Fentanyl Vaccine Called ‘Game-Changer’

A clinical-grade vaccine could be available in the coming months with clinical trials on humans soon.
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Could a fentanyl vaccine potentially save thousands of lives? A recent animal study published in the journal Pharmaceutics indicates that a fentanyl vaccine was able to block the drug from entering the brain of rats—thus making it a worthy candidate for human studies and eventually something available to the public that can save lives.

Researchers administered rats with three doses of the vaccine or immunization at three-week intervals, and another group of rats received a placebo. To determine if the drug was working, they tested the immunized rats’ pain responses by heating up their tails for up to 10 seconds and seeing how long they took to pull away.

The vaccination significantly reduced entry of fentanyl into the brain and anti-fentanyl antibodies targeted fentanyl with no cross-reactions to other opioids. 

“We believe these findings could have a significant impact on a very serious problem plaguing society for years—opioid misuse,” study lead author Colin Haile told University of Houston (UH) news. “Our vaccine is able to generate anti-fentanyl antibodies that bind to the consumed fentanyl and prevent it from entering the brain, allowing it to be eliminated out of the body via the kidneys. Thus, the individual will not feel the euphoric effects and can ‘get back on the wagon’ to sobriety.” 

Haile is a research associate professor of psychology at UH and the Texas Institute for Measurement, Evaluation and Statistics (TIMES), and a founding member of the UH Drug Discovery Institute.  

“The anti-fentanyl antibodies were specific to fentanyl and a fentanyl derivative and did not cross-react with other opioids, such as morphine. That means a vaccinated person would still be able to be treated for pain relief with other opioids,” said Haile. 

Meanwhile, over 150 people die every day of overdose from synthetic opioids including fentanyl, which is 50 times stronger than heroin and 100 times stronger than morphine. Just 2 milligrams of fentanyl, or the size of two grains of rice, can be fatal depending on the size of the person.  

“These preclinical results demonstrate efficacy in neutralizing [fentanyl]’s effects and warrant further development as a potential therapeutic for OUD and overdose in humans,” researchers wrote in the study. “We expect minimal side effects in clinical trials because the two components of our formulation (CRM and dmLT) are already in other vaccines on the market or have been tested in multiple human clinical trials and shown to be safe and effective. Further, the effective dose of dmLT used in human clinical trials is comparable to the dose used in the present study. Since low vaccine concentrations elicit adequate anti-[fentanyl] antibody levels, we expect there to be no adverse events when this vaccine is tested in humans.”

The vaccine did not lead to any adverse side effects in the immunized rats that were observed. 

Researchers plan to begin manufacturing a clinical-grade vaccine in the coming months with clinical trials on humans planned soon.  

Efforts are being made to abate the deadly toll fentanyl plays on America. The U.S. Drug Enforcement Administration (DEA) announced the results of a widespread drug operation last September, with data spanning May to September, resulting in over 10 million fentanyl pills and what they say is 36 million lethal doses of the drug.

The DEA says that fentanyl is the deadliest drug threat facing this nation. “In 2021, a record number of Americans—107,622—died from a drug poisoning or overdose,” the DEA release reads. “Sixty-six percent of those deaths can be attributed to synthetic opioids such as fentanyl.”

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