Four and a half years ago, we published an article on this blog called “Addiction Vaccines: Fact or Fiction?,” in which we discussed the potential of creating a vaccine for opioids like heroin, fentanyl, and other opioid-based drugs.
It’s time to revisit that topic, because what looked merely speculative close to five years ago now looks quite possible. Based on new evidence published this year, a vaccine for heroin, fentanyl, and other opioids may be closer to fact than fiction.
An addiction vaccine could be a very good thing.
Why?
Let’s take a look at the benefits of an effective vaccine.
The Centers for Disease Control (CDC) published the following data on death rates for various diseases before and after the production of vaccines for those diseases. Given the breadth and variability of the sources for this data, it’s not perfect, but these are the best estimates possible, given the information that had access to at the time.
Benefits of Vaccines: Reduction in Yearly Fatalities
- Smallpox:
- Before vaccine: 48,164
- After vaccine: 0
- Diphtheria:
- Before vaccine: 175,000+
- After vaccine: 1
- Pertussis (Whooping Cough)
- Before vaccine: 147,000
- After vaccine: 6,279
- Tetanus:
- Before vaccine: 1,314
- After vaccine: 34
- Polio:
- Before vaccine: 16,316
- After vaccine: 0
- Measles:
- Before vaccine: 503,202
- After vaccine: 89
In the year 2000, health officials in the U.S. determined measles was eradicated in the country. Unfortunately, though, there were several small outbreaks of measles in the U.S. Health officials attribute this to the refusal of some families to give the measles vaccine to their children. To drive the point home about the value of vaccines, let’s look at the impact of a more recent vaccine: the COIVD-19 vaccine. We retrieved this data from the CDC COVID Data Tracker:
- COVID-19 deaths, Week of January 9th, 2021, one month after vaccine approval, before widespread uptake: 25,845
- COVID-19 deaths, Week of September 23rd, 2023: 1,254
These numbers don’t lie: vaccines work. They worked in the 20th century when we eradicated diseases that had been killing children and adults for millennia, and they worked in 2021, when we faced a worldwide pandemic with a death toll in the millions.
How Do Vaccines Work?
To understand how a vaccine works, it’s important to understand they work because they use something that already exists in our body, and is very effective: our immune system. Here’s a quick rundown on how our immune system works:
- A pathogen (disease-causing virus bacteria, or other molecule) enters our body.
- Special cells in our body – our immune cells – recognize this pathogen as dangerous. In immunology, the dangerous invader is called an antigen.
- In some cases, immune cells destroy the invading cell immediately, but some replicate too quickly to prevent disease.
- In other cases, the immune system creates what we call antibodies, which are small proteins that recognize and attach to the known antigen, which marks it for destruction by other immune cells.
- For a new invader, the body takes time to create antibodies that recognize the antigen. Vaccines help us skip this step. They prepare the body to counter disease by introducing a harmless version of the antigen, which stimulates the formation of antibodies specific to that antigen. Then, when the antigen appears in the body, the immune system is ready: antibodies tag the invader, and immune cells sequester/eliminate/destroy the pathogen, or simply cause the body remove the pathogen via the lymphatic system.
When we have plenty of antibodies specific to an antigen, we say we have immunity to that antigen, or that we’re immunized. Immunization is not perfect, and it’s rare for a vaccine to completely prevent infection one hundred percent of the time. However, the data above shows that with regards to reducing disease-related fatalities, vaccines are one of the greatest accomplishments in the history of medical science.
That’s no exaggeration. Look at the numbers above, and consider the lives saved with vaccines: that’s why scientists are eager to create an addiction vaccine.
Can An Addiction Vaccine for Heroin and Fentanyl Work?
Theoretically, yes.
In the article we published back in 2019, we identified three primary hurdles to overcome in order to create and implement an addiction vaccine for any drug, including heroin or fentanyl: human, scientific and financial. We’ll talk about these hurdles, starting with the human component.
