Surveillance Evaluation of COVID-19 Pharmacovigilance—Karakalpakstan, Uzbekistan, 2022
Background: COVID-19 vaccines are safe and effective. Rapid rollout of vaccines reduced COVID-19 morbidity and mortality globally. Pharmacovigilance systems have ensured safety of these vaccines. Well-functioning vaccine safety surveillance builds public confidence in vaccine programs, but these systems may be lacking in limited-resource settings. To identify gaps in pharmacovigilance surveillance, we conducted an evaluation in Khojaly District, Uzbekistan, with a population of 120 thousand people.
Methods: We reviewed regulatory documents related to COVID-19 vaccination and registration of side effects after immunization. We also conducted a survey in April 2022 of 30 healthcare providers in 5 of 10 polyclinics in Khojaly districts whose responsibilities included vaccination of the population. The survey asked about their knowledge and practices related to adverse events following immunization (AEFI). AEFI was defined as any health condition that occurs after immunization and does not necessarily have a causal relationship with vaccination.
Results: From April 2021 to March 2022, 78,281 people had been vaccinated against COVID-19 and 9,318 people had refused vaccination. AEFI is not included in aggregated district reports, and individual-level AEFI data was complex to access and use for surveillance. Among healthcare providers surveyed, 7% did not know where or to whom they should report any AEFI. Half (50%) of providers had encountered a case of AEFI following COVID-19 vaccination and 20% encountered a case of severe AEFI. Cases of AEFI had only been registered in patient medical charts, and this information had not been reported into the AEFI surveillance system. Also, emergency notification reports had not been transmitted nor investigations conducted for severe AEFI cases.
Conclusions: Important considerations were identified in COVID-19 pharmacovigilance surveillance. The system can be strengthened by including summary AEFI data in district reports and through increased training of healthcare providers in standard operating procedures for identifying, reporting and investigating AEFI cases associated with COVID-19 vaccines.