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Two years ago, when a pair of Houston scientists first began crafting a cheap, easy-to-make COVID-19 vaccine, they had a tough time finding support for it at home in the U.S., a country that rewards expensive, flashy new tech.
They could have used help with their goal of combating the virus both locally and abroad, where it was morphing into more dangerous variants headed for U.S. shores.
But the team at the Texas Children’s Hospital Center for Vaccine Development at Baylor College of Medicine, led by Drs. Maria Elena Bottazzi and Peter Hotez, worked on their patent-free vaccine with donated money in relative obscurity, failing to garner much outside interest.
Then one thing finally broke through and spoke to the people who had been overlooking their open-science approach to the vaccine known by its first producer as Corbevax. It came without strings or a secret formula, making it a true humanitarian pursuit that could finally reach the unvaccinated corners of the developing world.
“Corbevax to beat inequity?” read a CNN News ticker beside a televised interview with the scientists last month.
Now, just weeks after their vaccine won emergency use authorization in India, international news agencies are lining up for interviews. Curious investors are reaching out to the scientists on social media from around the world. U.S. lawmakers from both sides of the aisle are pressuring President Joe Biden to step in and support the vaccine’s distribution abroad.
There’s even talk of a Nobel Peace Prize.
“You are providing sorely needed ethical & scientific leadership. Texas should be proud!” Ambassador Martin Kimani, Kenya’s permanent representative to the United Nations, wrote on Twitter in early January.
And all of this buzz before a single shot of Corbevax has gone into an arm outside of clinical trials.
“I think one of the reasons it’s been a bit viral is the fact that everybody’s been talking about equity, equity, equity and nobody does much of anything,” Bottazzi told The Texas Tribune. “And then all of a sudden they learn that we have this vaccine that has been open science, with no proprietary technology. And they’re saying, ‘Wait, where has this been?’”
The vaccine formula can be licensed by a vaccine producer in any low- or middle-income nation, which would then take ownership of it, produce it, name it and work with the government to get it to the people, Hotez said.
Corbevax, as it was dubbed by its Indian maker, was co-developed and manufactured by the biopharmaceutical company Biological E. Limited, headquartered in Hyderabad, India.
Doses are expected to be delivered to the Indian government starting next week for distribution to some half a billion people who are still unvaccinated in that country. Just over half the population of India is fully vaccinated, with another homegrown vaccine available there and a third recently authorized.
A halal version of the vaccine, for use in Islamic countries because it doesn’t contain animal-based ingredients, is in clinical trials in Indonesia.
Those five countries alone are home to a billion people who are not fully vaccinated.
“Hopefully, it will be game-changing for many countries,” Bottazzi said.
No patent means lower cost
Bottazzi and Hotez, both pioneers in the field of immunology, run Baylor’s National School of Tropical Medicine and have been developing coronavirus vaccines for more than a decade, including formulas for the SARS and MERS viruses.
Their vaccine uses the same recombinant protein technology already used for decades in the hepatitis B vaccine, a common childhood shot.
The vaccine technology has no intellectual property rights attached to it. That means the building blocks of the vaccine can be had for the price of a phone call. Once produced, the vaccine can be sold to governments for far less than any other vaccine currently on the market.
“Our intent was to make it available to millions of people in the world who would otherwise not have access to COVID vaccines,” said Hotez, dean of Baylor College of Medicine’s National School of Tropical Medicine.
The Indian government has secured a deal with Biological E to buy at least 300 million doses for less than $2 per dose. After that, Bio E has said it can make more than 1 million doses per month.
By comparison, the U.S. government is paying Pfizer about $20 per dose. Much of that is the cost of the intellectual property covered by the patent.
The idea of open science, open access and open source medicine and technology, like the “patent pledge” by Tesla in 2014, is not new, but it’s gaining traction for its focus on equal access over profit. Its critics argue that it can dampen competition and innovation.
There have been attempts to exempt COVID-19 vaccines from intellectual property rights and patents to increase global access, amid debate over whether that would result in more equitable distribution.
