More than 81,000 people died in 2023 due to synthetic opioid overdose, according to provisional data from the U.S. Centers for Disease Control and Prevention.
Almost 75,000 of those deaths were due to illicit fentanyl, a synthetic opioid.
Early results suggest that their method, a vaccine, not only accomplishes that goal but also eliminates fentanyl’s lethality in the vaccinated.
“About seven years ago, it became very clear that fentanyl was becoming a huge problem,” Haile told The Epoch Times.
Haile was the study’s lead author.
Thanks to the positive results and lack of adverse side effects in the immunized rats, human clinical trials are projected to start in early 2025.
“[A fentanyl vaccine] will eventually be available to help, and it'll save lives,” Haile said. “There’s hope.”
![U.S. Immigration and Customs Enforcement Enforcement and Removal Operations (ERO) officers apprehended 216 illegal immigrants convicted of drug offenses in March 2024. (Todd Packard/ICE)](/_next/image?url=https%3A%2F%2Fimg.theepochtimes.com%2Fassets%2Fuploads%2F2024%2F03%2F29%2Fid5617781-ICE-arrest-1200x800.jpg&w=1200&q=75)
Moreover, because of how opioids like fentanyl affect the brain—they activate the mesolimbic system (a reward and conditioned association), which releases dopamine, triggering pleasurable feelings—such drugs have been found to be incredibly addictive and difficult to recover from.
“We have indicated medications for Opioid Use Disorder, and we have rescue agents for overdose, but they’re not working for us,” Haile said.
“We need a different treatment strategy, and this vaccine technology is a different strategy completely.
“Typically, you have individuals that enter into a detox facility, get clean, and then are put on a maintenance therapy such as methadone, naltrexone, or buprenorphine—most likely buprenorphine—and then they’re eventually let out of the facility, and your prototypical scenario is they stop taking their medication.”
Haile said that once that happens, the individual who’s become “non-compliant” with their medication often seeks out illicit fentanyl and takes the same dose they took before going through detox.
The result is usually an overdose.
“Now, if individuals were to detox, and they were put on maintenance therapy and vaccinated, and become non-compliant on their medication, it doesn’t matter. Because they have anti-fentanyl antibodies.
![Photos of fentanyl victims are displayed at The Faces of Fentanyl Memorial at the U.S. Drug Enforcement Administration headquarters in Arlington, Va., on Sept. 27, 2022. (Alex Wong/Getty Images)](/_next/image?url=https%3A%2F%2Fimg.theepochtimes.com%2Fassets%2Fuploads%2F2024%2F07%2F19%2Fid5690179-Chiaa-Fetanyl-6-1200x800.jpg&w=1200&q=75)
“When they ingest fentanyl, those antibodies bind to the fentanyl and prevent it from getting into the brain. And ... prevent the euphoric effects and the deadly effects of fentanyl.
“In theory, that gives the individual a chance to get back on the wagon to sobriety.”
Explaining how the vaccine addresses fentanyl’s deadly effects, Haile said: “Fentanyl inhibits, at higher levels, the circuits involved in breathing, the inspiratory neurons in the base of the brain.
“There’s also a syndrome called wooden chest syndrome, and it causes intercostal rigidity, and you can’t move your chest, so you can’t move your diaphragm, so you can’t get oxygen into your blood.
“And then eventually, the individual develops what’s called hypoxemia—lack of oxygen in the blood—and then, unfortunately, they succumb.”
Full of Promise
The fentanyl vaccine, currently under development at the University of Houston, is one of four vaccines making its way to market.But Haile said his vaccine is the furthest one along.
Additionally, because his vaccine relies on previously developed ingredients, Haile believes it has a good chance of passing clinical trials.
“Part of our vaccine is already in multiple vaccines on the market, and it’s called the carrier protein, CRM197.
“The other part of the vaccine is an adjuvant that increases antibiotic reduction. It’s called dmLT and was originally developed at Tulane University by Dr. Elizabeth Norton.
“It’s been in 15 human clinical trials and will probably be on the market very soon, in combination with another vaccine,” Haile said.
“And then the other part of our vaccine is basically the backbone of the fentanyl molecule itself, and that’s linked to the carrier protein. And so that’s what we want antibodies to be generated against; is that fentanyl backbone and that part of the vaccine is called a Hapten.”
Haile explained that in his study, rats received an initial vaccination and boosters at three and six weeks. Human vaccination would likely follow a similar trajectory of three vaccines.
