Post-authorisation Passive Enhanced Safety Surveillance of Seasonal Influenza Vaccines

Post-authorisation Passive Enhanced Safety Surveillance of Seasonal Influenza Vaccines: Pilot Study in England

The purpose of this 2016/17 pilot study is to improve the combination of a card-based adverse drug reaction (ADR) system and the use of routine data to collect adverse events following vaccination with seasonal influenza vaccines, as per European Medicines Agency (EMA) guidance and Pharmacovigilance Risk Assessment Committee of EMA (PRAC) requirements, and to identify additional data which may need to be collected in order to appropriately address the requirement.

Inclusion Criteria:

• Volunteers receiving an influenza vaccine and receiving an ADR card at the beginning of the 2016/17 season.

Exclusion Criteria:

• In the database analysis, registered patients who have explicitly opted out of data sharing will be excluded from the analysis.