Addiction Vaccines: Challenges to Overcome
Challenge 1: People
The human component of the challenge involves choice. A vaccine can only work when a person wants to prevent or recover from addiction. Second, the human component involves stigma. Many people still believe that addiction is a moral failing or character flaw, and don’t understand the medical model of addiction, which defines addiction as a medical disease that responds well to evidence-based treatment.
In 2023, things have changed. The overdose death rate has increased every year, and millions of people now realize that in order to prevent further harm from addiction and opioid overdose fatalities, we need to move past stigma, and embrace any and all evidence-based prevention and treatment strategies. That includes accepting the medical model of addiction, and understanding that medical problems require medical solutions – like a vaccine.
Challenge Two: Science
The scientific challenges are significant. First, with regards to addiction in general, we’d need antibodies to every molecule that has the potential for addiction. From opiates to marijuana to alcohol to cocaine, scientists would have to create antibodies that recognize each of these antigens. That’s why the current research is narrow, with scientists focusing on creating vaccines for the drugs that present the most imminent danger of fatality, which are heroin and fentanyl.
Another scientific challenge is that opioids like fentanyl are an important part of relieving/preventing severe pain during surgeries. With regards to a vaccine for fentanyl, doctors expressed concern about what type of pain relievers to use during surgeries on people with fentanyl antibodies.
In 2023, we’ve come a long way. Initial studies on laboratory animals showed we can create antibodies specific to heroin and fentanyl that completely prevent those molecules from acting on the central nervous system. This is a big step forward. We’ll discuss the problem of pain relief during surgery below. For now, it’s important to understand that we’ve cleared the first part of this hurdle – creating successful antibodies in animals.
Challenge Three: Funding
In 2017, we prioritized funding in this order: reduce demand through prescription monitoring and education, disrupt the supply of illicit drugs through enhanced law enforcement funding/international coordination, and increase access to evidence-based treatment for people with addiction, specifically opioid use disorder (OUD).
One thing missing from this plan was allocating significant resources toward two things: harm reduction and research into new treatment approaches. In 2022 – when we realized the plan we created in 2017 needed revising – we took a new approach. Now our funding priorities are flipped: our first priority is funding for treatment, prevention, and harm reduction, our second priority is increasing access to evidence-based treatment, and our third – but clearly still important – priority is stopping the flow of illicit drugs through enhanced law enforcement funding.
In 2023, what this means is that the initial research into vaccines for heroin and fentanyl is now completely funded by the Helping to End Addiction Long-Term Initiative (HEAL). The HEAL Initiative sponsors projects in all 50 states, with 2.5 billion dollars of funding allocated for over 1,000 individual research projects and over 40 large scale research programs – including funding for vaccine studies, which we’ll discuss below.
Our point here is that, for all practical purposes, we’ve met and overcome these challenges. The challenge of stigma still exists, but we’ve done a good enough job educating people about addiction and treatment that most people now agree: it’s time to move forward, accept the medical model of addiction, and help reduce harm for as many people as possible staring as soon as possible.
The Status of Addiction Vaccine Research in 2023: Progress For Fentanyl and Heroin
To make sure we’re all on the same page on this topic, let’s remind ourselves why we need a vaccine for heroin and fentanyl. The reason: the opioid crisis. To learn more about the crisis, please navigate to the blog section of our website, and find the 67 articles (yes, 67) articles we’ve published on this topic by selecting this category from the blog drop-down menu:
The Opioid Crisis in America
You’ll find everything you need to know in those articles. The top-line information, though, is that overdose fatalities associated with opiates like heroin and fentanyl have increased over 725% since 2001:
- 2001:
- Total fatal drug overdose: 19,934
- Opioid-related: 9,486
- 2022:
- Total fatal drug overdose: 109,360
- Opioid-related: 82,797
We need vaccines for heroin and fentanyl to keep people from dying of heroin and fentanyl overdose. It’s that simple. We can’t estimate what would have happened if we hadn’t taken the steps we have until this point, but we have to face the fact that the steps we’ve taken up to this point have not stopped the yearly increase in overdose fatalities.