But much of the praise for Corbevax and its Texas inventors seems to be their willingness — and that of Bio E and the investors — to forgo a large profit in favor of the more altruistic goal of better access and distribution of the vaccine.
Last week, Bottazzi and Hotez were nominated for the Nobel Peace Prize for practicing what Hotez calls “Texas vaccine diplomacy,” by creating a path for the entire world to be inoculated.
“Dr. Hotez and Dr. Bottazzi’s effort to develop the Corbevax vaccine is truly one of international cooperation and partnership to bring health, security, and peace around the world by creating a COVID-19 vaccine and making it available and accessible to all,” wrote U.S. Rep. Lizzie Fletcher, D-Houston, in her official nomination. “It is a contribution that is of the greatest benefit to humankind.”
Whether their new fame translates into dollars for continuing their work on advancing the coronavirus vaccine program remains to be seen, Bottazzi said.
She hopes that once the vaccine's safety data is published for peer review and the vaccine starts going into arms, more support will follow.
They have some powerful voices showing up for them now, too. U.S. Rep. Michael McCaul, R-Austin, called on Biden last week to help with its distribution to American allies overseas who are struggling with what he called “ineffective and substandard vaccines from China and Russia.”
“While we recognize existing administration efforts to supply COVID-19 vaccines around the world, the global supply is woefully insufficient to meet urgent and pressing demands,” McCaul wrote in a letter signed by a bipartisan group of more than a dozen members of the Texas congressional delegation.
“We need to see the data”
All the Corbevax praise is coming in before the scientific trial data has been published in a peer-reviewed scientific journal, seen by experts as an important public vetting process for a new vaccine or medication.
“I’m excited about it. I see a huge potential. I can’t wait for something like this to come to fruition,” said Dr. Jason Morrow, a physician and medical ethicist at the University of Texas Health Science Center at San Antonio. “And I also have to be measured and patient and wait for the data.”
Data from company-run clinical trials in India proving that Corbevax is safe and effective was submitted to the Indian government regulators to review before they authorized it on Dec. 28 for emergency use.
Long before that, in the U.S., the Texas Children’s team published all of its information about the production processes for the vaccine technology in publicly available scientific journals.
The clinical trial results are not on the Indian regulator’s website yet, although early results have been released by the company and the team in public statements.
Biological E Limited reported during the approval process in India that in the company’s clinical trials, Corbevax showed up to a 90% efficacy rate based onimmune-bridging studies, and none of the 3,000 people who participated in the final stage ofclinical trials had any serious adverse reactions. It also showed only a minimal drop in protection after six months.
When the company’s testing methods and research are published in a scientific journal, that will give the public a look into how the researchers came to their conclusions about Corbevax’s effectiveness. Meanwhile, it’s creating some tension with those who want to support it but don’t have all the facts yet.
“The fact that it’s [Corbevax] open source, and it’s intended to be easy and cheap to make and to do so at a large scale is really exciting, and it’s exactly what we need to try to get the pandemic under control,” Morrow said. “But we need to see the data.”
The data for all the clinical trials, which began over a year ago, is expected to be published within weeks or even days, Bottazzi said.
Flipping the script
In 2020, the Houston team’s work was passed over for funding by Operation Warp Speed, the public-private partnership created by the federal government to accelerate treatments and vaccines for COVID-19. Developing the COVID-19 vaccine technology and the co-development efforts of Corbevax from the lab to authorization cost the laboratories between $5 million and $7 million, Bottazzi said.
That’s when philanthropy stepped in, specifically the Robert J. Kleberg, Jr. and Helen C. Kleberg Foundation, the M.D. Anderson Foundation and the JPB Foundation in New York, along with several other anonymous individual donors.
Even Love, Tito’s, the philanthropic arm of Austin-based Tito’s Handmade Vodka, put in $1 million.
By comparison, Operation Warp Speed spent more than $12 billion in federal tax dollars to develop and distribute the vaccines launched by Pfizer, Moderna and Johnson & Johnson. The three vaccines have been used to fully vaccinate nearly two-thirds of the U.S. population.
