Want to Boost Regional Vaccine Manufacturing? Let Countries Prioritize, Ensure Tech Transfer
Want to Boost Regional Vaccine Manufacturing? Let Countries Prioritize, Ensure Tech Transfer
Newsletter Edition #56 [Treaty Talks]
Hi,
When the dust settles down from these “pandemic” years, we will truly understand if and what lessons were learned in global health. Take regional manufacturing of medical products. Everyone wants to talk about it. There are endless calls to make developing countries self-reliant, diversify supply chains, so that the stranglehold of monopolies during health emergencies is broken, in order to swiftly respond to what public health demands.
However, when it comes to making real commitments, I am not sure countries are lining up yet to sign on binding obligations internationally. Well, you would ask, why not? After all the raw grief of COVID-19 and the inequities that were witnessed, is just beneath the surface. The easier, less political way out of this tricky problem would be to simply throw money, use financing to oil the machine of diplomacy and geopolitics, to boost local manufacturing as determined by donors. But money alone will not buy regional vaccine independence.
What is also needed is real technology transfer and know-how. And we know how terribly complicated all this is. There is resistance to sign up to obligatory tech transfer in an international treaty. The story is not over yet, as WHO member states are grappling precisely with these kinds of issues in on-going negotiations in global health.
In today’s edition, my colleague Anjali Britto, who is a part of this year’s Geneva Health Files Fellowship program, presents a timely analysis that ties together these moving parts of the puzzle for you.
Read on, and write to us/her with your thoughts.
If you find our work valuable, become a paying subscriber. Tracking global health policy-making in Geneva is tough and expensive. Help us in raising important questions, and in keeping an ear to the ground. Readers paying for our work helps us meet our costs.
Our gratitude to our subscribers who help us keep the lights on!
Until later.
Best,
Priti
Feel free to write to us: patnaik.reporting@gmail.com or genevahealthfiles@protonmail.com; Follow us on Twitter: @filesgeneva
I. ANALYSIS
Want to Boost Regional Vaccine Manufacturing? Let Countries Prioritize, Ensure Tech Transfer
By Anjali Britto
Building robust regional vaccine manufacturing capacity has been one of the many tough lessons in the aftermath of the COVID-19 pandemic. It was demonstrated particularly devastatingly in the case of Africa, which had some of the world’s lowest vaccination rates during the pandemic as vaccine producing countries focused inwards first.
Africa currently depends on the outside world for an overwhelming majority of its vaccines, a prospect that does not bode well for the continent’s ability to ramp up vaccine production for both routine immunizations, and to fight against the next pandemic threat. The vulnerabilities in the global landscape of vaccine production and the grave consequences that can have, which were laid bare during the COVID-19 pandemic, have prompted efforts to remedy this.
However, developing the infrastructure for vaccine manufacturing is only half of the battle. To support developing vaccine manufacturers as they grow into a sustainable and robust industry, demand for products must be consistent and dependable. Vaccine procurers are a crucial part of the picture, and overcoming the hurdle of potential high prices for regionally-produced vaccines is paramount. If growing vaccine manufacturers across the continent are not adequately supported, they run the risk of failing before they can reach economies of scale, unable to compete with existing and established vaccine manufacturers across the world who have had decades-long head starts. To reap the much-needed benefits of expanded regional manufacturing - the foundations of which have and are being laid now - support is required across the entire vaccine value chain, from start to finish.
The move towards building regional capacity
It has been made clear that the global infrastructure for routine immunizations, which has had decades to establish itself, was not successful in guaranteeing vaccine equity around the world during a pandemic. This highlights the importance of diversifying and strengthening regional vaccine manufacturing capacity and supply resilience, to ensure that if and when the next pandemic approaches, every part of the world has equitable access to the vaccines it needs. As highlighted in a report by Gavi, The Vaccine Alliance on the priorities for expanding a sustainable vaccine industry in Africa, regional supplier diversity and regional supply security are twofold goals of the effort to build local manufacturing capacity.
