Hyderabad: Leading vaccine maker Bharat Biotech announced that it has successfully developed COVAXIN, India's first vaccine candidate for COVID-19. In an exclusive interview with ETV Bharat, Dr Krishna Ella, Chairman and Managing Director of Bharat Biotech speaks about challenges of vaccine development, trials involved and the company's commitment to produce the cheapest COVID-19 vaccine in the world.
Q. There is a race for the vaccine. Will your company be the first to announce a successful vaccine?
A: Usually every vaccine takes 14-15 years to develop. So you want the 14-15 years to compress to one year, it is a challenging task for all of us- for every manufacturer, for every regulator.
And it is happening at the manufacturer's level and regulator's level.
Q. So you have been able to bring it to a short time period. Now that itself is an achievement as such. But is it because of global cooperation? A lot of scientific literature is also available and therefore researchers put it out in the open. Has this of scientific literature helped you?
A: On COVID-19 there was not much literature available 2-3 months back. A lot of data is coming in and I am glad that China, the US are putting it in the public domain. That is a good thing.
But from manufacturers angle, nothing is published. Whatever is published is more of animal data and clinical data. Manufacturing is always a trade secret. So nobody will put it in the public domain.
No manufacturing process is usually filed for patent also. They all keep it as propriety, technical know-how within the company.
Q. Can you tell us how the trial process begins and the stages involved before the vaccine is brought to the market?
A: National Institute of Virology (NIV), Pune isolated the virus. They characterised the virus and that virus is being given to us. Then we manufacture R&D batch and then GMP batch.
The one that goes into the human should be manufactured in Good Manufacturing Practise (GMP) batch. And we have to make three consistency batches, so that batch variations are not there.
After manufacturing three batches, we formulate, fill in the vile and one vile goes to stability and other goes to animal toxicology. Then we do three animal toxicology- mice, rabbit and rat. We give 1-2 doses of vaccine to animals, follow the immunology, toxicology and safety.
After finishing that we get phase-1, 2 clinical formations. In phase 1- the trial is for 28 days and serology analysis is done to recruit a COVID-19 free person.
Once the volunteers are recruited after rt-pcr test, doses are given and on the 28th-day samples are drawn. Then we do serology. The antibodies produced in the body will not allow the virus to multiply. This is called neutralisation.
We bring the blood samples and the virus in BSL-3 lab and that virus should not multiply. After that, we go to phase-2, 3. It is a lengthy process.
Q. How close are we to a vaccine?
A: Definitely a vaccine will be there for sure. We are working on three platforms and we are sure in two platforms it will work for sure. There are hundreds of R&D companies but only a few manufacturing companies with vaccine manufacturing experience.
Q. In India, NITI Aayog has said that there are six candidates who have made it to the list. How is Indian manufacturer looking? What is the ratio between labs and manufacturers in India?
A: In India, most manufacturers are in the vaccine field and R&D companies are very few. They don't have the expertise in quality control and vaccine research.
It is a long process, in the US many are R&D companies. In India, manufacturing companies are also R&D companies. Bharat Biotech is also an R&D company with over 100 scientists currently working.
Q. BSL-3: Is it a set of guidelines? Can you explain what it is?
A: BSL means Bio Safety Level. The lowest category is BSL-1 and BSL-3 is the highest. Similarly, we have BSL labs as well. Bharat Biotech is perhaps the only company with BSL-3 production facility. China recently sanctioned $200 million to build a BSL-3 facility. The US is also going to build one.
We would not have been allowed to manufacture live inactivated vaccine in India if we did not have BSL-3 facility. Without this facility, we cannot manufacture live virus vaccines. We are on the right track.
Q. A lot of manufacturers are using vero cell technology to manufacture inactive viruses. Is Bharat Biotech also using the same platform or has it developed something unique?
A: We are using the same platform. If we use a different platform there are more regulatory hurdles. I will have two products: cell culture and virus. So you have to characterise two products and it becomes complicated. Vero cell technology is a proven platform from a regulatory angle.
Also, we have the largest vaccine expertise in vero cells with 7-8 vaccines in this platform.
Q. If you will be able to get that vaccine, there will be a global demand. How will you scale up production?
A: We are in the initial stages- how to make the virus grow, how to make GMP batches, how to do toxicology and how to do clinical trials. Parallelly, we are trying to see how to scale up production.
We are the largest manufacturers of Rotavirus, Rabies vaccine in the world. That clearly shows we have the capability, we have scalability. But to this virus, it will take time to confirm that.
Read: Bharat Biotech’s COVID-19 vaccine first in India to receive nod for human trials
Q. What kind of help did you actually get from the government and the national institutes who are looking into COVID-19 outbreak?
A: The government is pro-active, there is no question about that. This inactivated vaccine is under a public-private partnership. As a manufacturer, we have limitations. R&D is easy but I have to deliver a product: safety and efficiency is important.
Q. There are several strains of COVID-19 that are being reported. Do we need a different vaccine for different strains or just one for all the strains?
A: All RNA (ribonucleic acid) viruses change via mutation very fast. Basically, a virus is a non-living organism, it cannot multiply on its own. So it has to enter the human body and use the machinery to multiply.
When you have a non-living organism using the human body, it tries to adapt differently to different host bodies to survive. The COVID-19 gene that binds to the lung receptor is important. Mutations may happen in other spikes but not in this one.
So, therefore, if a mutation occurs in this part we need to have a different vaccine. But as we see today, this region is unlikely to change too much.
Q. When it comes to patenting the vaccine, how does Bharat Biotech look at that aspect?
A: As a manufacturer, we need to file a patent for one main reason. I have to file a patent to be defensive and show the other manufacturer I have done it before you. It is a strategic game. I do not want MNCs to come and tell me that I have violated a patent. That is why we have 160 patents globally.
Q. When we look at pricing will it be affordable to common man once it reaches a large scale of people?
A: Rotavirus vaccine is sold for $65 in the US and $80 in Europe. We told the prime minister we will sell it for $1 dollar per dose. We will be selling at the lowest price in the world. We will be 10 times cheaper than China when it comes to COVID-19 vaccine.
As I have said, we have not taken any money from the government. The only reason why we have not taken the money is when the country is going through suffering, I do not want to exploit the system.
What is important is to save the lives of people and make the technology to work. That speaks of our commitment.
Read: Bharat Biotech in Hyderabad to develop intranasal COVID-19 vaccine
Q. How difficult was it for you to convince your employees because this is an extraordinary time?
A: The last two months was a nervous breakdown for us. How to catch up to China and the rest. That was a tremendous pressure as we were delayed by 4 months.
And the BSL-3 containment is where my employees have to work. I am thankful to my employees. They have not seen their families for the last two months. They are working in a virus area, they can't go to their families.
Once, phase 1 starts we are going to vaccinate them so that they are now protected. I think our employees are a gift to us and the country.
Q. When can we actually see this particular virus go away from this world? Will it take time to vaccinate a huge amount of people? What is the kind of logistical challenges that we face?
A: It is possible to vaccinate 1.3 billion people by next year. If the government can facilitate the process, it can happen.
