African countries need to unanimously agree on a central regulatory body for their pharmaceutical and medical products before the continent can set up functional manufacturing plants.
At the second Africa Centres for Disease Control and Prevention (AfricaCDC) stakeholders meeting on vaccine manufacturing held last week, global pharmaceutical players outlined challenges they face in finding local manufacturing partners for transfer of vaccine technical know-how. Key among them was the lack of a central regulatory body to streamline and expedite approval processes. Also lacking are high-performing national regulatory authorities to govern local vaccine manufacturing.
The companies that include Pfizer, Johnson&Johnson, Moderna and BioNTech said there was a need for a “robust regulatory environment, security and talent to encourage increased investments into manufacturing on the continent.”
Experts meeting at the Partnership for African Vaccine Manufacturing conference in Kigali last week said the pandemic had shown Africa urgently needed to tackle its dependence on imported vaccines. But they outlined daunting obstacles, from brain drain to power shortages.
Dr Charles Gore, head of the UN-backed Medicines Patent Pool, which seeks to boost drug making in developing countries, said seeking licences from pharmaceutical firms elsewhere was not a sustainable solution for Africa as it had few incentives to offer those firms.
He also cautioned against launching too many separate initiatives across the continent that would risk yielding only “white elephants”, instead urging governments, companies and research hubs to collaborate to create complementary capacities.
Martin Friede, coordinator of the World Health Organisation Initiative for Vaccine Research, noted that Africa needed to shift from being a test tube for pharmaceuticals to producing a workforce capable of designing and making vaccines.
In April, the African Union announced the launch of a partnership to manufacture vaccines at five research centres to be built on the continent in the next 15 years. The continent seeks to be able to manufacture 60 percent (or between 1.4 and 1.7 billion doses yearly) of its vaccines by 2040.
The launch of the African Continental Free Trade Area, and the ratification of the African Medicines Agency are seen as other ways to harmonise markets.
So far, 17 countries have ratified the Africa Medicines Agency.
Patrick van der Loo, regional president for Africa and the Middle East at Pfizer, noted that some regions in Africa lack central laboratories for product testing, making the process fragmented. Approval timelines in different countries were also long and inconsistent between different countries, he added.
The Coalition for Epidemic Preparedness Innovations and the African Union Commission Tuesday signed a memorandum of understanding to boost African vaccine research and development as well as manufacturing.
“I think African vaccine manufacturing could be enhanced, resulting in expanding the potential market as well, through [the African Medicines Agency’s] efforts,” van der Loo said.
To avoid a repeat of these constraints,
Multiple factors such as failure to obtain regulatory authorisation, India’s vaccines export ban in April, and protracted negotiations with firms such as Moderna and Pfizer have contributed to the supply constraints of the current Covid-19 vaccines to the continent.
Global pharmaceutical companies representatives have said that Africa’s dream to set up local vaccine manufacturing plants with the capability to supply the continent with up to 60 per cent of its vaccines by 2040 is marred by challenges.