Building regional vaccine production capacity is crucial to achieve goals of self-sufficiency and resilience in the face of epidemics and pandemics, especially in low-resource settings that are last in line when a crisis hits. Ideally, local vaccine production will be flexible and malleable, able to be rapidly molded to best fit the needs of the next pandemic response. This is especially true for Africa, as the continent works towards a future without dependence on importing vaccines for routine immunisations and in the case of extreme health events. A key issue that cannot be ignored is the potential for vaccine manufacturing capacity to ensure pandemic vaccine equity.
In addition, regional capacity strengthening allows countries to set their own disease area priorities, to fill existing gaps in the status quo. Regional strengthening of capacity means that potential solutions can be tailored to local contexts, and outbreaks can be gotten ahead of before they happen.
Developing regional capacity – Africa and beyond
Currently, Africa only makes 1% of the vaccines that it uses. Although grave, this is not a problem necessarily unique to the African continent. The global vaccine supplier landscape is one concentrated both in number and in geography. Only 10 vaccine manufacturers across the globe provide 70% of non-COVID-19 vaccine doses, and make up 85% of the global value of vaccines (WHO), with a majority of suppliers based in India, China, the EU, Indonesia, Japan, and the USA (WHO).
This problem is not unrecognised, however, and efforts are being made towards fixing it. In 2021, several nations proposed Resolution 74.6, calling upon member states to strengthen leadership, commitment, and support in aid of strengthening regional manufacturing, align national and regional policies in support of regional production. A 2023 progress report detailed efforts towards the goal of strengthening local production, including the establishment of the South African mRNA technology transfer hub in June 2021.
Focusing specifically on African vaccine manufacturing, the African Union (AU) mobilised the Partnership for African Vaccine Manufacturing (PAVM), with the intent of putting forth a program that is Africa-led, supported by the global system at large. Through its Framework for Action (FFA), the AU PAVM aims to enable the African vaccine manufacturing industry to produce 60% of the continent's vaccines indigenously by 2040, with 10% by 2025 and 30% by 2030. With an eye to pandemic preparedness and response, the PAVM FFA identifies 22 diseases of priority for the development of vaccines, including diseases which have the potential of causing outbreaks, and whose demand would need to be rapidly scaled in the event of an outbreak.
Africa isn’t starting from scratch. South Africa, Morocco, Tunisia, Egypt, and Senegal have some presence of vaccine manufacturers. There are several starting points for capacity building, with 13 operational vaccine companies, of which 10 have fill-and-finish capacity, five have drug substance capabilities, and three have research and development capabilities.
Africa, of course, is not the only region which could stand to benefit from growing a more robust vaccine ecosystem and working towards eventual vaccine independence. The mRNA vaccine technology transfer hub, based in South Africa, is sharing technical know-how with regional manufacturer ‘spokes’ in countries around the world, including Argentina, Bangladesh, Egypt, Nigeria, Serbia and Vietnam, creating a network of local manufacturing collaborators, as they strengthen global vaccine independence and strengthen South-South collaboration. So far, the mRNA hub in South Africa has completed the first stage of knowledge transfer to all but one of their 15 partners.
A 2021 survey of the vaccine manufacturing landscape across Africa, Latin America-Caribbean, South East Asia, the Western Pacific, and the Middle East found that the South-east Asia – Western Pacific region had the most established manufacturing capacities, while the Middle East, Latin America, and African regions were more likely to focus on specific elements of the vaccine manufacturing process.
Diversifying and expanding vaccine manufacturing capabilities across the world will ensure that countries are not marginalised by a lack of access to vaccines in the event of a global health emergency. Latin America is a region where progress is being made in this respect, particularly with mRNA vaccines information sharing.
The Cuban model of vaccine manufacturing that yielded a successful Covid-19 vaccination program has 30 years of support – including state support – behind it, demonstrating the importance of sustained assistance from the state and other stakeholders in growing and maintaining a successful vaccine manufacturing program.
