Active monitoring of the Safety of a COVID-19 Vaccine Study [COVID-19]
Research type
Research Study
Full title
Post-authorisation active surveillance of the Safety of COVID-19 Vaccine AstraZeneca (AZD-1222) in the UK: A consortium study
IRAS ID
292936
Contact name
Alison Evans
Contact email
Sponsor organisation
Drug Safety Research Unit
Duration of Study in the UK
2 years, 6 months, 1 days
Research summary
Research summary:
The aim of this study is to monitor the safety and utilisation of the COVID-19 Vaccine AstraZeneca (AZD-1222) administered to vaccinees under real-world use in the UK.
Adults and children vaccinated with a COVID-19 vaccine, at any vaccination site throughout the UK, will be eligible for inclusion in this surveillance. Vaccinees will be recruited via the mass vaccination programme through various vaccination sites and other methods of recruitment will be used where appropriate (e.g. through social media and in printed and online newspapers and magazines). Baseline information and any symptom/condition following vaccination reported by the vaccinee will be collected. Further information related to serious and adverse events of special interest will be captured from General Practitioners and/or healthcare professionals where appropriate.
Vaccinees will be contacted at various time points through text message, email or phone and asked whether they experienced an adverse event. If an adverse event has been reported by the vaccinee, they will be asked to provide further details via a questionnaire completed via an online portal or by phone. A minimum 18-month observation period will be used for each vaccinee.
A minimum sample size of 10,000 vaccinees is desirable.
Rationale and background
The COVID-19 vaccines were developed and tested rapidly, meaning that it was especially important to monitor their safety and effectiveness in the post-authorisation setting. The DSRU conducted a large-scale active surveillance study on the AstraZeneca COVID-19 vaccine in near real-time in the UK.Aim of the study
To monitor the safety and utilisation of the COVID-19 Vaccine AstraZeneca (AZD1222) administered to vaccinees under real-world use in the UK.Study design
A non-interventional post-authorisation active surveillance study.Study method
Vaccinees were recruited between 1st March 2021 and 31st August 2021 via vaccination sites and social media/advertisements within the UK, supported by the National Institute for Health Research Clinical Research Networks. Participants were eligible to sign up to the study if they had received AZD1222 as their first COVID-19 vaccine dose within 6 weeks and provided consent. Information was collected at baseline and participants were contacted to report any symptoms/conditions experienced following vaccination at weeks 1, 4 and 14 and then months 6, 9, 12 and 18 post first AZD1222 dose vaccination, via electronic data capture forms.Summary of results:
Results
Participants
At the datalock point for the Final report (6th April 2023), a total of 17945 participants were eligible and provided consent.Descriptive data
The majority of participants were female (n=10845; 60.4%) and the median (interquartile range [IQR]) age was 50 (43, 62) years. Most participants were from White ethnic groups (English, Welsh, Scottish, Northern Irish, or British) (n=13112; 73.1%).Outcome Data
The most frequently reported adverse events were headache and fatigue. Headache and fatigue were also the most frequently reported serious adverse events. The most frequently reported adverse events of special interest were anosmia (loss of smell) and/or ageusia (loss of taste). When compared to the pre-COVID-19 pandemic (2019) background rate in the UK, anosmia and/or ageusia were observed more frequently than expected. However, it is likely that this was a reflection of participants experiencing symptoms of COVID-19 infection. There were also more cases of anaphylaxis reported in this study than were expected. This possible side effect is listed in the Patient Information Leaflet for AZD1222.Conclusion
This large-scale active surveillance study allowed for real time safety evaluation and signal detection during the pandemic as adverse event data was shared in real-time with the Medicines and Healthcare products Regulatory Agency. There were no emerging safety issues identified in this study.REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
21/YH/0041
Date of REC Opinion
16 Feb 2021
REC opinion
Further Information Favourable Opinion