A New, Patent-Free Vaccine May Help End the Pandemic. Philanthropy Made It Possible

Ananchai Phuengchap/SHUTTERSTOCK

In early 2020, when COVID-19 was quickly morphing into the global pandemic it ultimately became, Texas-based vaccine and tropical disease researchers Peter Hotez and Maria Elena Bottazzi remembered the last time a coronavirus was threatening global health. That was the SARS outbreak of 2003, and at the time, with funding from the NIH, they’d developed a protein-based vaccine to protect against that strain of the virus. Fortunately, SARS faded away on its own, so Hotez and Bottazzi put their vaccines in the freezer and moved on to other research.

When COVID-19 started spreading, Bottazzi and Hotez, who are based at Baylor College of Medicine in Houston, were certain they could adapt their old vaccine for the new threat. They’d used protein subunit technology (using just a part of the disease-causing protein) that had been put to work in vaccines successfully and safely for many decades to protect against diseases such as hepatitis-B and pertussis.

The scientists first approached the NIH, which gave them a small sum to test the notion of reengineering their SARS vaccine. But when they went back to the NIH for the greater funding they needed to develop a new COVID-19 vaccine, the feds were focused on other strategies.

“We knew our vaccine would offer strong protection, but by then, the NIH seemed to be interested in the RNA vaccines and the Johnson & Johnson (vector) vaccines,” said Bottazzi, who is associate dean of the National School of Tropical Medicine at Baylor and co-director of Texas Children’s Hospital Center for Vaccine Development. “Only the newer, innovative technologies were supported because everyone thought they were going to be the quickest to develop. But they didn’t think of global scalability and stability and storage temperatures.”

Despite the lack of new NIH support, Hotez (who is also co-director of Texas Children’s Hospital Center for Vaccine Development) and Bottazzi were confident that their protein-based vaccine could play a crucial role in what was looking more and more like a global pandemic.

“We realized that this virus is not going to be easily contained and saw the urgency of the pandemic as a global issue,” said Bottazzi. “We predicted it wouldn’t be an easy path for many countries in the Global South and that we needed to support a global vaccine supply.” As has been widely reported in recent weeks, their predictions turned out to be spot-on: While wealthier countries managed to vaccinate 70% or more of their populations by the end of 2020, some low- and middle-income countries had vaccination rates well below 50%, even below 5%. These low global vaccination rates left the door open for variants like delta and omicron.

The Hotez-Bottazzi protein subunit-based vaccines were well-suited to address these global needs. They could be manufactured much more cheaply than the newer jabs, possibly as low as $1 a dose. They require only standard cold refrigeration, not the super-cold temps needed to preserve the RNA-based vaccines, and can be stored for years with no loss of effectiveness.

So Hotez and Bottazzi kept at it.

‘Every dollar helped’

In early 2020, Hotez, as an occasional guest on the medical-themed Peter Attia Drive Podcast, was discussing the need for broad global vaccination against COVID-19. He brought up the funding difficulties his team had in their vaccine development. Among those who heard the podcast were the funders at another notable Texas institution: Tito’s Handmade Vodka. 

“After hearing about their work over the past decade, and how close they were to finishing a vaccine, our team decided to reach out immediately and help fund the continuation of the research,” said Sarah Everett, director of global impact and research at Tito’s Handmade Vodka. This wasn’t the company’s only foray into health research philanthropy: In addition to another $2.5 million to the University of Texas at Austin’s COVID-19 Modeling Consortium, it has funded the development of snakebite antivenom in sub-Saharan Africa, new antibiotics, and editing of the microbiome for gut health, among other research. Everett’s team emailed Hotez and Bottazzi and asked how much they needed to continue the research and advance to clinical trials: $1 million was the answer. Tito’s gave them the million.

At around the same time, Hotez and Bottazzi were reaching out to other Texas-based philanthropic foundations, some that had supported their work in the past. One was the Dunn Foundation, a major funder of medical research and health services in the state; the trustees agreed to pitch in. Substantial support also came from the Robert J. Kleberg, Jr. and Helen C. Kleberg Foundation, a longtime supporter of Texas Children’s and a past funder of research by Hotez and Bottazzi. Other local funding came from the MD Anderson Foundation, which has supported health and other causes in Texas since its founding in 1939. 