A study assessing strategic prioritisation of small countries based on their potential for expanding manufacturing capacity identified Cuba and Singapore as two countries that have the capacity and capability to manufacture vaccines.
Demand and procurement - an essential element
Earlier this year , questions were raised when South Africa, despite housing the mRNA hub, bought pneumococcal vaccines from India rather than local producer Biovac. This incident illustrated the tension between the pressure of price and the need to support growing regional vaccine manufacturers. This illustrates a fundamental tension that must be overcome if goals of regional vaccine independence are to be achieved.
Global efforts to mobilise funding to support local manufacturing in low- and middle-income countries, if incomplete, will not yield viable local manufacturing environments. Without adequate frameworks to ensure support throughout the vaccine value chain, goals of strengthening regional capacity and achieving vaccine equity will go unrealised.
Procurement, one of the late stages in a vaccine’s production, is of essential importance as only consistent procurement can ensure that vaccine manufacturers stay in business. This is especially crucial as young manufacturers enter a complex market, and compete with suppliers who have been in the business for decades. With market forces stacked against them, emerging vaccine producers need support in order to achieve economies of scale and avoid being trapped between high prices and low volumes.
Intellectual Property as a barrier
The success of regional vaccine manufacturing efforts also relies on the intricacies of the intellectual property landscape. This is especially true in the case of the mRNA hub in South Africa, and in the ‘spoke’ countries that it will expand to. There have already been significant challenges posed to the partners involved in the South Africa mRNA hub project by Moderna’s patents on its COVID-19. To add to the complex and convoluted global landscape of mRNA intellectual property, patent laws in South Africa that granted patents to Moderna are posing challenges to the future of COVID-19 vaccine manufacturing in the country, demonstrating the impact that country’s regulatory environments can have in hastening or impeding efforts to build and sustain regional vaccine manufacturing capacity.
A new pandemic agreement might hold better prospects. A proposal on the negotiating text of the Pandemic Agreement put forth by the Bureau of the Intergovernmental Negotiating Body, has provisions on sustainable production (Article 10) and Technology Transfer and Know-How (Article 11), among others on research and development, supply chain and logistics. (See a previous analysis by Geneva Health Files on the negotiating proposal)
As reported earlier, in a new formulation, the article on sustainable production has provisions to identify and maintain production facilities, and to work with shortlisted manufacturers. The article also contains provisions on royalty free licenses; to waive and manage for a limited duration royalties for the use of technology related to pandemic products.
On tech transfer, GHF reported earlier on how the discussions on technology transfer have been one of the toughest with very little appetite for compulsory obligations on sharing technology on the part of developed countries – in course of informal consultations during the past few months.
The provision on tech transfer contains language on non-exclusive licensing of government-owned technologies and has text on time-bound waivers of IP rights in the context of pandemics. These issues have raised the heckles of the industry. For some stakeholders, having obligations on voluntary, non-exclusive licensing that involves pooling of patents, is a middle path compared to waiving of IP rights. There are preliminary proposals at the INB towards a potential Technology Access Pool modeled around the COVID-19 Technology Access Pool.
Among other strands of discussions on this, countries are also debating about the feasibility of obligatory tech transfer mechanisms that can be applicable within a bloc of countries. The model currently being discussed within the EU has been cited by some developing countries as a suggestion for tech transfer during health emergencies.
In addition, in the context of the amendments to the International Heath Regulations, in a proposed new Article 13A, some developing countries have suggested commitments assessing availability and affordability of PHEIC-eligible medical products, establishing an enforceable allocation mechanism, mapping raw materials for manufacturing, defining regulatory pathways for generic producers, waiving IP rules for relevant medial products, sharing regulatory dossiers to overcome rules on trade secrets among others.
Commitments on regional manufacturing in an international agreement?
