Wanted to save lives; also wanted to do our country proud

42-Going-Viral—Making-of-Covaxin Dr Balram Bhargava | Sanjay Ahlawat

AS WE WERE the main agency initially guiding the nation during the pandemic, I had a sense of responsibility as well as fear, as I had never dealt with such a major catastrophe. I had to anticipate and act swiftly, and my training as a physician as well as a cardiologist helped me immensely. More than 30 years in a public sector hospital have kept me in touch with the reality and suffering of a large number of our people.

I have been fortunate enough to treat nearly a quarter million patients during my life. During my career as a physician, being able to bring a smile on the face of patients or their relatives had always helped me cope with the challenges. This new experience was a much larger problem with no immediate smiles. However, the satisfaction of innovating, improvising, repurposing and calibrating the responses with results did boost my morale.

★ ★ ★

Every October, in the northeast-Indian state of Nagaland, members of the ethnic Bomrr clan of the Yimchunger tribe carry out a special harvest that they have practised for over seven generations.

Climbing up a cliff, the Bomrr stack firewood at the openings of the caves and light a fire to produce large plumes of smoke. Their targets are the thousands of bats that live in those caves. The bats either fall dead inside or are struck down with sticks as they fly out. They are cooked as a delicacy or dried and stored for future use.

Given that bats are known to be reservoirs of a number of deadly pathogens, including coronaviruses and filoviruses, an international team with Indian researchers carried out a study of the Bomrr tribe in 2018. The researchers collected blood samples from the bat hunters, who are exposed to saliva, blood and excreta from the bat species Rousettus leschenaultii and Eonycteris spelaea. Samples of the bats were also collected. The study presented the first evidence of a spill-over disease that goes from wildlife to humans, in this case filoviruses from bats infecting people.

The ICMR has been carrying out research on bat behaviour and ecology since 2001, an area of study that is relatively new in India. The NIV’s bat surveillance team, the only one of its kind in the country, has been carrying out a mapping exercise all over India to get a clearer picture of the distribution and abundance, as well as proximity of humans to bat species that are also carriers of various potentially dangerous viruses.

★ ★ ★

Unlike the other vaccines, including Covaxin, which are administered in two doses several weeks apart, the Johnson & Johnson vaccine is effective with just a single shot.

It was a conscious decision not to rely on Moderna, Pfizer or Johnson & Johnson because, first of all, they were limited in their production. Second, those vaccines required a very high cold chain of minus 70 degrees Celsius, which was a problem as far as India’s infrastructure was concerned. Covaxin can be stored at normal refrigerator temperatures. Scientists are also looking at vaccines which could be stored at room temperature.

Developing a vaccine for COVID-19 on our own was also hugely attractive as it would reduce both import costs and dependency on overseas suppliers or governments. While India was already known as the ‘pharmacy of the world’ for its export of low-cost generic medicines and vaccines, it did not have many entirely home-grown products. This was an opportunity to show to the world India’s ability to come up with a cutting-edge product developed with exclusively domestic expertise and resources. We wanted to save lives. We also wanted to do our country proud. Despite all the constraints, a few things worked in our favour. As luck would have it, Bharat Biotech had set up a high-quality manufacturing platform in Hyderabad to make injectable polio vaccines just before the COVID-19 pandemic struck. The company had also set up a BSL-3 laboratory for virus propagation at minimum risk. Its personnel quickly repurposed those facilities to help with the indigenous vaccine project.

The ICMR–Bharat Biotech partnership was destined to be an iconic Indian success story: a fruitful arranged marriage! The company had collaborated with the ICMR several years earlier for the development of JENVAC—an inactivated virus vaccine for Japanese encephalitis.

Bharat Biotech had the track record of making vaccines. Thus, we decided to share the virus with the firm and characterize the company’s vaccine by partnering with the Indian company. An MoU was put in place regarding the sharing of intellectual property (IP) rights. It was decided that five per cent of the earnings from the sales would be given to the ICMR. I think it was one of the first agreements of its kind where both the IP rights and the sales earnings were shared in the manufacture of a vaccine.

We constantly updated the agreement, for instance when we supplied to Bharat Biotech the variants—whether it be the Delta or the Delta plus variant—so that they could tweak the vaccine accordingly to meet the challenge of the new variants.

★ ★ ★

Although we are the pharmacy of the world, in most cases we are mainly generic product makers. We are not making new molecules. We are the pharmacy of the world because we are able to make expensive products, less expensive. And we are able to give them to the rest of the world, for example, we supplied the HIV drugs to all of Africa. With Covaxin, we proved that we could manufacture vaccines from start to finish, with the virus that has been isolated by an Indian scientist. The virus was isolated in an Indian lab and the vaccine was manufactured in an Indian lab. It was characterized in an Indian lab by an Indian scientist. It was studied in India on small and then large animals. The Phase I, II and III clinical trials were done in India by Indian scientists. Almost all the ingredients were from India, as far as the vaccine was concerned.

Covaxin is a hardcore, purely-homegrown product. In today’s inter-connected world, you can source the globe for certain components. But to be able to innovate, to be able to own the Investigational Product (IP) and to be able to manufacture it on your own, that is a feat, and we did that with Covaxin.

★ ★ ★

We pulled off an extraordinary feat. After the tension, the drama, the hard work, the long nights, the constant fear of illness and death, the brainstorming, the travel, the testing, the fatigue, the adrenalin rush... after all this, let’s pause and marvel. There is much to marvel at.

Last year, we had one lab that could perform COVID-19 tests. Today, we have several thousands.

Last year, a deadly disease came to our country and started killing people, and it was a terrifying mystery. Today, we know exactly what the ‘pretty virus’ is and exactly how to vanquish it. The lives lost, and the lives still in the balance are an incalculable loss, but now we know what to do.

Last year, the whole world shut down. This year, India has an Indian vaccine that will save millions of lives all over the globe and help the world come back to life.

Last year, we were known as a reliable vaccine manufacturer. This year, we are an acknowledged vaccine pioneer.

Today, I am filled with a sense of urgency to vaccinate India and prevent a repeat of the tragic second wave. We have to be very careful.

Ironically, the best way forward for us is to imitate our enemy: we need to mutate and evolve in order to outsmart the virus. And that is what we are doing. When it attacks, we defend. When it hides, we find it. When it changes course, we are right there behind it. When we need to, we call in reinforcements.

At this moment, as the world waits to see the pandemic in the rear-view mirror, the superheroes of the day are scientists: women and men who stay smarter than the virus, who change and adapt and innovate so we can all have our shot at a better tomorrow.

Excerpted with permission from Rupa Publications.

Going Viral—Making of Covaxin: The Inside Story

By Balram Bhargava

Published by
Rupa Publications

Pages 240;

price Rs295