Can India Be Mpox Vaccine Manufacturing Hub?

Can India Be Mpox Vaccine Manufacturing Hub?With the World Health Organization (WHO) declaring Mpox (formerly known as Monkeypox) a global health emergency for the second time in two years, the need for effective vaccines has become increasingly urgent. India, as one of the world’s largest vaccine producers, is well-positioned to play a crucial role in the global fight against Mpox. This article explores the Indian pharmaceutical companies that could potentially manufacture Mpox vaccines in 2024, analyzing their capabilities, experience, and the potential challenges they may face.

Key Indian Companies Capable of Manufacturing Mpox Vaccines

1. Serum Institute of India (SII)

• Overview: The Serum Institute of India, the world’s largest vaccine manufacturer by volume, has extensive experience in producing vaccines for a wide range of diseases, including smallpox, which is closely related to Mpox.
• Capabilities: SII has the infrastructure to produce large quantities of vaccines quickly, making it a strong candidate for Mpox vaccine production. The company’s experience with the smallpox vaccine could be directly applicable to producing an Mpox vaccine.
• Challenges: While SII has the capacity, it may face challenges related to the rapid scaling of Mpox vaccine production, particularly if there are unique formulation or distribution requirements.

2. Bharat Biotech

• Overview: Bharat Biotech, based in Hyderabad, is renowned for its innovation in vaccine development, having produced vaccines for diseases such as rotavirus, typhoid, and, more recently, COVID-19 (Covaxin).
• Capabilities: Bharat Biotech’s advanced R&D capabilities and experience in developing and distributing vaccines globally make it a strong candidate for Mpox vaccine production. The company’s expertise in handling live attenuated viruses could be particularly useful.
• Challenges: Developing a new Mpox vaccine or adapting an existing one may require significant time and resources. Regulatory approvals could also be a hurdle, especially for new formulations.

3. Zydus Cadila

• Overview: Zydus Cadila is a leading pharmaceutical company in India known for its pioneering work in vaccine development, including the world’s first DNA vaccine for COVID-19, ZyCoV-D.
• Capabilities: Zydus Cadila’s experience with DNA vaccines and other innovative platforms could be leveraged to develop an Mpox vaccine. The company’s strong manufacturing base and R&D capabilities further enhance its potential to contribute to Mpox vaccine production.
• Challenges: The development of a specific Mpox vaccine would require extensive clinical trials and regulatory approvals, which could delay the time to market.

4. Biological E. Limited

• Overview: Biological E. Limited, headquartered in Hyderabad, has a strong track record in producing pediatric vaccines and has been involved in developing vaccines for diseases like tetanus, diphtheria, and pertussis.
• Capabilities: The company’s expertise in producing combination vaccines and its capacity to scale production make it a viable candidate for Mpox vaccine manufacturing. Biological E.’s collaboration with global partners could also facilitate technology transfer and production.
• Challenges: The primary challenge for Biological E. would be the development of a new vaccine platform if existing technologies are not directly applicable to Mpox.

5. Indian Immunologicals Limited (IIL)

• Overview: IIL, a subsidiary of the National Dairy Development Board, is known for its work in both human and veterinary vaccines. The company has significant experience in producing vaccines for viral diseases.
• Capabilities: IIL’s capabilities in producing vaccines like rabies and Japanese encephalitis could be relevant for Mpox vaccine production. The company’s ability to produce vaccines at scale for both human and animal health positions it well for this challenge.
• Challenges: IIL may need to invest in new R&D efforts to develop an Mpox-specific vaccine, which could take time and resources.

Potential Market Opportunities

The global demand for an Mpox vaccine presents a significant market opportunity for Indian pharmaceutical companies. With the virus spreading to over 116 countries, there is a growing need for effective vaccines, particularly in regions that are seeing new outbreaks. Indian companies, known for producing affordable vaccines at scale, could play a critical role in meeting this demand.

Moreover, as global attention turns to preventing future outbreaks, Indian pharma companies could find opportunities in long-term contracts for vaccine production and distribution. This could lead to new revenue streams and increased market share, both domestically and internationally.

Regulatory and R&D Challenges

While Indian companies have the capacity and expertise to manufacture Mpox vaccines, several challenges must be addressed:

• Regulatory Approvals: Developing a new vaccine or repurposing an existing one requires rigorous clinical trials and regulatory approvals. This process can be time-consuming and may delay the availability of vaccines.
• R&D Investments: Significant investment in research and development will be necessary to develop an effective Mpox vaccine. Companies will need to allocate resources for clinical trials, safety assessments, and scalability studies.
• Global Collaboration: Given the global nature of the Mpox outbreak, Indian companies may need to collaborate with international organizations, governments, and other pharmaceutical companies to ensure the vaccine’s effectiveness and accessibility.

Conclusion

India’s pharmaceutical industry is well-equipped to respond to the Mpox outbreak by developing and manufacturing vaccines. Companies like Serum Institute of India, Bharat Biotech, Zydus Cadila, Biological E., and Indian Immunologicals Limited have the infrastructure, expertise, and global reach to play a crucial role in this effort.

While challenges related to regulatory approvals, R&D, and global collaboration exist, the potential benefits for Indian pharma companies are significant. By stepping up to address the Mpox crisis, these companies can not only contribute to global health but also enhance their reputation.