New Delhi: Suchitra Ella, the joint managing director of Bharat Biotech on Friday (May 21, 2021) expressed confidence in meeting commitments that have been made to the Government of India, with the company aiming to produce 1 billion COVID-19 vaccine ‘COVAXIN ‘ doses involving facilities in Hyderabad, Bangalore, and Ankleshwar.  

In an exclusive interview with WION, Ella also highlighted the need to ease out the supply chains and said that the company needs chemicals for testing and most of these chemicals come from either Europe or the United States.

She assured that the COVAXIN has been proved to be neutralizing the double mutant variant found in India and other variants from South Africa, the United Kingdom, and Brazil. Ella also pointed out that the vaccine has an ‘edge’ in dealing with the COVID-19 variant since it is an ‘inactivated whole-cell vaccine’. 

Asked about the clinical trials for the 2-18 age group, she said that it is getting started in the month of June and if all goes well, Bharat Biotech will complete it in the three months timeline.

This is to be noted that Bharat Biotech’s COVID-19 vaccine along with COVISHIELD and Sputnik are the only three vaccines have been allowed so far in India.

WION: According to a recent Centre’s announcement, 2 billion COVID-19 vaccines will be manufactured in India by the end of December. Out of this 55 crore will be COVAXIN. Where does the production capacity stands, and how do you plan to meet the growing demand in India by boosting capacity 

Suchitra Ella: We have conveyed our commitments to the Government of India. We have done it in a phased manner because of the reason that we have three different facilities in three different states or cities of India. In Hyderabad, we have a volume of about 200-250 million does per annum. In Bangalore, another facility has been deployed which will be able to produce to the tune of 500 million doses and at the third one in Ankleshwar, we expect to manufacture to the tune of 200 million doses of COVAXIN, Over a per annum capacity. So we are looking at close to a billion doses of COVAXIN that could be churned out from three different plants physically located in three different states of the country. India’s population is known to everyone, and even going by the Centre’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 will be able to fulfil the commitments that have been given to the Government of India and also as much as possible to ramp up more volumes. Since it is two 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 Kausali in HP, 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 equipment 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 the 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. 

WION: If you have to expand capacity, how important it is 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 these kinds 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 your supplies?

Suchitra Ella: 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 and 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 middle and high-income countries that have the buying power to place procurement with manufacturers for their 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: Lots 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 three or four vaccines that we already manufacture. This is a very stringent process, it is not about giving the patent or the tech transfer, it 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 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 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 expert’s committee and Drug Controller General of India 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 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 the three months 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. We are very well acquainted with trails 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 the Drug Controller General of India.

WION: Recently, the Centre came out with guidelines for the COVID-19 vaccination gap. While Covishield has a gap broadened, it wasn’t the case with COVAXIN. Why and how is it different?

Suchitra Ella: Most of the guidelines is by the Ministry of Health and the Drug Controller General of India which permits the doses and the administration and scheduling of vaccines. It comes based on the study and is also based on prior experience of getting such vaccines done. With the COVID-19 vaccine, technical data, research, and academic research going back and forth are almost changing by the day, if not by the hour. We have studied our vaccine, within 28 days apart, the Centre 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 the people, a little bit of tweaking of the timeline is not going to be a huge problem, because in many, the vaccine dosages are done between 0 to 30 and the third dose is done within 180 days as well, there is a booster dose which comes after a year. These kinds of these are done for many vaccines. In a covid situation, our is a whole unit vaccine and the entire inactivated vaccine is deployed and it’s not spike protein. We have a more uniform way of getting antibodies formed at a level that we have indicated. If there is information of data coming from the WHO or other agencies from around the world who have a lot of studies and work, then it is upon regular to advise what should be protocol or dosage for the country. 

WION: Tell us about COVAXIN and its ability to handle the COVID-19 variant?

Suchitra Ella: Our vaccine, COVAXIN has been studied from the very first strain we received in May 2020 when the initial work started. COVAXIN was also tested in variants that emerged in countries like  South Africa, Brazil and the UK. It was proved to be neutralizing all these variants including the double mutant, which has been observed in India. All these data have been published in peer-reviewed, in international medical journals to show that COVAXIN has effectively neutralized and 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 has been proven clinically and studied, subjected to peer review internationally.

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