Less than five years after the COVID-19 pandemic, the world faces the threat of another global health crisis. The World Health Organization (WHO) has, once again, declared mpox (formerly known as monkeypox) a Public Health Emergency of International Concern (PHEIC), following its outbreak in the Democratic Republic of the Congo (DRC), Africa, and subsequently spreading to over a dozen African countries. This comes on the heels of the Africa Centres for Disease Control and Prevention’s (AfricaCDC) declaration of a Public Health Emergency of Continental Security (PHECS), marking the first instance where both regional and global health emergencies have been declared concurrently for the same disease. In the days following the PHEIC declaration, cases of mpox were identified in Sweden, Pakistan and the Philippines, indicating that the virus has likely spread beyond the African continent.
This WHO declaration is significant as it is the first PHEIC announced since the May 2024 amendments to the International Health Regulations (IHR). And of all the IHR reforms, the inclusion of equity as a core principle was perhaps the most important. Although these amendments will not take effect until 2025, it is crucial that the global response to the mpox outbreak is grounded in this principle from the outset. Those amendments further expand WHO’s role as a facilitator of essential medical products during emergencies.
A PHEIC is intended to foster international cooperation. Countries, international organisations, and non-governmental organisations must collaborate to coordinate their responses, share information, and provide mutual assistance. The declaration should trigger the rapid mobilisation of financial and technical resources, including emergency funding, deployment of trained health-care workers, and provision of medical supplies.
Mirroring the COVID-19 pandemic response
One of the most glaring shortcomings exposed by the COVID-19 pandemic was the inadequacy of vaccine manufacturing capabilities in the Global South, exacerbated by the lack of technology transfers and the know-how to produce vaccines developed in the West. So far, the global response to the mpox outbreak appears to be following a similar trajectory.
However, the present response to mpox differs significantly from COVID-19 in one key aspect: the availability of a vaccine. The Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN), also known as Jynneos, is already in production by Danish manufacturer Bavarian Nordic. This vaccine, produced using primary chick embryo fibroblast (CEF) cell cultures, shares its production process with several other vaccines, including those for measles, mumps, rabies, and tick-borne encephalitis. Regulatory authorities in the European Union and United Kingdom (marketed as Imvanex®), United States and Switzerland (marketed as Jynneos®), and Canada (marketed as Imvamune®) have already approved the vaccine.
The mpox outbreak presents an opportunity to apply lessons from the COVID-19 pandemic by ramping up vaccine production in the Global South, and leveraging the existing MVA-BN vaccine. Indian manufacturers, in particular, have the potential to play a critical role in ensuring equitable access to this vaccine, ensuring it reaches the populations that need it the most, at the right time. Indeed, India was a critical partner during COVID-19, facilitating the mass production of the vaccine largely credited with saving the most lives — Oxford/AstraZeneca’s vaccine marketed in India as Covishield.
Ensuring technology transfers
As countries closely monitor the mpox outbreak, the demand for vaccines is expected to surge. The AfricaCDC estimates that 10 million doses are needed to stem the outbreak, yet only about 0.21 million doses may be available immediately. Bavarian Nordic has informed the AfricaCDC that it has the capacity to manufacture 10 million doses by the end of 2025. The price of an mpox shot has been estimated at $100. This underscores the need for sustainable, low-cost production of the MVA-BN vaccine.
India is well-positioned to meet this challenge. Three major vaccine manufacturers — the Serum Institute of India, Bharat Biotech, and Zydus Cadila — already have the experience of producing vaccines using CEF cells. Notably, the Serum Institute of India and Bharat Biotech played pivotal roles in both the national and global responses to the COVID-19 pandemic.
These manufacturers likely have the expertise to quickly scale up MVA production in CEF cells. Additionally, they may already have established supply chains for key materials, such as SPF eggs, which could be leveraged to expand production. The lower cost structure of manufacturers in lower-middle-income countries (LMICs) could also reduce the price of vaccines, increasing demand and making doses more accessible.
Rapidly scaling up MVA-BN production will require comprehensive technology transfer, including the sharing of biological resources, know-how, and patents. Often overlooked, the transfer of the relevant know-how is crucial and has historically been a major hurdle in outbreak responses. It is the sharing of knowledge, rather than just doses, that distinguishes charity from justice. Writing on the key contentious issues in the ongoing negotiations for the WHO Pandemic Treaty in this daily (Editorial page, “The global struggle for a pandemic treaty”, August 1, 2024), these writers argued that technology transfers “are needed to ensure diverse manufacturing capacities globally so that LMICs are no longer reliant on ‘charity’ from high-income countries and can maintain self-sufficiency”.
The Indian government, along with regulators, should collaborate with the United States, the European Union, and key international organisations such as WHO, Gavi, and the Coalition for Epidemic Preparedness Innovations (CEPI), to negotiate with Bavarian Nordic for the transfer of technology. By leveraging the expertise and the experiences of these organisations and working with manufacturers in developing countries, these efforts can help scale low-cost production and ensure equitable access to the MVA-BN vaccine, thereby curtailing the epidemic and preventing further outbreaks. That would benefit countries both in the Global North and South.
A move with impact
In a recent significant move, on August 7, India’s drug regulatory agency, the Central Drugs Standard Control Organization (CDSCO), waived the requirement for clinical trials in India for drugs approved in the United States, the United Kingdom, Japan, Australia, Canada, and the European Union. This waiver, which includes ‘new drugs used in pandemic situations,’ will expedite the availability of critical vaccines such as MVA-BN in the country.
In the face of the mpox outbreak, the global community has a critical opportunity to demonstrate its commitment to equitable prevention and health care by ensuring widespread access to a mpox vaccine, targeted to those most in need. By fostering international cooperation, prioritising technology transfers, and leveraging the manufacturing capabilities of countries such as India, we can not only address the current crisis but also strengthen our preparedness for future public health emergencies. The time to act is now, before history repeats itself.
Kashish Aneja is Lead, Initiatives in Asia, O’Neill Institute for National and Global Health Law, Georgetown University. Sam Halabi is Director, Centre for Transformational Health Law, O’Neill Institute for National and Global Health Law. Lawrence Gostin is Distinguished Professor and Director, World Health Organization Collaborating Centre for National and Global Health Law, O’Neill Institute and member of the World Health Organization International Health Regulations Review Committee
