In the global fight against the COVID-19 pandemic, the rapid development and distribution of vaccines have been pivotal in safeguarding public health. In Singapore, the government has undertaken a pioneering initiative to ensure the safety and efficacy of these vaccines.
The Active Surveillance System for Adverse Reactions to Medicines and Vaccines (ASAR) Project, a collaboration between Singapore’s Integrated Health Information Systems (IHiS) and the Health Sciences Authority (HSA), represents a groundbreaking approach to vaccine safety monitoring.
The ASAR project is an extension of ongoing efforts by IHiS and HSA to actively monitor the safety of COVID-19 vaccines approved in Singapore. Its primary objective is to empower HSA to proactively oversee the safety of these vaccines, ensuring that the benefits of vaccination consistently outweigh any potential risks. Unlike traditional approaches that rely on spontaneous reporting of adverse events (AEs) by healthcare professionals and companies, ASAR takes an active surveillance stance.
To achieve this, ASAR complements conventional AE reporting with active surveillance, utilising de-identified electronic health records to detect and validate potential safety signals. This data-driven approach allows for the early detection of emerging safety signals and facilitates timely risk mitigation measures to safeguard public health.
ASAR’s contributions extend beyond immediate safety monitoring. By leveraging the findings and investigations from the system, HSA has been able to inform vaccination policies in collaboration with the Ministry of Health (MoH) and the Expert Committee on COVID-19 Vaccination (EC19V). This collaborative effort ensures that vaccination strategies remain aligned with the evolving safety landscape.
The urgency of establishing ASAR became apparent as Singapore embarked on its mission to achieve population-wide immunity through mass vaccination campaigns. The deployment of COVID-19 vaccines to nearly the entire population of Singapore necessitated a robust and active safety surveillance system.
Jalene Poh, the Director of the Vigilance and Compliance Branch at HSA, highlighted the need for an active surveillance system to ensure the early detection of safety signals. Such signals could emerge from the diverse experiences of individuals receiving vaccines, making comprehensive safety monitoring imperative.
The successful implementation of ASAR underscores the significance of cross-government collaboration. This initiative was set in motion well before the approval of the first COVID-19 vaccine in Singapore, emphasising the importance of interoperability and accessibility of databases in the process.
The concerted efforts of HSA, IHiS, MoH, and the Health Promotion Board (HPB) played a pivotal role in swiftly establishing the necessary IT systems and processes for recording all COVID-19 vaccinations. These teams also ensured that the essential datasets were seamlessly integrated into the Business Research Analytics Insights Network (BRAIN), laying the foundation for ASAR’s analytical tools.
ASAR leverages cutting-edge technology, employing artificial intelligence (AI) to centrally aggregate over 2 million de-identified structured and unstructured health records daily. An AI-powered deep-learning algorithm is utilised to detect adverse events related to medicines and vaccines, allowing HSA officers to identify potential links between reported symptoms and administered treatments.
This data-driven approach has significantly enhanced HSA’s capacity to conduct research aimed at improving safety measures for public health protection.
ASAR’s impact on safety monitoring is notable. It has played a crucial role in detecting safety signals early on, such as adverse events like anaphylaxis and myocarditis associated with COVID-19 vaccines. These findings prompted the implementation of risk mitigation strategies, including extended observation periods and post-vaccination recommendations.
Also, ASAR has been instrumental in examining the frequency of serious events like myocardial infarction post-vaccination, providing valuable insights into the overall safety profile of the vaccines. HSA’s transparent publication of safety findings, with 14 safety reports as of February 2023, has bolstered public confidence in the vaccines used in the national vaccination campaign.
Andy Ta, the Director of Data Analytics & AI and Chief Data Officer at IHiS emphasised the potential of electronic health records for safety surveillance. Traditional systems rely on reports from doctors and drug companies, potentially resulting in underreporting and delays. ASAR harnesses electronic health records, offering real-world data for near-real-time safety risk detection and quantification.
ASAR represents a significant milestone in safety surveillance. It is the first nationwide system to employ both structured and unstructured medical records, taken from public acute hospitals and national databases, for active safety surveillance. This secure platform, BRAIN, is at the core of ASAR’s success, providing a modern analytics architecture that can adapt to evolving needs.
As ASAR continues to evolve, it has the potential to serve as a model for safety surveillance beyond COVID-19 vaccines. The collaboration between HSA and IHiS has yielded tools capable of detecting, analysing, and confirming safety signals, and these tools can be adapted for broader use in healthcare.
The adaptability of ASAR and its interoperability with other analytical platforms, including electronic health records, demonstrates its potential to advance safety monitoring across diverse data sources and systems.
