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When ideology overtakes pragmatism in crafting public policies, it portends danger to society. The recent decision by the Trump Administration to cancel $500 million in funding for mRNA vaccines, a game-changing technology that proved effective during the Covid-19 pandemic, is one such instance that shocked the global scientific community.

 

A total of 22 contracts with university researchers and private companies to develop new applications for mRNA technology now stand terminated. The impact of this thoughtless and impulsive move, announced by the US Health Secretary Robert F. Kennedy Jr., a vaccine sceptic, could be a huge blow to America’s dominance in biomedical research.

 

mRNA technology is considered the best option for protecting people from dangerous viruses and their mutants. In fact, mRNA vaccines helped save millions of lives across the world during the recent pandemic. While it is impossible to tell when the next pandemic will occur, there is a consensus among scientists that it will definitely happen, especially in the era of globalisation and human encroachment into new environments.

India ideally placed

 

Having emerged as a leading global player in the pharma and biotech sectors, India is ideally placed to become a role model in cutting-edge research. Already, a desi version of the mRNA vaccine—GEMCOVAC-OM—was launched in June 2023. It was developed using an indigenous platform technology with funding support from the Department of Biotechnology (DBT) and Biotechnology Industry Research Assistance Council (BIRAC).

 

The data suggests that mRNA vaccines have the potential to solve many of the challenges in vaccine development for both infectious diseases and cancer.

India must now seize the opportunity, step up research funding, attract the best global talent, and lead the way in developing new vaccine technologies that cater to the future needs of the world.

 

India's prowess in vaccine production has earned it the moniker "pharmacy of the world," accounting for 60 per cent of global vaccine production and contributing 40–70 per cent of the WHO demand for Diphtheria, Tetanus and Pertussis (DPT). During the Covid-19 pandemic, India's Serum Institute became the world's largest vaccine manufacturer.

 

Despite being a world leader in vaccine manufacturing, it lags behind in Research and Development. Historically, India’s R&D efforts in basic science get caught in a bureaucratic maze.

 

Vaccine science is very broad and encompasses many skills. It includes different classes of professions, including researchers, healthcare experts, machine handlers, and testers. It is estimated that the country will need 30 million professionals with digital skills by 2026, and 50 per cent of the current workforce is expected to be re-trained in emerging technology sectors.

 

Lessons from the pandemic

 

India’s capabilities in the manufacturing of vaccines came to the fore during the Covid-19 pandemic. It provided equitable access to resilient supply chains and logistics, further strengthening its position in the vaccine segment.

 

During the pandemic, India not only provided vaccines to a population of 1.4 billion but also catered to 101 countries by supplying 242 million low-cost and high-quality vaccines. Companies like the Serum Institute of India, Bharat Biotech, and Biological E are key suppliers to countries with low and high incomes, providing affordable vaccines. India was also home to vaccine innovations, such as a needle-free vaccine developed by Zydus Cadila and a unique mRNA vaccine candidate from Gennova Biosciences that does not require ultra-cool storage.

 

Besides, India has actively collaborated with international organisations like WHO, Gavi, and the Gates Foundation. Some of the indigenous vaccines, like Bharat Biotech’s Covaxin, highlighted the country’s growing capacity for innovative vaccine research.

 

The vaccine sector has driven substantial revenues and stimulated investments in healthcare infrastructure and R&D. The industry has been supporting thousands of jobs in manufacturing, R&D, and logistics, contributing hugely to the economic growth of India. This has positioned India as an attractive destination for pharmaceutical investment.

 

Challenges galore

 

However, inadequate cold chain infrastructure, high development costs, and regulatory hurdles are among the major challenges that India faces as it aspires to play a much bigger role in the global vaccine market.

 

While it is a major vaccine producer, particularly for the Global South, it struggles with ensuring timely delivery due to insufficient cold chain facilities. Maintaining the potency of vaccines requires a reliable and efficient cold chain from the manufacturer to the end-user.

 

India's vast geography and diverse climatic conditions pose a significant challenge in establishing and maintaining a robust cold chain network. Lack of adequate storage and transport facilities can lead to vaccine wastage and reduced efficacy.

 

Similarly, developing new vaccines requires significant investment in research, clinical trials, and manufacturing facilities. This can be a barrier for smaller companies to compete in the global market. Stringent regulatory requirements for vaccine production and approval often delay the launch of new vaccines.

Navigating the regulatory landscape, especially for exports, can be complex and time-consuming for Indian manufacturers.

 

India faces competition from established global players in the vaccine market. Securing access to international markets, particularly in developed countries, can be challenging due to various trade barriers and regulatory requirements. Addressing these challenges through strategic investments in infrastructure, streamlining regulatory processes, and fostering collaborations can further strengthen India's position in the global vaccine market.

 

Time to step up investments

 

It is time to scale up and invest in advanced technologies like artificial intelligence in life sciences, cell and gene therapy, and be prepared for future epidemics. The success of the Indian IT sector can be leveraged to bring new partnership opportunities for the life sciences industry to add more innovation and modernisation in manufacturing processes.

 

The pandemic prompted the pharmaceutical industry to reflect on its ability to scale up manufacturing facilities to reach people globally and domestically. India has over 740 US-FDA-approved plants that can be used to improve manufacturing processes in vaccine development.

 

The contribution of technology and cross-organisational collaborations will help us build a strong foundation for creating novel methodologies. In addition to this, strategic investments and skilled manpower with strong technical knowledge will enable us to stand out as the best. India's emphasis on innovation, research, and manufacturing excellence will pave the way for the nation to become a leading vaccine manufacturing hub globally.

 

India needs to increase its R&D spending and create a favourable local environment for end-to-end vaccine innovation and manufacturing. Adding innovative vaccine delivery platforms, such as a common viral vector or cell-based delivery platforms, to India’s growing vaccine portfolio can also help scale production.

 

Regulatory frameworks should also be redesigned to include platform-based approvals. Then, a single approved platform can be utilised to develop multiple vaccine products, thereby accelerating market entry through a streamlined regulatory process.

 

Furthermore, India’s non-COVID-19 vaccine portfolio is largely restricted to LIC (low-income country) and LMIC (lower middle-income country) sectors. There is a need to tap into HIC (high-income country) markets to accelerate growth in this sector.

 

Experts also suggest that the Indian vaccine industry should explore technology transfer and contract manufacturing opportunities for vaccines such as conjugate vaccines, pneumococcal vaccines, and rotavirus vaccines to enter the HIC segment. 

 

Also, novel applications should also be explored. For instance, vaccines are also likely to enable disease treatment, in cases such as norovirus and HIV infections. These opportunities should be explored further for the growth of the Indian vaccine sector. International collaborations can also help improve the production and delivery of vaccines at an affordable rate.

 

Global vaccine manufacturing is largely restricted to large pharmaceuticals such as Pfizer, Moderna, Sanofi, GSK, and Novartis. However, Intellectual Property licensing programmes and modular manufacturing approaches can enable Indian manufacturing of global vaccines and thereby provide improved access. Indian public and private sectors should explore these strategies to grow in this industry sector.

 

Sustainable vaccine manufacturing requires strategic commitments to developing the workforce, building a strong bioscience ecosystem, sustaining and expanding markets, and motivating the private sector to invest and innovate.