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Review

Vaccine pharmacovigilance in South Africa: successes and limitations of current approaches

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Received 08 May 2024, Accepted 26 Jul 2024, Accepted author version posted online: 08 Aug 2024
 
Accepted author version

ABSTRACT

Introduction

Despite the public health success of vaccination, there is an ongoing need to build public confidence in vaccines and improve systems to monitor safety while maintaining data security and patient privacy. African countries face multiple challenges in establishing systems for vaccine pharmacovigilance as was demonstrated during COVID-19 mass vaccination. We provide a framework for the development of pharmacovigilance using the COVID-19 vaccination roll-out as an exemplar.

Areas covered

We describe the pre-COVID-19 vaccine pharmacovigilance systems in Southern Africa and propose improvements based on our experience of COVID-19 vaccine roll-out in South Africa where we implemented systems to evaluate real-world safety and effectiveness of COVID-19 vaccinations. By conducting a pubmed review of the literature on pharmacovigilance with a focus on Africa and from guidance emanating from the World Health Organisation (WHO), we evaluate challenges and opportunities to improve pharmacovigilance in our setting.

Expert opinion

There are ongoing efforts to improve pharmacovigilance on the African continent with improved coordination at a national level with the support of WHO, the national regulatory authorities, and national departments of health. COVID-19 vaccine roll-out provided an opportunity to improve pharmacovigilance by integrating national vaccine platforms with active and passive surveillance including hospital and death registries.

Disclaimer

As a service to authors and researchers we are providing this version of an accepted manuscript (AM). Copyediting, typesetting, and review of the resulting proofs will be undertaken on this manuscript before final publication of the Version of Record (VoR). During production and pre-press, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal relate to these versions also.

Article Highlights

  1. Investing in the establishment of pharmacovigilance systems is imperative to improve the reporting and management of safety of vaccines and drugs registered for use in Africa.

  2. Training health care workers in pharmacovigilance will be critical for effective systems for vaccine pharmacovigilance.

  3. Data-linkages must ensure robust systems to protect data security and privacy breaches

  4. Passive and active surveillance enhances pharmacovigilance systems

  5. COVID-19 vaccine roll-out and the Sisonke case study provided an improved framework of pharmacovigilance in South Africa

  6. Innovations such as digitization of health care records and text messaging can improve the management of safety.

Declaration of interests

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contribution statement

J Peter, A Takalani3, JC Meyer and G Gray: conceived and wrote the first draft, were involved with the editing, addressed reviewers comments and were responsible for the final manuscript.

B Semete-Makokotlela, S Collie, I Seocharan, A Goga, N Garrett, and L Gail-Bekker: provided comments, input on regulatory aspects, data management, and input on the safety as well as editing.

Additional information

Funding

This paper was not funded.

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