Kenyans will wait longer for the locally-made human vaccines after the Health ministry said the country has not met the standards required to produce the pharmaceuticals.
The ministry disclosed that the government has not attained the Maturity Level 3 (ML3) status by the Pharmacy and Poisons Board to enable the Moderna vaccine facility to make the vaccines, signalling a worrying state of the medicine regulatory body.
The ML3 is the mark of a stable, well-functioning, and integrated regulatory system, according to the World Health Organisation. This status increases a country’s local pharmaceutical growth enabling it to tap into the huge market.
Only five African countries, including Tanzania, Ghana, Nigeria, Egypt, and South Africa, have achieved the ML3 rating on their National Medicines Regulatory Authorities(NMRAs). Kenya’s PPB is currently operating on level two of maturity.
Sustainable vaccine manufacturing in Africa demands that the capacity of African NMRAs be strengthened to reach ML3.
Sultani Matendechero, deputy director-general for health at the State Department of Public Health and Professional Standards, told the Business Daily that despite sealing the deal with the American biotechnology firm, Moderna, the government is still in the process of attaining the regulatory measures that would enable the facility to produce vaccines at advanced levels to boost the economic scale.
“Effective regulatory systems play a critical role in assuring the quality, safety, and effectiveness of medical products, including Covoid-19 vaccines, and are fundamental to national health systems. The Moderna facility might take a while to put up since these standards cannot be rushed,” said Dr Matendechero.
In March, the government finalised a deal with Moderna to build a $500 million messenger RNA (mRNA) vaccine facility in Nairobi that would produce up to 500 million doses of the vaccines each year, to boost local manufacturing and improve commodity security and export capacity.
The revelation however comes amid concerns that the production glut of Covid-19 vaccines could derail the plan to build a vaccine plant, at a time the country is on a full recovery journey from the Covid-19 pandemic that raved the health systems.
The ministry of health however clarified that the facility will manufacture vaccines for other diseases beyond Covid-19.
The Africa Centres for Disease Control has set a target for the continent to produce 60 percent of the vaccines needed on the continent by 2040.
