KENYA – The Kenya BioVax Institute (KBI) is in advanced talks with the United States Pharmacopeia (USP) focused on pandemic preparedness and local vaccines production as well as expounding areas of collaboration in building vaccine production capacity.
The KBI is a state corporation whose mandate is the manufacturing, packaging and commercialization of specialized human health products and technologies, including vaccines, biomedical therapeutics and diagnostics.
The Ministry of Health in Kenya announced in an official statement that the state-owned firm has embarked on establishing its local manufacturing capacity of human vaccines through enhancing the ecosystem by strengthening its pharmaceutical regulatory environment.
“Other areas of discussion during the meeting included; plans to secure the certification for lot release of manufactured vaccines, post-marketing surveillance, licensing and inspections and conducting of a regional joint vaccine manufacturing workshop planned for later in the year,” the ministry said.
KBI’s Chief Executive Officer Dr. Michael Lusiola met and had talks with a delegation from USP on knowledge transfer, workforce development, regulatory and product approvals in ongoing efforts towards developing the ecosystem for human vaccine manufacturing in the country.
The meeting comes at a time when USP is in the process of developing a curriculum in regulatory affairs, vaccines technology and manufacturing for the African region as part of the preparations for human vaccine manufacturing that will spell out the mandate of regulators and vaccine manufacturers.
They also discussed areas of partnership in development of a curriculum to ensure the workforce is prepared to embark on human vaccine production as well as continuous learning.
“In planning for local production, we have looked at the key market drivers, including where there is demand / huge unmet medical need, the ease of production of the vaccines, as well as the budgetary allocation from the Exchequer,” said Dr. Lusiola.
“We want to enter the human vaccine production space when the regulatory framework has a strong foundation, and as already embedded in law,” the KBI head said.
Dr. Lusiola said KBI has prioritized collaboration with the national medicines regulatory authority, the Pharmacy and Poisons Board (PPB), ahead of the roll-out of human vaccine production.
“We have broad timelines in terms of our work plan but we are keen to have the process run concurrently with other preparations, including strengthening the regulatory framework,” he outlined.
Additionally, Dr. Lusiola indicated that the KBI will kick off its operations with the manufacture of childhood vaccines for routine immunization, whilst simultaneously developing the capacity for pandemic preparedness.
Ms. Zlatka Lenard, the Vaccines Director at Promoting Quality of Medicines Plus (PQM+) from USP, said they had already engaged the PPB and the National Quality Control Laboratory to provide technical support in developing the regulatory guidelines specific to Kenya’s need.
He disclosed that they are working in six African countries to strengthen regulatory and manufacturing capacity while supporting the national regulatory authorities to fulfill regulatory obligations.
The USP Director further said that they are working with the countries to achieve the World Health Organization global benchmarking tools for ‘Maturity Level 3’ (ML3), adding that the selected nations include Kenya, Ghana, Senegal, Nigeria, Rwanda and South Africa.
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