Health Tech Podcast

How Invoice Gates, a valley stuffed with snakes and one entrepreneur took on a plague

India Minister of Health and Family Welfare Dr. JP Nadda administers Rotavac to an infant. The vaccine is the result of a decades-long international collaboration and sells for just $1. (Research Council of Norway Photo)

In 1996, Bill Gates read a story in the New York Times that sparked his passion for health. The story was about a disease he’d never heard of: rotavirus. At the time it killed more than half a million children every year.

That moment was one of the factors that led him to co-found the Gates Foundation with his wife, Melinda, and become one of the most influential figures in the history of public health.

What Gates didn’t know is halfway across the globe, a scientist in New Delhi had made a discovery that could be the key tool in fighting rotavirus. Over the next twenty years, a huge international collaboration between Bill Gates, scientists and policy makers across the globe and one exceptionally determined Indian entrepreneur turned that discovery into a unique new vaccine, called Rotavac.

The vaccine has made waves as a case study for global health solutions created in and by developing countries, with help from a network of international powers. It’s also getting attention for its incredibly low price: just $1 a dose.

We tell the story of how it all happened on the latest episode of GeekWire’s Health Tech Podcast.  Listen to the episode in the player below, subscribe to the show in your favorite podcast app, and continue reading for more.

The story of Rotavac starts at the All India Institute of Medical Sciences in New Delhi. A group of scientists led by Dr. Raj Bahn noticed that some of the children in the hospital appeared to have rotavirus, but did not develop the disease’s telltale symptom: diarrhea so intense it can kill a child in a matter of hours.

“They started to look at it a little bit more in detail,” said Duncan Steele, a virologist who has spent the bulk of his 35-year career studying rotavirus. He has spent time working at the World Health Organization and Seattle-based global health nonprofit PATH, which coordinated Rotavac’s development. He now works in vaccine development at the Gates Foundation.

Steele said Bahn and his colleagues noticed the children, “were basically asymptomatic. They had very mild disease, if any at all. And then following them up, they saw that they were actually protected once they went home and did not become ill with rotavirus infection.”

In other words, the strain was acting like a natural vaccine: It did not make children sick, but protected them from getting rotavirus in the future.

Duncan Steele, a longtime rotavirus researcher who has worked on Rotavac through roles at the World Health Organization, PATH and the Gates Foundation. (GeekWire Photo / Clare McGrane)

This was a breakthrough. Rotavirus is incredibly deadly in the developing world, primarily affecting children under the age of five.

Even though there is an effective treatment for the disease, it must be administered very quickly and many people in India and beyond do not have quick and easy access to medical treatment or the funds to pay for it. An affordable vaccine seemed to be the only way to reduce deaths from rotavirus.

Fast forward to the late 1990s. Bahn and a group of scientists at the National Institutes of Health in the U.S. had modified the rotavirus strain so that it could be used as the basis for a vaccine.

But it would need a biotech company to turn the raw virus into a safe and effective treatment. That is no easy task — vaccine development takes decades of complicated scientific work and huge clinical trials.

Thankfully, the rotavirus vaccine would find an unlikely champion in Dr. Krishna Ella, a molecular biologist and biotech entrepreneur with no experience developing vaccines or treating viruses. Despite his lack of expertise in the field, Ella had two strong convictions that made him jump into Rotavac’s development.

Dr. Krishna Ella founded Bharat Biotech to bring innovation to India. The company developed and launched Rotavac as part of a huge international collaboration. (Bharat Biotech Photo)

“One was 200,000 children dying in India,” Ella said. “The second is there is no innovation that’s being done in India. Only two points. That made me get into this project.”

Ella had just founded Bharat Biotech, a company that was first intended to develop a Hepatitis B vaccine. He teamed up with the Indian government and started building the company’s infrastructure from scratch, in an area outside Hyderabad known as Snake Valley. Ella explained that the nickname comes from the poisonous King Cobra and green snakes that called the valley home.

Now, the area is known as Genome Valley, the hub of India’s biotech industry. Bharat biotech was the valley’s first occupant, and it is now home to labs and offices of companies like Merck, Roche, Johnson & Johnson and even Monsanto.

