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HOUSTON– The end to the fentanyl crisis may be in sight, thanks to a team of researchers in Texas who claim they have successfully developed a vaccine that could be a “game changer” in addiction treatment.

A team led by the University of Houston has developed what they say is a fentanyl vaccine that can block the synthetic opioid from entering the brain — essentially curing addiction by eliminating the euphoric high.

“There’s no question about it. We developed something that’s a new game changer,” Dr. Colin Haile, a research associate professor of psychology at UH and the Texas Institute for Measurement, Evaluation, and Statistics (TIMES) told Fox News during a recent tour of the research facility.

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“It’s a completely different strategy of treating an individual with opioid use disorder.”

Their vaccine works in an entirely different way, said Dr. Haile, from other treatments for opioid use disorder and overdose deaths.

It essentially produces antibodies much like other vaccines make those antibodies against a virus or bacteria.

Dr. Haile’s vaccine does the same by blocking fentanyl from entering the user’s brain.

Proteins are used to keep the drug in the bloodstream—then it is flushed out through the kidneys.

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“It’s similar to the hepatitis B vaccine. The vaccine stimulates the body to make antibodies against fentanyl,” Dr. Haile said, “and if an individual consumes fentanyl, those antibodies will bind to the drug and prevent it from getting into the brain. “

He added, “Without the vaccine, fentanyl penetrates the brain quite readily, stimulates euphoric centers, and also can stimulate parts of the brain that control respiration, leading to overdose and death.”

Testing on lab rats and mice showed very promising results, said Haile, and he believes they will see the same findings once human trials begin in the coming weeks.

“We have done extensive studies in mice and rats and the effect of the vaccine was quite dramatic,” he says. We demonstrated that, yes, the vaccine prevents fentanyl from penetrating the brain. It keeps it in the blood. And then the fentanyl is removed from the body.”

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He believes the vaccine could be available to the public within two years, he said.

“Given that the vaccine is already made up of components that are already on the market and already have been tested in humans, we feel that when it comes time to submit our application to the FDA, we are hopeful that the approval process will be expedited .”

The team began working on the fentanyl vaccine nearly six years ago.

Dr. Haile and his team began working on the vaccine nearly six years ago when an unprecedented rise in overdose death started to surface. The vaccine was developed from two protein strands already used in other vaccine treatments.

Fentanyl and other synthetic opioids have become the primary cause of overdose deaths in the US and it’s estimated that over 110,000 occurred between August 2021 and August 2022 – a stunning record for a single 12-month period.

With over 150 people dying every day from overdoses of synthetic opioids, according to the CDC, the vaccine comes at a crucial time as the drug crisis grips the country.

“Unfortunately, starting about 10 years ago or so, the manufacture of fentanyl was increased, and it became much more part of the mainstream in terms of illicit drug markets, to see it first being part of the drug supply and more recently, just completely taking over for any other illicit opioid,” Dr. Wilson Compton, deputy director with the National Institute on Drug Abuse, which consults with Dr. Haile’s research team, said to Fox News.

“So, heroin [use] is dropping in many parts of the country because fentanyl is cheaper, easier to smuggle, and produces the same brain effects.”

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The vaccine development has been funded by the Department of Defense, where officials tell Fox News that backed the project after the need to address the prevalence of addiction among the families of many service members.

“We need this vaccine…There’s so many people that can be helped.”

Dr. Haile points out that this vaccine would be best for those who have already undergone detox, as it will prevent relapses.

“This vaccine is for individuals that want to quit. It is not for individuals that do not want to quit,” he says.

“A vaccinated individual — if they do not want to quit their opioid addiction, they can take other drugs, other opioid drugs, or just other drugs that are vaccine antibodies do not target.”

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People have already been contacting the team at the University of Houston asking to be added to the upcoming trials — something that Dr. Haile says underscores the need for this treatment.

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“We need this. We need this vaccine. And there’s so many people that can be helped,” he says.

“It needs to happen, and it will happen.”

Fox News’ Evan Goldman contributed to this report.

Trouble getting pregnant, fatigue, erectile dysfunction, and hair loss are all common symptoms of low testosterone. Ads from a booming testosterone industry remind us of this constantly, as do food and fitness “hacks” touted by so many influencers. Professional opinions on the right levels of testosterone for men vary widely — even among tenured experts. No wonder so many men obsess over their testosterone levels. A new study aims to clear up what can be defined as low T — by outlining the differences in testosterone through age. But some doctors wonder whether the proposed change could throw tens of millions of men into even more confusion over where they stand and what to do about their testosterone.

Getting To A New Testosterone Threshold

The new study, published in The Journal of Urology, argues that the standard cutoff point for clinically low testosterone levels in men needs to be adjusted. There’s currently a single cutoff for low blood testosterone: 300 nanograms per deciliter (ng/dL). But the study researchers argue that what counts as low T depends on a man’s age — an aspect previously overlooked because most data collected came from men over 40.

