Potential New Vaccine Blocks Fentanyl’s Deadly Effects, Say Researchers

Fentanyl users work off their drug-high on the sidewalks of the Tenderloin District in San Francisco, Calif., on May 16, 2024. John Fredricks/The Epoch Times

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.

In comparison, the number of U.S. troops who died during the entire 20-year Vietnam war was 58,220, according to the National Archives.

To help address the opioid crisis, doctors such as Dr. Colin Haile of the University of Houston’s Drug Discovery Institute are hoping to block fentanyl’s ability to enter the brain, eliminating the drug’s euphoric effect, or “high.”

Early results suggest that their method, a vaccine, not only accomplishes that goal but also eliminates fentanyl’s lethality in the vaccinated. Those potentially targeted for the vaccine include those in rehabilitation clinics, as well as first responders and teenagers, who are at risk of accidental exposure.

“About seven years ago, it became very clear that fentanyl was becoming a huge problem,” Haile told The Epoch Times.

At the time, he and his colleague Dr. Thomas Kosten were researching new vaccines for cocaine and methamphetamines but switched to studying fentanyl once they noticed the shifts in the drug market.

Their research led to the published study, “An Immunoconjugate Vaccine Alters Distribution and Reduces the Antinociceptive, Behavioral and Physiological Effects of Fentanyl in Male and Female Rats,” in October 2022, which detailed the effects of their fentanyl vaccine in rats.

Haile was the study’s lead author.

Thanks to positive results and a lack of adverse side effects in the immunized rats, human clinical trials are projected to start in early 2025.

Therese Kosten, the director of the Developmental, Cognitive & Behavioral Neuroscience program at the University of Houston and one of the study’s co-authors, called the potential new vaccine a “game changer.”

Fentanyl is 50 times stronger than heroin and 100 times stronger than morphine. As a result, just two milligrams of fentanyl—the equivalent of 10 to 15 grains of table salt—is deadly, Texas Health and Human Services states.

“The shift from plant-based drugs, like heroin and cocaine, to synthetic, chemical-based drugs, like fentanyl and methamphetamine, has resulted in the most dangerous and deadly drug crisis the United States has ever faced,” said Anne Milgram, the Drug Enforcement Administration (DEA) Administrator in a press release in May.

In its 2024 National Drug Threat Assessment, the DEA stated that the Sinaloa and Jalisco Mexican Cartels, working with companies in China, are at the “heart of the crisis” and that they’re reaping “huge profits” from the sale of these illicit drugs that prey on both unsuspecting Americans and those struggling with addiction.

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

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 difficult to recover from.

Some studies put relapse rates as high as 91 percent, according to American Addiction Centers.

“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.”

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.

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

“And then eventually, the individual develops what’s called hypoxemia—lack of oxygen in the blood—and then, unfortunately, they succumb.”

If an individual is vaccinated, however, researchers say fentanyl won’t enter the brain and would instead be eliminated from the body via the kidneys, avoiding that deadly response.

In Development

The fentanyl vaccine, currently under development at the University of Houston, is one of four vaccines making its way to market.

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 antibody production. 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

“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.

According to Haile, the next step is for his team to start phase one clinical trials in conjunction with the company Ovax. These trials will test the vaccine’s safety in a small group of 30 to 50 people.

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.

“The phase three result will be vital to obtaining approval from the [Food and Drug Administration] and to bring the vaccine to market,” Haile said.

Police, Youth At Risk

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

“And these are fake medications, and many of them contain deadly levels of fentanyl.”

Matthews Voice, a nonprofit organization dedicated to raising awareness on illicit fentanyl, was started by Wendy Thomas after her son, Matthew, died of accidental overdose.

“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.”

Her website cites a DEA report that found that six out of every ten fentanyl-laced fake prescription pills checked in 2022 contained a potentially lethal dose of 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

According to the CDC, in 2022, there were 57,308 overdose deaths among 15 to 44-year-olds, making it one of the leading causes of injury deaths.

“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.”

Haile caveated his statement by saying that he primarily sees this as a vaccine for adults and young adults, and that while there is a need to protect younger children, the vaccine must undergo additional testing before it can be given to a younger demographic.

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.

“There are always going to be some percentage ... of people who will have a side effect, some of them minor, some could be major,” said an anonymous 64-year-old female, who identified as a clinician with Addiction Medicine Expertise.

“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

“I don’t really believe in [vaccination] that much. Like, I always worry that I’m always going to get, like, more sick when I get ... the vaccine,” said an anonymous 24-year-old who identified as having a personal history with Opioid Use Disorder. “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.