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As the world grapples with the latest mpox (formerly known as monkeypox) outbreak, which has reportedly caused over 600 deaths in the Democratic Republic of Congo (DRC), there is a crucial need to produce vaccines and diagnostic tests to bolster India’s health security and to supply vaccines to the African continent. More than 17,000 cases have been detected in Africa, with a few cases identified in Sweden, Pakistan, the Philippines, and Thailand. As the Union Cabinet announced Biotechnology for Economy, Environment, and Employment (BioE3)—a policy for fostering high-performance biomanufacturing—the need for India to boost its vaccine and diagnostics production has never been more apparent.
A tale of three epidemics
Last week, the World Health Organisation (WHO) declared mpox as a Public Health Emergency of International Concern (PHEIC)—the second time in two years—without hesitation, unlike its response during the 2014 and 2018 Ebola outbreaks, sparking global concern about the disease. Mpox is a self-limiting viral infection that can cause complications in certain groups of populations including malnourished children, pregnant women, and immunocompromised persons. Transmission occurs through sexual contact, contact with the skin of an infected person and contaminated surfaces, and vertical transmission, i.e., mother to foetus. An alarming concern regarding the current outbreak, based on epidemiological data, is the increased number of cases, particularly in children; multiple variants with possibilities of higher transmission rates; severe disease outcomes; and limited vaccine supply.
Mpox is a self-limiting viral infection that can cause complications in certain groups of populations including malnourished children, pregnant women, and immunocompromised persons.
Presently, there are three mpox epidemics occurring at the same time, each with a different viral variant. Cases from Clade Ia strain have been on the rise in DRC for several years and is predominantly affecting children. The Clade 1b and Clade II strains have been observed in different regions across Africa and in Nigeria respectively, spreading through close contact in poorly sanitised conditions and through sexual contact. Current data from DRC and Nigeria indicate that the mortality rate from Clade I is around 10 percent, while that of Clade II is 3.6 percent. However, researchers claim that there is insufficient data available to determine which variant is more dangerous, since health outcomes are dependent upon prior health status and quality of healthcare services. It is unclear whether differences in disease severity are due to the virulence of different strains or the route of transmission. In addition, a worrying trend is that nearly half of DRC’s mpox cases this year affected children, and globally, out of all the people who have succumbed to the illness, at least 463 were children. In the case of infections in children, acquisition is likely due to underlying nutritional deficits or compromised immunity, chiefly since many grow up in areas of conflict and displacement and are already under the threat of malnourishment and other diseases, such as polio and cholera.
Why are there outbreaks occurring now?
A factor responsible for the increased incidence of outbreaks is due to zoonotic spillover events. The reservoir host of mpox is not unknown but it is likely to be rodents, with a wide range of intermediary hosts. Increased urbanisation, population growth, and bushmeat consumption brings people into closer contact with rodents, driving zoonotic spillover events. The recurrent mpox outbreak further demonstrates the need for health security dimensions to focus on the factors that trigger zoonotic outbreaks and the need for a “One Health” approach to tackling infectious diseases.
Researchers hypothesise that since vaccination campaigns against smallpox ceased in 1980, a considerable part of the population no longer has immunity towards smallpox (and mpox) and herd immunity is thus on the decline.
In addition, the emergence of periodic mpox outbreaks has been linked to waning immunity against smallpox, a related virus with similar molecular features. Vaccinations against smallpox provide a certain degree of immune protection against mpox. Researchers hypothesise that since vaccination campaigns against smallpox ceased in 1980, a considerable part of the population no longer has immunity towards smallpox (and mpox) and herd immunity is thus on the decline. Accordingly, the mpox vaccines that are currently approved by regulatory agencies—JYNNEOS, ACAM2000, and LC16—were initially developed for smallpox. JYNNEOS and ACAM2000 are considered as safer third-generation vaccines that elicit protective immune responses against mpox and have been enlisted as Emergency Use Listing by WHO. WHO recommends a targeted vaccination strategy to combat mpox by immunising those that are most vulnerable or are at most risk of exposure—pre-exposure and post-exposure preventative vaccination protocols.
