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Could the Fentanyl Vaccine Breakthrough Reduce Overdoses?

Peter Manza, PhD profile image
Reviewed By Peter Manza, PhD • Updated Oct 15, 2023 • 12 cited sources

Imagine getting one shot to protect you from your next fentanyl-tainted dose of drugs. Researchers in Texas hope to make this dream a reality with a vaccine they’re developing.[1] But they warn it could be years before you roll up your sleeve for the jab. 

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If you’re using drugs right now, know they could be contaminated with fentanyl. You may not know the drug is there until you overdose. Every fentanyl overdose has the potential to be fatal.

Several medications, including a few injectable products, could help you overcome opioid use disorder (OUD). Using medications like Suboxone or Sublocade now could mean lowering your risk of fentanyl overdose. You’ll be protected, even if this vaccine never makes it out of a laboratory. 

What Is the Fentanyl Vaccine?

Researchers spent five or so years working with rats in a laboratory in Texas. In October 2022, they had enough data to publish a study in the journal Pharmaceutics.[1]

In that study, they outlined how vaccinated rats exposed to fentanyl had fewer physical signs of overdose, such as the following:[1]

  • Low oxygen saturation 
  • Slow heartbeat
  • Reduced activity (sedation)

Critically, the vaccine didn’t prevent the rats from getting high when using opioids like morphine, methadone or buprenorphine. Their vaccine worked on fentanyl and fentanyl alone.[1]

In interviews, researchers explained that the vaccine works by generating antibodies for fentanyl. If the drug is detected, the antibodies bind and keep it from entering the brain. Instead, the drug is removed via the kidneys.[2] 

A second study involving both rats and pigs demonstrated that adding a second ingredient made the vaccine more effective. And this ingredient made the rates and pigs use the drug less often too.[3]

Put these results together, and an exciting image emerges. With one vaccine, someone with OUD could get help with cravings. That person could keep using common Medication for Addiction Treatment (MAT) therapies. And if the person slips and takes drugs contaminated with fentanyl, an overdose is blocked. 

Why Experts Hope a Vaccine Works 

Developing any kind of vaccine takes time, persistence and financing. Typically, companies only develop products to treat conditions that are incredibly serious and/or life-threatening. Fentanyl overdoses certainly fit this model. 

Officials at the National Institute on Drug Abuse say fentanyl is associated with one of the deadliest addiction crises in the United States. Between June 2019 and 2020, fentanyl was responsible for 48,000 out of 83,335 overdose deaths. That rate has increased more than 29-fold since 2012.[4]

Fentanyl appeals to drug dealers and cartels due to the following properties:[4]

  • Ease: It’s relatively simple to manufacture large doses of fentanyl.
  • Power: Since fentanyl is 50 to 100 times stronger than heroin, dealers only need to move a little bit across the border. 
  • Profits: A small amount of fentanyl can be cut with inert ingredients (like baking soda) to make lots of doses for minimal costs. 

Many opioid-related deaths in the United States are caused by accidental ingestion. Someone believes they’re buying cocaine, methamphetamine or another drug. They get fentanyl added in.[4] They often have no idea fentanyl is present until they overdose.

In some parts of the country, fentanyl has completely displaced heroin.[5] Any heroin a person buys contains something else altogether. And the dealer may never disclose that fact. 

A vaccine could work like a harm protection strategy. People might continue to buy from their dealers. But if they get fentanyl, they won’t overdose. Death rates might drop dramatically as a result. 

How Long Before You Can Get the Shot?

While the news of a fentanyl vaccine is exciting, it could be years before a viable product ends up on pharmacy shelves. And as a worst-case scenario, it may never arrive at all. 

In interviews, researchers say they have several steps to complete, including the following:[6]

  1. Create a clinical-grade vaccine. 
  2. Test that vaccine to meet U.S. Food and Drug Administration (FDA) toxicology requirements. 
  3. Submit an FDA application to begin human trials. 
  4. Complete a phase 1 trial with 40 to 50 participants with OUD.
  5. Complete a phase 2 trial with a larger participant base.
  6. Complete a phase 3 trial with an even larger participant base. 

Researchers said they hoped their work would be complete in two or three years.[6] 

But right now, the only research conducted has involved rats and pigs. Humans are very different. The reactions researchers see in animals could vary from those in people. Sometimes, research falls apart when researchers switch to human subjects. 

Who Would Get the Shot?

If a vaccine makes it through all of the research steps, humans must still be convinced to get the vaccine. That’s not always easy. 

In one study of the vaccine’s viability, 76% said they thought the intervention could save lives.[7] Results like this could convince a manufacturer to spend a lot on a name, packaging and a marketing campaign. 

