Inside India's Vaccine Ecosystem
Business Today|December 13, 2020
A blow-by-blow account of how indian vaccines are being readied
P.B. Jayakumar And Joe C. Mathew

THE BIG INVESTMENTS ON CORONA VACCINES

Serum Institute

₹2,100 crore

It plans to invest another ₹900 cr

Zydus Cadila

₹500 crore

Bharat Biotech

₹300-400 crore

When the first Corona cases surfaced during January and February in Kerala and Mumbai, it was an opportunity for scientists at the Indian Council of Medical Research (ICMR)’s National Institute of Virology (NIV) in Pune to study the virus. Professor Priya Abraham, a renowned pathologist and former head of department of Clinical Virology at Christian Medical College, Vellore, had taken over as the new NIV director a couple of months before. Abraham and her team isolated 11 strains of the virus, making India the fifth country after China, the US, Thailand and Japan to do so. Scientists realised the strains were 99.98 per cent similar to the virus then causing havoc in Wuhan. Vaccine development was a possibility. After completing characterisation, immunological biomarker studies and initial pre-clinical studies such as stability, they planned two animal studies. By March, the vaccine was injected in 20 monkeys and the results were 100 per cent sterilising immunity (the virus will not spread to others and within the body) without a single infection. The trial on Syrian Hamsters (a rodent used in trials because they can have similar viral infections in human) also proved 100 per cent immunity. Within two months, ICMR roped in Hyderabad-based Bharat Biotech as the technical partner and industry collaborator.

Around the same time, Adar Poonawala, CEO, Serum Institute of India, was among the first to get in touch with Oxford University’s Jenner Institute and Oxford Vaccine Group, led by Professor Sarah Gilbert and Professor Adrian Hill, who started work on a vaccine from January 10. Jenner Institute had been working on one against another coronavirus, Middle East Respiratory Syndrome (MERS), with trials scheduled in Saudi Arabia, and on a malaria vaccine for two decades, using a technology that centered on altering the genetic code of a familiar virus.

Serum had been a partner to Jenner and had licensed the ‘R21 malaria vaccine candidate’ in 2017. After successful results in rhesus macaque monkeys, which are closest in genetic make-up with humans, the newly developed Corona candidate vaccine — ChAdOx1 nCoV-19 — was tried on 1,077 healthy adults in five UK hospitals in April and May. Data revealed it induced strong antibody and T-cell immune responses for up to 56 days. When Oxford roped in AstraZeneca by end-April as global partner for further development, the Anglo-Swedish drug maker and Oxford were happy to board Serum Institute.

Zydus Cadila is the third Indian company that got involved in Covid-19 vaccine development. Unlike the other two, Zydus is a pharmaceutical company with strong interest in vaccines. Pankaj Patel, Chairman, Zydus Cadila Group and his son Dr Sharvil Patel, had in 2010 developed India’s first H1N1 vaccine and later, tetravalent seasonal influenza and varicella (chickenpox) vaccines. Zydus researchers had started studying the novel coronavirus in January. Two teams were formed, one at the Zydus Vaccine Research Centre in Ahmedabad and another at Etna Biotech in Italy, an acquired research facility. A few years ago, they had developed a vaccine candidate for MERS and SARS virus, from the same family of Covid-19. It entered the first-phase clinical trials, but by then the virus vanished and the company stalled research. But the results were promising. It was a DNA plasmid platform and the team in Ahmedabad resurrected the project to pursue Covid-19 vaccine.

“It is an opportunity to show India’s scientific skills to the world,” says Krishna Ella, Chairman and MD of Hyderabad-based Bharat Biotech. What makes this battle special is the vigour Indian manufacturers have shown for cutting-edge research. It has been 12 months of quick research decisions, enriching partnerships, capacity expansions and funding arrangements. Indian regulators, too, have been highly supportive. Never have approvals come so quickly. Three of Covid vaccine candidates are already undergoing final stages (Phase III) of clinical trials in India. Globally, there are about a dozen that are in final stages of trial.

And all these just within a year after the first case of Covid-19 was officially declared. While it took 34 years of global research to launch the world’s first chickenpox vaccine, the one for cervical cancer was released after 15 years of research. Mumps, measles and polio vaccines took four, nine and seven years, respectively, to complete the whole lab-to-market cycle. On an average, it takes 10.7 years to get a vaccine out into the market. But then, those were preCovid days.

Here’s the inside story of how Indian vaccine makers did it in the final lap of the sprint, even eclipsing many big global life science companies. The results will soon be visible as a quarter of Covid-19 vaccines for the world will be produced in India. It’s all the more important since at a time when governments in the US and the UK were pumping billions of dollars to aid big pharma research to find Covid-19 vaccines, Indian firms by and large were doing it on their own — with meagre funds, scientific resources and infrastructure.

8.2 bn doses

Cumulative installed capacity of Indian vaccine manufacturers per year

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