Exclusive: Bharat Biotech's Joint MD Suchitra Ella confident on Covid vaccine production commitments

Indian Covid vaccine maker Bharat Biotech's Joint Managing Director Suchitra Ella expressed confidence over meeting commitments that have been made to Government of India. The company aims to produce 1 billion Covid vaccines (Covaxin) doses from facilities located in Hyderabad, Bengaluruand Ankleshwar.

Ella co-founded the company along with Dr Krishna M Ella and the company'sCovid vaccine along with Covishield and Sputnik are the only 3 vaccines allowed to be administeredin India.

Speaking exclusively to Wion's Principal Diplomatic Correspondent Sidhant Sibal, Ella highlighted the supply chain issues and the Ministry of External Affairs reaching "out to us to take this forward to help ease the supply chain in these areas which are specific to vaccine manufacturers." The company needs chemicals for testing and most of these chemicals come from either Europe or the US.

She assured that "Coovaxin was proved to be neutralizing" the double mutant variant found in India and other variants from South Africa, UK, and Brazil. She pointing out that the vaccine has an "edge" in dealing with Covid variant since it is an "inactivated whole-cell vaccine". Asked about clinical trials for the 2-18 age group, she said, "It is getting started in the month of June" and if all goes well, Bharat Biotech hoped to complete the trial in 3 months timeline.

Wion: According to a recent government announcement, 2 billion vaccines will be manufactured in India by the end of December. Out of this 550 million be Covaxin. Where does the production capacity stand? And how do you plan to meet the growing demand in India, by boosting capacity?

Suchitra Ella: We have conveyed our commitments to the govt of India. We have done it in a phased manner because of the reason that we have 3 different facilities in 3 different states or cities of India.

In Hyderbad, we have a volume of about 200 -250 million does per annum. In the city of Bangalore, Karnataka another facility has been deployed which will be able to produce to the tune of 500 million doses and the 3rd one that got included yesterday in our release was the plant which we already operating in Ankleshwar, Gujarat where we also expect to manufacture to the tune of 200 million doses of Covaxin per annum.

So we are looking at close to a billion doses of Covaxin that could be churned out from 3 different plants physically located in 3 different states of India. India's population is known to everyone, and even going by govt's indication and the requirement for the COVID-19, we stand at least 2 billion-plus in order to get the country vaccinated. I would for sure believe that we at Bharat Biotech will be able to fulfill the commitments that have been given to govt of India already and also as much as possible, to ramp up more volumes. Since its 2 doses of vaccine, everything is double, so there is the challenge.

Wion: Vaccine production is a very complicated and sensitive issue. Give us a sense of supply chain challenges.

Suchitra Ella: The supply chain for us mostly comes in terms of a lot of consumables that are needed for testing. Vaccines involve a tremendous amount of quality testing which is done in-house, which is done out of animal labs, product labs, institutes in Kasauli in Himachal Pradesh, so we consume a lot of chemicals for testing protocols which have to be used day-in and day-out for every batch of the vaccine.

Most of these chemicals come from either Europe or the US, and it will be good to have supplies of these. They are not ingredients but testing chemicals. We also need some equipment in terms of bioprocess areas. They are smaller equipments that go into processing where the bulk of the material is processed.

These again are ordered from companies like the US and Europe. These are the main ingredients used on day to day basis. The equipment, more than 60 to 70% of our equipment which is already been procured and has been installed, they also come from western countries where we have internationally validated vendors.

We already have the equipment not just for Covaxin but also for other vaccines. Certainly, it would help, if the supply chain is eased out. Volumes have gone up, what we normally manufacture on an annual basis, say 200 or 300 million doses of say a polio vaccine, today we looking at a billion doses for the same year of Covaxin. Pressure comes because of the high volume of pandemic vaccines that need to be manufactured in a shorter time frame.

Wion: How much of your supply chain is dependent on external sources? Have you taken this up with the Indian govt and if yes what kind of support you have got from them?

Suchitra Ella: It is very well appraised to the concerned department who almost talk to us frequently and aware of many of the areas of the inputs that have to go into vaccine production. Ministry of health, Ministry of Pharma is aware of it.

