Mapping Data Flows for COVID-19 Vaccine Safety Surveillance in Namibia
Medicines and vaccines have transformed the modern world. Thanks to these innovations, diseases that used to kill large populations have been controlled over the past century, enabling more of the world’s population to live long and healthy lives and contribute to the global economy and scientific advancements. Key to the success of these tools is the science of pharmacovigilance—the detection, assessment, understanding, and prevention of any adverse effects related to the use of a specific medicine or vaccine. While all medicines and vaccines undergo rigorous clinical trials, such testing environments cannot account for all factors that products will come in contact with when used by large, heterogeneous populations over long periods. Due to time restraints and limitations on the types of individuals eligible to participate in clinical trials safely (typically not individuals with concurrent diseases, young children, or pregnant women), some side effects related to vaccine or medicine use can only be detected after the products have been widely released.
Countries require robust safety surveillance systems capable of timely detection, reporting, and analysis of adverse events in order to ensure the long-term safety of drugs and vaccines once they are available on the market. Such systems implement advanced pharmacovigilance approaches to ensure healthcare workers diagnose these events, quality data is captured for each event, and teams of experts are available to review the data and take appropriate actions. Ensuring comprehensive and timely surveillance is critical to individual patient safety and an essential factor in ensuring the public trust in medicines and vaccines.
In resource-limited health systems, many challenges impede routine detection and reporting of adverse events: inadequate resources for training health workers on the diagnosis and reporting of adverse events; fragmented and/or siloed health information systems creating backlogs or incomplete data; and limited messaging to the general public on how to identify and report adverse events accurately. With the rapid deployment of the COVID-19 vaccines, health systems worldwide have been even further challenged to monitor the safety of these novel vaccines and maintain the public trust in these lifesaving interventions.
Akros Research supports the Africa Centres for Disease Control and Prevention (Africa CDC) and the Mastercard Foundation to strengthen safety surveillance on the African continent through the Saving Lives and Livelihoods initiative. As the initiative supports countries in increasing the uptake of the COVID-19 vaccines, Akros is supporting ministries of health and other local stakeholders to strengthen systems for diagnosing, reporting, and analyzing adverse events following immunization (AEFI). In October 2022, the Akros team traveled to Namibia to execute a mapping exercise of the existing AEFI data flow channels. The Akros staff visited health facilities, district health offices, national health information units, and one private sector service provider, all in the Khomas region, to understand current processes for identifying and reporting AEFI data. Findings from the mapping exercise revealed multiple parallel streams of AEFI data following discrete pathways into siloed databases. The complexity of these multiple reporting pathways resulted in a large digitization and reporting burden at the district level, producing a backlog of data and challenges at the national level responding to cases in a timely manner. The burden is also experienced at the national level, where paper-based reports have to be entered manually into the VigiBase. Following a validation workshop where stakeholders reviewed these findings, Akros has proposed a path forward to simplify these data streams and create efficiencies in the reporting pathways. These efficiencies should reduce the workload across all levels and provide more timely data to AEFI case investigators. As the Saving Lives and Livelihoods initiative continues to deploy COVID-19 vaccines, the Akros-proposed solutions in Namibia will support stakeholders to monitor vaccine safety better and continue to build public trust in this essential public health tool.