But some manufacturers could be leery of investing in a vaccine post COVID. Consumer mistrust of any vaccine rose during the past few years. Researchers say COVID vaccine status was closely associated with education, income, employment and health insurance.[8]

While anyone could develop OUD, people with severe problems may not have health insurance or a steady income. They may need the vaccine more than anyone else. But they may not have the means or willingness to do so. 

Understand Your Current Treatment Options

While you can’t pop into your doctor’s office and ask for a fentanyl vaccine, you can disclose an OUD. If you do, your doctor could offer MAT programs to help you get better.

MAT programs combine FDA-approved medications with therapy.[9] Experts say these programs are effective OUD treatments that can result in sustained recovery. 

The following three types of medications are FDA approved for opioid use disorder:[10]

  • Methadone: Brand-name medications like Dolophine and Methadose, as well as generic methadone, can reduce cravings and ease opioid withdrawal symptoms. These medications are typically taken daily at a clinic.
  • Buprenorphine: Brand-name medications like Suboxone, Subutex, Sublocade and their generic counterparts can reduce cravings and lessen (or even eliminate) withdrawal symptoms. Oral and injectable products are available, and any qualified clinician can prescribe them. You can take these medications at home.
  • Naltrexone: Brand-name medications like ReVia and Vivitrol, along with generics, can keep opioids from affecting the body. Long-acting injections could prevent relapse and overdose. 

None of these FDA-approved therapies are vaccines. But they could offer critical protections that could keep you from using street drugs and/or overdosing. 

How MAT Can Save Your Life

Research shows that combining medications and therapy can successfully treat OUD. And MAT can also prevent or reduce opioid overdoses.[11,12] 

These therapies aren’t new, and they may not seem miraculous. But they could save your life. And for now, they’re the best options we have to prevent even more deaths from fentanyl.

Reviewed By Peter Manza, PhD

Peter Manza, PhD received his BA in Psychology and Biology from the University of Rochester and his PhD in Integrative Neuroscience at Stony Brook University. He is currently working as a research scientist in Washington, DC. His research focuses on the role ... Read More

  1. Haile CN, Baker MD, Sanchez SA, Lopez Arteaga CA, Duddupudi AL, Cuny GD, Norton EB, Kosten TR, Kosten TA. An Immunconjugate Vaccine Alters Distribution and Reduces the Antinociceptive, Behavioral and Physiological Effects of Fentanyl in Male and Female Rats. Pharmaceutics. 2022; 14(11):2290. 
  2. Fickman L. Fentanyl vaccine potential ‘game changer’ for opioid epidemic. University of Houston. Published November 14, 2022. Accessed August 21, 2023. 
  3. Crouse, B., Miller, S.M., Muelken, P. et al. A TLR7/8 agonist increases efficacy of anti-fentanyl vaccines in rodent and porcine models. npj Vaccines 8, 107 (2023). 
  4. Volkow ND. The epidemic of fentanyl misuse and overdoses: challenges and strategies. World Psychiatry. 2021;20(2):195-196. doi:10.1002/wps.20846
  5. Kilmer B, Pardo B, Caulkins J, Reuter P. How much illegally manufactured fentanyl could the U.S. be consuming? The American Journal of Drug and Alcohol Abuse. 2022;48(4):397-402. DOI: 10.1080/00952990.2022.2092491 
  6. Schindler M. Anti-fentanyl vaccine making progress. 12 WBOY. Published December 23, 2022. Accessed August 21, 2023.
  7. Weitzman ER, Kossowsky J, Blakemore LM, et al. Acceptability of a Fentanyl Vaccine to Prevent Opioid Overdose and Need for Personalized Decision-Making. Clin Infect Dis. 2022;75(Suppl 1):S98-S109. doi:10.1093/cid/ciac344
  8. Allen JD, Fu Q, Shrestha S, et al. Medical mistrust, discrimination, and COVID-19 vaccine behaviors among a national sample U.S. adults. SSM Popul Health. 2022;20:101278. Published 2022 Nov 12. doi:10.1016/j.ssmph.2022.101278
  9. Information about medication-assisted treatment. U.S. Food and Drug Administration. Published May 23, 2023. Accessed August 21, 2023.
  10. Medication-assisted treatment (MAT) for opioid use disorder. National Association of Counties. Published June 20, 2023. Accessed August 21, 2023.
  11. Medications for substance use disorders. Substance Abuse and Mental Health Services Administration. Published July 31, 2023. Accessed August 21, 2023. 
  12. Au, V.Y.O., Rosic, T., Sanger, N. et al. Factors associated with opioid overdose during medication-assisted treatment: How can we identify individuals at risk?. Harm Reduct J 18, 71 (2021).

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