Post-authorisation passive enhanced safety surveillance of seasonal influenza vaccines: Pilot study in England
Background and Rationale
The European Medicines Agency (EMA) has set out new requirements for influenza vaccine safety surveillance that all Marketing Authorisation Holders (MAHs) providing vaccines in the EU must address. The key objective of the EMA enhanced safety surveillance is to rapidly detect a significant increase in the frequency and/or severity of expected reactions (local, systemic or allergic reactions) that may indicate a potential or more serious risk, as exposure to the vaccine increases.
The objective of the study is to conduct a pilot assessing adverse event of interest (AEI) frequencies amongst flu-vaccinated patients using routinely collected data in ten primary care practices. Our primary surveillance is of 7-day AEI, post vaccination, but we do not exclude events recorded outside this window, which are analysed separately.
What is the design of the study?
We have recruited ten practices representing urban and rural localities across England, and the three major computerised medical record (CMR) suppliers in the UK. The start date for data collection was in September 2017.
The method and governance procedure has been developed by the University of Surrey as part of previous work with the Royal College of General Practitioners Research and Surveillance Centre (RCGP RSC) and Public Health England (PHE), using an approved provider, Apollo Medical Software Solutions Ltd. Apollo extracts data using the Apollo automated extraction system. Communication is via a SOAP (Simple Object Access Protocol) web service, no special firewall configuration is needed. These arrangements may change from time-to-time and we will notify members if any changes occur. Patients are given AEI reporting cards by practice staff to complete; the data from completed cards is entered in the CMR by practice staff.
Data extractions are conducted in accordance with the Research Group’s standard operating procedures in data extraction, pseudonymisation, and transfer. All data are stored and managed by the University of Surrey. The information security policies and procedures of the Research Group have been approved by NHS Digital.