As pharmaceutical companies and the federal government race to find a coronavirus vaccine, one Austin company is running clinical trials to see if the contenders have what it takes.
Benchmark Research is recruiting volunteers for four coronavirus vaccine trials—and preparing for more than a dozen more in the next few months—across five different cities, including more than 8,300 in Austin alone.
"We're just trying to find the vaccine as quickly as we possibly can," CEO Mark Lacy told Austonia.
But there are some challenges, including the warp speed of these trials and finding enough volunteers to participate.
A speeded-up process
The approval process for a vaccine is typically four to five years, Lacy said. But the coronavirus trials aren't typical.
"This is an extraordinarily speeded-up process," Lacy said.
Benchmark handles vaccine trials in the second and third stages—once they've already been tested on animals and are considered safe for humans. The goal of these later stages is to test for efficacy.
To do this, Benchmark recruits volunteers who meet the necessary criteria. In the case of the coronavirus trials, the company is largely focused on enrolling high-risk populations: essential workers, minority groups, individuals over 65 and those with chronic health conditions.
The government-funded trials are also focused on regions "heavily in surge," Lacy said.
Eligible volunteers will be enrolled in the coronavirus studies, which generally require a one- to two-year commitment, with regular in-person checkups and some other requirements.
One of the vaccines Benchmark is helping to study is from the Boston-based biotech firm Moderna.
The company, in partnership with researchers from the National Institutes of Health, developed a potential vaccine and produced it for human trials in record time—66 days after scientists sequenced the viral genome.
The first trial began in early March, and early results were published on Tuesday. Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Disease, told Bloomberg the Moderna vaccine data is "really quite promising."
The vaccine trial entered its final phase this month, with Benchmark studying whether it prevents symptomatic COVID-19 among volunteers.
At the current dose, the company is on track to deliver around 500 million doses a year by 2021, according to a June 11 press release.
While every stage of vaccine development has been rushed, finding volunteers to test it on takes time.
Over the last 15 years, Benchmark has worked with more than 28,000 trial participants and studied vaccines for everything from anthrax to the Zika virus. But these coronavirus studies have been different.
"It's a bigger challenge than anyone would expect, because while there is a great interest in finding and being able to be one of the first ones with a cure, there's also a tremendous amount of fear," Lacy said.
Volunteers have many reasons to participate, including altruism, but they are also compensated for their time—usually between $1,000 and $1,500.
Money is what drew Katlyn Hahn, a 32-year-old Cedar Park resident, to participate in a Benchmark trial studying an Ebola vaccine in 2015.
Initially, Hahn had some reservations. "But I felt more at ease when they let me know that I wasn't the very first guinea pig," she said.
Once enrolled, Hahn attended appointments every week or two, where a doctor would draw blood and review her diary, where she recorded her vitals and any side effects. Each time, she would walk out with almost $200.
"I would say that I was happy to help because I felt fulfilled that I was doing something to help my fellow man," she said. "And also—I think that I got the placebo."
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Austin's Delta 8 industry has been turned on its head after Texas health officials clarified that the cannabinoid is on the state list of illegal substances, though it was previously believed to be legal by most retailers, consumers and manufacturers.
House Bill 1325, which was signed in June 2019 by Gov. Greg Abbott, and the Farm Bill, signed into law by former President Donald Trump in 2018, legalized any hemp product containing less than .3% THC. The same bills were thought to have made Delta 8 legal, though the Texas Department of State Health Services added a notice on its website saying it was still a controlled substance as of Friday, Oct. 15.
Both the federal and state governments keep separate lists on what is considered a controlled substance. Marijuana is considered Schedule I, a category reserved for substances with "no currently accepted medical use and a high potential for abuse," both statewide and federally.
Austin-based CBD retailer Grassroots Harvest CEO Kemal Whyte, like many CBD shop retailers, was blindsided by the announcement. Many small businesses rely on Delta 8 for their sales—Green Herbal Care CBD said about 90% of its sales come from Delta 8—and Whyte said he is frustrated by the inconsistencies in the drug scheduling system.
Since 87% of Texans support the legalization of marijuana, at least for medical use, per a recent poll, Whyte said he wonders who this legislation is for.
"It's gonna have a massive impact on small businesses—there's just no way around it," Whyte said. "The reality is, we don't want to push out anything bad for our customers, we want this to benefit our customers and to help them. If we can make money while doing it, that's the American dream. What are we doing, whose benefit is this for?"
Delta 8 surged in popularity after the perceived legalization—consumers enjoyed its lower psychotropic potency, decreased anxiety while using it and the peace of mind as a legal way to get high. So in order to protect their products and livelihoods, both Grassroots Harvest and Austin-based manufacturer Hometown Heroes are taking legal action.
Whyte said Grassroots Harvest is suing DSHS, saying their action is creating negative effects in the market. Meanwhile, a Hometown Heroes spokesperson said the company is in the process of filing a temporary restraining order that would pause the ban on Delta-8 in the state of Texas.
Threats against Delta 8 are not new—DSHS lost a lawsuit trying to make "smokable hemp products" illegal last year and Texas lawmakers had been considering a bill that would make Delta 8 illegal, though it was dropped after the clarification was made.
Hometown Heroes released a formal statement in response to the DSHS rule.
"I need to be clear—we love Texas, we're just choosing to fight for the will of the people in regards to cannabis in Texas," Hometown Hero CEO Lukas Gilkey said in a statement. "(Texas DSHS) are using backhanded ways to create legislation and go against the will of the people."
Whyte laments the fact that it would be easier legally to "open up a strip club that also sells guns," and said he can't post customer testimonials that mention the benefits of Delta 8 without getting hit with a cease and desist from the Food and Drug Administration. Whyte said he isn't opposed to regulation—far from it—he just wants to see it go through the correct channels.
"The fact that they're stunting our ability to communicate with our clients that want to learn about this, you're preventing us from communicating with them and teaching them, or spreading information that we know," Whyte said. "I think that that in and of itself opens up a lot of questions."
Grassroots Harvest still has Delta 8 products on its shelves for the time being but for how long, Whyte doesn't know.
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Austin Public Health and other clinics around Austin are now providing booster shots for all three vaccines, including Pfizer, Moderna and Johnson & Johnson, to fully vaccinated individuals after both Pfizer and J & J were approved by the CDC on Wednesday.
APH and Austin clinics, which were already administering the approved Pfizer booster, will begin distributing shots as soon as Friday.
Those who received the second dose of the Pfizer and Moderna vaccine more than six months ago are elligble to receive a booster if they are over 65 or if they are over 18 and:
- Live in a long-term care environment
- Have underlying medical conditions
- Work or live in high-risk settings, such as schools, hospitals or correctional facilities
Austin-Travis County Health Authority Dr. Desmar Walkes said in a media Q&A Friday that APH is encouraging boosters just as much as they have urged residents to get their first and second doses.
"Boosters are incredibly important to keeping our community protected and hospitalizations low," Walkes said. "If we can stay on top of our vaccinations, we provide protections for our most vulnerable and make it that much harder for COVID to spread in our community."
Eligible residents are free to choose the same booster as their first doses or "mix and match," per the CDC announcement.
Those looking for another dose can simply bring their vaccination card to APH centers or the dozens of Walgreens and CVS locations in the metro, which began administering doses Friday.
Additional updated guidance from the CDC allows for all eligible individuals to choose which vaccine they receive as a "mix-and-match" booster dose. It is advised to remember to bring your CDC COVID-19 Vaccination Card showing the original doses with you when going for booster shots.
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