Electronic, self-reported active vaccine safety surveillance - A three-country comparison of AusVaxSafety (Australia), CANVAS (Canada) and V-safe (United States) - ARTICLE COMMENTARY

Sep 29, 2026

Upload by acoobca

Active vaccine safety surveillance actively engages vaccine recipients to solicit adverse events following immunization, complementing spontaneous reporting systems. This article commentary compares three national self-reported active vaccine safety surveillance systems—AusVaxSafety (Australia), CANVAS (Canada), and V-safe (United States)—across six evaluation attributes. Each system contributed during the COVID-19 pandemic and continues informing post-marketing vaccine safety surveillance, with distinct strengths and limitations that guide future program design.

LanguageEnglish

CategoryResearch & Report

FormatPDF

Pages7

Reading Time18 min

AccessFree to download

Introduction

Active surveillance and limitations of spontaneous reporting

Overview of three systems: development and evolution

AusVaxSafety (Australia)

CANVAS (Canada)

V-safe (United States)

Comparative evaluation across key attributes

Design, implementation, and performance

Implications for future vaccine pharmacovigilance

ARTICLE COMMENTARY Electronic, self-reported active vaccine safety surveillance: A three-country comparison of AusVaxSafety (Australia), CANVAS (Canada) and V-safe (United States) Nicola Cartera,b, Phyumar Soec, Lucy Denga,d,e, Jackson Younga, Catherine Kinga,b, Helen Quinna,d, Kristine Macartneya,d,e, Julie A. Bettingerc,f, and Nicholas Wooda,d,e aNational Centre for Immunisation Research and Surveillance, The Childrens Hospital at Westmead, Westmead, NSW, Australia; bFaculty of Medicine and Health, The University of Sydney, Camperdown, NSW, Australia; cVaccine Evaluation Center, BC Children’s Hospital Research Institute, Vancouver, British Columbia, Canada; dChildren’s Hospital Westmead Clinical School, The University of Sydney, Westmead, NSW, Australia; eThe Children’s Hospital at Westmead, Westmead, NSW, Australia; fDepartment of Pediatrics, University of British Columbia, Vancouver, British Columbia, Canada ABSTRACT Active vaccine safety surveillance, which involves directly engaging with vaccine recipients to actively solicit information on adverse events following immunization, complements spontaneous reporting systems. This commentary provides a comparative overview of three national active vaccine safety surveillance systems: AusVaxSafety (Australia), CANVAS (Canada) and V-safe (United States) across six key surveillance system evaluation attributes. Each system played an essential role during the COVID-19 pandemic and continues to contribute to global post-marketing vaccine safety surveillance. Each has various strengths and limitations. AusVaxSafety, established in 2014, is well integrated with routine healthcare settings for opt-out surveillance and offers frequent public reporting. CANVAS, established in 2009, offers a unique cohort-based design with inclusion of control groups. V-safe, established in 2020, has proven scalability and broad population reach due to its accessible web-based design. The various features of each system offer insights to inform future vaccine safety surveillance efforts. ARTICLE HISTORY Received 6 October 2025 Revised 21 November 2025 Accepted 2 December 2025 KEYWORDS Active vaccine safety surveillance; vaccine safety surveillance systems; AusVaxSafety; CANVAS; V-safe; Australia; Canada; United States; immunisation; safety; post-marketing surveillance Introduction The unprecedented scale and speed of the global COVID-19 vaccination roll-out exposed many of the limitations inherent to traditional spontaneous (passive) vaccine safety surveillance systems, which rely on individuals or their healthcare providers voluntarily reporting adverse events following immunization (AEFI) . 1 While spontaneous systems form the foundation of national vaccine pharmacovigilance, their reliance on the voluntary reporting of AEFI often leads to underreporting,2,3 which may limit their ability to effectively identify and respond to potential vaccine safety concerns. Active surveillance, a form of safety surveillance, involves directly engaging with vaccine recipients to actively solicit AEFI.4 Some active surveillance systems facilitate early detection and investigation of potential vaccine safety concerns.5 For systems using electronic tools for self-reporting this is often achieved through a questionnaire delivered via SMS messaging, mobile applications or online. Figure 1. Key steps of active vaccine safety surveillance outlines the key steps of active vaccine safety surveillance from vaccine administration to public health response. The COVID-19 pandemic prompted new development and adaptation of existing active surveillance systems to complement existing spontaneous surveillance to provide a comprehensive, timely and transparent assessment ofvaccine safety. Australia’s AusVaxSafety and the Canadian National Vaccine Safety Network (CANVAS), which were well established national systems prior to the pandemic, underwent rapid adaptations to monitor COVID-19 vaccines.5,6 I

FAQs

What makes active vaccine safety surveillance different from spontaneous reporting?

Active surveillance directly engages vaccine recipients to actively solicit adverse events following immunization, whereas spontaneous systems rely on voluntary reporting by individuals or healthcare providers.

Which three national systems are compared in the commentary?

The commentary compares AusVaxSafety (Australia), CANVAS (Canada), and V-safe (United States).

How were the systems used during the COVID-19 pandemic?

They were pivotal during COVID-19 and underwent adaptations or development to monitor vaccine safety, with each system continuing to contribute to global post-marketing surveillance.

Sep 29, 2026

Upload by acoobca