We have explained to them that these are some of the areas where things can be eased up. Ministries have been extremely proactive and like to say this very clearly that almost all the ministries we have been like dept of science and tech. The MEA being the bridge between us and other economies of the world, these countries are all friends of India and I'm sure they will understand that India is not just seeking for the sake of manufacturing or supplying vaccine for its own population but also we all know, India is 60 per cent supplier of vaccines to the world at large. So it goes to show India has a very large role to play and the MEA has reached out to us to take this forward to help ease the supply chain in these areas which are specific to vaccine manufacturers.

Wion: if you have to expand capacity, how important is it to ensure external flows and smooth supply chains?

Suchitra Ella: We have made our calculations as to how we have factored in for the first 6 months of the year, for the second 6 months of the year, so certainly in order to reach that one billion doses or volume required by us, the input should come in a regulated, frequent and consistent interval. The quantity of these supplies has to be met in a very consistent manner in order to reach this kind of capacity we are talking about. I am hopeful, this will get done and countries of the world will certainly be talking to India and amongst themselves to ensure a free movement of all these inputs that go into vaccine production.

Wion: Sales of vaccines abroad have been done as commercial commitments and to establish our brand globally. How important are these sales to encourage the global supply chains to keep you supplies?

Suchitra Ella: So we are very much aware of our commitments that we have to keep in mind, serving the country, the children of our country and for sure during the pandemic, we know the requirement of the country.

In addition to that, we also cater to many countries of the world. We have supplied to 125 countries around the world. We also supply to Gavi, Unicef who procure directly from us as manufacturers, very high volumes of vaccines that get distributed to poorer nations of the world.

We also have countries, middle and high-income countries, that have the buying power to place procurement with manufacturers for their countries' requirements of the vaccine. The tremendous role and responsibility Indian manufacturers have to play in being able to get this volume but also to the rest of the world in the right and effective time frame, that is very important right now. We are all racing against time. We normally have 12 months to supply. This is not like that, it's a race against time. Humanity needs it, the world needs us, and it's time for all of us to get together in the best possible manner to save lives.

Wion: Lot of talk about patent transfer. Are you okay with sharing the patent of the vaccine with other companies?

Suchitra Ella: Our vaccine has one of the most difficult process technology vaccines which is developed on an inactivated zero cell platform. It's a classical vaccine process that we deploy...in 3 or 4 vaccines that we already manufacture. This is a very stringent process, it is not about giving the patent or the tech transfer.
This is about having the infrastructure to manufacture such a vaccine. We have one of the most stringent biosafety levels which is the BSL 3 facility in which we make sure organism should not escape to the environment.

It is the negative pressure environment of the facility that has to be deployed in order to make such vaccines such as the Covaxin. It is very important to keep that in mind, that the quality of the product is important and the safety of the environment where this material will be deployed is very important. People who work in these facilities are also human beings and their lives should be extremely protected and safeguarded by the manufacturer.

So this is a tough process to be deployed or given away to anybody out there unless that particular organization has demonstrated or has a very long record of manufacturing viral vaccine under the guidelines that are required and followed the world over.

Wion: Clinical trial for children. How soon can we expect the results? can it be given Emergency Use Authorization or EUA like in the case of the adults?

Suchitra Ella: Clinical trials are a very time-consuming process, though we have timelines for it...standards, timelines, goals etc are conducted as per the special experts' committee and Drug Controller General of India (DCGI) who gives us the authorization to conduct these trials.

Children's trial has been permitted for Covaxin by the Drug Controller General of India and we hope to start it very soon. It is getting started in the month of June.

Since Covaxin has been studied extensively for 8-9 months, and even some parts of the study are still happening in an adult population where we have deployed 27000 volunteers. We have extensive data on safety and immunogenicity and on efficacy. This has been very well established in adults.

In order to ensure children can also receive the vaccine, the drug controller and the national regulatory authorities of the country will permit us and we will take up this clinical study and will take us 2-3 months.
If all goes well in the pandemic situation we are in, we hope to complete the trial in a 3-month timeline. So the vaccine will be the same. It is the study that is important so that safety aspect is important in the subject who be children this time. That is very important.

We are normally very well acquainted with the pediatric vaccine trial because most of our vaccines cater to the pediatric segment of the world. We are very well acquainted with trials of this nature. But this time around since Covaxin has come in a reverse manner to children, we will certainly able to do this study for safety in children, especially the age group required. So we will be able to demonstrate that study data, and hopeful and positive that Covaxin can be administrated to children once the data is accepted and approved by DCGI.

