AZ Covid Vaccine study

We were approached by AstraZeneca to conduct a Post-authorisation Safety Study of the COVID-19 Vaccine AstraZeneca (AZD1222) in the UK as part of the risk management plan.
The DSRU proposed a large-scale active surveillance study which would allow for near real-time monitoring of the use and safety of the COVID-19 vaccination programme under real-world use in the UK.
A fundamental function of the study was the prompted reporting by vaccinees to facilitate early identification of safety signals.
Vaccinees were recruited via the mass vaccination programme at vaccination sites within the UK, utilising the DSRU’s collaboration with the National Institute for Health Research Clinical Research Networks. Further recruitment of vaccinees through social media and other direct forms of advertisement was used.
Vaccinees were contacted at various time points over an 18 month period and asked whether they experienced an adverse event and provide further details of the events if so, including contact with GP, attendance at A & E or hospital admission.
Variables collected included age, gender, race/ethnicity, pregnancy status, breastfeeding status, vaccination details and specific comorbidities/conditions.
Specific objectives included describing and characterising serious adverse events and adverse events of special interest (AESI) and well as examining use and safety in populations with missing information.
A health-related quality of life study was also conducted among a sub-population of vaccines.
Suspected adverse drug reactions (ADRs) were submitted to the MHRA within regulatory reporting timelines. In addition, regular interim reports were provided to the company and MHRA/EMA, enabling the regulators to monitor the safety of these vaccines on an ongoing basis.
The final report for the study was completed in December 2023. A summary of the study results is available here