Rapid assessment of enhanced safety surveillance for influenza vaccine.

OBJECTIVES

The enhanced safety surveillance for seasonal influenza vaccines established by the European Medicines Agency is required each season. Therefore, a registry capable of rapidly detecting and evaluating potential new safety concerns is needed. The aim of the study is to demonstrate the effectiveness of the vaccine information system of the Valencia region to make a rapid assessment of the influenza vaccine safety and describe the safety of the two vaccine types used in the 2017/2018 season.

STUDY DESIGN

It is a population-based descriptive study.

METHODS

Adverse events following immunization reports collected from 23rd October 2017 to 15th March 2018 were analyzed.

RESULTS

A total of 55 adverse events for influenza vaccine were reported in season 2017/2018 with a reporting rate (RR) of 0.77 per 10,000 administered doses. Injection site reactions had a RR of 0.30 and 0.47 per 10,000 for subunit and adjuvanted vaccines, respectively. Differences per vaccine, sex, and risk group did not reach statistical significance.

CONCLUSIONS

Reported events of the two influenza vaccine types used were similar than in other seasons and consistent with their safety profiles.