Bharat Biotech – the Covaxin Story

Bharat Biotech’s Vaccine wizards

On the border between Tamil Nadu and erstwhile Andhra, lies the temple town of Tiruttani, one of the six famed abodes of Lord Muruga.  Krishnamurthy Ella was born at Tiruttani in 1969, in an agricultural family. Read this story of the scientist who made India proud as a researcher and global producer of a covid-vaccine.

Having an agricultural background attracted Krishna Ella to pursue higher education in agriculture. His father wasn’t pleased – he told his son: “nobody becomes a farmer by just studying agriculture.” Unfazed, Krishna joined the University of Agricultural Sciences in Bengaluru. His passion earned him a gold medal. He wasn’t content. After under graduation he worked briefly in the agricultural division of Bayer Pharma.  He longed for more. He got a Rotary Club scholarship to move to the US, to do his PhD in the University of Wisconsin. There was no looking back since.

Dr Krishna Ella – the Brain behind Bharat Biotech

His speciality molecular biology

While in the US, he met Suchitra, also from Tiruttani and married her.  Neither came from business families- Suchitra had a background in economics and marketing, while Krishna’s  was technical. For a first generation entrepreneur to thrive in a heavily regulated industry is never easy.  When obstacles pile up, dreams gain  orbital velocity.

Most Indian scholars who graduate from the US universisites would dream of a green card and settle down in that country (of migrants, that excels in attracting and retaining talent from across the globe so cheap!). Krishna was different: he dreamt of producing low cost vaccines for millions in India. He wanted his dream to become a reality in India.

Krishna started Bharat Biotech in the newly formed Genome Valley in Hyderabad. The first product was caesium-free Hepatitis B vaccine – the first in the world. His work caught the attention of the Bill & Melinda Gates Foundation – whose funds enabled Bharat Biotech to develop the rotavirus vaccine and conjugate a typhoid vaccine – again for the first time in the world.

It took 16 long years to make the rotavirus vaccine a reality. The vaccine cost $ 85 in the western world, but Krishna had brought its price down to an astounding $ 1! The vaccines are made available in 70 countries and Dr Krishna and his team have 140 patents.

Then Covid came….

The race for the vaccine started. The virus was new. No one knew what would work for sure – and everyone was hedging bets. Meanwhile, Adar Poonawalla, the billionaire CEO of the world’s largest vaccine manufacturing company, was in talks with Oxford and Astra Zeneca for manufacturing an adenovirus vaccine. Half a dozen companies from India tried, but realistically the collective fate depended on these two men.

They couldn’t have been more different. Poonawalla was a born billionaire, young and dashing, dressed in immaculate tuxedos, driving luxury cars and flying private jets to London. Krishna was a scientist from a family of farmers, a salt of the earth man who had risen through sheer hard work and grit.

The global race to develop a vaccine had many approaches. It’s a little like betting on many horses at the same time. Krishna realised that the vaccine should not just be safe and effective, but also easy to handle. That meant no difficult storage or movement conditions.

So mRNA vaccines were out. The adenovirus vaccine tricks the body into believing that it has infection by sending just the spike protein the virus uses to enter the cell. The immune system once primed, remembers this and when the real virus attacks, is able to protect. There was one glitch – the protection wasn’t full, at least in the early stages when tested on chimpanzees. Krishna toyed with the idea of modified rabies virus as a vector, but it didn’t work too. His collaboration with University of Wisconsin, his alma mater and Thomas Jefferson Institute too, didn’t yield many results.

Covaxin was born

When the rest of the world went for cutting edge mRNA tech, Krishna decided to go the retro route. Sometimes, old is gold. And he struck gold with the killed virus vaccine, developed in association with ICMR.

It had to be tested though, initially on mice and guinea pigs and then on humans. There were numerous struggles in phase 1 and phase 2 trials. It was a race against time. Corona was killing people in thousands. Previous vaccines had taken long years of research. And he had just a few months to prove the technology and create facilities for mass production.

Will Covaxin work? Will it be safe? These were the questions in everyone’s mind.

With the help of India’s virologists, the company shortened the testing phase. They gave the vaccine to volunteers and after 28 days  their blood samples were taken. They were tested with the deadly virus in a high biosafety lab. If the vaccine had worked, the antibodies in the blood sample would neutralise the virus and there won’t be any growth.

To their ecstasy, the vaccine worked brilliantly! At long last, Krishna had developed a vaccine that was made in India and for the world.

Amazingly, Krishna Ella had achieved this without getting funds from the government.

