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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Scientists with a new research center at the University of Washington are working on a vaccine to help fight the opioid epidemic in a bid to stem the tide of overdose deaths that has swept the nation over the past two decades. 

Marco Pravetoni, the head of the new UW Medicine Center for Medication Development for Substance Use Disorders, is leading the effort to develop the vaccine. Similar to immunization against an invading pathogen, the vaccine under development would stimulate the body’s immune system to attack and destroy opioid molecules before they can enter the brain. 

Such a vaccine would not prevent drug cravings commonly experienced by those with opioid abuse disorder. But the treatment, if successful, would block the effects of opioids including euphoria, pain relief and even overdose, thus likely reducing abuse.

The new research center opened this month and has raised more than $2 million in initial funding. Pravetoni hopes to raise enough money to complete further research on the vaccine under development.

“What I’m hoping to achieve is pretty much every year, we’re going to start a new clinical trial,” Pravetoni told the Seattle Times in early January.

An Epidemic of Opioid Overdoses

In November, provisional data from the U.S. Centers for Disease Control and Prevention showed that during the 12-month period ending April 2021, 100,306 Americans died of drug overdoses. Synthetic opioids were involved in nearly two-thirds of the overdose deaths reported.

The overdose-reversal drug naloxone has been shown to save lives in emergencies. Additionally, treatments for opioid abuse disorder including methadone and buprenorphine can help those struggling with addiction, although opioid replacement therapy drugs have their own risk of addiction. New treatments could increase the chances of success for those struggling with opioid abuse, according to Rebecca Baker, director of the National Institutes of Health’s Helping to End Addiction Long-term Initiative, a program that has helped fund Pravetoni’s research.

“(Existing medications) don’t work for everyone. And a lot of people don’t stay on them in the long term,” Baker said. “Would the outcomes be better if we had more options?”

The University of Washington’s opioid vaccine project is building on research published in the journal Nature in 1974. In that study, a rhesus monkey had been trained to self-administer heroin and cocaine. After being given an experimental vaccine to block the effects of heroin, the monkey continued to use cocaine but greatly reduced its use of heroin, suggesting the vaccine had done its job.

That study led to further research into the possibility of creating a vaccine for nicotine addiction. Although early results appeared promising, human trials showed the treatment was only as effective as a placebo. A vaccine developed to fight cocaine addiction saw a similar fate, and neither treatment received approval from the Food and Drug Administration.

Kim Janda, a chemistry and immunology professor at Scripps Research Institute in California, has spent decades researching vaccines against addictive drugs. He believes that continued research could eventually produce an effective vaccine.

“We’ve learned a lot more [about] what is possible, what’s maybe not going to be as fruitful,” Janda said, adding that vaccines may not work against all drugs of abuse. “But if there’s enough money to put behind these vaccines, and you had the infrastructure to do it, then you could move it along fairly quickly.”

This year, Pravetoni and a researcher with Columbia University have launched the first Phase 1 clinical trial of a vaccine to prevent opioid abuse. The safety and efficacy of the vaccine, which is designed to block the effects of oxycodone, is being tested in people who are already addicted but not receiving the disease.

Is an Opioid Vaccine Worth the Cost?

But human drug trials are expensive. Pravetoni estimates that bringing an effective opioid vaccine to market could cost up to $300 million. Some addiction experts, including Dr. Ryan Marino, an emergency medicine physician and medical toxicologist at Case Western Reserve University in Ohio, wonder if the money could be better spent.

“It is true that more treatment options are generally better,” Marino told Filter. “But what doesn’t make sense to me—as someone who treats both overdose and addiction—is putting so much funding towards this when we already have an antidote for opioids, a long-acting opioid blocker and two other evidence-based treatment options for opioid use disorder that both reduce opioid use and prevent overdose.”

Harm reduction activists working on the ground with people who have substance abuse disorders say that limited funds could be spent more effectively. Jessica Blanchard, the founder of Georgia a mobile harm reduction program called 229 Safer Living Access, distributes safer sex supplies and naloxone provided by other groups. But she personally covers the other costs to administer the program, which limits its operations substantially.

“With funding, not only could I afford to buy in bulk, greatly reducing cost, but I could also give participants more supplies to share with those unable to make contact with the program,” Blanchard said. “I would pay program participants to do secondary distribution. (They) are the experts here. They express a desire to participate in distributing supplies and educating their peers. But without the ability to compensate them for their time and lived-experiential knowledge, I simply can not ask them to help.”

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Is it OK to use CBD or THC pre or post-vaccine for COVID?

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