Ready to scale up Covaxin production; efficacy against strains established: Suchitra Ella

Responding to a question on whether Bharat Biotech would be open to make the production of Covaxin open to other entities, Ella said this might not be the best way forward

Bharat Biotech is prepared to ramp up production of its coronavirus vaccine, Covaxin, stated the company's Joint Managing Director Suchitra Ella. The company is in the process of scaling up production of the anti-COVID-19 vaccine at three facilities - in Hyderabad, Bangalore and Ankleshwar - to 1 billion doses per annum.

Responding to a question on what hurdles Bharat Biotech might face in the process of scaling up Covaxin production, Ella, who was part of a panel on the matter on India Today TV, confidently responded that the company will benefit from the prior experience it has on vaccine development.

"These are existing facilities deployed for production of other viral vaccines. These are not completely different or out of line with what Bharat [Biotech] and other sister concerns have deployed for the last 10-15 years. We have been doing this consistently," she said.

"The Ankleshwar facility was acquired from GSK. It was their Rabipur vaccine plant. It's a WHO pre-qualified facility where Rabipur was being manufactured. All of them are active sites. The only, if at all, concern or a little bit of cautious planning will be in the ramp-up at Bangalore because it is almost four-fold increase in volume. The bioprocesses area is going to have above 3,000 fermenters. This is an area of caution we are playing very cautiously, but again, we have had similar experience and expertise in manufacturing the foot and mouth vaccine from an adjacent facility," Ella further added.

Responding to a question on whether Bharat Biotech would agree to relaxing intellectual property rights for Covaxin, Ella said this might not be the best way forward.

"Being open to an IPR made public at this point of time for the world or the humanity or all the countries at large is not the issue. The issue is that biological processes are not so simple that they work with an IPR or what is written in a patent document in black and white. There are so many interlinked processes and technologies that are again connected to different sources and materials and adjuvants come," she said.

Echoing Ella's opinions, Biocon Founder Kiran Mazumdar-Shaw, who was also part of the panel said that technology transfers take a long time to reach viable scale.

"It is the politically right statement to make. It is a good rhetoric to have globally. At a time like this when we want vaccine adequacy and vaccine equity, obviously, everyone would want vaccines to be produced at huge scale... While it is great to say that we need to have patent waivers and we need to get into compulsory vaccine licensing, I don't think the layperson or politicians or the policymakers realise what biological processes are all about, what technology transfers are all about and how long it takes to start from lab to scale up in terms of producing a quality product with all the quality release requirements and regulatory requirements," Mazumdar-Shaw said.

It takes anywhere between 9 months and 12 months at least for another company to take a Bharat Biotech vaccine and produce it at a decent scale, the Biocon Founder pointed out.

On whether Covaxin production can be scaled up in time to beat COVID-19 mutations that may crop up in future, Ella said that the vaccine has shown efficacy against the existing strains so far, including the Indian double mutant.

"We have already gone ahead and exchanged our vaccine samples with the NIV, because we don't have access to foreign strains, being a private manufacturer and a private developer. So the strains from the UK, Brazil and South Africa have been sent to NIV, Pune and including double mutant of India have all been neutralised by Covaxin," she said.

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