Brand-specific enhanced safety surveillance of GSK’s Fluarix Tetra seasonal influenza vaccine in England: 2017/2018 season

ABSTRACT

In compliance with the European Medicine Agency guidance to detect any potential safety concerns associated with influenza vaccination, an enhanced safety surveillance study was conducted in England during the 2017/18 influenza season. The primary objective was to estimate the incidence rates of adverse events occurring within seven days of vaccination with Fluarix Tetra. In nine General Practices, seasonal influenza vaccine was administered to patients according to local guidelines. Events following immunization were collected using customized cards (enhanced component) combined with electronic health records [EHRs] (EHR component) to estimate incidence rates of adverse events experienced post vaccination. The study ran from 01-Sep-2017 to 30-Nov-2017. A total of 23,939 subjects were vaccinated of whom 16,433 received Fluarix Tetra. The cumulative incidence rates of adverse events of interest for Fluarix Tetra were 7.25% [95% CI, 5.95–8.73] for events reported by card alone, and 9.21% [95% CI, 7.37–11.34] when combined with EHR data. The type and frequency of events reported were consistent with the Fluarix Tetra Summary of Product Characteristics. The study supports and confirms the safety profile of Fluarix Tetra.

ClinicalTrials.gov number: NCT03278067

PLAIN LANGUAGE SUMMARY

What is the context?

• Influenza disease is an acute viral respiratory infection. Seasonal influenza has a substantial health and economic impact every year. Vaccination remains the primary prevention strategy. Since the influenza virus evolves continuously, the vaccine needs to be frequently adjusted. Influenza vaccination programs are implemented over a short period of time and many individuals receive the vaccine in a short period of time, increasing the need for regular and timely assessment. The European Medicines Agency requires influenza vaccine manufacturers to implement annual surveillance called ‘enhanced safety surveillance’. The aim of this requirement is to rapidly detect any increase in the frequency or severity of adverse reactions following seasonal influenza vaccination.

What is new?

• An ‘enhanced safety surveillance’ study has been conducted in England in 2017–2018. In this study, electronic health records of registered patients were used to evaluate the safety of the vaccine in different age groups and in subjects with different risk level for the disease. To collect adverse reaction experiences more exhaustively, reporting cards were used.

What is the impact?

• In this study, no adverse reactions were detected which could impact the benefit of influenza vaccination from a public health perspective. The vaccine safety profile was similar regardless of the health status of the people vaccinated. The enrolled population essentially covered groups targeted for vaccination, showing that the vaccine’s recommendations in England were followed appropriately.

KEYWORDS:

• Safety management
• medical records systems
• adverse reactions
• influenza vaccines
• general practice
• England

Acknowledgments

The authors thank the patients and practices who allowed pseudonymised data to be extracted from their general practice EHR systems and who participated in this study. The authors also thank Dominique Rosillon, Stephanie Gilon, Anne Yeakey, Tom Chan, Katie Smith and Pegah Rouhi for their contribution at study and/or publication level. Finally, the authors thank Business & Decision Life Sciences platform for editorial assistance, manuscript coordination and writing support, on behalf of GSK. Rachel Emerson provided writing support, and Bruno Dumont coordinated manuscript development and editorial support.

Disclosure of potential conflicts of interest

SL reports grants from the GSK group of companies for this and previous studies. SL has also been a member of Global Advisory Boards for Seqirus and Sanofi. SD, GDS and ASc declare they are employed by the GSK group of companies and holds shares in the GSK group of companies. RB, FF, CMG, SP and IY have nothing to disclose. VS reports he is employed by VPN Consultancy Limited working on behalf of GSK. ASm reports he was employed by the GSK group of companies at the time of the study and reports he holds shares in the GSK group of companies.

Authors’ contribution

The idea and contents of the article emerged from discussions among the authors, who have experience in epidemiology, vaccinology, and vaccine safety. All authors participated in the design or implementation or analysis, and interpretation of the study; and the development of this manuscript. GDS wrote the first draft; all authors contributed to subsequent revisions and approved the final version. The authors are solely responsible for final content and interpretation. The authors received no financial support or other form of compensation related to the development of the manuscript. The material is original and has not been submitted elsewhere.

Trademark statement

Fluarix Tetra is a trademark of the GSK group of companies.

Supplementary material

Supplemental data for this article can be accessed on the publisher’s website at https://doi.org/10.1080/21645515.2019.1705112

Additional information

Funding

GlaxoSmithKline Biologicals SA was the funding source and was involved in all stages of the study conduct and analysis. GlaxoSmithKline Biologicals SA also funded all costs associated with the development and the publishing of the present manuscript. All authors had access to the aggregated data and agreed with the submission of the publication.