Sovereign Oversight: Strengthening African Vaccine Regulation for Local Production

About the cover image: Dr. Solomon Owusu Sekyere (bottom right) guides the team from a partner country through an ELISA test.

In recent times, the quest to scale up local vaccine manufacturing capacity in Africa has witnessed a significant transitioning from being a policy option to a more structured effort directed at producing 60% of the continent's vaccine needs by 2040. This pivotal shift was predominantly catalysed by the covid 19 pandemic and the more recent zoonotic disease outbreaks like Mpox and Marburg virus which exposed critical vulnerabilities in many health systems across the continent to support provision of reliable access to life-saving vaccines at speed. In order to achieve a sustainable vaccine self-sufficiency, however, manufacturing expansion must advance in parallel with regulatory strengthening.

Regulation of vaccines - as carried out by national medicines regulatory authorities (NMRAs) and national quality control laboratories (NQCLs) - is central to functional pharmaceutical manufacturing ecosystems and assigned by WHO as one of health systems’ basic functions.  It ensures that vaccines that are manufactured for public use are of high quality, safe and efficacious; a priority articulated in the United Nations Sustainable Development Goals. 

A strong regulatory system is therefore a foundational requirement to safeguarding public health. Consequently, African countries pursuing local vaccine manufacturing must aim to attain at least WHO Maturity Level 3 (ML3) status, which serves as a global benchmark for a stable, well-functioning and integrated regulatory system. Achieving this foundational milestone is critical for African-made vaccines as it also enables WHO prequalification and subsequent procurement by international agencies like GAVI and UNICEF for global distribution.

The current status, however, is that most NMRAs in Africa lack the required regulatory capacities and competencies to optimally support local manufacturing of vaccines and other biological products. Such weak regulatory systems risk undermining the public trust necessary for uptake and hinders sustainable vaccine manufacturing efforts. 

VaccRelease is a project at the Paul-Ehrlich-Institut within the Global Health Protection Programme (GHPP) of the German Federal Ministry of Health (Bundesministerium für Gesundheit, BMG) initiated in 2023 with an aim to contribute to strengthening the capacities of partner NMRAs/NQCLs for the official lot release of vaccines. By investing in the GHPP this way, Germany contributes to global efforts aimed at supporting the capability to detect and contain infectious disease outbreaks at source before they escalate into global threats.

A baseline gap analysis of the regulatory oversight and quality control system for locally produced vaccines in the partner countries revealed several issues, including:

1. inadequate or non-existent regulatory structures and processes 
2. limited technical expertise in experimental testing of vaccines and other biologics, as well as in evaluating the quality aspects of marketing authorization dossiers
3. inadequate infrastructure, including laboratory spaces, equipment and digital systems and
4. lack of harmonized processes and regulatory frameworks across countries

With this backdrop, VaccRelease formulated a three-tiered capacity strengthening strategy which provided interventions at the national- (i.e. through partner countries), regional- (through vaccine Regional Centers of Regulatory Excellence (RCOREs)) and continental-level (through the African Medicines Quality Forum vaccines sub-committee). Specifically, we first provided technical assistance in self-benchmarking of the NMRA approval system of vaccine batches using the WHO global benchmarking tool (GBT). As a next step, we supported the development of regulatory structures and processes including regulations, guidelines and Standard Operating Procedures (SOPs) and further provided expanded hands-on trainings either virtually or on-site at the Paul-Ehrlich-Institut to upskill human resource capacity. Additionally, we facilitated the establishment of a platform for information sharing and trust building through annual study tours.

Overall, the systematized approach in initially identifying strengths and areas of improvements before tailoring interventions to addressing them was pivotal in successfully developing regulatory structures and processes for lot release in partner NMRAs. 

The collaborative nature of our strategy in forging an operational relationship with other partners such as GIZ, PTB, EDQM and WHO in jointly embarking on annual study tours also proved effective. It helped to prevent duplication and provided maximized impact that contributed to the establishment of the Network of African Reliance Laboratories’ workstream for continental lot release harmonization.

• Agile Monitoring and Evaluation: A prospective M&E protocol that allows for early problem identification, enabling real time corrections and dynamic adjustments for agile improvements is vital in achieving regulatory capacity strengthening outcomes.

• Practical on-site impact: Conducting hands-on trainings in-person at host institutions is an invaluable asset that presents a practical understudy template essential for implementation at partner institutions.

• Importance of local context: Prioritizing local context nuances and challenges ensures training content or newly developed procedures are easier implemented on the ground. 

• Leveraging partnerships: Regulatory capacity strengthening for oversight and quality control of locally produced vaccines is often complex and multi-faceted and requires coordinated efforts by different partners.

After over three years of VaccRelease’s regulatory capacity strengthening intervention in vaccines lot release, some challenges still remain, including:

• Restricted testing capabilities and administrative barriers to new NMRAs/NQCLs partnerships

• Confidentiality issues in sharing SOPs, samples, critical reagents that are vital in capacity strengthening activities

• Limitation in providing requisite equipment that aid implementation and facilitate achievement of training-related outcomes

Aside doner organizations that support infrastructure and laboratory systems strengthening, technical partners such as other well-resourced testing laboratories, research institutes and vaccine lot release RCOREs are equally crucial in supporting the regulatory capacity development agenda. Summarily, they help to extend testing scopes and increase the variety of vaccine-specific tests for NQCLs’ trainings, equip new staff with fundamental technical skills for biological testing methods and deepen south-south cooperation which fosters regional harmonization respectively. A coordinated, collaborative, and expert-driven partnerships in regulatory capacity strengthening would therefore be crucial for achieving the resilient and credible regulatory systems needed to anchor sustainable local production of vaccines and other biological products in Africa.

We asked Dr Solomon Owusu Sekyere, project manager of the GHPP VaccRelease 2.0 project of the Paul Ehrlich Institute, to share with us the significance of the project and his experiences in strengthening African vaccine regulation. The views expressed are his own and do not necessarily reflect those of Global Health Hub Germany.