While COVID exposed the urgency of ensuring that Africa, through Gavi’s African Vaccine Initiative, can manufacture vaccines, the current mpox and cholera outbreaks have painfully underscored the continent’s vulnerability.
African countries affected by mpox are dependent on vaccine donations from wealthy countries, while a dire global shortage of cholera vaccines has forced the World Health Organization (WHO) to advise countries to give people one dose instead of the optimal two.
Back in June, the vaccine platform, Gavi, launched the African Vaccine Manufacturing Accelerator (AVMA), together with the African Union and Africa Centres for Disease Control and Prevention (Africa CDC).
“AVMA is a financing mechanism established to make up to $1.2 billion available over 10 years, commencing with AVMA’s launch in June 2024, to accelerate the expansion of commercially viable vaccine manufacturing in Africa,” a Gavi spokesperson told Health Policy Watch.
High hopes are invested in AVMA, but the initiative has also been criticised for offering incentives that favour established international manufacturers rather nurturing than smaller, truly African manufacturers.
Initiative ‘favours major producers’
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“Without proper attention to who owns and controls the production and underlying technologies, there is a risk that well-meaning donor investments reinforce market dynamics that favour a handful of major international producers over truly local efforts. This is particularly relevant for AVMA,” argue researchers Els Torreele and Heather Sherwin in the journal, PLOS.
Gavi defines local production as “geographically located on the African continent”, which means that international non-African companies are eligible for financing.
“We have clearly stated throughout extensive consultations, as well as in public board documents, that eligibility for AVMA is based on geographic location of manufacturing rather than location of ownership,” Gavi’s spokesperson told Health Policy Watch.
Gavi wants to build “a thriving and sustainable vaccine manufacturing sector on the African continent” and is “dedicated to fostering a sustainable and resilient manufacturing base in Africa”.
“With that objective in mind, any manufacturing operations physically located in Africa which serves that end, irrespective of ownership, will be eligible,” added the spokesperson.
‘Not building equitable access’
But Torreele, in an earlier article, argues that this will not build equitable access.
“To ensure equitable vaccine access in low and middle-income countries when and where needed, countries and local producers in the Global South must have ownership and decision-making over vaccine manufacturing technology and facilities, what they produce, and for whom,” she says.
“Moderna or BioNTech producing their proprietary vaccines in Africa does not build sustained regional capacity or resilience to respond to local health needs. Instead, it risks deepening dependencies on commercial interests that will always be prioritised over people’s health needs in shareholder-driven companies.”
But Gavi believes that its recipe of international and local players offers the best remedy for the dearth of African manufacturers.
“Developing a substantial and durable vaccine manufacturing industry in Africa, starting from a small base, needs local and regional entrepreneurs, and international resources and capacity,” says the spokesperson.
“The AVMA’s structure, with caps on the total amount of support individual manufacturers can receive and inclusion of African and international owners, is designed to attract support and investment from the broadest possible constituency,” it argues.
“This will allow the continent to benefit from a broad ecosystem of actors if long-term capacity is to be established from a relatively low baseline. This will also incentivize investment and ensure critical skills and capacity are transferred to the African continent.”
High bar for AVMA support
AVMA offers subsidies at two critical points: when a company is awarded World Health Organization (WHO) pre-qualification for “priority vaccines”; and per-dose on delivery if they are successful in securing Gavi-UNICEF vaccine tenders.
Critics say this bar is too high, as WHO pre-qualification favours large international companies with access to capital to finance product development and a regulatory dossier, rather than local players.
“While we would wish that African manufacturing gains momentum and builds scale as soon as possible safety, standards and quality assurance are vital elements,” Gavi responds.
“Adherence to correct regulatory processes is absolutely essential, hence the WHO pre-qualification requirement.”
The spokesperson also called for national, regional and global actors to build “the right regulatory environment” for “sustainable vaccine manufacturing on the continent”.
A critical component of this is the African Medicines Agency (AMA), which is limping along without ratification from many of the continent’s powerhouse countries. It would enable continental approval of medicines instead of all 55 different countries having their own approval processes, which are painfully slow.
One of the hitches with mpox vaccine donations has been the slow pace of countries to grant regulatory approval for them. The Democratic Republic of Congo, which has been battling large mpox outbreaks for two years, only approved the vaccine in late June.
Vaccine accelerator’s focus
AVMA’s payments to manufacturers are incentive-based, with the highest – called “milestone payments” – being offered to “modes of manufacturing most likely to support pandemic preparedness.”
“Accelerator payments” are also being offered, which are a per-dose top-up in addition to the market rate that manufacturers are paid on winning Gavi-UNICEF tenders. These payments acknowledge the cost and risk of vaccine development and production.
AVMA will support mRNA and viral vector platforms covering eight key vaccines for cholera, malaria, measles-rubella (MR), hexavalent (wP), Yellow Fever, pneumococcal, Ebola, Rotavirus as well as the six -in-one hexavalent vaccine (protecting against diphtheria, tetanus, whooping cough, poliomyelitis, Haemophilus influenza type B and hepatitis B).
“The idea is to focus manufacturers on production in the most viable markets, or priority antigens, helping to secure accelerated, competitive entry of new manufacturers where there is an unmet market need,” said the spokesperson.
Support will be “predominantly directed towards vaccines whose drug substance is manufactured in Africa, with initial consideration also given for ‘fill & finish only’ projects using imported drug substance.”
Business-as-usual ‘will not deliver equity’
But Torreele is sceptical: “Many of the investments in local vaccine manufacturing, even with public funds, seem to assume that new producers will be able to successfully compete and be profitable in the global vaccine market.
She describes the vaccine market as ”cut-throat and oligopolistic”, with “significant entry barriers, and favouring the biggest players adopting economies-of-scale business models”.
“In 2021, excluding COVID-19 vaccines, just four pharmaceutical corporations (MSD, GSK, Sanofi and Pfizer) captured 73% of the global vaccine market worth $42 billion, while the single biggest producer by volume, the Serum Institute of India, barely captured 2% of the value while supplying 20% of all doses at near-cost prices,” she notes.
Torreele and Sherwin urge AVMA and the European Union’s Global Gateway African investment initiative to “target the needs of emerging local producers”, including “access to affordable capital to finance at-risk the technical work needed to adapt, optimize, and establish a regulatory dossier for submission to regulatory authorities and other push incentives.”
“Business-as-usual market dynamics will not deliver equity,” they argue.
What about the Pandemic Agreement?
Meanwhile, during the resumed pandemic agreement negotiations in Geneva on Monday, the South Centre said: “Current efforts for equitable and timely access to vaccines, treatments and diagnostics (VTD) are ad hoc, voluntary, uncoordinated, underfunded and focused on last-mile delivery.”
The South Centre, which represents 55 organisations in the Global South and is a stakeholder in the negotiations, called for the core provisions of the pandemic agreement to “provide for concrete means to enhance equity and development allocation and procurement of these VDTs”.
A robust pandemic agreement, together with AVMA and other initiatives may finally change Africa’s vaccine desert – but these efforts need political will, innovative thinking and financial resources.