“Young men have different testosterone reference ranges than older men,” said lead author Alex Zhu, DO, a urology resident at Michigan Medicine, in a press statement. “Our findings suggest we should be using age-specific cutoffs when assessing testosterone levels in younger men.”

How much testosterone a cisgender man has in his body — measured through a blood test — can change throughout his lifetime, and most start experiencing a decline around age 30 to 40 as the glands that produce testosterone, including those in the testicles, start slowing down . Testosterone levels also drop when a man becomes a dad, which may have an evolutionary root in the dad giving up hunting for new mates and instead becoming a family man, increasing the survival of his baby.

Before that decline begins, “normal” testosterone levels range from about 264 ng/dL to 916 ng/dL, according to the Endocrine Society. But different studies over the years have yielded slightly varying results of what normal ranges can be.

To learn more about normal testosterone levels throughout a man’s lifetime, Zhu’s team analyzed testosterone data from nearly 1,500 US men between the ages of 20 and 44. For each age group, they split up the testosterone levels they found into thirds: a low third of the population, an average third, and a high third. They found that with every year a man gets older, his testosterone drops by an average 4.3 ng/dL.

The researchers found that a testosterone level anywhere below 409 ng/dL — well above the current low testosterone cutoff — is already low for a man in his early 20s compared to the average T levels of his 20- to 24-year-old peers. This calls for an update to low testosterone standards, Zhu’s team argues, and that man should be considered to have low T and be eligible for insurance-covered testosterone therapy.

The Argument For Age-Specific Testosterone Cut-Offs

With these findings, clinicians could use age-specific low T cutoffs instead of a “one size fit all” approach, according to Zhu’s team. Changing the official thresholds used by doctors — like the one set by the American Urological Association Testosterone Deficiency guidelines, which came out in 2018 and probably won’t get updated for a few more years — could make it easier for younger men who may need it to access testosterone therapy. Currently, insurance only tends to cover patients who fall below the standard 300 ng/dL cutoff.

But having lower testosterone than your peers — specifically, falling into the lower third of testosterone levels for your age group — doesn’t necessarily mean you’ll have symptoms of low testosterone or need treatment, says Kevin Campbell, MD, a urologist at the University of Florida Health who was not involved in the study. Not everyone under 300 ng/dL has symptoms that can be traced back to low T, and not everyone above that level is symptom-free.

“We do have to take it with a grain of salt,” says Campbell. Testosterone, like everything in the body, operates in a complex system — although blood levels of testosterone can be high or low, the amount of T actually available to the body might be different, because testosterone is bound to other molecules that orchestrate whether testosterone is used or not.

“The concept of age-appropriate thresholds for testosterone deficiency makes a lot of sense,” says Guillaume Paré, MD, a molecular epidemiologist at McMaster University in Ontario, Canada, who was not involved in the study. Paré does, however, worry that testosterone deficiency is too often defined as testosterone concentration below the 33rd percentile, basically saying that one in three men will always be testosterone-deficient. He doesn’t think that’s reasonable.

“By design, current thresholds categorize a third of males as having low testosterone. This is a large proportion of individuals and might not reflect whether biologically there is too little testosterone,” says Parè.

The Risks And Rewards Of Testosterone Treatment

He believes that there should be stricter thresholds for low testosterone, and worries that a diagnosis of testosterone deficiency at a young age could lead to overzealous long-term treatment with testosterone replacement therapy, of which the potential side effects are yet to be researched in detail .

“The potential side effects of such treatment are not well understood,” Parè says. “Our own research suggests it could lead to an increased risk of prostate cancer, high blood pressure, and baldness,” he says, pointing to his 2020 study in the journal eLife.

The FDA has issued warnings that testosterone therapies can increase the risk of heart failure. However, its European equivalent, the EMA, notes that the data doesn’t sufficiently support that testosterone therapy causes heart problems. The scientific jury is still out on other effects of the therapy, including whether it betters or worsens sleep apnea, for example.

A 2022 study by Northwestern Medicine suggests that commercial brands providing testosterone therapy are quick to provide medication without going through its pros and cons — for example, 83.3% of the surveyed brands did not mention the possibility of an increase in blood thickness.

“We should make sure there is a clear benefit to each patient started on testosterone replacement therapy, as it might not be as benign as sometimes assumed,” Parè says

To avoid unnecessary treatment, it’s important not to interpret testosterone levels in isolation, says Richard Anderson, Ph.D., MD, co-director of the Center for Reproductive Health at The University of Edinburgh in Scotland, who wasn’t involved in the study. Whether the man is experiencing symptoms, has other health issues, has been under recent stress, or has experienced any lifestyle changes that could affect his testosterone levels, such as increased smoking or drinking, is imperative for interpreting testosterone blood levels in context.

Sometimes patients are able to wean off of testosterone replacement therapy, though they would likely have all the same symptoms that first brought them to therapy. And stopping high-dose testosterone therapy can cause drastic withdrawal symptoms.

“We know of the consequences of very low levels, and it is clear that treatment is beneficial,” says Anderson. “But this is not the case for less marked low levels, and we must avoid over-treatment, as it’s very difficult to stop treatment later.”