Expert Opinion on Drug Safety journal publishes research on vaccine pharmacovigilance in South Africa, co-authored by Discovery Health Intelligence unit

The need for enhanced vaccine pharmacovigilance systems in African countries was highlighted during the COVID-19 pandemic. It remains to necessary to build public confidence in vaccines and improve pharmacovigilance systems in general.

 - Pharmacovigilance is a discipline that relates to the detection, assessment, understanding and prevention of adverse effects caused by medicines. This field is important both for monitoring new medicines or vaccines for and detecting rare adverse events once the medicines or vaccines have been registered for use.

An article published in the Expert Opinion on Drug Safety journal in August 2024 describes the pre-COVID-19 vaccine pharmacovigilance systems in Southern Africa and proposes improvements, based on the COVID-19 vaccine roll-out in South Africa where systems to evaluate real-world vaccine safety and vaccine effectiveness were implemented. The review uses the South African example and the Sisonke study as case studies.

The Sisonke Study used comprehensive data from the private medical schemes to gain insights into COVID-19 vaccine outcomes in South Africa. Data from the schemes administered by Discovery Health and the Government Employee Medical Scheme were crucial in evaluating vaccine efficacy and safety in this regard. These schemes' databases contained detailed demographic information, medical authorisation data, admission data, and administrative claims data, all categorised with valid WHO ICD10 codes. Together, the two medical schemes accounted for around half of the participants in the Sisonke Study.

These collaborative efforts highlight the value of private-sector data in conducting real-time pharmacovigilance and improving public health responses to vaccination programmes. Often, medical schemes do not cover an entire population. This means that the results obtained may not be generalised. So, continuous monitoring and analysis are essential to accurately capturing and reporting on vaccine-related adverse events across both public and private health sectors.

Key findings from the paper

• Investing in the establishment of pharmacovigilance systems is imperative to improving the reporting on and management of the safety of vaccines and drugs registered for use in Africa.
• Training healthcare workers in pharmacovigilance will be critical to ensuring effective systems for vaccine pharmacovigilance.
• Data-linkages must ensure robust systems to protect data security and privacy breaches.
• Passive and active surveillance enhances pharmacovigilance systems.
• The COVID-19 vaccine roll-out and the Sisonke case study provided an improved framework of pharmacovigilance in South Africa.
• Innovations such as digitisation of healthcare records and text messaging can improve the management of safety.

Conclusion

Overall, the Expert Opinion on Drug Safety publication concluded that the World Health Organization (WHO) Global Advisory Committee on Vaccine Safety (GACVS) was an important global resource that could support national vaccine programmes.

Nationally, co-operation between the Expanded Programme on Immunisation (EPI) and the National Regulatory Authority was vital for vaccine safety and surveillance. The publication recommended that regulatory authorities develop systems to ensure the quality, safety and efficacy of medicines and vaccines once they were rolled out for use.

The COVID-19 vaccine roll-out process was beneficial to the assessment of the safety and effectiveness of vaccines. These included the establishment of the Electronic Vaccine Data Systems (EVDS), the digitisation of safety reporting systems which linked to the EVDS, and the establishment of links between the EVDS and hospital surveillance systems and death registries. Social media platform strategies and direct engagement with communities via text messaging also helped to improve real-time safety reporting.

Study authors recommended that healthcare provider pharmacovigilance training be improved.

The Sisonke Study helped to highlight the importance of strong collaboration between various entities to achieve pharmacovigilance. During South Africa's response to COVID-19, public and private sectors collaborated, harnessing the unique strengths and capabilities of both sectors to benefit the entire population. The Sisonke Study provided a best-case example of pharmacovigilance with integration and harmonisation of national vaccination, hospitalisation and death registries database, linkages between public and private healthcare datasets, and combined active and passive adverse event following immunisation (AEFI) reporting.

- Read the Expert Opinion on Drug Safety publication  in full.

Interested in knowing more or reporting on these findings?

Please contact us on MEDIA_RELATIONS_TEAM@discovery.co.za to request any updated data available since publication and to obtain any further context required.

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