Real World Evaluation of COVID-19 vaccines in England – a post-authorisation effectiveness (PAES) and safety (PASS) study programme utilising population level data from the NHS Digital Trusted Research Environment - AstraZeneca

Patients

December 2024

Summary

Assessing Covid-19 vaccine effectiveness and safety in England using NDS data

AstraZeneca, in partnership with the University of Oxford, used a variety of de-identified patient databases, including GP records, vaccination history and hospital admissions reports, to evaluate real-world effectiveness and safety of one COVID-19 vaccine in England. 

Astrazeneca

About this study

Understanding how effective vaccinations have been within the wider population is central to guiding future vaccine development and influencing decision making. The study looked at population-level data for approximately 47 million individuals aged 16 and older, registered with GP practices in England. 

All, anonymous, patient data sources from the NHS COVID-19 Data Store, were accessed and analysed through a secure portal called the NHS Digital Trusted Research Environment (TRE). To protect patient privacy, data was redacted to ensure only essential figures are used for analysis.

Access to public patient data was crucial for this study as it enabled a comprehensive evaluation of COVID-19 vaccine effectiveness.

Data sources used:

• NHS COVID-19 Data Store: A comprehensive data library that combines datasets to support pandemic response and research. It includes GP data (GDPPR) for COVID-19 planning, Hospital Episode Statistics (HES) for patient admissions and appointments, COVID-19 testing results from hospitals and community settings, vaccination status and adverse reactions.

• Civil Registrations of Death (ONS Mortality): Deaths of all individuals in UK

Benefits of the study

The study used the data to understand vaccine effectiveness across one, two, and three doses, analysing variations by age, time between vaccinations, and underlying conditions. Second, the data was used to evaluate vaccine safety, focusing on the likelihood of adverse events or deaths and whether patients had any underlying health conditions. 

This access, safeguarded by strict privacy measures within the NHS Digital TRE, allowed AstraZeneca to determine the true effectiveness and safety of their vaccine in the wider population. In the future, the results from this study will help pharmaceutical companies, the Government and the NHS to make important decisions relating to vaccine development and rollout. 

Further information

Read the clinical study

Last modified: 15 February 2025

Last reviewed: 15 February 2025