV-19 - adverse effects
Clinical medicine
COVID-19 - prevention & control
COVID-19 vaccines
COVID-19 Vaccines - administration & dosage
COVID-19 Vaccines - adverse effects
Drug Utilization
Epidemiology
Family physicians
Female
Headache - chemically induced
Headache - epidemiology
Humans
Immunization
Male
Middle Aged
Non-pharmacological intervention
Original Research
Pandemics
Product Surveillance, Postmarketing
Public health
Regulatory agencies
Safety
SARS-CoV-2
Surveillance
United Kingdom - epidemiology
Vaccination
United Kingdom
United Kingdom > UK
Drug Utilization
Vaccination
Safety
ISSN:2044-6055, 2044-6055
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Summary:ObjectivesTo monitor the safety and utilisation of AZD1222 under real-world use in the UK.DesignA non-interventional post-authorisation active surveillance study.SettingVaccination sites in the UK.ParticipantsA 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 measuresThe 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.ResultsThe 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)).ConclusionsThe 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 numberThis study is registered with the HMA-EMA Catalogue of RWD studies (EUPAS44035).
Bibliography:Original research
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The Drug Safety Research Unit (DSRU) is an independent academic institution which works in association with the University of Portsmouth. All authors have no competing interest to declare. This study (EUPAS44035) was conducted with support from AstraZeneca UK Limited.
Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.
ISSN:2044-6055
2044-6055
DOI:10.1136/bmjopen-2024-093366