Vaccine production in Africa for Africa

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DESPITE Africa having much lower COVID-19 cases and following equally, if not more stringent, public-health safety protocols than countries whose citizens faced no quarantine restrictions, the majority of African countries were shut out of international air travel vital to their economies.

Electronic or digital vaccine registries, a particularly promising tool during COVID-19, ensured equitable access by identifying sections of communities with limited access to vaccines.

Vaccine registries provided certification to re-establish international connectivity.

Once set up, the platform provided the backbone for the digitisation of healthcare delivery, from diagnosis to treatment to more efficient referrals. 

They can also help to reconnect Africa to the world economy.

Beyond interconnectivity, COVID-19 presented African governments with a catalyst to reorganise health systems and a starting point to modernise essential health services.

For instance, only 25 percent of the human public health laboratories have the necessary staffing, equipment and reagents to perform culture and susceptibility testing on human samples, which limits the diagnostic capabilities of healthcare professionals treating patients and the availability of antimicrobial resistance data to guide clinical practice and policymaking.

The foundations of a digital nation should enable other public services — from proof of health status to authorising social welfare payments.

 The pandemic also accentuated the unfairness and imbalance in the global system of vaccine manufacture and distribution. Left unaddressed, these may pose a risk to global health resilience in the future.

More than 12 billion vaccine doses were administered globally.

However, Western countries jumped the queue and pre-ordered stocks, leaving poorer countries in sub-Saharan Africa with no choice but to accept the COVID-19 vaccines they were given, regardless of whether they wanted them or were tested for efficacy among their populations.

COVID-19 vaccines.

This was not only unfair; it risked increased vaccine hesitancy among populations. 

In the medium-to-long-term, with the real risk of other potential future viral and pathogen outbreaks, Africa needs its own domestic and regional manufacturing capacity rather than relying on reserved doses.

Since we can expect more viral pandemics and mobile pathogens in the 21stCentury, African countries need to work together to detect and eliminate them.

Thus, much collaboration will be essential. In 2018, the East African Community hosted the East African Vaccine Symposium under the banner of ‘Vaccine Production in Africa for Africa’.

It stressed the “…strategic importance of local production.”  

However, so far, only nine sub-Saharan African countries are members of the African Vaccine Manufacturing Initiative (AVMI), which aims to support and promote the establishment of sustainable manufacturing capacity on the continent through advocacy, partnership, income generation and capacity building. 

A missing element of public commitment is the lack of regulation and certification of healthcare products.

During the recent COVID-19 pandemic, only two of the 43 vaccines underwent clinical trials in Africa; and in only two countries (Kenya and South Africa). 

There was significant risk that the vaccines would not have the same clinical benefits on Africa’s population; and would not be accepted by all communities. For instance, people had uncertainties and doubts concerning adverse side effects, symptoms or outcomes of disease.

This was especially true in the case of a novel, rapidly spreading and potentially deadly virus like COVID-19.

The need for vaccine and pharmaceuticals manufacturing capacity in Africa has repeatedly been made by concerned leaders.

A detailed study by the AVMI, in 2017, into vaccine production in Africa, identified many arguments for, and against, production on the continent; COVID-19 has made it imperative to reconsider many of them.

The development and testing of vaccines will help to counter any credence that the continent is used as a ‘testing lab’ for the leading vaccine candidates from the US, Europe and/or China.

For instance, in February 2021, South Africa set a target to fully vaccinate 67 percent of the population (40 million people) by the end of that year.

By mid-January 2023, only 35 percent (21million people) had been fully vaccinated.

 In Soweto, a massive cluster of some 30 underdeveloped, racially segregated urban (township) areas in the south of Johannesburg, with about 1,7 million inhabitants, only about 20 percent were fully inoculated.

COVID-19 demonstrated that when everyone needs the same thing, only those who can produce it can be guaranteed supply. A recent study noted that Africa has 375 drug manufacturers to a population of 1,3 billion.

China and India, which have roughly the same population each, have around 15 000 and 5 000 drug manufacturers respectively. 

These numbers became even starker when data showed that most African facilities are in North Africa, and between 70-90 percent of the drugs Africans take are imported, at prices they cannot influence or afford. Zimbabwe’s essential medicines list (EML) was last updated in 2015.

Although the country’s vaccination coverage rate for children under one year is at 89 percent, Zimbabwe faces significant and growing resistance in common infections such as TB, malaria, HIV, respiratory infections, sexually transmitted infections (STIs), urinary tract infections 

(UTIs), meningitis and diarrheal diseases.

While a significant dent has been made in the occurrence of rotavirus diarrhoea 

through vaccination, the persistent challenges of poor water, sanitation and hygiene practices have kept diarrhoea cases related to typhoid and other bacteria causes as common occurrences in Zimbabwe.

Transitioning the continent from dependency to self-sufficiency and security of supply is a vital goal; but this ambition 

faces challenges, among them cost and time.

Establishing vaccine manufacturing capacity requires a substantial investment entailing hundreds of millions of dollars. African manufacturers would need to manufacture sufficiently large volumes and have access to a large market to benefit from economies of scale.

Further, WHO estimated that only seven percent of African countries have moderately developed regulatory capacity for healthcare products and more than 90 percent have minimal or no capacity at all.

Efforts to improve this include the African Vaccine Regulatory Forum established by the WHO in 2006, and the Pharmaceutical Manufacturing Plan for Africa, first initiated by the AU in 2007.

But the former has focused mainly on drugs rather than vaccines while the latter has emphasised product development and clinical trials rather than manufacturing. Pharmaceuticals, not vaccines, continue to be the lens through which most African countries perceive ‘Good Manufacturing Practices’.

With regards time, the UN Industrial Development Organisation (UNIDO) estimates that even modest vaccine manufacturing facilities – with low volume capacities of less than 10 million doses per year and antigen imported from abroad rather than fermented in the country — would take between two-and-a-half  to five years to build and would cost US$14 to US$29 million to construct in the developing world.

A vaccine antigen is the core of what makes a vaccine work. Whether for flu, rotavirus or measles, the vaccine antigen activates your immune system and prepares you for future threats.

When domestic antigen fermentation is considered (which is essential for achieving fully integrated self-sufficiency in production), construction time can range beyond seven years.

A further challenge is that vaccine manufacturing in sub-Saharan Africa suffers from limited commitment from both the public and private sectors.

The public and private sector, therefore, must work together to facilitate the necessary technology and knowledge transfer for regional manufacture in Africa. Many stakeholders are concerned that bilateral licensing agreements might take too long and could be excessively restrictive.

The Global Alliance for Vaccines and Immunisation (GAVI)  that financed and organised clinical groups in under-developed countries with COVID-19 vaccination preparedness, acknowledged that individual technology transfer is expensive – around US$4 to US$5 million per recipient, depending on the nature of the agreement – and that transferring to a sufficient number of manufacturers to mitigate risk of failure can be extremely costly.

A suggestion was made to adapt the logic of the Medicines Patent Pool through an intellectual property, technology and know-how (IPTK) bank, which would bring together the necessary intellectual property rights, manufacturing process information, know-how and regulatory expertise into a single platform that could be licensed as a package with associated training modules.

Multiple manufacturers in developing countries could be licensed under this scheme to sell in a defined geography. The AU has similarly called for these assets to be made available as a full package, but went further – it called for them to be shared ‘openly’ rather than licensed, with “…full rights to use, manufacture and supply globally.”  

Dr Tony M. Monda BSc, DVM, DPVM, is currently conducting Veterinary epidemiology and Agro-economic research in Zimbabwe.E-mail:tonym.MONDA@gmail.com

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