TITLE:
Assessing Kenya’s Readiness for Vaccine and Biotherapeutics Manufacturing by BioVax: Challenges, Strategies, and Stakeholder Insights
AUTHORS:
Abook Brian, Cecilia Wanjala, Joāb Odhiambo, Serah Muteru
KEYWORDS:
Vaccine Manufacturing, Biotherapeutics, Public Health, Pharmaceutical Industry, Regulatory Frameworks, Healthcare Innovation
JOURNAL NAME:
World Journal of Vaccines,
Vol.16 No.3,
August
6,
2026
ABSTRACT: In Kenya, there is a need to assess readiness for vaccine manufacturing, given the challenges in affordability and availability of vaccines and biotherapeutics. Through stakeholder mapping, this study aimed to evaluate the potential of Kenya BioVax Institute in producing vaccines and biotherapeutics and the implications for the health sector. The objectives were to identify the key enablers and barriers influencing local production and provide actionable policy recommendations for a sustainable biopharmaceutical industry. The research used a scenario planning methodology, concentrating on the four stages of defining the scenario question and time frame, determining the main drivers of change, and creating and using possible scenarios. The health systems strengthening framework informed this methodology. The findings reveal twelve critical drivers of change, with regulatory support and financial investment emerging as the most significant. Other drivers include technological capabilities, supply chain resilience, and intellectual property policies. Based on these drivers, four plausible future scenarios were outlined: Full-Scale Local Manufacturing, Limited Production, Prolonged Dependency on Imports, and Manufacturing Failure. Key opportunities encompass achieving self-sufficiency, fostering economic development, and establishing Kenya as a regional manufacturing hub. Conversely, some challenges identified are regulatory constraints, high startup capital, a shortage of skilled personnel, reliance on imported raw materials, and public skepticism regarding vaccine safety and efficacy. In conclusion, while the potential for a viable local manufacturing industry exists, its realization is highly contingent on strategic interventions. Thus, there is a need to capitalize on opportunities and mitigate significant barriers. The study recommends that the Kenyan government rationalize the regulatory process to accelerate approvals, increase research and development investment, put incentives to lead foreign and private investment in place, improve public-private partnerships, and enhance trust in the public by raising awareness and communicating transparently.