There is a growing demand for effective pharmacovigilance systems, especially with the increased use of vaccines. Monitoring adverse events following immunisation (AEFI) is essential for ensuring vaccine safety and public trust. The national pharmacovigilance center (NPC) in Saudi Arabia plays a crucial role in establishing a reporting system for AEFI but faces challenges such as underreporting and limited awareness among healthcare professionals. Low reporting rates and reliance on traditional methods has in turn hindered data quality and decision-making. To address these issues, the NPC has launched initiatives with the Ministry of Health, appointed regional coordinators, and promoted timely reporting and AEFIs.
In an effort to create a more responsive and transparent system for reporting AEFI, the NPC has implemented a comprehensive action plan that includes direct reporting through an enhanced electronic system as well as a three-day training workshop in collaboration with experts from the World Health Organization (WHO). The workshop brought together approximately 40 participants from WHO, the AEFI committee, the SFDA, and the national immunisation programme (NPI) in Saudi Arabia to enhance the SFDA, NPI, and AEFI committee's ability to monitor vaccine safety by sharing WHO guidelines, best practices, and tools. This included evaluating vaccine safety monitoring systems and effectively using AEFI data to identify, assess, and manage vaccine safety events, conducting AEFI causality assessments, and providing feedback to stakeholders. The discussions had in the workshop culminated into a national work plan for 2024-2025.
Prior to the workshop, participants' knowledge about vaccines and the reporting mechanisms for adverse effects was assessed, yielding an average score of 12.5 out of 20 (62.5%). Following the workshop, this score significantly improved to an average of 18 out of 20 (90%).
Following the success of the workshop, the NPC developed and implemented a comprehensive work plan to do the same for regions that did not report during previous quarters of 2024, referred to as "silent areas." The plan focused on preparing training materials and coordinating with the NIP for in-person visits to these silent areas to carry out workshops aimed at enhancing awareness of vaccine safety. Coordinators are also tasked with organising ongoing training to ensure sustained awareness about vaccines.
Additionally, the NPC conducts regular remote meetings with regional coordinators to establish key performance indicators, which are monitored on a monthly basis. Following these assessments, response levels are evaluated, and necessary corrective actions are implemented if needed.
As a result of these efforts, no silent areas were identified during the last quarter of 2024. The improvements made to the adverse event reporting system have led to enhanced quantitative and qualitative outcomes, as well as faster responses to investigative reports, facilitating the analysis and classification of cases in accordance with international standards set by organisations such as WHO and the Council for International Organizations of Medical Sciences.
Furthermore, serious cases are routinely presented to the causality assessment committee, which is responsible for decision making regarding the relationship of these cases to vaccines. The processing time for reports has significantly decreased, enabling quicker responses and immediate engagement with potential high-risk cases.
In light of ongoing global health challenges and the imperative to enhance vaccine safety and efficacy, the experts from WHO recommend several strategic initiatives going forward to strengthen the capacity of “Emerging Market” countries, such as the SFDA, and ensure comprehensive immunisation efforts. In line with our previous agreements, we plan to carry out the following activities in the near future:
- Further capacity building on vaccine safety
- Performing more clinical trials of new vaccines
- Piloting immunisation studies related to pregnancy
- Participating in the coordination of training on VigiMobile for vaccines
These positive developments highlight the importance of sustaining our efforts and affirm the effectiveness of investing in the enhancement of pharmacovigilance systems to ensure vaccine safety.
