We can make over 1.5 bn doses in 2021: Biological E MD & CEO Mahima Datla

Though our target is a billion doses, we may have an upside as we are evaluating various doses in the phase-1 and -2 studies, said Datla

Hyderabad-based Biological E is readying a billion vaccine doses for Texas-based Baylor College of Medicine (BCM), and about 500 million doses for Johnson & Johnson (J&J) unit Janssen Pharmaceutica. Despite planning for such huge capacities (the world's largest vaccine maker Serum Institute of India made 1.5 billion doses in FY20), the company feels risk-sharing for clinical trials, and manufacturing infrastructure is a must. Mahima Datla, MD & CEO of Biological E, who is also a board member of Gavi, tells Sohini Das that vials, adjuvants, and cold chain may result in a supply constraint in the initial stages. Edited excerpts:

You are making 1.5 bn doses of vaccines in 2021. Is there scope for further scale up? 

Though our target is a billion doses, we may have an upside as we are evaluating various doses in the phase-1 and -2 studies. One billion is based on the worst case scenario, assuming we put in the most amount of antigen in making a dose. We used the pichia pastoris (a yeast) platform to express the BCM candidate. Since we have experience of large scale manufacturing using this platform, we could scale up easily. Now, we have scaled this process to at least 600 litres, and intend to scale to the a billion. 

J&J is also looking to produce around 500 million doses from our facility. So, we will be making a minimum of 1.5 billion doses. We do not yet have the data from the phase-1 and -2 studies. If these show that less antigen content is required to generate the same immune response, then our capacity will go up. I don't want to think about the upside too much. In the past five years, we have made 3 billion doses. So, it is not a far reaching thing for us. 

Will the high volumes bring down the prices? 

Three primary factors influence pricing — one is the tech platform and the adjuvant used, second is the decision on kind of scale of capacity, and the third is what is the source of finance. 

Most manufacturers are using adjuvants. If you do not manufacture the adjuvant, you have little control over the cost contribution of the adjuvant. Vaccine manufacturing is a highly fixed-cost intensive business. Before phase-3, one has to build large-scale facilities. This is a double-edged sword. If you don't have market certainty, you would invest in smaller capacities. For larger capacities, the economies of scale ensure that the per dose cost is lesser. The problem is if you are not able to sell, the person who has invested in a larger capacity suffers all the more. 

By when will you decide on a price band?

We are now primarily funded through debt. If the funding related to development and infrastructure is self-financed, then one needs to build that into the cost of the product. But, if the government or someone funded us for infrastructure, then that could pass through in the cost of the product. 

In our case, the technology platform is promising, so we believe we can have a really affordable product. We are in the process of scaling up. By the end of December-January, we will be able to narrow down on a price band. 

Are you looking at raising funds for capacity augmentation?

We are not looking for too much money for infrastructure. We are looking at supplementary infrastructure. Clinical trial is a major cost, as this is not a follow on vaccine. So, we need to do efficacy studies on large groups of 30,000-40,000 people. The cost of doing that alone is about $100 million because we have to do it not only in India, but in Latin American, and Africa, etc. Our concern is now where is the visibility to that. 

Then there is the issue of at-risk manufacturing. Typically, manufacturers do not make vaccines unless they get the licence. But, in this case, you lose the opportunity to stock-pile the product. The day your licence is ready, you should be in a position to supply the product immediately. From a regulatory pathway, India has cleared this. 

The government really needs to think about the 'push' side (to developing vaccines) — the money for phase-3 clinical trials, the money for at-risk manufacturing, and eventually also tie up for sale of a product. We have not seen any concrete action on this. There are enough financial instruments available that protects the government's risks as well as the company's needs. We are requesting funding for infrastructure. Infrastructure can be de-risked easily. If our product does not click, we can deploy that capacity for any manufacturer whose product is successful. It’s not a risk investment. Clinical trials need risk sharing. 

When will you start at-risk manufacturing? 

We need to be making phase-3 material now, as our phase-3 trials should start early next year. When the trials are underway, we would look to start manufacturing around March. Our internal aim is to have a 100 million doses ready at the day of launch. If the government says they want us to make 200 million, we have to start making them earlier. 

Do you see any supply crunch in India, or globally? 

There will be a demand-supply shortage in the next two years. This is not a Gavi or WHO position. It’s not just the vaccines, we will need that many vials, syringes, cold-storage facilities. Raw materials are not going to be a major issue for actual scale. Issue will be the final product containers. For some vaccines, if you don’t have the right preservatives… Maybe you can fill in only two doses in a vial, and this increases the cold-storage requirements. If you can fill 20 doses in a vial, we would need less vials. There are very few tubing manufacturers in the world. Vaccine makers can forward buy from vial suppliers and enter into forward contracts. Proprietary adjuvants are also not in unlimited supply. Vials, adjuvants, and cold storage could constrain the supplies. 

Does India have the requisite cold-storage facilities for Covid-19 vaccines?

Most vaccines will need 2-8 degrees Celsius cold-storage facilities. India also has -20 degrees Celsius cold-storage facilities because we manufacture the polio vaccines that need to be stored at that temperature. At a manufacturer level, we can carry two-three-month inventory. To deliver to the end-mile, the cold-storage facility has to be at the endpoint. Either the government manages inventory really well, or they ask the manufacturers to store and then give, or they can expand a few geographical locations. There can be hubs that connect to the rest of the country. Cold chain expansion is one of the easier things to do. We have been in discussions with cargo handlers and airports as they are trying to understand if they need to expand for export requirements.