To stop that yearly increase, scientists have already conducted successful trials on heroin vaccines in non-human primates. Researchers conducted that study in 2017. In 2023, two additional studies – read about them here and here – showed success for fentanyl vaccines in laboratory rodents.
Now, according to an article called “Doctors Are Getting Ready To Give Patients A Vaccine That Blocks Fentanyl’s Effects: This Could Be Huge” scientists are ready to start human trials on vaccines for both fentanyl and heroin.
About These New Trials
These trials are completely funded by grants from the HEAL Initiative we mention above. To be clear, human trials mean the researchers plan to give the vaccine to humans, expose them to the target antigen, and record the results. Although the studies on fentanyl were published already and the studies on heroin are forthcoming, researchers on these trials plan to study heroin first. Here’s how Dr. Jay Evans of the University of Montana (UMT) – a lead researcher on the study – describes this next phase of research on a vaccine for heroin and fentanyl in an interview published by the UMT:
“We anticipate testing our vaccines in humans in early 2024. The first vaccine will target heroin, followed shortly thereafter with a fentanyl vaccine in Phase I clinical trials. Once we establish safety and early efficacy in these first clinical trials, we hope to advance a combined multivalent vaccine targeting both heroin and fentanyl.”
In the first stages of clinical trials for a vaccine, safety is paramount. Researcher most often start with an amount of the vaccine they think won’t work, or will have a weak effect. In this case, researchers expect their first dosages to create antibodies, but not in the amounts that would prevent a typical dose of heroin or fentanyl from reaching the brain. Then, when they’re sure the antibodies – and the vaccine – are safe, and don’t cause any unforeseen complications, they’ll gradually increase the dosage until they find a dosage that meets these criteria:
- Vaccine produces correct antibodies
- Antibodies attach to the correct molecules
- Targeted molecules – i.e. fentanyl and/or heroin – do not cross the blood/brain barrier and cause the euphoria or high associated with fentanyl and/or heroin
- The antibodies and tagged molecules don’t cause any harmful side effects
That last point is the most important. A vaccine does no good if it causes more problems than it solves. To prevent any potential harm, researchers on this project will spend a significant amount of time and energy on making sure item #2 is as perfect as can be.
Creating the Right Antibody
Why does the antibody need to be perfect – or as perfect as possible?
To avoid causing additional harm.
Other molecules that are similar to heroin and fentanyl have legitimate medical purposes. First, fentanyl is a powerful analgesic that’s commonly used in surgeries. To ensure someone who takes any potential fentanyl vaccine, and later need fentanyl in a surgery, the researchers plan to create antibodies that last for several years – long enough for someone to be stable in recovery – then fade. Those antibodies can be renewed with a booster vaccine, if necessary.
In addition, it’s critical that these vaccines don’t prevent the action of medications for opioid use disorder (MOUD) in use in medication-assisted treatment (MAT) programs nationwide. These medications work by occupying opioid receptors and blocking the action of opioids in the brain. But if the antibodies bind to these molecules, they’ll lose their therapeutic effect, which we don’t want to happen.
Medications that are similar in structure to heroin and fentanyl:
All these medications are critical in our current treatments for OUD, and it’s important that any vaccine skip these molecules and have affinity (high likelihood of binding to) only their target molecules. That way, a person can engage in MAT with MOUD and take a vaccine at the same time: that would be the best of both worlds, and is one of the primary goals of this stage of research.
Addiction Vaccines for Fentanyl and Heroin: One Piece of the Puzzle
When we talk about addiction vaccines, we need to be careful. Just like we know addiction itself is about more than the drug the person misuses, treatment is about more than one single medication, even if that medication is an effective vaccine.
We know the best treatment for substance use disorder (SUD) is a combination of therapy, counseling, medication, lifestyle changes, education, family support, and peer support. If we discover an effective addiction vaccine for heroin and/or fentanyl, we won’t throw out everything we already know helps reduce harm. We’ll put a vaccine in the medication category. Then, we’ll use it as part of an overall, holistic whole person approach to treatment.
Why?
Because we know that’s how we help people achieve more than remission of symptoms. It’s how we help people achieve long-term recovery in the context of total health.