![A health worker prepares a vaccine in Finland in a file image. (Emmi Korhonen/Lehtikuva/AFP via Getty Images)](/_next/image?url=https%3A%2F%2Fimg.theepochtimes.com%2Fassets%2Fuploads%2F2024%2F06%2F25%2Fid5675079-finland-vaccine-1200x800.jpg&w=1200&q=75)
“In the study, we gave a high dose of fentanyl to the unvaccinated and vaccinated rats, and then took blood samples in the brains, and we assessed simple levels in both.
“And what we show in the manuscript is that we prevent 90 plus percent of fentanyl from getting into the brain in both male and female rats. And again, that’s the primary mechanism of action of how the vaccine works,” he said.
If phase one goes well, the next step is phase two, which also tests safety but across a much wider scale of hundreds of people.
Phase three would follow, and that, according to Haile, involves efficacy.
Demand for Protection
If the vaccine passes all three phases, Haile said he sees the primary treatment group as those in rehabilitation clinics and two secondary treatment populations: first responders and teenagers.Haile explained that despite popular belief, fentanyl doesn’t absorb through the skin unless it is manufactured in a way that allows it to cross the skin. However, accidental exposure can still occur.
“We had a couple of police officers in Dallas who were investigating a crime scene, and they had gloves on, but it was a hot day, and both of them wiped their faces. And essentially, the fentanyl got into their system when they wiped their faces. It’s rare, but that is a possibility,” he said.
“Now the other interesting population is, I’ve been contacted by numerous parents that are absolutely terrified of their kids being poisoned by fentanyl because they know that they’re either experimenting with drugs in college, for example, or they’re buying drugs off the Darknet, such as ADHD medications, anti-anxiety medications, or analgesics such as oxycodone.
![April and Austen Babcock a day before Austen died of fentanyl poisoning (Courtesy of April Babcock)](/_next/image?url=https%3A%2F%2Fimg.theepochtimes.com%2Fassets%2Fuploads%2F2024%2F08%2F17%2Fid5707522-Austen-a-day-before-he-died-1200x1554.jpg&w=1200&q=75)
“And these are fake medications, and many of them contain deadly levels of fentanyl.”
“Matthew died of fentanyl poisoning in 2020, in July. He was 20 years old,” Thomas told The Epoch Times.
“He took what was supposed to be Percocet, and it was fentanyl.”
Young people must be made aware of the danger, she concluded.
“I decided to go ahead and focus on high schools. I’ve been to several high schools in North Carolina, and the biggest thing that surprises me is that most of them have not even heard of illicit fentanyl,” she said.
“I thought maybe if Matthew had heard about it sooner ...” she said before trailing off.
![Attendees of "The Lost Voice of Fentanyl" rally march in Washington on July 13, 2024. (Joseph Lord/The Epoch Times)](/_next/image?url=https%3A%2F%2Fimg.theepochtimes.com%2Fassets%2Fuploads%2F2024%2F07%2F14%2Fid5685978-IMG_4950-1200x900.jpg&w=1200&q=75)
“Fentanyl has been found in cocaine. It’s been found in methamphetamine. It’s been found in heroin. It’s even been found in marijuana, believe it or not, which is crazy,” Haile said.
“What we’re trying to do is save lives. And so, if it can save lives, I’m all for it.”
Community Reactions
In July, Dr. Elissa Weitzman, the director of research for Boston Children’s Division of Addiction Medicine, led a study with 74 volunteers, who were asked to give their views on a possible fentanyl vaccine.And while many of the volunteers expressed enthusiasm for the vaccine, especially parents who'd lost children due to overdose, some volunteers voiced concern.
“For example, thimerosal is a fairly commonly [added substance in vaccines], now people are understanding that asking for a thimerosal-free vaccine might make the difference between them accepting a vaccine or not.
“There are many different side effects that vaccines can have.”
![Mock sizing of a potentially lethal dose of fentanyl, on April 1, 2022. (John Fredricks/The Epoch Times)](/_next/image?url=https%3A%2F%2Fimg.theepochtimes.com%2Fassets%2Fuploads%2F2023%2F07%2F11%2Fid5387723-Fentanyl_Mock-Up_JF_04-1200x754.jpg&w=1200&q=75)
“And then there’s ... a bunch of conspiracy theories that I don’t completely buy into, but I’m ... a little iffy about [vaccines].”
In 2022, Weitzman conducted a similar study with 64 volunteers that revealed generally positive attitudes towards a fentanyl vaccine, with some expressing concern.
In both studies, Weitzman concluded that effective communication would be crucial for the acceptance of a fentanyl vaccine.