McALLEN — Inside an office just behind Valley Medical Art Clinic, a construction crew worked to add final touches to a workspace where clinicians, researchers and a select group of community members are joining a global effort to mount a counter-offensive in the fight against the novel coronavirus.
On Monday, researchers at Centex Studies Inc. in McAllen will launch COVID-19 vaccine trials, the only clinic to do so throughout the Rio Grande Valley.
Dr. Joel L. Solis, one of the clinicians overseeing the studies, said that after months of dealing with the coronavirus pandemic, he wants the vaccine trials to offer the public something to look forward to.
“Everyone’s deflated,” he said. “This is a message of hope.”
Centex will be participating in Phase 3 of trials for a drug developed by Moderna for which the clinic will recruit 500 participants.
Solis said their focus is people who are at high risk of developing severe symptoms from the disease, such as people with diabetes and individuals with underlying pulmonary or other chronic conditions.
Black and Hispanic communities are at an increased risk of getting sick and dying from COVID-19, according to the Centers for Disease Control and Prevention.
There are currently 89 sites throughout the U.S. where vaccine trials are being conducted which U.S. Rep. Henry Cuellar said included clinics in McAllen, Laredo and San Antonio.
“They purposely cover a lot of the areas that have high numbers of minority communities,” Cuellar, D-Laredo, said during a news conference call on July 27. “And that’s why the McAllen area, the Valley area, the Laredo area, the San Antonio area are extremely important.”
To discuss diversity within the clinical trials, Cuellar — along with members of the Asian, Black, Hispanic, and Native American Congressional caucuses — met with Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, and Dr. Francis Collins, the director of the National Institutes of Health.
During that meeting, Fauci acknowledged that the virus has more of a damaging effect on people with underlying conditions and particularly those with diabetes.
“We are the capital for diabetes in the country,” Solis said about why the Valley was an optimal location to conduct the studies.
Researchers are also interested in participants who are at high risk of contracting COVID-19 because of their work, such as emergency room doctors, nurses and other ancillary staff.
Healthcare workers — not just those in hospitals but those in nursing homes and clinics — are also a population of interest.
Additionally, they’re interested in law enforcement such as police and also U.S. Border Patrol agents.
“These two types of job descriptions, you’re front-line in different capacities, so that’s kind of who we’re reaching out for,” Solis said.
But people who don’t necessarily fall into those categories are still encouraged to apply.
“The vaccine trials are still looking for participants that might not have these high risk criteria, as all research needs a collective group of different people,” he said.
But of the 500 people they’re recruiting for the Moderna study, all of whom will be compensated, Solis said they want a significant number to be people with those risks.
“Those are the ones getting sick quicker and worse,” he said. “So we want to see how the vaccine protects them as opposed to the healthy, no illnesses, not in that higher risk environment.”
People who definitely cannot participate are individuals who were already infected with COVID-19 or who are pregnant.
Of those who are enrolled in the study, half of them will receive the actual vaccine while the other half will receive a placebo. However, the studies will be double-blind meaning neither the participants nor the researchers will know who gets which.
Each participant will get two doses, the first will be on day 1 of the study and the second will be on day 29.
The goal of the vaccine among the study participants is to develop neutralizing antibodies, Solis said, clarifying that participants will not be injected with a live vaccine which uses a weakened form of the germ that causes the disease.
“So you’re going to have your own internal defense that recognizes COVID,” he said, “so if you come in contact with COVID, your defense might not let COVID come in.”
But if COVID-19 does enter the body, the researcher will measure how long it lasted and how it affected the participant.
They will also want to know how long did someone have immunity — whether the vaccine will wear off in a year or within a matter of months.
Getting to that answer will be a collaborative effort.
About five physicians around the Rio Grande Valley — from Mission, Edinburg and Weslaco — will be cooperating to provide clinical oversight and Centex will also be working with Lee’s Pharmacy.
“I’m here to conduct this research with the collaborative community, clinical community effort, so that we can give all this data to those companies and they can analyze,” Solis said. “But it takes people getting involved. That’s the altruistic behavior I’ve seen.”
He’s even seen it among his own patients who’ve expressed interest in helping out.
“It’s almost like that altruistic behavior is coming to the forefront, knowing that they can contribute to give us some normalcy again in the future,” he said. “We can’t get there if we don’t have volunteers.”
If the data is positive enough, he said, the vaccine may be ready to launch as early as December or as late as February or March.
During the meeting with Dr. Fauci and Dr. Collins, Cuellar questioned the availability of the vaccine to minority communities once it is publicly available.
“Ultimately, we will have a lot of vaccines because we’re doing a number of guaranteed purchase agreements with companies,” Fauci said, “as well as getting assurances from the companies — assurances because the federal government is bankrolling a lot of it — is to make a number of doses even before we know that the vaccine works so that if at the end of the year, the beginning of 2021, we have a safe and effective vaccine.”
Fauci said they will have tens of millions of doses early on and hundreds of millions of doses by the end of 2021.
“They’re not going to arrive on the very first day so we’re going to try to get a prioritization that reflects the need of those who can benefit most,” Fauci said.
Through the Families First Coronavirus Response Act, any future COVID-19 vaccine must be made available to all U.S. consumers at no direct cost.
But there’s still months to go before the general public has to cross that bridge. Until then, researchers at clinics such as Centex Studies must continue carefully recruiting and vetting participants.
“It’s a process and it has to be done correctly,” Solis said, “so that’s up to us, as a team, to make sure my colleagues, our staff, we collect the patients accordingly.”