BV Academia Series: PPP critical to develop indigenous vaccines

Prof. Soma Rohatgi, Department of Biological sciences and Bioengineering, Indian Institute of Technology, Roorkee shares her views on the factors behind the success of vaccine sector in India. Prof. Rohatgi is currently working on fungal, viral and bacterial vaccines.

What role have the Indian research institutes and other stakeholders played in the innovation and development of indigenous vaccines?

Forging public-private partnerships has played a crucial role in the innovation and development of indigenous vaccines. Industry partnerships with Dept of Biotechnology, Govt of India, AIIMS, ICMR, CSIR and other Indian research Institutes like NII, THSTI, NIV, ILS, CCMB etc has spearheaded vaccine development using novel platforms. Availability of BSL-3 and BSL-4 Research facilities, scientific know-how, trained manpower etc provided by Indian research Institutes contributed directly or indirectly to the development of home-grown vaccines. These institutes have been supported by government-funded programs and are a significant source of technical expertise.

What do you consider the key achievements of Indian vaccine industry?

The Indian vaccine industry contributes to around 65% of vaccine need of the world. Indian pharmaceutical companies including Serum Institute of India, Bharat Biotech, Dr Reddy’s Laboratories, Zydus Cadila, Biological E, Gennova Biopharma, Panacea Biotech, Shantha Biotech, Indian Immunologicals Ltd, BIBCOL are among the leading vaccine manufacturers. During the Covid-19 pandemic, the Indian vaccine industry developed a number of home-grown Covid-19 vaccines and accomplished an incredible task of vaccinating 70% of the population with Made in India vaccines.

Which factors could be attributed to the success of the Indian vaccine industry?

Setting up of both public sector and private sector vaccine manufacturing units, granting permission for clinical trials and final licensing, marketing authorization for vaccines in India, presence of robust pharma industry, vast experience in clinical trials and testing, Universal Immunization Program (UIP), National Immunization Program, National Vaccine Policy, WHO pre-qualifications, low cost of production, generic drug industry, polio mass vaccination drives, are some of the factors that can be attributed to the success of the Indian vaccine industry. The idea of ‘Aatmanirbhar Bharat’ and ‘Made in India” programs also contributed to motivate and drive Vaccine Industry towards vaccine self-sufficiency.

In which ways has the Covid-19 pandemic accelerated the vaccine development process?

India’s position as a world leader in vaccine manufacturing and development became prominent during the Covid-19 pandemic, when the world witnessed India’s manufacturing capability and capacity. Vaccine development usually is a time consuming multistep process, including regulatory approvals by different government bodies. Due to global emergency, scientific database, strain sequences and novel research outcomes were made accessible to all, resulting in real time global knowledge sharing never seen before. All the processes were accelerated by unprecedented collaborative efforts among scientists, industry and government bodies. Academia-Industry came up with multiple vaccine candidates and government provided fast tracked approvals for pre-clinical/clinical trials & regulatory approvals with ‘restricted emergency use’ provision under New Drug & Clinical Trials (NDCT) Rules 2019. By following the principle of “Vasudhaiva Kutumbakam – the world is one family”, India not only vaccinated its 1.4 billion population; but also provided millions of vaccine doses to several other countries.

Would it be possible for the vaccine companies to sustain the momentum?

During the pandemic, in a short time the vaccine companies not only came up with vaccine candidates but also enhanced their capabilities to cope up with global demands for vaccines. It was the result of fast-tracked approvals by government as well as focused approach by industry and academia. Although it is hard to sustain the same momentum due to obvious reasons, however, now the vaccine industry is primed and ready for any such challenges.

Any regulatory or policy related challenges? What kind of support is expected from the government?

Promoting and facilitating more Industry-academia partnerships with global organisations such as GAVI and Coalition for Epidemic Preparedness Innovations (CEPI) will help. Setting up Consortiums between clinical and research institutes will facilitate ease of conducting clinical trials. Expedited regulatory approvals under restricted use in emergency situation concerning public health emergencies would also be beneficial. Govt. should provide more funding opportunities for Indian researchers working in either individual capacity or having joint collaborations in the field of vaccine development. Increasing funding support for pre-clinical studies will be fruitful for the earlier stages of vaccine development process.

How do you look at the future trends that would shape up the Indian vaccine industry?

Although preventive vaccines are necessary for protection against future pandemics; however, in immunocompromised individuals passive transfer of ready-made life-saving antibodies would be helpful. Therefore, more research should be conducted on alternative therapies such as monoclonal antibody-based therapies. It would be beneficial for National health to maintain the momentum of vaccine development against other deadly diseases.  Apart from viral pathogens, there are many other drug-resistant bacterial and fungal infectious diseases having high mortality, which require extensive pre-clinical studies to evaluate the potential of vaccine candidates. Further, moving towards new vaccine platforms, and strengthening the cold chain infrastructure in remote hospitals is the way for future.