14 vaccine candidates from India look promising: Dr Renu Swarup, Department of Biotechnology

Human trials for at least 3-4 candidates are likely to begin in the next 2-6 months. Biotechnology Industry Research Investment Council (BIRAC) a public sector of Department of Biotechnology, has been at the forefront since the inception of the CO...

In an interview with ET, Dr Renu Swarup, Secretary, Department of Biotechnology, talks about the development of various vaccines in India. Edited Excerpt:

At the global level, there are at least 90 candidates in the fray. Efforts are on with 30 vaccine potentials by industry and academicians in India. What stage are we in for these vaccines?
Out of the various vaccines being developed globally, about 30 vaccine candidates are being developed in India. Nearly 14 being developed by industry and academia show promising leads. There are also efforts where Indian academia and industry are participating in global partnerships. Many academic and research institutes are working as part of the consortium to develop platforms for vaccines. Four of these candidates are at advanced stages of development.

Oxford Jenner institute has started human trials a month back and is confident of developing a vaccine by September. What is stopping up from reaching any closer to human trials?
We are making our best efforts to expedite our home-grown vaccines. The recombinant BCG candidate has begun with the Phase III studies in April. If the results demonstrate acceptable efficacy, this candidate has the potential to make it by the year end. Also, global collaborations are being looked at between Indian companies and global vaccine groups. We will support groups in India which have potential vaccines development plan including phase II/III studies. There are also efforts to provide an enabling ecosystem. A Rapid response regulatory framework has been notified which will facilitate speedy vaccine development through the pathway. There are also discussions with the Global key stakeholders to prepare for Global Vaccine trials in the country to enable both Indian and Global players to bring their vaccines to market early.

How many vaccine candidates from India are at animal testing and invitro stage?
A number of vaccine development efforts are going on in the country and have progressed well. From the various candidates from the Indian companies, around nine are in early stages of development, some five in advanced stages of development and two candidates: Serum’s recombinant BCG and Cadila Pharmaceuticals' Mycobacterium candidate are in Phase III studies. Under DBT-BIRAC Consortium call, 10 vaccine proposals have been recommended for funding support. These are in different stages of development.

DBT has recently funded Serum Institute for BCG vaccine, Cadila for DNA vaccine candidate, Bharat Biotech for rabies vector platform and Gennova m-RNA vaccine candidate. What is the amount of funding and which candidate looks most promising right now?
Each candidate is unique and has its own scientific merits and has its own potential. However, right now I can say that the Serum BCG candidate is in phase III studies and the trial is being supported by DBT-BIRAC COVID consortium, if it shows acceptable efficacy has the potential to be implemented by the end of the year. The DNA vaccine, Rabies platform and mRNA vaccine have their own merit and are at advanced stages

Is there any other prominent company or academia with which Department of Biotechnology is working closely for vaccine development?
Yes, besides, Serum, Cadila, Bharat Biotech and Gennova that have been named earlier, we have recently recommended funding support to CMC, Vellore, NII, New Delhi and Enzene Biosciences for efforts in vaccine development. In addition, the DBT Autonomous Institutes THSTI and ICGEB are also working on different vaccine candidates.

How close are we to human trials? Being the chairperson of BIRAC that serves as a bridge between labs and industry, what are some of its key achievements for COVID management?
Human trials for at least 3-4 candidates are likely to begin in the next 2-6 months. Biotechnology Industry Research Investment Council (BIRAC) a public sector of Department of Biotechnology, has been at the forefront since the inception of the COVID crisis. The COVID Research Consortium initiative that started early on in March is being facilitated at BIRAC. The focus has been on Vaccines, Therapeutics and Diagnostics. It has been central to assisting startups and connecting them to investors and investments. A fast track review mechanism for COVID-19 has also been facilitated at BIRAC to fund startups and also to find co-funding partners for fast tracking efforts for COVID solutions. BIRAC is also working towards mobilizing CSR funds through Invest India platform for COVID-19 Research Consortium. A virtual partnering platform has also been developed that aims to gather the global pharma industry to connect and help bring forward solutions against the novel coronavirus pandemic. Regular weekly FIRST HUB sessions are also being held to provide regulatory support to startups. A special legal webinar series was also conducted on business implications of COVID-19. There has also been a major effort on indigenization of Resources to respond to the call of our Prime Minister for an Atmanirbhar Bharat. In the Diagnostic sector we today have moved from 100% Testing kit import in March to today having nearly 20 Indigenous manufacturer’s and a kit manufacturing capacity of over 50 Lakh kits per month. We have also launched the Pilot N-BRIC a National Biotech Resource Indigenization Consortium which provides for indigenous resources for all product development. Today we have sufficient capacities to provide complete indigenous resources for our local kit manufacturers.

Serum is throwing its weight behind Oxford and is confident of a vaccine by September. Is the target reasonable and what is the basis for this claim?
Serum is the largest manufacturer of vaccines globally and has earned credibility for WHO prequalified vaccine manufacturing. We wish them all the best for their collaboration with Oxford. They have announced that they will be manufacturing this vaccine; we will have to wait to see the results of the trial

Please give a time limit by when we can expect a vaccine in India.
We are all optimistic and hope that if all goes well, we should have vaccine in the next 12-18 months. This is the situation globally as well. Our Scientists are working very hard.




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