Africa’s appeal for vaccines
Accordingly, the need currently rests at producing vaccines to ensure India’s health security and to supply optimal vaccine doses to protect vulnerable populations in the African continent. The African Centres for Disease Control and Prevention (CDC) declared a regional and a continental public health emergency a day prior to the WHO’s announcement. This may be reflective of the continent’s public health inequities and the need to garner attention to the issue. India and Africa hold friendly relations and India pioneered the permanent inclusion of the African Union into the G20. Moreover, India is a primary health service provider to Africa as evidenced by the export of medicines during the COVID-19 pandemic and, notably, the recent allocation of malaria vaccines. To address the current health emergency, various countries—the United States, France, Germany, and Japan—have pledged to provide Africa with mpox vaccine doses. Reports indicate that 10 million doses are necessary to control the current outbreak but only a fifth of this has been pledged thus far. Moreover, despite the allocation of US$ 1 billion to the continent’s vaccine manufacturing capabilities under The African Vaccine Manufacturing Accelerator programme, this venture has excluded the production of mpox vaccines. Nevertheless, to address the current dilemma, the WHO’s Expression of Interest in Emergency Use Listing has set in motion mechanisms to prompt GAVI and UNICEF to procure vaccines for distribution.
India is a primary health service provider to Africa as evidenced by the export of medicines during the COVID-19 pandemic and, notably, the recent allocation of malaria vaccines.
BioE3 and vaccine production
The mpox epidemics present an immense opportunity for India to take part in vaccine production. While India’s Health Ministry opines that the chances of spread to India are low, India reported its last case in March earlier this year and had 30 confirmed cases in the 2022 mpox outbreak, indicating that domestic production of mpox vaccines would serve India’s health security measures. The Serum Institute of India (SII) has expressed its plans to work with Novavax to produce mRNA vaccines to combat mpox. International collaborations, such as SII with Novavax and the University of Oxford, and Bharat Biotech with GlaxoSmithKline, resulted in the production of malaria vaccines, which were subsequently exported to Africa. In a similar vein, steps could be initiated to produce and distribute mpox vaccines to the continent as part of India’s vaccine diplomacy initiatives. Ensuring technology transfer and sharing of biological resources with global partners would aid in bolstering the sustainable production of vaccines, making healthcare more accessible and equitable.
The Union Cabinet’s recent decision to formulate a high-performance biomanufacturing policy under BioE3 is set to attract INR 10,000 crore investments. Strategic implementation of the manufacturing of vaccines can boost India’s bioeconomy, which has grown exponentially in the last 10 years from US$ 10 billion to US$ 130 billion and can promote India’s health security. In addition, the Indian Vaccine Manufacturers Association recently reiterated India’s endeavour to support Africa’s healthcare machinery and to ensure compliance with regulatory agencies to remain globally viable. Bolstering vaccine production through increased public-private partnerships and international collaborations would expedite the process and would demonstrate India’s proactive role in global health initiatives.
In addition to a limited supply of vaccines, the WHO recently urged mpox diagnostic kit manufacturers to ramp up production under the EUL procedure. Reports reveal that 1,000 suspected mpox cases were identified in the DRC alone this week signifying a rise in the demand for diagnostics. The availability of diagnostics is of great concern, particularly in lowand middle-income African nations, and is essential to timely healthcare. India’s Central Drugs Standard Control Organisation (CDSCO) recently approved the manufacturing of domestically developed mpox diagnostic kits that have been validated by ICMR. This is a significant stride to building resilience during the current PHEIC and a chance address the demand for diagnostics.
Until a steady supply of vaccines is available, the public is urged to employ judicious health practices to prevent infection and curb the spread of mpox. In addition, in light of the multiple strains with potentially varying severity and the heightened threat to children, biosecurity frameworks need to consider the importance of surveillance and detection, which will subsequently aid in tracing outbreaks and in carrying out epidemiological studies. Collectively, this latest outbreak presents an opportunity for India’s biotech and pharma industries to spearhead the production of essential vaccines and diagnostics to strengthen its health reserves in the event of an outbreak in India and to supply vaccines to a continent that is in dire need of defence. As India envisages ‘Viksit Bharat 2047’, India needs to employ proactive measures under BioE3 to ensure health security and to remain a responsible global health power.
Lakshmy Ramakrishnan is an Associate Fellow at the Observer Research Foundation
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