BioAsia 2022: India’s biotech sector stakeholders discuss learnings from pandemic

Normally a vaccine development process takes 6-8 years for research and trials, but path-breaking work has been done in India

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New Delhi: “We looked at only one thing and that is safety in adult vaccination. And we are extremely good in the inactivated vaccine as we have seven vaccines on inactivated vaccines strategy. We are one of the very few people in the world who have expertise in inactivated vaccine strategy domain. We are also number one vero cell culture with 13 vaccines platform. We wanted to pool in what we are good at,” remarked Dr. Krishna Ella, Managing Director, Bharat Biotech International at a panel discussion on the sidelines of BioAsia 2022 on 24th February, 2022.
Themed ‘Two years into the pandemic – Challenges, successes and what next?’, the session was moderated by Dr. Gagandeep Kang, Virologist and Professor, Dept. of Gastrointestinal Sciences, CMC Vellore.
“We partnered with ViroVax in US to get adjuvants and later scaled up with IICT in Hyderabad. We also needed public private partnership because as private companies we cannot do studies on monkeys in India. National Institute of Virology in Pune has got that expertise and we used the facility to prove that it works on animals,” added Dr. Ella.
Talking about his experiences on trials, Dr Ella said: “What is important is an efficacy trial. Also, the regulatory was a bit delayed in the beginning in India. If that was a little activated, the mRNA vaccine could shift before the animal trial also and we could shift straight to human trial. Had we had that luxury in India, we would have got it in the efficacy trial when the delta was there. But we vaccinated in Phase 3 trial and there was no disease for four months. Then suddenly the delta variant came and we were the only ones doing an efficacy trial during a delta epidemic. We captured that time very quickly with the entire efficacy trial over in 15 days.”
Amitabh Kant, CEO, NITI Aayog said: “Huge efforts were provided by companies like Bharat Biotech, Biological E., Zydus Cadilla, Serum Institute to come out with Indian-made vaccines. And that was a sterling work. Normally a vaccine development process takes 6-8 years for research and trials, but path-breaking work has been done in India. In addition to that the telemedicine guidelines came out. The ‘Swasth App’ which driven by the Indian tech garage had a huge impact, the Sanjeevani app for telemedicine were some of the initiatives. But states across the country increasingly adopted the digital tool technology across the healthcare systems. There were several major challenges because a crisis like this was never confronted by anyone before.”
“Before Sars-Covid, people would ask whether we had a pandemic portfolio, we would say no because it is too unpredictable, too risky, and if jump into something unpredictable or risky, it jeopardizes our ability to supply to the predictable pediatric population. It was an unprecedented situation. We were called to action, but at the outset we had three things on mind –First that it works and is effective, second is safety was a huge concern because the deployment was going to be literally for an entire population of the world so wanted to make sure that safety was taken care of. Third it was going to be affordable because we understand that when the pandemic first broke out, resources were made available, but health budgets were severely constrained in many countries. Ultimately we came to know that if it was to be a full-blown pandemic something like a multi-year, we knew that there wouldn’t be unlimited resources. It needed to be affordable enough for each countries health systems with somewhat to take accountability for the cost systems associated with it. The fourth thing was a match to our infrastructure,” said Mahima Datla, Managing Director, Biological E Limited.
“Our ability to scale or be fast predicated upon what large-scale infrastructure we already had. If we had to set up green-field manufacturing facilities, we would still be talking about a vaccine launch two years from now. So these four factors helped us choose the vaccine platform that we did which is the recombinant subunit – of course because a lot of our experience with Hepatitis B vaccine with several hundred million of doses supplied, both individually and in the form of a pentavalent and the large scale infrastructure that supports it. But I also felt that by and large we could down select the clones and engineered clones whether it was for this or another variant fairly quickly once the manufacturing system was set. Did it give the speed of mRNA technology? No, but it gave us the scale and the give us the opportunity to deploy this in a manner that makes it extremely affordable,” added Datla.
“From a scientist’s perspective, one of the most important things is an embedded scientific thinking in the society that we have seen. If there were demonstrations in India, it would have got challenging. People showed their belief in diagnostics. We had focused only the pathogen, but it is the post-Covid issue that needs to be critically addressed,” said Dr. Rajesh S Gokhale, Secretary, Dept. of Biotechnology, Government of India.
“There is a new confidence that has been built in the effectiveness of Government in the life science sector. The life science industry requires a supporting system unlike the IT industry for it to wholesomely evolve and grow. The important role that the DBT played in terms of self-sufficiency of diagnostic sector wherein DBT very early on started funding startups which came in very handy by enabling manufacture of a large number of kits and now most importantly do genome sequencing and tracking every variant. All this has been possible due to the DBT years’ of investment in Human Resource Development and setting up a variety of infrastructure and institutions that allows you to utilize them when you really  need them. It has been a learning experience for all of us in diagnostics and vaccine trials,” added Dr. Gokhale.
.”We are over the phase of supply shortage we saw in 2021. We have enough visibility to supply for the demand. The challenge is going to be that there are many countries that are not able to mount the vaccination programmes which India has successfully been able to do,” said Dr. Soumya Swaminathan, Chief Scientist, WHO.
“There is a lot of support needed on the ground in terms of technical support, workforce, funding, logistic support etc. Covax will have to keep boots on the ground and help these countries scale up the high targets. We have to plan for variants – WHO is working on scenarios where we might need variant proof and broadly acting vaccines and inhaled vaccines that the likes of Bharat Biotech are working on. For the future we need distributing manufacturing network for which we have the mRNA technology transfer hub in South Africa. We are now initiating various spokes. Many companies are working on second generation mRNA technology. No region must be dependent on other countries for imports of vaccines or other health products. I would like to see India also take TB as a challenge and develop new generation vaccines for TB and eliminate it,” added Dr. Swaminathan.