Dr Renu Swarup, Secretary, Department of Biotechnology, in an interview with ET, talks regarding the development of a variety of vaccines in India. Excerpt Edited:

Globally, there are almost 90 candidates in the battle. Efforts are going on with 30 vaccine potentials by academicians and industry in India. What stage is India in for these developing vaccines?

About 30 vaccine candidates are developed in India, out of the variety of vaccines being developed globally. Almost, 14 vaccines are being developed by academicians and industry which shows promising leads. Efforts are being made for Indian academic world and industry participating in global partnerships. Several academic and research institutes are also working as part of the association to develop stand for vaccines. Four of these vaccine candidates are already at advanced stages of development.

Oxford Jenner institute has going ahead with human trials a month ago and is positive of developing a vaccine by September this year. What is stopping India from getting any closer to human trials?

Best efforts are being made to accelerate India’s home-grown vaccines. The recombinant BCG candidate has initiated with the Phase III studies in April. If the results exhibit acceptable efficacy, then the candidate has the potential to be produce by the year end. Global association are also looked between Indian companies and global vaccine groups. We shall support groups in India that has plan for potential vaccines development including phase II/III studies. Efforts are being made to provide an enabling ecosystem. A Rapid response regulatory framework has been alerted that will assist speedy vaccine development through the pathway. Also, discussions with the Global key stakeholders to organize for Global Vaccine trials in the country are in process to allow both Indian and Global players to get their vaccines to market as early as possible.

How many vaccine candidates are from India at animal testing and in-vitro stage?

Several vaccine development efforts are happening in the country and have well progressed. Approximately 9 candidates from the Indian companies are in early stages of development, five candidates are in advanced stages of development and 2 candidates such as Serum’s recombinant BCG and Cadila’s Mycobacterium are undergoing Phase III studies. Under DBT-BIRAC Consortium term, 10 vaccine proposals are recommended for funding support and are in different stages of development.

Recently, DBT has funded Serum Institute for BCG vaccine, Cadila has funded for DNA vaccine candidate, Bharat Biotech has funded for rabies vector platform and Gennova has funded for m-RNA vaccine candidate. What is the total funding and which of these candidates seems to be most promising at present?

Each of these candidates is unique and has their own scientific qualities and potential. At present, I can only say that the Serum BCG candidate is undergoing phase III studies and is supported by DBT-BIRAC COVID consortium. If the trial shows acceptable efficacy then it has the potential to be executed by the end of the year. Rabies platform, the DNA vaccine and mRNA vaccine have their own advantage and are in advanced stages.

Is there any other well-known company or academia with which the Department of Biotechnology is working for vaccine development?

Besides, Bharat Biotech, Serum, Cadila and Gennova, we have of late recommended funding support to CMC, Vellore, NII, New Delhi and Enzene Biosciences for development in vaccines. Also, the DBT Autonomous Institutes THSTI and ICGEB are working on various vaccine candidates.

Are we close to human trials? What are key achievements for COVID management?

Human trials for almost 3-4 candidates will begin in the coming 2-6 months. Biotechnology Industry Research Investment Council (BIRAC) is a public sector of Department of Biotechnology, and has been at the front since the beginning of the COVID-19 crisis. The COVID Research Consortium programme that started in early March is being assisted at BIRAC. The focus is on Vaccines, Therapeutics and Diagnostics. It has been assisting in start-ups and also connecting them to investors and investments. A fast track review mechanism for COVID-19 has been assisted at BIRAC to fund start-ups and find co-funding partners for fast following efforts for COVID solutions. BIRAC is working towards mobilizing CSR funds through Invest India platform for COVID-19 Research Consortium. A virtual partnering platform is developed that intend to gather the global pharma industry to connect and bring solutions against the coronavirus pandemic. Regular weekly FIRST HUB sessions are held to provide regulatory support to start-ups. A special legal webinar series was conducted on business implications of COVID-19. A major effort on indigenization of Resources to respond to the call of our Prime Minister for an Atmanirbhar Bharat has been initiated. In the Diagnostic sector, from the import of 100% testing kit in March to almost 20 Indigenous manufacturer’s and a kit manufacturing capacity of more than 50 Lakh kits per month, we have move forward. We have also launched the National Biotech Resource Indigenization Consortium (Pilot N-BRIC) that provides for indigenous resources for all product development. At present, we have adequate capacities to offer complete indigenous resources for local kit manufacturers.

Serum is putting its weight on Oxford and is confident of a producing vaccine by September. Is the target practical and what is the basis for such claim?

Serum is one of the largest manufacturers of vaccines globally and has earned credibility for WHO prequalified vaccine manufacturing. We wish them all the best for their partnership with Oxford. As they have announced that they would be manufacturing this vaccine; we have to wait and see the results of this trial.

Can you give a time limit by when a vaccine is expected in India?

We are all hopeful that if all goes well, we should have produce vaccine in the next 12-18 months and our scientists are working hard on it. Globally, the situation is same as well.

Source: ET Healthworld