Word also spread beyond Texas: New York-based JPB Foundation committed another $1 million. Though generally focused on domestic social equity and economic causes, as the COVID pandemic gained momentum, JPB looked for ways to contribute to biomedical research—and specifically sought to support an underfunded area where their contribution would be most needed. An advisor alerted them to the Hotez/Bottazzi vaccine research, and as they’d been in contact with Hotez a few years before, they quickly signed on to help. JPB has also funded other COVID-related work, including research to develop therapeutics.

Bottazzi said the researchers were struck by the willingness of the foundations to broaden their focus beyond U.S. borders. “These are all American foundations, and they primarily work on issues in America, so we weren’t sure if they would respond to this global need, but they did,” said Bottazzi.

“The fact that this particular vaccine was going to be easier and cheaper to manufacture and distribute in poorer nations was important to us,” said Margret Bamford, grants administrator at Kleberg. “You’ve got to get it into people’s arms—one thing that the pandemic has taught us is that we’re all connected.”

Word of the Hotez-Bottazzi vaccine technology spread beyond organized philanthropy. “We even got emails and contributions from individuals, people who had heard Peter on the podcast or seen him on TV. They just wanted to help. Some sent a few dollars or a few thousand, whatever they could afford,” said Bottazzi. “Every dollar helped.”

No patent, no problem

The Texas vaccine differs from those developed by U.S. and European companies in another important respect: Hotez, Bottazzi and their institutions left it patent-free. They will provide non-exclusive licenses to vaccine manufacturers and will assist with reagents and guidance. So they won’t get rich, but they’ll probably save countless lives around the world, prevent many people from getting sick, help slow the rise of new COVID variants—and possibly accelerate the end of the pandemic for the planet.

It’s a refreshing contrast to the profit-driven pharmaceutical industry. In fact, the limitations of vaccine patents have become a source of great debate in public health—and in philanthropy. Bill Gates last year drew criticism for opposing the temporary lifting of patent protection for COVID vaccines, though later, the Gates Foundation relented and voiced support for lifting patent protection. And Moderna is currently in a feud with the NIH over patent rights of its vaccine: The NIH says its scientists co-invented Moderna’s RNA-based COVID vaccine, but the company says it’s the sole inventor. 

Texas Children’s Hospital and Baylor College of Medicine have already licensed the vaccine to India-based pharmaceutical company Biological E, which is manufacturing it under the brand name Corbevax. Clinical studies have shown Corbevax to provide more than 90% protection against the original COVID-19 variant, and more than 80% protection against the delta variant. The safety profile was equally strong, with about half the rate of adverse reactions of the vaccines it was compared to. Studies involving the omicron variant are next. Late last month, the Drugs Controller General of India (DCGI) granted the vaccine emergency-use authorization to launch in India.

Meanwhile, said Bottazzi, licensing to pharmaceutical companies to manufacture the vaccine in other countries is underway, including in Indonesia and Bangladesh. Other pharmaceutical companies will give the vaccine their own brand names. The vaccine has also been licensed to ImmunityBio Inc., the California-based pharmaceutical company founded by Patrick Soon-Shiong. Soon-Shiong, who’s also the owner of the Los Angeles Times, was born and raised in South Africa: ImmunityBio plans to make the vaccine for use in South Africa and Botswana.

The Texas vaccine could potentially even raise vaccination rates in another country where many people remain unvaccinated: the United States. Due to the rampant spread of misinformation, some people came to fear the newly developed RNA and viral-vector vaccines authorized for use in the U.S.—perhaps some of them will be more likely to accept a shot based on the older protein subunit approach. At the moment, they don’t have an American or European partner, and it’s not clear if they can bring the vaccine to the U.S., but it could be a big help, even in countries where people have had ample access to the other vaccines.