A research consortium is set to further establish a vaccine safety evidence-generation network in Africa, seeking to understand the general prevalence of anticipated adverse events specifically relevant to African populations.

CEPI is providing up to US$9.9 million for the Background Rates of Adverse Events for Vaccine Evaluation in Africa project led by the Global Vaccine Data Network (GVDN)—based at Auckland UniServices Limited in the University of Auckland—in partnership with the University of the Witwatersrand in South Africa, Navrongo Health Research Center in Ghana, International Foundation Against Infectious Diseases in Nigeria, Eagle Research Center in Rwanda, and Health Research Operations Kenya (operating as KEMRI-Wellcome Trust Research Programme) in Kenya.

 CEPI funds will support local researchers across these research sites to understand incidence rates of naturally occurring clinical events, such as Guillain-Barré Syndrome, sensorineural hearing loss, and others, that typically occur in African populations (i.e., without any medical interventions).

With this baseline data, or background rates, researchers in Africa will then be able to evaluate whether an adverse event reported in a vaccine trial may be associated with the vaccine—an adverse event of special interest (AESI)—or is coincidental and occurs at a rate within expected background levels in the general population.

This comprehensive monitoring—specific to African populations—helps set expectations for what might be expected when the vaccine is rolled out more widely, minimising the risk of trials being halted or public confidence in the vaccines being undermined. Crucially, this data enables regulatory authorities to make informed decisions about vaccine safety on its path to approval and roll-out.

Until now, vaccine safety infrastructure in African countries has often relied on background rates of adverse events data generated in the Global North. However, African populations are known to respond differently to some infections and vaccinations, so safety data generated outside of Africa may not be an appropriate comparison.

Further, as more vaccines targeting diseases endemic to Africa are developed and introduced directly to African countries, pre-existing vaccine safety data will not exist.

“Having this newly formed network in place will help contextualise any adverse events reported in clinical trials and will ultimately enable timely evidence generation of vaccine safety during public health responses in Africa,” said Jakob Cramer, Director of Clinical Development, CEPI.

“Access to data on expected adverse events specific to the region will further support decision-makers in interpreting safety findings from clinical trials, speeding up access to safe, effective vaccines for affected populations during emergencies.”

GVDN Co-Director Dr. Steven Black states “With this collaboration, the GVDN will be helping provide data to assure vaccines used in Africa are both safe and effective. With new pathogens emerging in this region, developing this capacity is critical.”

UniServices acting CEO, Dr. Greg Murison, welcomes the creation of the consortium: “I am thrilled the GVDN has been involved in creating and leading this priceless work towards improving vaccine safety in Africa. This work reflects the GVDN’s core principles of working with multiple agencies—including global health agencies and non-profit health alliances—to help ensure the safety and risk-benefit of vaccines through vaccine monitoring.

This work will benefit the whole consortium as we share and analyse knowledge and results and go on to benefit many people.”

The project will leverage a platform developed by Gavi, the Vaccine Alliance, which performed the only active vaccine safety surveillance study to estimate the risk of AESI in Africa during the COVID-19 pandemic.

 The network will initially apply the background rate of adverse events data to Lassa vaccines under development in CEPI’s portfolio, enabling the interpretation of any AESI observed during these clinical trials.

CEPI and GVDN are committed to enabling equitable access to the outputs of this CEPI-supported programme, in line with CEPI’s Equitable Access Policy. Project results will be published on GVDN’s public dashboard and made freely available for the benefit of the global scientific community.

Additional quotes from research partners:

Clare Cutland, Scientific Coordinator, African Leadership in Vaccinology Expertise (ALIVE), University of the Witwatersrand in South Africa: “As efforts to combat infectious diseases, including Lassa fever, through vaccine development progress, it is crucial to establish robust systems for monitoring the background rates of adverse health events in Africa. Understanding the baseline incidence of conditions that could be mistaken for vaccine-related events allows us to accurately assess vaccine safety and effectiveness. Given the unique epidemiological and healthcare contexts across African countries, such data are vital for building public trust and ensuring the safe rollout of vaccines. Comprehensive surveillance not only supports the success of vaccination programs but also enhances our ability to detect, respond to, and mitigate risks associated with this critical public health intervention.”

Professor Stephen Obaro, Co-Founder, International Foundation Against Infectious Diseases in Nigeria (IFAIN) and Professor of Pediatric Infectious Diseases at the University of Alabama: “Vaccines continue to be our greatest asset in preventing infections and associated suffering and deaths, particularly amongst communities with fewer resources, where treatment is unavailable or unaffordable. Many lessons were learnt from the COVID-19 pandemic, some for the global good but others detrimental. Investing in generating data from Africa is crucial for improving our scientific understanding of vaccine value and performance in the context of local disease epidemiology and potential adverse events following their use. This data plays a key role in combating misinformation and building local capacity in vaccine science.”