There were further struggles ahead – testing in humans.  The pandemic had created a virtual babel of tongues, magnified a million times by the social media – with doubts raised on the vaccine at every stage of development.  Indian regulatory authorities were helpful – they expedited the process at every stage.

India became the only ‘developing’ country to develop a vaccine on its own. With the Vaccine Maitri initiative, it supplied vaccines to many countries.

India’s moonshot moment….

In the 1960s, President Kennedy announced that America would put a man on the moon within a decade – even though no one knew how. It came to be known as the “moonshot.” Covaxin is India’s moonshot moment or perhaps the “coroshot” moment, achieved not in a decade, but within a year.  Its our own success in the war against an invisible foe. The fruits of this victory, will be shared – with the poorest of countries.

They say, seeing is believing. Great men reverse this adage: they believe with such intensity that they see what they believe. Believing is seeing. To her credit, Suchitra Ella reversed another cliché too. She changed “behind every successful man is a woman,” into “beside every successful man is a woman”, by being the co-founder of Bharat Biotech.

As I write this, I remember Soorarai Potru, a Tamil movie that chronicles the tale of a man who dreamed of piloting through the skies. Krishna Ella’s story is even more audacious. It’s a story of how a farmer’s son from Tiruttani rose up to meet the biggest challenge of our lifetime. It’s the story of how India metamorphosed from a bystander to a vaccine superpower.

The author, Dr Karthik Balachandran is a Consultant at Sri Ramachandra Medical College & Hospital and Billroth Hospitals, Chennai

The WOMAN BESIDE THE MAN

They seem to have been made for each other: both Suchitra and Krishna Ella were born and brought up in Tiruttani. Suchitra graduated in Economics and Social Sciences from the Madras University, followed it with a diploma in business development from the University of Wisconsin-Madison, a diploma in real estate management from the University of South Carolina and a post-graduate diploma in patent law from NALSAR—Hyderabad.

They seem to be complementary to each other: while Krishna focused on technology, production and other aspects, Suchitra seems to excel in  effective communication and marketing.

In a delightful interaction with Shobana Kamineni, past President of CII, at the annual general meeting of CII (SR), Suchitra, just then elected the Deputy Chairman of CII (SR), provided a comprehensive picture of the success of Covaxin production. She pointed to the capability of India to reach a production rate of two billion vaccines by the end of the year. In lucid terms she described the rapid establishment of the technology and production within a year and the capability of vaccinating not just all in India but also meeting 60 per cent of needs across the globe.

Excerpts from her presentation at the CII:

We manufacture more than 12 different pediatric vaccines. We also supply vaccines to more than 125 countries around the world and to large organisations such as GAVI, UNICEF… which procure directly from us and distribute to several nations of the world.

Standards, protocols, set in gold

With tight timelines, clinical trials are a time-consuming process. The standards, the protocols and the guidelines are set in gold. Expert committees and the Drug Comptroller General of India provide the authorisation to conduct the trials.

We have three different production facilities: in the Genome Valley-Hyderabad, we have capacity for 200-250 million doses per annum. In the facility at Malur-Karnataka we plan to produce around 500 million doses. In the third facility at Ankleshwar-Gujarat, we expect to manufacture around 200 million doses per annum. Thus close to a billion doses can be churned out from these three plants.

Plans are underway for Biovet Pvt Ltd, an associate firm of Bharat Biotech, to manufacture vaccines at Manjri in Pune from end of August.

Quality testing of vaccines is being done at the Central Research Institute (CRI) in Kasauli-Himachal Pradesh.

Testing protocols for every batch of the vaccine requires testing chemicals from Europe and the United States. We also need a lot of equipment in bio process areas where bulk of the material is processed.

Tested on 27000…

Trials on children’s vaccine have begun in June itself. Covaxin has already been extensively studied for about 8-9 eight months and is still continuing in the adult population for which we have deployed 27,000 volunteers. Extensive data is available on safety, immunogenicity and efficacy. Most of our vaccines are catered to the pediatric segment. To ensure that children also receive this vaccine, we take up the clinical study with the permission of the Drug Controller and the National Regulatory Authority.

We have expertise in pediatric vaccines and have conducted studies involving more than 500,000 infants and children in some  20 countries.

Covaxin was  tested in the variants that came up in countries like South Africa, Brazil and  the UK. It proved to be neutralising these variants, including the double mutant new strain, which has also been observed in India.

All this data has been published and reviewed international medical journals.

We have a team of more than 2000 in working in our facilities. –TEAM IE