Vaccine Safety and Pharmacovigilance in the African Region: Recent updates

Abstract

Introduction: The number of subjects in clinical trials, is often limited and inadequate for detection of all adverse events which may be associated with vaccines, especially very rare ones. In addition, there is a surge in introduction of new vaccines into national immunization programmes in the WHO African Region, some of which have been used in a limited number of people, highlighting the need for functional national for pharmacovigilance systems for adverse events following immunization (AEFIs). Recognizing this, WHO and partners are supporting countries to develop national plans, providing training and investments in vaccine safety and pharmacovigilance. Despite these efforts, surveillance for vaccine safety in many countries remain weak. This paper reviews cases of AEFI reported by countries countries in the WHO/UNICEF Joint Reporting Form of WHO/AFRO between 2010 and 2015, discusses some of the causes of the low reporting while exploring how countries can rely on new opportunities and systems to improve their reporting and vaccine safety in general. Methodology: The implementation status of multi-stakeholder national plans developed by national immunization programmes, Pharmacovigilance Centres (PVCs) and the National Regulatory Authorities (NRAs) of 28 countries was reviewed. Using data from the WHO/UNICEF Joint Reporting Form and the introduction of new vaccines by countries in the WHO African, the impact of these plans on reporting of AEFIs was assessed for the countries. Results: The analysis of performance revealed that only five countries have fully implemented plans for vaccine safety monitoring and pharmacovigilance in accordance with the Global Vaccine Safety Initiative (GVSI) blueprint. Implementation of the plans in the remaining 23 countries is slow. From 2010 - 2015, just 28 countries reported AEFIs as part of the WHO /UNICEF JRF. Yet 83% of countries introduced at least one new vaccine, with an average of 2 to 3 new vaccines being introduced per country over the period. Many countries have not fulfilled the responsibility of establishing expert committees on AEFI, developed guidelines, trained their staff on vaccine safety and put in place effective vaccine safety communication. Discussion: The low AEFI reporting and weak pharmacovigilance demands special emphasis on capacity building, tailored to country needs to improve the reporting to meet the GVAP goals and UMC ADR guidelines. More sustainable support in ways that strengthen pharmacovigilance in general for all medical products and AEFI surveillance in particular in countries is needed. Opportunities are presented by the GVAP, the GVSI, networks such as the African Vaccine Regulatory Forum (AVAREF), Developing Countries Vaccine Regulatory Network (DCVRN), Developing Countries Vaccine Manufacturers Network (DCVM) and the International Federation of Pharmaceutical Manufacturers (IFPMA) as well the African Medicines Regulatory Harmonization (AMRH). African countries should exploit these opportunities to further strengthen their AEFI monitoring and pharmacovigilance.