Manufacturing products locally for more equitable pandemic responses
Every year, vaccines prevent nearly 5 million deaths around the globe. Yet, Africa produces less than 1 percent of the vaccines it needs to protect patients and communities across the continent.
Of the vaccines that African countries produce locally, little to none are for regional export; they’re used almost exclusively for national supply. The continent is currently ill-equipped for large-scale production.
Only 1% of vaccines in Africa are produced on the continent. By 2040, Africa plans to manufacture 60% of vaccines regionally.
Expanding vaccine manufacturing across Africa will improve public health and save lives. Increasing capacity will also help the continent respond to future health emergencies, provide more treatment options to patients, diversify markets, shorten medical supply chains, and spur economic growth.
“Vaccine inequity is a problem we saw coming: our experience with HIV, the H1N1 flu pandemic, and other global health challenges has taught us that market forces alone will not achieve equity” - Dr. Tedros Adhanom Ghebreyesus, WHO Director-General
Vaccine manufacturing requires infrastructure, capacity, and resources to support research and development and enable drug substance production and complex formulation, all of which are currently limited across Africa. In the absence of locally produced and affordable vaccines, Africa previously relied on importing products.
Of 55 countries in Africa, only eight have the capability and technology necessary to manufacture vaccines locally. Of these countries, five have end-to-end manufacturing capacity, and three can import, label, or pack vaccines, a process known as fill and finish. In addition, six countries are either currently acquiring or planning new or additional vaccine manufacturing capabilities.
Improving access to vaccines:
Quality-assured vaccines will help countries respond to future pandemics
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While fill and finish is the last step of the manufacturing process, establishing robust end-to-end manufacturing capabilities would include the ability to produce raw materials, active pharmaceutical ingredients (APIs), and finished products.
However, few companies are developing fully integrated manufacturing capabilities that include drug substance generation and purification, as well as complex drug product manufacturing operations. There is currently limited vaccine research and development of novel vaccines.
Next steps to expand capacity
Reducing vaccine inequities across Africa, whether for COVID-19, Ebola, Mpox, or routine immunizations, requires reducing reliance on imported products by building strong partnerships across multiple sectors, including government regulatory agencies.
Strengthening regulatory expertise is necessary to improve facility inspection and authorization, product dossier review and approval, and post-marketing surveillance and pharmacovigilance for vaccines and other medical products.
Readying African vaccine manufacturers for the next pandemic
Pivoting to greater local production
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According to WHO, approximately 30 percent of national medicine regulatory agencies worldwide have the tools and capacity they need to perform core regulatory functions to ensure the quality of medicines, vaccines, and other medical products.
In Africa, a few countries have been assessed as performing at WHO maturity level 3, including Ghana, Nigeria, and Tanzania, which have been benchmarked for imported and distributed vaccines. Only Egypt and South Africa achieved that level for the regulation of vaccines manufactured, imported, or distributed in their countries.
Last-mile manufacturing of vaccines
Expanding ‘fill and finish’ and the final few steps
A more resilient supply of vaccines is also necessary to minimize supply chain interruptions and shortages of routine childhood vaccines against polio, DPT (diphtheria-pertussis-tetanus) and measles, among others.
To help make vaccine manufacturing in Africa a reality and improve sustainability across the continent, we recommend the following four actions:
Catalyze technical assistance
- Train, expand, and retain the intellectual knowledge base of the workforce necessary to sustain all disciplines within the vaccine ecosystem.
- Provide independence for Africa to pursue its own vaccine development agenda and meet its needs.
Enhance vaccine manufacturing strategies
- Reduce competition, optimize collaboration, and enhance manufacturers’ self-reliance and sustainability.
- Expand local and regional distribution or export to decrease dependency on imported vaccines.
Strengthen regulatory systems
- Streamline the approval process for vaccine manufacturers through continental harmonization of regulatory requirements.
- Increase trust in vaccine authorization among African countries with more knowledgeable and efficient national regulatory authorities and quality control laboratories.
Leverage the role of governments and stakeholder collaboration
- Facilitate country, regional, and continental vaccine needs and production strategies to align across public health sectors.
- Guide short-term and long-term objectives of national immunization plans and support sustainable expansion of manufacturing to reduce dependence on donor funding.
For more information, see the full white paper