From program suspension to the pandemic: A qualitative examination of Australia's vaccine pharmacovigilance system over 10 years.

ABSTRACT

BACKGROUND: In 2010, the Australian seasonal influenza vaccination program for children under 5 years of age was suspended due to an unexpected increase in fever and febrile convulsions causally associated with one particular influenza vaccine brand. A subsequent national review made seven recommendations to improve vaccine pharmacovigilance. Ten years on, in advance of implementing the COVID-19 immunisation program, we evaluated views on the capacity of Australia's vaccine pharmacovigilance system to promptly detect, examine and communicate a signal. METHODS: Semi-structured interviews were conducted between July and October 2020 with individuals with expertise in vaccine safety in Australia using an interview guide informed by key Australian and international frameworks. Interviews were digitally recorded and transcribed verbatim. Thematic analysis was used to code data using a deductive approach. RESULTS: Interviews with seventeen participants enabled six themes to be identified. Participants described improvement and significant innovation within Australia's vaccine pharmacovigilance system over the decade since 2010, particularly through establishment of a new active, cohort event monitoring system using short message service surveys. Participants thought Australia had a good foundation for COVID-19 vaccine safety surveillance; implementation of the COVID-19 immunisation program was seen as a potential driver for ongoing enhancement through a) improved integration of the active surveillance and spontaneous reporting systems, and; b) development of population-level active surveillance, including through data linkage. Transparent communication was considered essential to address the unprecedented challenges of COVID-19 and broader vaccine safety concerns. CONCLUSIONS: Vaccine safety experts in Australia convey confidence in the innovative pharmacovigilance systems implemented over the past 10 years. While Australia has a multifaceted system incorporating both active surveillance and spontaneous reporting systems, COVID-19 vaccine implementation represents an opportunity to enhance current systems and to develop new, systematic approaches to vaccine pharmacovigilance that should make both a local and global contribution.