Opioid deaths started trending down in 2023, but fentanyl remains a complicating factor since small amounts of the drug can have serious—and even fatal—effects, and the drug is difficult to detect without specific tests. Dealers often cut fentanyl into other drugs, leading to overdoses even among people who use stimulants and making the opioid’s use even more pervasive.
Fortunately, Suboxone® (important safety information) and naloxone have been saving lives during this crisis, and scientists are continuing to look for new solutions. Over the last several years, research groups have been developing anti-fentanyl vaccines, which are now entering clinical trials. This is what we know so far about the potential new way of treating opioid user disorders (OUD).
How would a fentanyl vaccine work?
The mechanics
A fentanyl vaccine would act like any other vaccine: It would teach the body’s immune system to identify a foreign substance or toxin as a danger and produce antibodies to fight it off. Think of an opioid as an intruder and the antibodies as a barrier. If a person with the vaccine takes or is unknowingly given an opioid, they would already have antibodies to prevent the opioid from crossing the blood-brain barrier. Since the opioid can’t reach the brain, there would be no “high” effect, no decreased respiratory rate, and no overdose.
The goal
A vaccine for fentanyl is designed to complement and support ongoing OUD treatments. The vaccine would work alongside medications like Suboxone that manage withdrawal and cravings and wouldn’t interfere with naloxone, which is an overdose rescue drug. A fentanyl vaccine could create antibodies that look for fentanyl specifically, creating an extra layer of protection while also allowing the body’s natural pain management system and medications to work normally.
When combined with existing medications, the fentanyl vaccine could provide more comprehensive treatment, making recovery easier and reducing the risk of relapse.
What progress has been made in fentanyl vaccine trials?
Early trials
Mice were among the first living subjects for the fentanyl vaccine since they are genetically and biologically similar to humans. In fact, they are susceptible to most of the same diseases that we are, including chemical dependence. They have very similar brain reward pathways, allowing researchers to chart the impact of addiction and the results of treatment.
The University of Houston has been developing a vaccine for fentanyl for more than five years and ran trials on mice and rats in 2022. After solving reagent and component clumping issues, the number of anti-fentanyl antibodies grew significantly in subjects. During these trials, they found that the vaccine fully blocked fentanyl’s effects for five to six months.
Current status
It should be noted that there are multiple teams working on fentanyl vaccines, and they are in different stages of development. For example, the University of Minnesota Medical School began human trials for its vaccine in 2021, and the University of Montana has been conducting trials on heroin and fentanyl vaccines with the goal of creating a combined vaccine in the future.
Currently, several medical centers are running human trials. In Minnesota and Houston, the volunteers are opioid users and aren’t taking any medications to combat their OUD. The control group will be given placebos, while the experimental group will be given a low or high dose of the active vaccine. As a result, researchers can determine the efficacy and safety of the fentanyl vaccine and if it produces enough antibodies to prevent the oxycodone “high.”
These studies are still in progress, so the conclusions are not yet known. But one thing is clear: Research is moving forward in a meaningful way now that human trials are underway.
Looking ahead
Researchers are hoping to move along to the further phases of clinical testing and refining the fentanyl vaccine so it’s effective for one to two years rather than the five to six months seen during animal testing. The one-to-two-year threshold is something of a sweet spot for researchers. That way, a patient can gain pain relief if fentanyl is needed during a legitimate medical emergency down the line.
If a vaccine for fentanyl is approved, it will likely be administered via injection, though another option may be possible. The vaccine being developed by the University of Houston is sublingual, or administered under the tongue the way Suboxone is most often taken. That would make treatments more convenient for patients. Theoretically, they would be able to get a prescription for the sublingual vaccine and take their treatment at home. Not only would this make the process more comfortable, but it would also be less disruptive to their routine.
As exciting as these developments are, it’s important to be patient. Even the fentanyl vaccines that are furthest along in testing are likely still a few years away from a potential green light from the Food and Drug Administration (FDA). It can take at least 10 years to develop and fully assess a vaccine for safety and immune response, and that doesn’t include the time it takes to obtain regulatory approval and manufacture enough for widespread distribution.
Why is education on fentanyl vaccines so important?
Perception of addiction
Addiction is an illness that has environmental, biological, and genetic causes. It rewires neural circuits concerning pleasure and self-control, making it difficult to kick the habit even though most users want to.
Unfortunately, there is still a prominent belief that addiction is a moral failing that could be treated with greater willpower. This belief stigmatizes users, who then choose to hide their addiction. They may also hide their attempts at starting a recovery journey or abstaining from use, leading to incomplete treatment that doesn’t address the root causes of addiction, like underlying trauma or mental health issues. Stress and a lack of social support can then become triggers for OUD relapse.
The perception of moral failure has bled into the discussion around developing a vaccine for fentanyl. Many individuals who feel that addiction is a personal shortcoming also believe that a fentanyl vaccine would be seen as an acceptance of illicit drug use. Providing detailed information and opioid addiction resources can change attitudes on the vaccine, OUD, and addiction itself.
Perception of vaccines
Admittedly, a vaccine for fentanyl does sound strange. When people think of vaccines, they think of infectious diseases rather than behavioral or cognitive health disorders. There is also the perception of “new vaccines” to contend with. During COVID-19, researchers conducted a study gauging public opinion on a potential fentanyl vaccine. There was a fair amount of acceptance, but many people were concerned that the vaccine would be rolled out too quickly without properly ensuring safety or understanding the long-term effects it might have. These combined issues can make a fentanyl vaccine difficult for many people to embrace.
While it may take time to adjust to the idea of vaccines being used to treat addiction, the treatment itself is not being rolled out quickly. The adjuvant in the University of Houston’s vaccine has been used in many vaccines since the early 2000s, establishing one of its major components as safe for use. Meanwhile, the earliest research into a fentanyl vaccine began between 2015 and 2016, which aligns with the average timeline for the development of safe vaccines. Sharing this information can help correct the record about fentanyl vaccines as they reach the next phases of development.
Reality of fentanyl
Illicit fentanyl itself likely isn’t going anywhere due to its widespread availability and the fact it can be easily consumed by accident. Fentanyl’s prevalence has forced people and institutions to make changes. For instance, in 2022, The Los Angeles Unified School District made Narcan available in all K-12 schools to reverse possible overdoses. That same year, the NYC Hospitality Alliance launched the Nightlife Opioid Agonist Program, which put Narcan rescue kits in bars, restaurants, and clubs.
These community harm reduction efforts reflect the urgency of the situation. Developing a vaccine for fentanyl is also a response to this crisis. If approved, it can be a significant preventative measure and save many lives in the process.
Better research for better patient outcomes
Opioid treatment has come a long way in a few short years, thanks to the emergence of telehealth as an effective, accessible way to connect patients and clinicians. Ophelia goes a step further by sharing our team members’ research to help inform other healthcare providers, as well as current and future patients and the people who care about them.
As researchers across the country work toward the future of OUD treatment, Ophelia is here to help patients access Suboxone and comprehensive care that fits into their daily lives. Find out how we eliminate barriers to care and provide patients with the support they need to leave opioids in the past.
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