Wion: Any timeline when it can be given for it?

Suchitra Ella: Sidhant it's very difficult to give a set timeline. We are in a pandemic and to get volunteers to hospitals, trials are not conducted within 4 walls, on laptops or systems. It is a physical trial in a hospital or medical college and conducted by medical practitioners.

It is a site where volunteers have to physically go and a lot of protocols have to be followed. In spite of all this, we are hoping since we already have a lot of data in Covaxin in adult studies we hope...children are children and there is none of us can go and talk to a parent.

As a company, I cannot go to a parent and convenience them to allow the participation of their children in a trial. It is something they have to do by themselves in a voluntary mode. The hospital will create awareness and will educate the parent and the parent have to be willing.

The parent has to give consent, children have to understand the process. It is a medical process and biological process and need to bear in mind it is very sensitive and at the same time, we do it all the time. We have conducted studies involving more than 500,000 infants and children for many of our pediatric vaccines in about 20 countries of the world. We understand the regulation very well and we only hope we will be able to take it forward especially at a time pandemic. Sensitivities involving children, we have to get all aspects put together well and get it done in best possible time frame.

Wion: Recently, government came out with guidelines for the vaccination gap. Covishield has a gap broadened, where it wasn't the case with Covaxin. Why and how is it different?

Suchitra Ella: Most of the guidelines are by the Ministry of Health and DCGI who permit the doses and the administration and scheduling of vaccines. It comes based on the study, also based on prior experience of getting such vaccines done. With Covid vaccine, technical data, research, and academic research going back and forth is almost changing by the day, if not by the hour.

We have studied our vaccine, within 28 days apart, govt has also gone ahead and said we could extend it to 45 days. It's a zero-day and the second dose is within 45 days. The second dose is always a booster dose.

So in order to ensure booster dose is effective in most of people, a little bit of tweaking of the timeline is not going to be a huge problem, because in many vaccine dosages are done between 0 to 30 and 3rd dose is done within 180 days as well, there is a booster dose which comes after a year. These kinds of things are done for many vaccines. In a Covid situation, our is a whole unit vaccine and the entire inactivated vaccine is deployed and its not spike protein. We have a more uniform way of getting antibodies formed at a level that we have indicated.

If there is information oR data coming from WHO or other agencies from around the world who have a lot of studies and work, then it is upon regulator to advise what should be protocol or dosage for the country.

As a manufacturer, our responsibility ends with dispatching vaccines to govt hospital, govt depots or private hospitals at this point of time. Administration of vaccines and distribution happens at the hospital and the govt intuition. The regulation comes from the ministry itself, this is a multi-pronged collective approach, collective data, collective approach, and best of the practices and information sharing coming from rest of the world is also kept in mind when such decisions are made for certain populations of the world.

Wion: Covaxin and its ability to handle Covid variant...

Suchitra Ella: Our vaccine Covaxin has been studied from the very first strain we received last year in the month of may when initial work started. Covaxin was also tested in variants that emerged in countries like South Africa, Brazil, UK. Covaxin was proved to be neutralizing all these variants including the double mutant, which has been observed in India. All this data has been published in peer-reviewed, international medical journals to show that Covaxin has effectively neutralized (the virus) being an inactivated whole-cell vaccine probably gave it an edge to overcome all the different strains, changes that are happening, the mutation that is happening. As of now, it is working well on all of them and it has been proven clinically and studied, subjected to peer review, internationally.

Wion: How do u feel as a women entrepreneur?

Suchitra Ella: Personally, for me, entrepreneurship is not about gender. Entrepreneurship is not gender-based, it's the mindset with which you come. It is the vision, you have to look at the challenge and turn it into an opportunity or try and see if there is a way to finding a solution for it, which is what we as a company from the days our inception is to innovate. Continuously Develop technology, intellectual property to bring solutions to public health.

We collectively, as an organization have a huge team of more than 2000 people on the Hyderabad campus. We have facilities in Bangalore and Ankleshwar, all put together we are a multi-centric company with multi facilities across the state. Through the pandemic, we have been collectively working in bringing Covaxin which is very important for us as an innovative company because we believe that such innovation can also be brought from India. That was the passion, vision. We worked in mission mode and confidently say, not any employee has gone for vacation. It has been physically and emotionally challenging and we have stood together. I am proud and happy to be where we are for Covaxin.