In the latest meeting of the INB, the proposed negotiating text swelled to more than 90 pages with countries seizing back the opportunity to add some of their language across a range of provisions through the text.
How commitments on regional manufacturing will eventually feature in a pandemic agreement will also depend on text on research and development, and global supply chains, apart from provisions on production and tech transfer.
The provision on global supply chain and logistics network envisions assessing and mapping demand and potential supply from manufacturers and identify efficient procurement mechanisms. (Article 13).
Some countries have been keen to look at the question of equity and access to medical products as a continuum spanning R&D, sustainable production, supply chain and procurement issues. These proposals were not taken on board and now countries will work to address these issues holistically.
In general, there is recognition in the proposed negotiation text of the pandemic agreement that inequitable access to vaccines, therapeutics and diagnostics needs to be addressed through increasing manufacturing capacity.
The parties commit to both the strengthening of existing mechanisms and the development of new mechanisms to promote and incentivise technology and know-how transfer to developing countries and encourage manufacturers, presumably in developed countries, to grant licenses to LMIC manufacturers. (Article 10 & 11).
The document also makes mention of strengthening regional regulatory mechanisms, including harmonisation at the international and regional level and promoting the strengthening of research and development capacities in LMICs. (Article 14)
The principle of common but differentiated responsibilities, a key principle was not a part of the proposed negotiating text. But developing countries are keen that States that have greater capacity in response and prevention capabilities must bear, where appropriate, a degree of responsibility proportionate to their capacities. Demand side responsibilities are one avenue through which higher capacity states might exercise this greater responsibility.
International and regional institutions have put forward potential frameworks to get out of this bind of ensuring demand for regionally manufactured vaccines.
Gavi’s ten point plan identifies roles and actions to be taken by different sectors, calling upon G7 development ministers to contribute towards advance market commitments to signal future demand, calling upon the private sector to build partnerships across the entire vaccine value chain, and committing itself to find ways to ensure more predictable demand for African-produced vaccines, while cognizant of the nuance involved in building financing tools that can support emerging manufacturers, without driving up vaccine prices owing to a resulting drop in volumes sold by existing manufacturers. The report argues for the merits of African countries signalling demand through collective action.
For Africa, the AU PAVM offers a concrete example of a way forward. To address the challenge of procurement, the AU PAVM hopes to build off the existing African COVID-19 Vaccine Acquisition Task Team (AVATT), to create a procurement pooling mechanism to support emerging African manufacturers from within the continent. By extending AVATT’s mandate beyond COVID-19 vaccines, and mobilising the political will of AU countries to commit to supporting local and regional manufacturers and signalling demand, this mechanism could result in sustainable and reliable volumes demanded of regional manufacturers, allowing them to reach economies of scale. Bolstered by greater certainty and real signalled demand, regional manufacturers can build on existing foundations and grow, bringing up a step closer to achieving global vaccine equity.
Britto is an Associate at Global Health Strategies in Washington D.C. She can be reached at anjali.britto@gmail.com.
Priti Patnaik contributed to this article.
II. PODCAST CORNER
Don’t wash away hygiene for health
According to WHO, improving access to water, sanitation and hygiene (WASH) can save 1.4 million lives a year. In this episode, host Garry Aslanyan is joined by Annie Msosa, the Advocacy Advisor for WaterAid in Malawi, who speaks about a recent cholera outbreak in her country that revealed the dangers of unsafe water in health care facilities. David Wheeler, the Executive Director of the Reckitt Global Hygiene Institute in the United States, makes the case for investing in WASH as an essential approach to preventing disease.
Garry Aslanyan is the host and executive producer of the Global Health Matters podcast. You can contact him at: aslanyang@who.int
[This is a sponsored advertisement: Get in touch with us if you want to promote books, webinars, job postings. Write to patnaik.reporting@gmail.com.]
Global health is everybody’s business. Help us probe the dynamics where science and politics interface with interests. Support investigative global health journalism.