Updated: August 9, 2021 5:41:56 am
While India is vaccinating its population with Covishield and Covaxin, country’s first mRNA vaccine developed by Gennova (a subsidiary of Emcure Pharma), is all set to be made available by end of the year. Satish Mehta, founder and CEO of Emcure Pharmaceuticals, told Sandeep Singh that while he is very satisfied with the primary outcome on safety of the vaccine, he will soon submit the data with CDSCO and apply for next phase trials. Stating that while he is focussing on meeting government target of supplying 60 million doses by year end, he is in talks with potential partners both in India and abroad, to augment the capacity substantially. Excerpts:
There are concern of a third Covid wave, do you think we are well prepared to handle it and what do you make of the pace of vaccination?
Some studies are projecting daily peaks of anywhere between 80,000- 150,000 in the third wave. If it remains to that level we should be able to handle it well. Also, all across the country there has been massive learning after the second wave. District administrations and authorities are taking steps according to the situation in their area. Last week relaxations were announced in 25-30 districts of Maharashtra, but Pune was not part of it as R-factor remains above 1.
Also, with higher number of vaccinations now, hospitalisation and fatalities would be lower. Data coming from US shows that people who have taken two shots are getting Delta variant, but hospitalisations are low. There is clarity now in hospitalisation rates between those who are vaccinated and those who are not.
I think India has done a great job on vaccination and in the hindsight one can always say that we could have done better. At the same time, while there has been learning and we may be prepared, there could be surprises and we don’t know what the Delta variant would do.
Gennova has been given target to supply vaccines by the year end, what stage are you on your mRNA vaccine?
Government has given us a target of 60 million doses by the end of the year and we are on track and are committed to delivering it. Right now we are in Phase 1. We are very satisfied with the primary outcome of safety. As we speak, secondary outcome of efficacy or immunogenicity is also being reviewed and studied by drug safety and monitoring board — an independent body. Post that, we will submit our data with CDSCO and apply for phase 2 and 3. That’s when the regulatory bodies would comment and guide us in terms of next steps.
We are on track but there are different types of challenges. First and foremost is that the product has to be shown safe through the clinical trial process. Simultaneously, the supply chain aspects are daunting because gaining access to some of the key raw materials (particularly for the mRNA vaccines) is a big challenge. So we are taking efforts to plan for manufacturing and securing raw material supply. We are repurposing some of our own capacities within the company for fulfilling the requirement of the vaccine. We are all gearing up to ensure that as and when the authorisations come through, we are able to meet the target that the government has set.
By when do you think you would you be able to do second and third phase trial?
We don’t have a timeline for that and it is very difficult for me to say that as of now. We can focus on the processes and do them diligently, then we have to work closely with government agencies. I am very optimistic. The government is handholding and supporting us quite a lot.
How do you see your vaccine and demand for it?
We are very bullish on our mRNA vaccine because within 45-50 days the vaccine can also be developed for the new variant including Delta variant. Unlike other vaccines (that we have) which has Adenovirus or attenuated live virus, this has a dynamic platform where you can come out with a new vaccine. It is important because I think this cat and mouse game would go on for 2-3 years.
While mRNA is undoubtedly the best vaccine that we have, Pfizer and Moderna are supplying to the regulated markets. I think the rest of the world (emerging markets) would be happy to take mRNA and we see them as a market for us.
While Moderna and Pfizer are required to be kept at very low temperatures. The vaccine that we have developed is stable between 2 and 8 degrees and that makes the job lot easier.
In India, around 50 crore vaccine doses have been administered till now and mathematically we can say that around 25 crore people have got both vaccines. Around 100 crore are still left to be vaccinated. So, even if you go at the rate of 8-9 crore a month (which is the pace at which we are going), I think this is going to continue for 8-10 months. Also people have started talking of third booster dose. So, this is likely to continue for 3-4 years.
What kind of capacities are you looking to build and what are the investment plans?
As of now, the full focus is on meeting the 60 million target the government has given and from there we will recalibrate and look at the situation towards the end of the year— how the demand is and how emerging markets are looking like and then look at larger capacities.
One area that we got lucky is that Emcure had lot of injectible capacity and we can reconfigure and get them ready.
On the API side we are making a lot of investment to bolster the capacity and in the near term there won’t be a bottleneck on the API side. We anticipate that we have limit on capacity on the finished formulation side. But, there we are not averse to working with other partners who may be able to lend some of their capacity. We are talking to partners both in India and outside who can partner with us and the could augment the capacity substantially.
I think, we have the wherewithal to handle this 60 million requirement and anything that comes subsequent to that in the same ballpark, but a step function up from that would require some investments and partnering with other partners.
I think heavy investments will comes as we progress to commercial scale.
How are you addressing the raw material supply challenges?
Since mRNA is a nascent technology, companies that supply specialist chemicals and enzymes were very few and not at the scale that is required. So that is the challenge. It is something we envisaged and have work proactively for the last 6-8 months. So for some of the key raw materials, we are doing backward integration within our R&D and will subsequently also add manufacturing scale because the enzymes part is something where we already have the platform and Gennova can manufacture. For other key chemicals, we are working at Emcure’s Labs.
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