Adequate and sustained resourcing of TGA are vital to vaccine safety

WE read with interest Boyd and Mintzes’ recent article published in InSight+, and Skerritt’s reply, regarding the Therapeutic Goods Administration’s (TGA) oversight of medication safety in Australia. Valid points regarding the importance of transparency for medication safety and sufficient resourcing for pharmacovigilance systems were discussed in both.

We wish to make additional comments regarding post-licensure vaccine safety monitoring during the current COVID-19 pandemic as an important case study with relevant lessons for medication safety more broadly.

The enormous scale of Australia’s COVID-19 vaccine program, and associated increase in the number of adverse event following immunisation (AEFI) reports nationally (here and here), required significant adaptations across vaccine safety systems at all levels. The TGA played a central role, with enhanced online reporting channels, improved data visualisation, expansion of signal detection mechanisms, publication of regular vaccine safety reports, and partnership with local and international vaccine safety networks (here and here).

Importantly, this work was supported by jurisdictional vaccine safety services (eg, Surveillance of Adverse Events Following Vaccination In the Community [SAEFVIC] in Victoria) and their partners, who provided a large proportion of AEFI reports.

The TGA is not resourced to clinically follow up AEFI reports. This is undertaken by jurisdictional services, who followed up case details to enable classification according to international (Brighton Collaboration) criteria, facilitated referral pathways to enable clinical follow-up for individuals, and developed enhanced surveillance mechanisms to complement existing spontaneous reporting structures.

As described by Professor John Skerritt in his InSight+ article, alternate sources of reports beyond health professionals can have significant value.

The COVID-19 pandemic highlighted difficulties in relying on spontaneous adverse event reporting from busy health professionals working in often overwhelmed health care environments. Consumer AEFI reporting, both spontaneous and through solicited surveillance (eg, SMS surveys following immunisation) formed a core component of vaccine safety surveillance in this context, reconfirming the value of consumer reports in safety monitoring.

Development of additional active surveillance methods, such as syndromic surveillance and data linkage within a variety of de-identified health care data sources, has also enabled strengthening of surveillance systems during the pandemic. These methods have significant potential application for safety monitoring for other medications beyond vaccines.

Providing transparent, up-to-date communication with health professionals and the public, strengthening signal detection and response capacities, and complementing spontaneous AEFI reporting with alternative surveillance modalities has all required a well resourced, agile and coordinated pharmacovigilance system, with close collaboration at state, national and international levels. These elements remain critical to the success of Australian vaccine programs moving forward, including community vaccine confidence.

Importantly, some of these aspects, as flagged by Boyd and Mintzes, could also hold relevance for medication safety more broadly in Australia. Adequate and sustained resourcing, and strategic planning, will be vital to ensure that the partnerships and system strengthening built through the COVID-19 vaccine program are continued and expanded in collaboration with the TGA.

Dr Ingrid Laemmle-Ruff is a general paediatrician and public health physician. She works in vaccine safety at SAEFVIC (Surveillance of Adverse Events Following Vaccination In the Community ) and in community paediatrics.

Professor Jim Buttery is a paediatric infectious diseases physician and vaccinologist. He is the inaugural Professor of Child Health Informatics at the University of Melbourne, heads Epidemiology and Signal Investigation for SAEFVIC, and serves as a member of the Therapeutic Goods Administration’s Advisory Committee on Vaccines.

 Associate Professor Nigel W Crawford is a general paediatrician and vaccinologist. He is the Director of SAEFVIC, Head of Immunisation Services at the Royal Children’s Hospital, Melbourne and the current Chair of the Australian Therapeutic Advisory Group on Immunisation (ATAGI).

The statements or opinions expressed in this article reflect the views of the authors and do not necessarily represent the official policy of the AMA, the MJA or InSight+ unless so stated.

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