Bharat Biotech, which recently received approvals to conduct late-stage human trials of Covaxin — its Covid19 vaccine candidate — has committed “significant” investment towards expanding its ability to make the vaccine, according to the company’s executive director, Sai Prasad. In an interview with PRABHA RAGHAVAN, Prasad details the company’s discussions with the government to bring out the vaccine here, as well as its discussions with other countries to supply Covaxin globally. Edited excerpts: You’ve recently received approval to conduct phase 3 trials for Covaxin. Could you walk us through the details of the volunteers and sites and whether this will be through the intramuscular or intradermal route? The current enrollment that we are planning for is anywhere between 25,000 to 26,000…This is based on attack rates, efficacy parameters, and case accumulation numbers. This is a statistical requirement, what we’re planning. The sites–it’s approximately about 25 sites. It could even go more than that…We’ve had good discussions. For the last two months, we’ve been trying to establish and develop these sites.
This will be across 12 to 14 states in India…a few examples would be (Telangana), Tami Nadu, I believe Haryana, we have Maharashtra…it’s well spread between north, south, east and west. We are planning on Bihar, and in UP also, I think they’re talking to a couple of sites. We have data on the intramuscular dose already, and (for) the intradermal…the safety data is in, (but) the immunogenicity data is something that we are still waiting for. But, we thought for phase 3, we would go with the intramuscular (route) first and, later on, if the correlates of protection are established,
we can also develop an ID regime, like how we do in our rabies vaccine, where it can be given both (through) intradermal and intramuscular (route). Has the government made any commitment, in interactions, towards procuring a specific number of doses of Covaxin at-risk? If yes, how many? No, we are producing Covaxin at-risk. We do have certain quantities of stock already manufactured and kept ready, but we’ve not had a (commitment towards procurement of specific doses). We’ve had many discussions with the government, but not about procurement of a certain fixed quantity as of yet. We’ve had discussions on … what kind of quantities we can produce a vaccine in, what timelines the vaccine will be available …
what kind of product profile will it be available in, what will be the formulation, what will be the stability, packaging, distribution systems — many different aspects of the vaccine. There are several ministries that we are discussing with, and they are all very proactive in terms of how they are supporting us. They want to know our cold chain footprint, what the packaging dimensions will look like, whether we have storage capacity … I think those are discussions that we’ve already had, and discussions on … any new facilities and investments that we are making.
What is your cold chain and manufacturing capacity? Are you expanding this and how much have you invested towards Covaxin so far? In terms of manufacturing capacity, we are at about 150 million doses per year right now. We have an existing facility, and we’re also building a brand new facility in Hyderabad itself right next to (it). That is going to be online during December. We’re also exploring another facility in another city, which is very early-stage exploratory work, to see whether we can make Covaxin over there. So, I think we are trying our best to increase this capacity north of 500 million doses as soon as possible.
We’ve also committed a significant amount of investments, because (for) our phase 3 clinical trial alone, the budget is approximately Rs 150 crore in terms of the conduct of the clinical trial (for) 25,000-26,000 subjects and all other ancillary aspects of a clinical trial of that size. In terms of CAPEX and OPEX, while we are using the existing facility now, this new facility (in Hyderabad) is also costing us anywhere between Rs 100-250 crore. I think we’re geared up to supply good quantities to the government when it is acquired. I think, in terms of our own cold chain capacity, we have two locations in Hyderabad … which have large cold chain capacities. We’re also building a very large integrated warehouse right on our campus right now, and that is supposed to come online by mid next year, so I think we will have enough capacity in Hyderabad. We have a very similar kind of capacity in Bangalore —
we have another site where we do other kinds of products over there. We also have a site in Ankleshwar in Gujarat, which is the Chiron Behring (site) that we acquired recently from GSK. So, these are our own sites where we have very, very large capacities … in the hundreds of millions of doses in multi-dose vials, we can store over there. But, eventually, these are just to hold our vaccines when we manufacture them. Our assumption is that, once the government wants to deploy it, they will ask us to deploy it directly from our site to the state that is required. That’s what we do for the national immunization programs right now. Does the lack of certainty on procurement impact your approach to at-risk manufacturing and the timelines you’ve set for your vaccine’s development and launch? It absolutely does.
The more positive reinforcement we get in terms of volumes and procurement commitments, the faster we can work because that air of uncertainty can be removed. But, our teams are discussing with other countries … and there is a lot of interest from other countries to try to get Covaxin. Some countries were also talking about technology transfer and getting it manufactured locally in their respective countries, so we’re not trying to look at this purely as an India issue. Obviously, India is our home country, we will supply, but we’re also looking at other countries. Which countries are you considering for further clinical trials and tech transfers? In two, maybe three different countries, we are in the final stages of discussions to conduct clinical trials in those countries. The final design of those studies is in discussion right now and, once we have an agreement and a commitment, I think we will announce that in the days and weeks to come.
I can’t share (those details) right now, because, the way we are progressing with this is we’re trying to be cautious, we’re trying to be safe. We’re not trying to be too bombastic in our projections and our discussions… we want to be 100 percent sure and have good, well-established relationships. It’s not our intent to just go sign up (countries). (Those interested in) procurement (are) about 20 countries, I would say. In terms of clinical trials, I think it’s a fewer number of countries, but the main thing is, countries are looking at what the Indian NRA is doing.
Many countries around the world respect the knowledge and the capabilities of the Indian NRA, especially a lot of middle-income countries. We’ve also committed already that we will obtain WHO pre-qualification for this vaccine … so, I think governments in other parts of the world are quite happy about that. We are an innovative company, we know we can manufacture at scale, we have other prequalified vaccines, we supply many of these vaccines to their countries — rabies or typhoid, rotavirus, polio, Japanese encephalitis, for example. So they know the facility, the company, and the people behind this. I can’t share (those details) right now, because, the way we are progressing with this is we’re trying to be cautious, we’re trying to be safe. We’re not trying to be too bombastic in our projections and our discussions… we want to be 100 percent sure and have good, well-established relationships. It’s not our intent to just go sign up (countries). (Those interested in) procurement (are) about 20 countries,
I would say. In terms of clinical trials, I think it’s a fewer number of countries, but the main thing is, countries are looking at what the Indian NRA is doing. Many countries around the world respect the knowledge and the capabilities of the Indian NRA, especially a lot of middle-income countries. We’ve also committed already that we will obtain WHO pre-qualification for this vaccine … so, I think governments in other parts of the world are quite happy about that. We are an innovative company, we know we can manufacture at scale, we have other prequalified vaccines, we supply many of these vaccines to their countries — rabies or typhoid, rotavirus, polio, Japanese encephalitis, for example. So they know the facility, the company, and the people behind this.
