By\u00a0Karen Brooks Harper\r\nThe day before COVID-19 claimed its first Texas victim in 2020, Dr. Peter Hotez was a guest on the popular Austin-based podcast \u201cThe Drive.\u201d\r\nAfter 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, \u201crescue the world\u201d from the deadly emerging coronavirus pandemic.\r\n\u201cYou\u2019d think that people would be pretty eager to support us to move this forward, but so far it hasn\u2019t happened,\u201d the Houston pediatrician and vaccine scientist\u00a0told the host, Dr. Peter Attia, on March 14, 2020.\r\nBy the following week, major cities in Texas began to shut down to avoid widespread community outbreaks.\r\nBut Hotez\u2019s 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\u2019s Hospital Center for Vaccine Development, co-directed by Hotez and Dr. Maria Elena Bottazzi in Houston \u2014 both of whom are celebrated pioneers in the area of vaccines for neglected tropical diseases like chagas and schistosomiasis.\r\n \r\n\r\n\r\n\r\nAmong the gifts was a $1 million infusion of cash in May 2020 by the philanthropic arm of Texas-based Tito\u2019s Handmade Vodka, whose director of global impact and research, Sarah Everett, was tuned in when Hotez asked for help in reviving their research.\r\n\u201cWe decided that somebody should help restart that work immediately,\u201d Everett said.\r\nNow, nearly 18 months later, the Houston team\u2019s vaccine, called Corbevax by its maker in India, is cheap, has no patent, can be made by many vaccine producers globally \u2014 including those in low- and middle-income countries \u2014 and is poised to receive approval for widespread global use.\r\nThe 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.\r\nA halal version of the vaccine, for use in Islamic countries, because it doesn\u2019t contain animal-based ingredients, is also about to start clinical trials in Indonesia.\r\nAnd 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.\r\nBut here in the United States, this \u201ctruly Texas vaccine,\u201d as its creators like to call it, has no home.\r\nA Texas-style vaccine\r\nThe 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.\r\nThose 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.\r\nThe 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\u00a0billions\u00a0at the Houston lab.\r\nMost experts, including Hotez and Bottazzi, agree that\u2019s because most of the funding and the attention \u2014 and the bets \u2014 are on the vaccines made earliest in the pandemic, and with the newest technology, by Pfizer, Moderna and Johnson & Johnson and a few others.\r\n\u201cWe\u2019re pushing the new ways because they\u2019re better and faster,\u201d 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. \u201cWhy wouldn't you want to have it all?\u201d\r\n\r\n\r\n\r\nCompetition from new tech\r\nThe mRNA vaccines by Pfizer and Moderna use messenger RNA, a molecule the virus needs to produce a \u201cspike protein\u201d and bind to human cells, to prompt the immune system to produce antibodies against that protein. Five years ago, Neuman said, that process hadn\u2019t been made effective yet.\r\nBut by the time Hotez was making his plea on Attia\u2019s podcast, Moderna was already\u00a0starting up clinical trials\u00a0of 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.\r\nAnd by late 2020, when BioE was rolling out its phase 1 clinical trials with Corbevax in India, Pfizer was already getting emergency use authorization\u00a0from the U.S. Food and Drug Administration.\r\nThe Bottazi and Hotez vaccine relies on a production process very similar to the way the Hepatitis B vaccine is made that\u2019s 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.\r\nBut aside from a handful of philanthropies who can see the value of the domino effect \u2014 more vaccinations outside this country help lower infections around the world and here \u2014 Hotez and Bottazzi have heard nothing about producing or distributing here at home.\r\n\u201cWhy weren\u2019t conventional vaccine technologies given the opportunity of being at the same table as all these other technologies?\u201d Bottazzi said.\r\nThe answer, Neuman says, is that while conventional technologies \u2014 or what he jokingly derided as \u201cthe obvious answer\u201d \u2014 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.\r\nNewer 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.\r\nBut 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.\r\nThose challenges can be solved, Neuman said, but until then, the majority of the planet should be vaccinated \u201cby any means necessary,\u201d including with conventional vaccines like the one created by Bottazzi and Hotez, if it proves to be safe and effective.\r\n\u201cWhatever gets the job done the fastest as long as it's safe for everybody involved,\u201d he said.\r\n\r\n\r\n\r\n\u2018One plane flight away\u2019\r\nWhile 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.\r\nThey 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 \u2014 or if the scientists will share the formula for the prototype.\r\nThe scientists share the formula with any country or lab who asks for it and help in other ways, however, they can.\r\n\u201cWe\u2019re kind of practicing our own version of Texas vaccine diplomacy,\u201d Hotez said.\r\nVaccination 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%.\r\nIn India, where nearly a billion doses of three different vaccines \u2014 Covishield, Covaxin, and Sputnik V \u2014 have been distributed, more than 80% of the population remains unvaccinated. In Brazil, less than a third of the country is inoculated.\r\n\u201cWe\u2019re 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,\u201d said Dr. James Cutrell, an infectious disease expert at UT Southwestern Medical Center.\r\nRight now, the World Health Organization is already monitoring\u00a0several variants\u00a0that have been traced to developing countries including Indonesia (21% fully vaccinated), Peru (with one of the\u00a0highest\u00a0COVID-19 mortality rates in the world), Colombia, the Dominican Republic and South Africa.\r\n\u201cMuch of sub-Saharan Africa, large swaths of Latin America and other places like that \u2014 they really don\u2019t have access to the [mRNA] vaccines,\u201d said Cutrell, an associate professor in the department of internal medicine. \u201cThat makes it really important and attractive to have some of these cheaper, easier-to-distribute \u2014 but hopefully similarly effective \u2014 vaccines with more traditional technology, which I think this vaccine and other vaccines like it can contribute.\u201d\r\nAmerican problem, international solution\r\nAs the world scrambles for doses to meet the vaccination demand elsewhere, this nation\u2019s 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.\r\nHotez and Bottazzi believe their vaccine would likely be more accepted by those who don\u2019t trust a vaccine that is unfamiliar to them, like those by Pfizer and Moderna.\r\nBut from the start, inoculating reticent Americans was never the Houston team\u2019s first priority.\r\nBottazzi 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.\r\nFast 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\u2019d focused on throughout their careers.\r\nThe 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\u00a0that chipped away at public acceptance. And as this nation\u2019s vaccination rate hovers around 57%, it\u2019s a matter of debate what is needed to achieve a higher level of immunity as a country.\r\nNeuman said he isn\u2019t 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.\r\n\u201cI think that comes from a lot of different places, and I think the main place is sort of, \u2018You\u2019re not the boss of me,\u2019\u201d he said. \u201c\u2018Who says you get to tell me what to do?\u2019 And I don't think it matters what it is.\u201d\r\nEven if it would make a difference, the path to emergency use authorization for a COVID-19 vaccine in this country starts with money \u2014 for research, for trials, for materials \u2014 and ends with firm commitments from the U.S. to support its mass production.\r\nThe Bottazzi-Hotez shot, at this point, has neither.\r\nAnd 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\u2019t or won\u2019t 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.\r\n\u201cIt\u2019s a pretty ambitious, audacious goal,\u201d Hotez said. \u201cBut I think we could get there.\u201d\r\nThis story originally published by the Texas Tribune.