Real-time benefit-risk assessment of vaccine exposure across a nationally representative primary care sentinel network: cutting edge technologies to prevent disease

Lead supervisor: Prof Simon de Lusignan, Nuffield Department of Primary Care Health Sciences

Co-supervisors: Prof Richard Hobbs, Dr Mark Joy, Nuffield Department of Primary Care Health Sciences

Commercial partner: EMIS Group, Leeds

Background

Despite good evidence about safety and effectiveness, vaccine ‘hesitancy’ or refusal is a contemporary problem acknowledged by both WHO and European Centre for Disease Control.

Currently there are few robust comparisons of individual brands or types of influenza vaccine, and a range of different vaccines will be introduced for coronavirus 2019 disease (COVID-19) in the coming season. 

The national community surveillance system for influenza and other respiratory infections, the Oxford-Royal College of General Practitioners Research and Surveillance Centre, has expanded to >1,700 general practices (N>15,000,000). Its data are linked to hospital, death, and Public Health England’s virology databases.^[1]   It extracts pseudonymised data from practice records twice weekly. 

We have developed with EMIS, the UK’s largest computerised medical record system (CMR) suppliers, a daily data extract, and a collaboration to be able to collect questionnaire data directly from patients through the EMIS “Patient Access” app.  This is widely used by patients to request prescriptions, book appointments and look at results, for example 67,000 people in Oxfordshire are registered to use this app with 10 million users nationally (2.4 million prescriptions ordered monthly). We will use this app to enable patients to report contemporaneously about any adverse events of interest (AEIs) or if they have a vaccine preventable disease, post administration.

Aim

To develop and evaluate a real-time vaccine benefit-risk (VB-R) platform that includes direct contributions from patients, linked to their medical records.

Method

We will make use of conventional test-negative case-control (TNCC)^[2] and cohort studies to measure vaccine effectiveness and use self-controlled case series (SCCS)^[3] to report AEIs.  Whilst patient questionnaires have had a high take up,^[4]  they lack the immediacy of online reporting.

The novel in our study will be recruiting a representative sample of patients attending for vaccination to report AEIs, in the short term (7 days post-vaccination), medium term (3 months), or long term (one year).

MRC priorities:

Prevention and early detection are a key priority; rapid VB-R would enable more effective prevention programmes.  Cellular manufacture of vaccines is rapid, enabling in-season deployment of a new vaccine if effectiveness were low.

Benefits for EMIS & academics:

EMIS would strengthen our relationships with practices and patients, and its Patient Access app would become a VB-R tool. EMIS is looking to expand its work with the research community and facilitate the uptake and automation of primary care research; this would provide an appropriate case study.

Changing from an end of season to real-time VB-R would demonstrate academic impact.

The novel in our study will be recruiting a representative sample of patients attending for vaccination to report AEIs, in the short term (7 days post-vaccination), medium term (3 months), or long term (one year).