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Researchers at the San Antonio-based Texas Biomedical Research Institute have answered the call as scientists the world over seek a safe vaccine and antiviral medication to combat COVID-19, which was officially declared a pandemic by the World Health Organization on Wednesday. But even if it is able to find a cure for the novel coronavirus, it could take months or years before it becomes publicly available.
Biomedical scientists at the institute have begun working on several different projects related to the novel coronavirus, which range from growing and identifying the genetic makeup of the virus to testing a live attenuated (genetically modified) vaccine and antiviral medications on baboons.
From diagnostics to in vitro testing and animal studies to eventual human clinical trials, more than a dozen rounds of testing on the virus and at least two or more rounds of funding are needed before a COVID-19 vaccine or medication is available to the public. This process usually takes more than a year to complete.
A definitive time could not be given before the coronavirus vaccine is ready for human use, but researchers at Texas Biomed said they’re working as quickly as they can.
While other labs have said they want to have a vaccine in clinical trials in the next six months to a year, Luis Martinez-Sobrido, one of the institute’s researchers focusing on creating a Live Attenuated Vaccine (LAV), said that would be extremely fast, adding he’s not sure that can actually be done safely.
Texas Biomed’s researchers are collaborating with about 15 other labs around the world, he said. Texas Biomed scientists videoconference weekly with other researchers around the world to discuss different methods to tackle the rapidly spreading coronavirus, he said.
Researchers at Texas Biomed have been studying older strains of the coronavirus since 2003, which has laid much of the groundwork for the novel coronavirus, added Ricardo Carrion Jr., the program co-lead in disease intervention and prevention for the institute’s Southwest National Primate Research Center.
Three weeks ago, Texas Biomed scientists received an isolate of the SARS-CoV-2, the virus that causes COVID-19 or the novel coronavirus illness, from a Washington State case. The institute’s researchers are beginning to study it following internal approval this past weekend.
“Right now we’re planning to start amplifying it – growing up that virus in our laboratory with the intent of characterizing it, meaning we’ll look to see how many particles there [are], etc.,” Carrion said.
The stock grown in the lab setting will be used for all the institute’s projects, and will take a couple of weeks to make, he added. The virus is being handled in Texas Biomed’s newly renovated 7,500-square-foot Biosafety Level Three laboratory. Biosafety Level Four is the highest biosafety level laboratory and reserved for extreme contagions, such as Ebola, which Texas Biomed also studies.
Scientists are equipped with special suits with respirators, and the lab has enclosed and ventilated biosafety cabinets to ensure the safety of the scientists and containment of the virus.
Following the creation of stock of the virus, the researchers will build in vitro models – real tissue infected with the virus – to study the virus’s makeup. This step is essential to determining what characteristics are needed for the virus to replicate in a human and for it to actually cause disease.
In this phase, researchers will start to test how the virus reacts to antiviral medications, Carrion said, adding that research from San Antonio’s Southwest Research Institute might prove helpful to this step.
Last month, SwRI President Adam Hamilton told the Rivard Report it has a tool that has identified a shortlist of drugs that could potentially slow or prevent the spread of the novel coronavirus.
The screening tool, called Rhodium, recently evaluated the effectiveness of 2 million drugs by analyzing how protein structures in the virus might bind with drug compounds.
Still, the resulting shortlist has about 100 potential drugs on it, Carrion said, each of which still needs testing.
It’s also in this phase that experimentation on the virus’s genome will begin to find out how to modify the live virus to be safe for an LAV, which is Martinez-Sobrido’s focus.
A live attenuated vaccine differs from an inactivated vaccine in that an LAV inserts a living virus into a patient. However, the live virus’s ability to reproduce or cause disease has been genetically removed, rendering it safe. An inactivated vaccine inserts a dead version of the virus into the body. Each results in the body creating specific antibodies in an effort to fight off the wild strain of the virus, Martinez-Sobrido said.
Following the in vitro testing, the researchers will move to animal models, studying the virus’s effects on baboons, Carrion said.
“We can kill the virus all day and all night in a tissue culture flask, but it means nothing until you do it in a relevant system,” he said.
Texas Biomed is the only known research center experimenting on baboons, Carrion said. Other labs are doing similar tests on other primates or animals, but no two labs are approaching their experiments the same way, making the weekly conference calls with other labs vital, he added.
Realistically, Texas Biomed will have the virus ready to go into monkeys in the next two months, Carrion said. Following infection, however, it may take months of studying to find an LAV and medication that works against the novel coronavirus, he said.
“You do the infection, and it’s like a human getting sick,” Carrion said. “You follow it for several weeks, you collect samples during that time. I think we have some imaging capabilities, so we’ll do some imaging to see what the lungs look like during the course of the infection.”
Researchers will use the data to determine whether changes are needed to the current approach, or if they’re ready to move on to the next round of testing, Carrion said.
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Fine-tuned LAVs can be tested on healthy monkeys to see if they remain healthy if exposed to the wild strain of the novel coronavirus, Martinez-Sobrido said. Meanwhile, medications can be tested on the infected monkeys to see how they react to the drugs, Carrion said.
It’s only after LAVs and medications have passed all these tests that researchers will be able to move onto clinical trials, which usually consist of another three or four rounds. Safety is the most important element in these trials, Carrion said. These can take months or even years.
Only once they pass clinical trials do the LAVs or drugs go out for production, which follows a government-regulated request for proposals process that can take just as long.
While vaccines and medications are developed in local labs, they are always manufactured in GMP, or good manufacturing practice, facilities. These use the highest-quality ingredients and sterilization techniques to make products ready for human use, Carrion explained.
“We have research-grade material to use in an animal lab, but the one they use in humans [has] to be at GMP facilities,” he said.
Funding is a whole separate issue, Carrion added. While the National Institutes of Health often help researchers with funding in the early development phase, scientists then usually have to turn to the Biomedical Advanced Research and Development Authority for later funding, or find other means, which can add even more time to the process, he said.
The NIH issued Texas Biomed a $60,000 grant for the baboon model research, and an undisclosed amount for characterizing the virus, Carrion said. Texas Biomed’s other three projects have been funded from part of the institute’s annual $50 million budget, but the nonprofit is still searching for other means to fund these projects.