Those companies’ vaccines use messenger RNA, a molecule the virus needs to produce a “spike protein” and bind to human cells, to prompt the immune system to produce antibodies against that protein.
It’s a method that’s been in development since the 1970s and in clinical trials since 2008. What’s new about the mRNA vaccines are the systems for producing and delivering them in mass quantities. That’s the part that was patented by the mRNA vaccines’ creators in exchange for the pharmaceutical companies Pfizer and Moderna investing in the science behind it and funding the research. The cost of that investment gets passed on to the buyers, which include governments.
And the richer the government, the more vaccines it can buy. Some poor governments can’t afford any at all, and they rely on donations from other countries, like the U.S., for what little vaccine they can get.
The Corbevax formula is also not new — but unlike the mRNA shots, its recombinant protein technology has been in widespread use globally for decades. In some ways, that familiarity and older technology is what put Corbevax behind the newer, more modern mRNA vaccines in the race for funding two years ago.
Now the lack of a patent and the fact that the formula that can be replicated almost anywhere is flipping the script, making Corbevax the new and buzz-worthy vaccine while others can get bogged down in vaccine hesitancy, cost, production limitations and politics.
“They [Hotez and Bottazzi] have found a way to get enough money to develop it without the people who are providing the money demanding intellectual property protection,” said Dr. Benjamin Neuman, a Texas A&M University virologist who has been doing coronavirus research since 1996. “That’s the trick. Finding a funder that is willing to say, ‘Here’s the money, let’s do this for people everywhere,’ you know?”
Reaching the global population
Every week, Bottazzi and Hotez field calls from more nations that are interested in the vaccine, that want to know how to obtain it and how to make it.
The World Health Organization is expected to issue an emergency use listing in the coming months for Corbevax, which could help fast-track it in other countries that need it.
For answers as to why vaccine equity in low- and middle-income countries matters, doctors say to look at the ravages of the omicron wave, which is just starting to subside nationwide and in Texas.
More than 64% of the world’s population has gotten at least one dose of a COVID-19 vaccine, but the vast majority of those people are concentrated in wealthier, more developed countries, nations that are predominantly white. Only 10% of the people in poorer countries have received at least one shot.
An article published in the medical journal The Lancet last month, authored by a handful of scientists including Hotez, warned of the “alarming inequities” in access to testing, treatment and vaccines by poorer countries that have “set the tone of this pandemic.”
By September 2021, they wrote, 5.82 billion vaccine doses had been administered worldwide. Less than 2% of the people in less wealthy countries had received at least one dose.
Nations like Kenya, Uganda and South Africa, where the omicron variant was first publicly reported last Thanksgiving, are still dealing with vaccination rates ranging from 4% to under a third of the population.
Scientists have never confirmed a country of origin for omicron, and it was documented in white, wealthy, western European areas around the same time it was being reported by South Africa, but with no apparent geographical connection.
But the high numbers of unvaccinated people found in poorer countries make them particularly vulnerable to the ravages of new variants, experts say.
The World Health Organization estimates that for the pandemic to wane globally, vaccines should reach 70% of the world by mid-2022. Currently, about 3 billion people are still unvaccinated, and up to 9 billion doses are needed to get them all fully vaccinated and boosted.
Reducing virus spread abroad means fewer infections in the United States and Texas. It took less than a month between the time the omicron variant was first reported in South Africa and Europe and the time it was breaking records in some major Texas hospitals.
“We all have an interest in everybody getting the vaccine, and that means we really need to build systems that can ensure equity,” said Dr. Rachel Pearson, a hospital pediatrician at the Center for Medical Humanities and Ethics at UT Health San Antonio. “We really need to have a more integrated global system with a focus on access in the developing world, because vaccine inequity has been a major source of unnecessary death and suffering.”
Disclosure: Texas Children’s Hospital, the University of Texas Health Science Center at San Antonio, Tito’s Handmade Vodka and Texas A&M University have been financial supporters of The Texas Tribune, a nonprofit, nonpartisan news organization that is funded in part by donations from members, foundations and corporate sponsors. Financial supporters play no role in the Tribune’s journalism. Find a complete list of them here.