In November 2022 the WHO, with “financial support” from USAID, finalised a project on vaccine safety monitoring in Kyrgyzstan. Described as providing support to its government in response to the COVID-19 pandemic, it focused on “adapting and implementing regulatory pathways and procedures” for public health emergencies. It further “strengthened the pharmacovigilance, monitoring, and surveillance of adverse effects following immunisation (AEFI)”.
High standards for all
Promoting the notion of “shared responsibility” the WHO statement indicates that vaccine safety monitoring in Kyrgyzstan is covered by several stakeholders, including the National Immunisation Programme and the National Regulatory Authority for Medicines. Among the achievements of the project was the “establishment of client follow-up and self-reporting systems on AEFI”.
Recording and monitoring AEFI against COVID-19 has taken place since March 2021, with the development of an electronic database. This was integrated with the national system for registering vaccinated persons. Consequently, more than 2109 AEFI could be registered in the system by September 2022. Validated AEFI were shared with the WHO database, VigiBase.
VigiBase is a “unique” global database of potential side effects for medicinal products. It contains over 30 million reports of suspected adverse effects and is continuously updated. Its purpose is to ensure that medicine-related safety problems are quickly identified.
In Kyrgyzstan more than 800 health care workers were trained in the “surveillance and reporting” of AEFI against COVID-19 and pharmacovigilance. Furthermore, over 100 experts from the Department of Medicine and Medical Devices were trained in “vaccines and medicines regulation”.
“Training was provided by recognised experts, including from the Eurasian Economic Union, and capacity-building training on causality assessment of adverse effects following immunisation and adverse drug reactions was also conducted.”
Internal strength: legislation, policy, and coordination
During the project, revisions were made to the regulatory framework for reporting, surveillance, and monitoring of AEFI. Results of the procurement and supply chain management system assessment and the evaluation of state drug policy for 2016-2020 were “communicated”
“These are building on the foundation for the future development of the strategy document on medicines, vaccines, and medical devices regulation, including in emergencies.”
WHO states that one of the “main objectives” was to “build institutional capacity in vaccine development management, and regulatory mechanisms”. Furthermore, preparation for coordination within “future activities” was developed.
The announcement comes just days after the WHO’s publication of the Global Vaccine Market Report 2022 in which national regulatory and development efforts were promoted. If you would like to hear more about legislation and regulatory importance then get your tickets to the World Vaccine Congress in Washington 2022.