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The ongoing mpox outbreak, previously known as monkeypox, has highlighted the urgent need for increased vaccine production. With over 600 deaths reported in the Democratic Republic of Congo (DRC) and more than 17,000 cases across Africa, this crisis calls for a robust response. For India, this moment presents a pivotal opportunity to enhance its health security and support global health efforts, particularly in Africa. The Union Cabinet's recent introduction of the Biotechnology for Economy, Environment, and Employment (BioE3) policy, aimed at fostering high-performance biomanufacturing, underscores the need for India to bolster its vaccine and diagnostics production capabilities.

The Global Mpox Crisis

Mpox Declared a Public Health Emergency

The World Health Organisation (WHO) has declared mpox a Public Health Emergency of International Concern (PHEIC) for the second time in two years, a marked contrast to the delayed response during the Ebola outbreaks of 2014 and 2018. Mpox is a viral infection that is generally self-limiting but poses severe risks to vulnerable groups, including malnourished children, pregnant women, and immunocompromised individuals. The virus spreads through sexual contact, skin-to-skin contact with infected individuals, contaminated surfaces, and vertical transmission from mother to fetus.

Variants and Regional Spread

Currently, three distinct mpox epidemics are occurring simultaneously, each associated with different viral variants:

• Clade Ia Strain: Predominantly affects children and has been on the rise in the DRC for several years.
• Clade 1b and Clade II Strains: Identified in various regions across Africa, including Nigeria, where they spread through close contact in unsanitary conditions and sexual transmission.

The mortality rate for Clade I is around 10 percent, while Clade II has a mortality rate of approximately 3.6 percent. However, data are insufficient to determine which variant is more dangerous, as outcomes depend largely on the individual's prior health status and the quality of available healthcare. Notably, nearly half of this year’s mpox cases in the DRC have affected children, who are particularly vulnerable due to malnutrition, compromised immunity, and exposure to other diseases like polio and cholera.

Factors Driving the Outbreaks

Zoonotic Spillover Events

A significant factor driving the current mpox outbreaks is zoonotic spillover, where the virus jumps from animal hosts to humans. The primary reservoir host of mpox is believed to be rodents, with a wide range of intermediary hosts. Increased urbanization, population growth, and the consumption of bushmeat bring humans into closer contact with these animals, facilitating zoonotic transmission. The repeated outbreaks of mpox underscore the need for a comprehensive "One Health" approach that addresses the interconnected factors triggering zoonotic diseases.

Declining Immunity Against Smallpox

Another critical factor is the decline in immunity against smallpox, a related virus with similar molecular characteristics. Vaccinations against smallpox provide cross-protection against mpox. However, since global vaccination campaigns against smallpox ended in 1980, a significant portion of the population has lost this immunity, reducing overall herd immunity. The currently approved mpox vaccines—JYNNEOS, ACAM2000, and LC16—were initially developed for smallpox. JYNNEOS and ACAM2000, classified as third-generation vaccines, are considered safe and effective in eliciting immune responses against mpox. WHO recommends a targeted vaccination approach, focusing on pre-exposure and post-exposure preventative vaccination for those most vulnerable or at risk.

Africa's Appeal for Vaccine Support

Public Health Emergency and Vaccine Demand

The African Centres for Disease Control and Prevention (CDC) declared regional and continental public health emergencies in response to the mpox outbreak, highlighting the continent's public health disparities and the urgent need for vaccines. Despite commitments from various countries, including the United States, France, Germany, and Japan, to supply vaccine doses, the demand far exceeds the supply. Approximately 10 million doses are required to control the outbreak, yet only about one-fifth of this amount has been pledged. Although The African Vaccine Manufacturing Accelerator programme has allocated significant funding to bolster vaccine manufacturing in Africa, mpox vaccine production has been excluded from this initiative.

India's Role in Supporting Africa

India's longstanding health partnership with Africa, demonstrated by its role as a primary supplier of medicines during the COVID-19 pandemic and the recent provision of malaria vaccines, positions it uniquely to respond to Africa's current health emergency. By leveraging its existing relationships and capabilities, India can play a pivotal role in supplying mpox vaccines to the continent.

BioE3 Policy and India’s Vaccine Production Potential

Opportunities for Domestic Vaccine Production

The current mpox outbreaks present a critical opportunity for India to expand its vaccine production capabilities. Despite India's Health Ministry stating that the likelihood of mpox spreading in India is low, the country reported 30 confirmed cases in the 2022 outbreak, with the most recent case occurring in March 2024. This indicates a clear need for domestic mpox vaccine production to enhance India's health security. The Serum Institute of India (SII) has announced plans to collaborate with Novavax on producing mRNA vaccines for mpox, building on successful international partnerships that resulted in malaria vaccine production for Africa.

BioE3 Policy and Economic Implications

The Union Cabinet's BioE3 policy aims to attract investments of INR 10,000 crore, supporting the development of high-performance biomanufacturing in India. By strategically focusing on vaccine production, India can further expand its bioeconomy, which has grown from US$ 10 billion to US$ 130 billion over the past decade, and reinforce its health security. Moreover, the Indian Vaccine Manufacturers Association has reiterated India's commitment to supporting Africa's healthcare systems and maintaining compliance with international regulatory standards.

Addressing the Demand for Diagnostics and Surveillance

Production of Diagnostic Kits

In addition to vaccine shortages, the WHO has urged mpox diagnostic kit manufacturers to increase production under the Emergency Use Listing procedure. The availability of accurate diagnostics is vital, particularly in low- and middle-income countries in Africa, to ensure timely and effective healthcare responses. India has recently taken a significant step in this direction, with the Central Drugs Standard Control Organisation (CDSCO) approving the domestic production of mpox diagnostic kits validated by the Indian Council of Medical Research (ICMR). This move strengthens India's position to meet the diagnostic demands of the current public health emergency and offers a critical opportunity to build resilience against future outbreaks.

Importance of Surveillance and Detection

Until a steady supply of vaccines is available, the public is urged to adopt prudent health practices to prevent infection and curb the spread of mpox. Given the multiple strains with potentially varying severity and the heightened threat to children, biosecurity frameworks must prioritize surveillance and detection. Effective surveillance will aid in tracing outbreaks, conducting epidemiological studies, and implementing timely interventions.

Conclusion

The ongoing mpox outbreak represents a crucial moment for India’s biotech and pharmaceutical industries to lead in producing essential vaccines and diagnostics. These efforts would not only bolster India's health reserves but also contribute significantly to global health, particularly in regions like Africa that are in dire need of medical support. As India envisions becoming a developed nation by 2047, proactive measures under the BioE3 policy will be essential to ensure health security and uphold India's role as a responsible global health leader. By fostering international collaborations, enhancing technology transfer, and prioritizing biosecurity frameworks, India can position itself at the forefront of global health initiatives and make meaningful strides toward a safer, healthier future for all.