Clinically tried and tested: Bharat Biotech boss Ella wins Covaxin fight

September 2019, months before the Covid-19 pandemic broke out and all hell broke loose, a bio-safety-level (BSL) 3 facility was almost ready at Hyderabad’s Genome Valley.

Dr Jacob John, senior virologist and former head of the departments of clinical virology and microbiology at Christian Medical College, Vellore, was in Hyderabad for a meeting. “When Krishna Ella learnt that I was in the city, he invited me over to see his upcoming facility and give a talk to his team,” John recollects.

“I was surprised to see a BSL-3 facility, and asked him what his idea behind it was. Ella said he wanted to ensure that his team was 100 per cent safe when they dealt with deadly viruses,” John says.

A BSL-3 facility is one in which research work or production is performed with agents that may contaminate the environment and cause people working in it to inhale serious or potentially lethal diseases.

Typically, a BSL-2 facility is sufficient for a vaccine manufacturer, John says. Ella, he adds, was thinking ahead.

People who know Ella agree that he is indeed a man with a futuristic vision.

Dr Gagandeep Kang, noted scientist and professor at CMC, Vellore, says Ella is very committed and very forward thinking. “The idea of having a combined dengue-chikungunya-Zika vaccine even before the Zika outbreak is an example of forward thinking,” she points out.

Bharat Biotech was the first company globally to file the patent on the Zika vaccine.

Sixty-two-year old Ella and the company he built over 25 years has been in the spotlight over the past year. Covaxin was India’s first indigenously developed vaccine to be approved, controversially under “clinical trial mode” in the first week of January. Work on phase 3 trials covering around 26,000 people was underway then and the firm had not yet reported the efficacy results.

The decision received considerable flak from the scientific community at that time principally because it was considered unethical to give it to citizens without efficacy data. The common view was that Bharat Biotech was being given this preferential treatment because of its collaboration with the government body Indian Council of Medical Research.

The issue snowballed into a controversy after rival vaccine maker Serum Institute of India’s (SII) Adar Poonawalla made a passing remark on a television channel that only three vaccines in the world had passed all scientific evaluations, with others only “safe like water”. It was a charged statement since Poonawalla’s Covishield, a vaccine developed by British drug major AstraZeneca and the University of Oxford, had been granted the approval on the same day.

Ella was irked. He called a press conference the following day at which he said, “It hurts us as scientists…. we work 24 hours. Do we deserve this bashing?”

Poonawalla and Ella had patched up soon. But the controversy did impact the acceptance of Covaxin in the country. States such as Chattisgarh and Union Territories like Chandigarh had openly expressed their concerns about administering Covaxin to their citizens.

Finally, on March 3 two months after it was administered in clinical trial mode, Bharat Biotech announced the interim efficacy results from its phase 3 trials — Covaxin has an efficacy of 81 per cent versus the 62 per cent for Covishield. On Thursday, India’s drug regulator granted an emergency use approval to Covaxin, doing away with the “clinical trial mode” status.

A senior consultant who works with pharma firms said that no one doubted Dr Ella’s integrity. “The entire fraternity was with Dr Ella at that point as the war of words was very unnecessary. Ella is emotional as he is passionate about his work,” he says, requesting anonymity.

John, who has known Dr Ella at a personal level for many years, says he admires his patriotic streak. “He came back from the US only to work for his country. He has invested his fortunes to build this company and is married to his work. Rarely does one see such commitment,” he said. John backed up this confidence by taking Bharat Biotech’s Covaxin.

In a 2011 interview with rediff, Dr Ella had spoken about his journey of becoming a molecular biologist.

Hailing from a family of farmers from a village in Thiruthani, Tamil Nadu, Ella had studied agriculture after finishing school.

“After school, I decided to study agriculture which my father didn’t approve of. He felt nobody became a farmer just by studying agriculture! But I got so interested in the subject and wanted to be a farmer,” Ella had said then.

He worked briefly with Bayer in its agricultural division before moving to the US with a scholarship. It is in the US that he studied molecular biology, a decision that would change his life.

He returned to India in 1996 and started Bharat Biotech with his own savings, a loan from IDBI Bank and contributions from the Technology Development Board. Ella has said in interviews that it was his mother and his wife who encouraged him to take risks. He famously said in one of his interviews that his mother told him, “Son, you only have a nine-inch stomach and however much money you make, you can’t eat more than that. You come back and do whatever you want; I will see to it that you get food! As long as I am alive, you will not starve.”

This encouraged Ella to take risks and the Hepatitis B vaccine was born. It was launched by then President Abdul Kalam in 1999.

The company has maintained a track record of coming out with a vaccine every three to four years. It has over 160 global patents and is working on at least three candidates for the coronaviruses, including an intra-nasal vaccine.