It’s cheap, easy to make and in demand overseas. So why can’t this Texas-born COVID-19 vaccine break into the U.S. market?

By Karen Brooks Harper

The day before COVID-19 claimed its first Texas victim in 2020, Dr. Peter Hotez was a guest on the popular Austin-based podcast “The Drive.”

After 10 years of research into coronavirus vaccines, Hotez and his Houston team needed an infusion of cash to build on their past work and make a vaccine that could, as Hotez told listeners then, “rescue the world” from the deadly emerging coronavirus pandemic.

“You’d think that people would be pretty eager to support us to move this forward, but so far it hasn’t happened,” the Houston pediatrician and vaccine scientist told the host, Dr. Peter Attia, on March 14, 2020.

By the following week, major cities in Texas began to shut down to avoid widespread community outbreaks.

But Hotez’s plea worked. The donations started coming in support of efforts in the deadly new pandemic at the Baylor College of Medicine at the Texas Children’s Hospital Center for Vaccine Development, co-directed by Hotez and Dr. Maria Elena Bottazzi in Houston — both of whom are celebrated pioneers in the area of vaccines for neglected tropical diseases like chagas and schistosomiasis.

 

Maria Bottazzi replaces vials of the RBD-based SARS-CoV-2 vaccine into a freezer at the Tropical Medicine Lab at Texas Children’s Hospital Center for Vaccine Development in Houston on Oct. 5, 2021. Credit: Justin Rex for The Texas Tribune

Among the gifts was a $1 million infusion of cash in May 2020 by the philanthropic arm of Texas-based Tito’s Handmade Vodka, whose director of global impact and research, Sarah Everett, was tuned in when Hotez asked for help in reviving their research.

“We decided that somebody should help restart that work immediately,” Everett said.

Now, nearly 18 months later, the Houston team’s vaccine, called Corbevax by its maker in India, is cheap, has no patent, can be made by many vaccine producers globally — including those in low- and middle-income countries — and is poised to receive approval for widespread global use.

The Indian government has promised the biopharmaceutical company Biological E Limited, which is making the vaccine in that country, that it will buy 300 million doses with the potential for more.

A halal version of the vaccine, for use in Islamic countries, because it doesn’t contain animal-based ingredients, is also about to start clinical trials in Indonesia.

And later this year, the company hopes the vaccine will be endorsed by the World Health Organization for use globally, which could open the doors to quicker authorization in several countries that need it.

But here in the United States, this “truly Texas vaccine,” as its creators like to call it, has no home.

A Texas-style vaccine

The fact that the vaccine even exists can be traced to a lot of Texas money, including funds from The Robert J. Kleberg, Jr. and Helen C. Kleberg Foundation and the M.D. Anderson Foundation. Several high-level and anonymous individual donors pitched in, as well as the JPB Foundation in New York.

Those donations funded a vaccine prototype with the initial doses mixed in the Houston lab and transferred to Biological E in India in May 2020. By November, BioE began clinical trials of the vaccine in India, where the delta variant was first identified and which has one of the lowest vaccination rates in the world. Total cost from creation to market was between $5 million and $7 million, Bottazzi said.

The U.S. government has yet to get on board. Operation Warp Speed, the public-private partnership created by the federal government to accelerate treatments and vaccines for COVID-19, spent none of its billions at the Houston lab.

Most experts, including Hotez and Bottazzi, agree that’s because most of the funding and the attention — and the bets — are on the vaccines made earliest in the pandemic, and with the newest technology, by Pfizer, Moderna and Johnson & Johnson and a few others.

“We’re pushing the new ways because they’re better and faster,” said Dr. Benjamin Neuman, a Texas A&M University virologist who has been doing coronavirus research since 1996, though he was not involved in any of the approved vaccines’ development. “Why wouldn’t you want to have it all?”

First: Maria Bottazzi holds a vial of the RBD-based SARS-CoV-2 vaccine at the Tropical Medicine Lab at Texas Children’s Hospital Center for Vaccine Development in Houston on Oct. 5, 2021. Last: A lab worker works on a project at the Texas Children’s Hospital Center. Credit: Justin Rex for The Texas Tribune

Competition from new tech

The mRNA vaccines by Pfizer and Moderna 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. Five years ago, Neuman said, that process hadn’t been made effective yet.

But by the time Hotez was making his plea on Attia’s podcast, Moderna was already starting up clinical trials of its mRNA vaccine in partnership with the National Institutes of Health, the biomedical research arm of the U.S. government and the largest center of its kind in the world.

And by late 2020, when BioE was rolling out its phase 1 clinical trials with Corbevax in India, Pfizer was already getting emergency use authorization from the U.S. Food and Drug Administration.

The Bottazi and Hotez vaccine relies on a production process very similar to the way the Hepatitis B vaccine is made that’s been produced and used around the world for decades. The two argue that the familiarity with the process and the ease with which the materials can be gotten makes it easier to quickly ramp up global production compared to the newer vaccines, even if they came onto the market a little later.

But aside from a handful of philanthropies who can see the value of the domino effect — more vaccinations outside this country help lower infections around the world and here — Hotez and Bottazzi have heard nothing about producing or distributing here at home.

