Q. With Covid-19 cases increasing constantly, COVAXIN will be a big relief for India. What is this vaccine and its origin?
A. The vaccine candidate was developed by BBIL in collaboration with the National Institute of Virology (NIV). NIV isolated a strain of the novel coronavirus from an asymptomatic Covid-19 patient and transferred it to BBIL early in May. The firm then used it to work on developing an “inactivated” vaccine — a vaccine that uses the dead virus — at its BSL-3 facility in Hyderabad.
Q. Is it completely owned by Indian technology? Can we call it an “Aatamanirbhar” product?
A. Yes, it is a completely indigenous vaccine. We are proud to say it is the first vaccine for Covid-19; it’s a Madein-India vaccine developed by Bharat Biotech and the only vaccine candidate that got DCGI approvals to commence Phase I and Phase II Human Clinical Trials.
The strain was isolated in India! Researched in India! Clinical Trial conducted in India! Manufactured in India!
Q. What kind of lab facility is required to produce such vaccines? Do you have a world-class facility?
A. BSL-3 (Biosafety level-3) is a facility that includes work on microbes that can cause serious or potentially lethal disease through inhalation. Bharat Biotech is the only company to have a BSL-3 manufacturing facility in India. To grow and replicate this vaccine candidate, a BSL3 (Biosafety level-3) manufacturing facility is a must. Since SARS-COV-2 is a novel virus, it has to be carefully handled within the confines of such a facility.
Q. Where did you get the strain of this virus?
A. The virus strain was first isolated from an asymptomatic Covid-19 patient and characterised at NIV, Pune, an organisation under ICMR institute.
Q. What is the whole procedure you have gone through?
A. Upon receipt of the virus strain from the NIV Pune, Bharat Biotech was able to quickly layout the GMP protocols for the manufacture of the vaccine candidate. Bharat Biotech took to develop the first set of GMP batches within 40 days and upon completion, the pre-clinical trials commenced. COVAXIN™ was evaluated in animals on Schedule Y Guidelines from India and WHO Guidelines. COVAXIN™ was reported to be safe and immunogenic in all animals. We have now moved forward towards the clinical development of this vaccine.
This Public-Private Partnership was quite assuring for Bharat Biotech to help accelerate the development of the vaccine, and move towards the fulfillment of this project. An added advantage was the quick turnaround time from DCGI for all the approvals that were needed thus far.
Q. On how many animals have you done trials?
A. We have conducted trials on the standard statistical number of animals required for a vaccine of this kind.
Q. When are you going to start trials on Humans? In how many centres and hospitals are you going to start trials?
A. We plan to begin the first phase of human clinical trials this month, which will be followed by phase 2 clinical trials. Cohort enrolments are underway, and the trials will be conducted in 10 different sites in India which include the NIMS Institute in Hyderabad and AIIMS in New Delhi.
Q. How have you arranged funds and how much investment is required in the whole project?
A. It is a self-funded project by Bharat Biotech, while we are grateful that ICMR is facilitating their support through NIV.
Q. How did you decide to work on this vaccine? What clicked in your mind?
A. We are proud to state that we have been at the forefront of forecasting many epidemics in the past. We were the first company to develop in India H1N1 in 2009 and are currently working on Chikungunya and Zika. Our expertise in the indigenous, proprietary vaccine development methodologies has given us the courage to embark on multiple projects to develop a vaccine for Covid-19.
We are currently working on three vaccine programmes, and COVAXIN™, the ICMR-NIV and Bharat Biotech collaborative programme, has shown great progress and it is most promising as the pre-clinical trials data has shown good immune safety in the animal trials.
Q. Have you spoken to the PM regarding this achievement?
A. According to reports, we hear that the Prime Minister has mentioned the vaccine in his recent speech to the nation.
Q. When is it expected to get a vaccine? How much is your capacity?
A. With the clinical trials about to commence and based on the successful results of phase 1 and phase 2, we will progress to the larger clinical trials.
Bharat Biotech is now scaling up efforts to evaluate the appropriate dosage requirements. The exact requirement will be stated in due time. Currently, Bharat Biotech is looking to target a capacity to produce 300 million doses per annum.