Vaccines are rightly held to the highest possible safety standard of any pharmaceutical product. To ensure this high standard is met throughout the world, WHO works with Member States to ensure that national guidelines are in place to:
- detect any serious adverse event following immunization (AEFI);
- investigate and assess whether the event was causally linked to vaccination;
- respond effectively, including communicating to the public at all stages of the investigation and response.
The Republic of Moldova is currently revising its national AEFI surveillance system based on WHO principles, including the development of a first-ever set of national guidelines. To support the Ministry of Health, Labour and Social Protection in raising national capacity to develop and implement these new guidelines, WHO/Europe conducted a technical mission to Chisinau on 25–29 June 2018.
Almost 120 participants attended the training, from the National Agency for Public Health, the Mother and Child Care Health Institute, the national drug regulatory authorities, the national expert committee for reviewing AEFI, and primary health care and hospital services.
In her opening remarks, Secretary of State Aliona Serbulenco, stressed that “vaccines are the safest and most tested pharmaceutical products… I’m glad that Moldovan health professionals have the opportunity to learn from top experts about AEFI causality assessment, diagnosis and correct classification”.
Comprehensive capacity-building
The training allowed participants to:
- review the national AEFI surveillance system and WHO basic concepts, terms and definitions in AEFI surveillance;
- review AEFI surveillance system objectives, events to report and roles and responsibilities, including procedures and tools for AEFI reporting and investigation;
- review data reporting elements (variables and forms), data processing and management procedures;
- gain an overview of the national mechanism and procedures for AEFI causality assessment;
- review AEFI crisis management and risk communication.
A special group of experts was trained separately to conduct AEFI-related trainings for frontline health workers from all districts.
First-ever AEFI guidelines in Republic of Moldova
The new guidelines will define AEFIs as any adverse events occurring in the post-vaccination period and that are not necessarily caused by the use of the vaccine. This and other standard WHO definitions will help improve the quality of the reported data and causality assessments. The new system will also allow reporting of any AEFIs by both medical workers and the public.
A national competence-based expert committee will be established to assess the causes of AEFIs and to classify them accordingly. This will allow for timely and effective risk communication to avoid rumours and misinterpretation of the data.
Based on recommendations provided by WHO experts, a national working group will finalize the draft of the national guidelines on AEFI surveillance and conduct a series of cascade trainings at institutional and local levels by the end of November 2018.