“Why weren’t conventional vaccine technologies given the opportunity of being at the same table as all these other technologies?” Bottazzi said.

The answer, Neuman says, is that while conventional technologies — or what he jokingly derided as “the obvious answer” — have a role in global vaccine development, the newer vaccines are stronger than the traditional types that Bottazzi, Hotez, and other scientists around the world are developing.

Newer vaccines also have a quicker production process than conventional vaccines, said Neuman, a member of the international committee that named SARS-CoV-2, the virus behind the COVID-19 pandemic.

But Neuman agrees that the newer vaccines have distribution challenges: the tangles of intellectual property patents, the availability of materials to produce billions of doses in a short period of time, and the logistics of a more complicated transport and storage process.

Those challenges can be solved, Neuman said, but until then, the majority of the planet should be vaccinated “by any means necessary,” including with conventional vaccines like the one created by Bottazzi and Hotez, if it proves to be safe and effective.

“Whatever gets the job done the fastest as long as it’s safe for everybody involved,” he said.

Peter Hotez at the Tropical Medicine Lab at Texas Children’s Hospital Center for Vaccine Development in Houston on Oct. 5, 2021. Credit: Justin Rex for The Texas Tribune

‘One plane flight away’

While the Houston team waits for a production and distribution partner, the team fields calls every week from other countries asking them for help getting access to the vaccine, Bottazzi said.

They ask if they can get the spare doses that Americans are declining or if they can get connected to BioE to export to them from their Indian-made stocks — or if the scientists will share the formula for the prototype.

The scientists share the formula with any country or lab who asks for it and help in other ways, however, they can.

“We’re kind of practicing our own version of Texas vaccine diplomacy,” Hotez said.

Vaccination rates for developing countries are still in the single digits. About 38% of the world population is fully vaccinated against COVID-19. Many African countries, such as Sudan, Kenya, and Ethiopia, have a rate below 2%.

In India, where nearly a billion doses of three different vaccines — Covishield, Covaxin, and Sputnik V — have been distributed, more than 80% of the population remains unvaccinated. In Brazil, less than a third of the country is inoculated.

“We’re one plane flight away from seeing a variant that developed in a country that has very little vaccine end up on our shores and set off a new wave of the pandemic,” said Dr. James Cutrell, an infectious disease expert at UT Southwestern Medical Center.

Right now, the World Health Organization is already monitoring several variants that have been traced to developing countries including Indonesia (21% fully vaccinated), Peru (with one of the highest COVID-19 mortality rates in the world), Colombia, the Dominican Republic and South Africa.

“Much of sub-Saharan Africa, large swaths of Latin America and other places like that — they really don’t have access to the [mRNA] vaccines,” said Cutrell, an associate professor in the department of internal medicine. “That makes it really important and attractive to have some of these cheaper, easier-to-distribute — but hopefully similarly effective — vaccines with more traditional technology, which I think this vaccine and other vaccines like it can contribute.”

American problem, international solution

As the world scrambles for doses to meet the vaccination demand elsewhere, this nation’s vaccination effort has flagged, hitting a wall of hesitation by a significant portion of the American public that is declining the new vaccines, although they have proven to be safe and effective.

Hotez and Bottazzi believe their vaccine would likely be more accepted by those who don’t trust a vaccine that is unfamiliar to them, like those by Pfizer and Moderna.

But from the start, inoculating reticent Americans was never the Houston team’s first priority.

Bottazzi and Hotez began their work developing coronavirus vaccines as part of their mission at the National School of Tropical Medicine, where Hotez is dean and Bottazzi is associate dean, to inoculate developing nations against tropical viruses.

Fast forward to January 2020, when SARS-CoV-2, the virus that causes COVID-19, was setting off alarms in the U.S. medical community. Bottazzi and Hotez began working to repurpose their coronavirus research program to develop a vaccine against the new virus and distribute it to the same countries they’d focused on throughout their careers.

The speed with which the Pfizer and Moderna vaccines were developed and the fact they used newer formulas seemed to spook some Americans and helped fuel politically motivated misinformation campaigns that chipped away at public acceptance. And as this nation’s vaccination rate hovers around 57%, it’s a matter of debate what is needed to achieve a higher level of immunity as a country.

Neuman said he isn’t so sure that a more familiar vaccine formula would change a lot of minds in the United States, where the resistance appears to be more political than scientific.

“I think that comes from a lot of different places, and I think the main place is sort of, ‘You’re not the boss of me,’” he said. “‘Who says you get to tell me what to do?’ And I don’t think it matters what it is.”

Even if it would make a difference, the path to emergency use authorization for a COVID-19 vaccine in this country starts with money — for research, for trials, for materials — and ends with firm commitments from the U.S. to support its mass production.

The Bottazzi-Hotez shot, at this point, has neither.

And so Hotez, who is an internationally known and outspoken warrior against the anti-vaccine movement, and Bottazzi redouble their attention abroad to protect Americans who can’t or won’t protect themselves. If they can get more of their vaccine overseas within a few months, they can keep the variants from percolating and landing on U.S. soil.

“It’s a pretty ambitious, audacious goal,” Hotez said. “But I think we could get there.”

This story originally published by the Texas Tribune.