The road to a vaccine was far from smooth sailing. Just as Bharat was getting off the ground, its biggest competition, RotaShield, ran into a problem.

RotaShield was being developed by Wyeth, a multinational pharmaceutical company, and was being tested in the U.S. and a few other countries. Then scientists realized it had a rare but deadly side effect. Wyeth completely pulled the project, announcing it would no longer pursue a rotavirus vaccine.

“A lot of my peer colleagues in India they question me: How can you develop this vaccine anymore? You should not develop it. You should back out,” Ella said. “So, many regulatory people, many scientific policymakers, they were very, very skeptical. That was a major setback for us in the beginning.”

Ella took no heed of the doubters. He thought of the 200,000 children dying of rotavirus in India each year and kept going forward with Rotavac’s development.

Then there was the problem of funding. Bharat Biotech was up against two other vaccine makers also working on rotavirus: Merck and GlaxoSmithKline (GSK), two of the global superpowers in medicine.

Unlike those companies, Bharat didn’t have access to the kind of financial resources needed to develop a vaccine.

“It’s impossible for me to borrow the money,” Ella said, explaining that returns on biotech investments come decades too late for most bank lenders. “Also, there’s no private equity also in this country to fund this sort of project. There’s nothing”

That’s when Bill Gates stepped in. The Gates Foundation, still a young philanthropy, made a pledge to fund Rotavac’s development and eventually put nearly $65 million into the project.

The process took more than 15 years, starting with a series of tests and modifications in labs; then moving to small safety tests in children; then, finally, a years-long Phase 3 trial in almost seven thousand children across India.

In the meantime, Merck and GSK released their own rotavirus vaccines, called RotaTeq and Rotarix, respectively. Those vaccines would be Rotavac’s competition, so the data from the vaccine’s Phase 3 trial would be a key benchmark of how well it performed compared to the other two.

“When we looked at that and saw that it actually was giving good protection in these children, and at least equivalent to what we saw with Rotarix and RotaTeq in developing country children, that was… that was mind-blowing,” Steele said.

But Rotavac has more than just effectiveness on its side. It’s one of the few global health products that was discovered, developed and tested in the country where it is most needed, and the project kick-started India’s presence in global biotechnology.

It also has that incredibly low price: $1 a dose, a fraction of what RotaTeq and Rotarix might cost. And Bill Gates had a hand in that idea, too.

Years before the Phase 3 trial was complete, Bill Gates and Ella signed a contract agreeing to price Rotavac at just $1 a dose once it was on the market. Because millions of low-income children are at risk of the disease, the price could have a huge impact on its effectiveness.

After RotaTeq and Rotarix launched, Gates and Ella met again, in Amsterdam. Gates asked Ella to publicly release the contract with the goal of pressuring Merck and GSK to drop the prices of their own vaccines.

“I had a discussion internally with my colleagues, all my colleagues said: ‘You should not make it public,’” Ella said. His colleagues thought it would make the international community think Rotavac was cheap, and not good quality.

But once again, Ella stuck to his convictions. He agreed to make the contract public, and less than an hour after he made the announcement, GSK dropped the price of Rotarix to $2.50, a significant price drop.

If Rotavac is priced at just $1 a dose, Bharat must be making less money from Rotavac than Merck and Roche make from their vaccines. Why do it?

“You know, money comes, but money can come later,” Ella said. “You don’t want to be greedy. If you’re greedy in the vaccine field, I don’t think you can survive. Vaccine field is like a… corporate social responsibility.”

Rotavac has now been used to vaccinate 12 million children. Next year, it will be part of the first country-wide vaccine initiative in India, which aims to vaccinate every at-risk child against rotavirus.

And Rotavac and other vaccines are making a difference in the fight against rotavirus. In 2000, when there were no rotavirus vaccines on the market, the disease killed about 530,000 thousand children worldwide. By 2013, that number was cut in half to about 215,000.

Ella said he is hoping that Rotavac can cut that number even further by reaching children in impoverished regions where paying even five dollars for a vaccine may be out of reach.

“If I can save 50 percent of the children, I will be more than happy. That is a major success for my life,” Ella said.

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