Top Indian vaccines and bio-therapeutics manufacturer Bharat Biotech is at the forefront of the fight against COVID-19. Its vaccine against the disease has completed the pre-clinical trial and is now entering the human trial stage.
The company has been working with the National Institute of Virology (NIV) under the Indian Council of Medical Research (ICMR) to develop the vaccine, named COVAXIN.
The vaccine will be developed by making 'living coronaviruses' stored by it non-virulent. These specimen are kept in over 200 litres of storage facility at the Genome Valley in Hyderabad.
Suchitra Ella, one of the founders of Bharat Biotech, details the research to Onmanorama. She says her company's aim is to develop a vaccine by early next year.
What is COVAXIN? How is it developed?
When a pathogenic virus is introduced into the body, there is the possibility that the immune system will produce the antibodies to kill the virus. These antibodies are used for vaccination.
Our research is in association with the National Institute of Virology (NIV), which is a part of the Indian Council of Medical Research (ICMR). They provided us the coronavirus strain for the study.
The first step is to allow the virus to multiply through cell culture.
In short, there is a large number of ‘living coronavirus' in our facility. They are either killed or their RNA components are destroyed by using certain chemicals.
This is to prevent the virus from multiplying after it enters the body's cells. Viruses that lose the ability to multiply become harmless and are used to make a vaccine.
A study on the side-effects of the vaccine is also going on simultaneously.
What were the initial stages of the research? What were the results?
The pre-clinical study of the vaccine was done after a detailed academic research. During this stage, COVAXIN was tested in hamsters, mice and rabbits as per the laid-out guidelines to ensure its safety. This stage took us three months.
The results were promising and we submitted them. It was based on these results that the Drug Controller General of India gave us the permission for human trials.
This is not just a claim made by us. The tests were conducted simultaneously at the government-run NIV and the results were verified.
What about the human trials, the final stage?
The volunteers who will be selected for the human trial will be those who never got the disease. The RT-PCR test will be conducted on the volunteers to ensure they don't have COVID and about 1,200 volunteers will be selected.
The candidates are from several parts of the country and of various age groups. They will be administered the vaccine.
The dosage required for humans cannot be acsertained with the results obtained from animal testing. The decision on dosage is yet to be made.
As mentioned earlier, harmless viruses that can't multiply will be used to make the vaccine. The body will think it is under attack from the virus and will start making antibodies. Blood samples will be collected after 28 days and live viruses that are safely stored will be made to grow on them.
We can be certain that the experiment has succeeded if the virus doesn't multiply and becomes non-virulent (neutralization). This test will take at least three months. We are trying to commence the tests by mid-July.
How is your COVAXIN research different from those being conducted abroad?
We have adopted a different approach for every aspect of the research right from the technical details to the way the vaccine will be made.
The virus strain required to make the vaccine and those that will be a part of the research will all be from India. The vaccine-maker too is Indian.
Not just 100 per cent, you can call it a 200 per cent Indian vaccine.
The research is being done in association with the NIV. What is the cost of the study?
We are doing the research on our own. We have not accepted any funds from the government.
NIV is also associated with the research on COVAXIN. Naturally, they will do their part with assistance from the government.
When will the vaccine be ready? How much will it cost?
Vaccine research takes many years. Bharat Biotech has developed 16 vaccines, including the ones for HIV, rotavirus, Japan fever, measles, chikungunya, Zika and typhoid. It took us 16 years to find the vaccine against rotavirus.
In the case of COVID, the situation is a little different. The whole world needs it. Our goal is to develop a vaccine by early next year.
We are not thinking about the price and other things now. The vaccine is the most important.
30-odd Indian firms developing COVID vaccine
Thirty-odd companies in India are involved in the research to develop a COVID vaccine.
The research of some companies has been very promising and they are at an advanced stage of their studies, the Union Science and Technology Ministry has said.
Besides Bharat Biotech, companies such as Pune-based Serum Institute of India, Zydus Cadila, Indian Immunologicals Limited, Biocon, Shantha Biotechnics, and Genova Bio Pharmaceuticals are actively involved in the research.
2 more COVID vaccines from Bharat Biotech likely
Bharat Biotech has also joined hands with two foreign institutions to conduct research on COVID vaccine.
It is working on a vaccine named CoroFlu in association with the University of Wisconsin-Madison in the UK.
In the US, it has joined hands with Thomas Jefferson University to develop another vaccine.
Both the vaccines are in the pre-clinical stage.
