Researchers Developing Vaccine to Fight Opioid Use Disorder

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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New York City’s Supervised Injection Sites Call for Biden’s Support

Only a few weeks after opening, supervised injection sites in New York City have potentially saved dozens of lives, leading city leaders to call on the Biden administration to authorize the use of similar harm reduction programs nationwide.

New York Mayor Bill de Blasio and the city’s health department announced on November 30 that the nation’s first publicly recognized overdose prevention centers (OPCs) had commenced operations in the city. Also commonly known as supervised injection sites, OPCs offer people a safe place to consume illicit drugs under the supervision of staff trained to intervene in the event of an overdose.

Other services including clean needle exchange, HIV testing and referrals to addiction treatment programs are often commonly available at supervised injection sites.

De Blasio, who has been calling for an OPC pilot program since 2018, noted that more than 2,000 people died of a drug overdose in New York City in 2020, the highest number since reporting began in 2000. Nationwide, more than 90,000 people died of an overdose in 2020, according to the Centers for Disease Control and Prevention, the worst year ever recorded.

Supervised Injection Sites Save Lives

Internationally, supervised injection sites have been saving lives for decades. Research over 30 years at more than 100 such facilities has proven the efficacy of such programs. No overdose deaths have ever been recorded at a supervised injection site, and research has also shown that the sites reduce public drug use, litter from syringes and drug-related crime in surrounding neighborhoods.

“After exhaustive study, we know the right path forward to protect the most vulnerable people in our city, and we will not hesitate to take it,” de Blasio said in a statement at the time. “Overdose Prevention Centers are a safe and effective way to address the opioid crisis. I’m proud to show cities in this country that after decades of failure, a smarter approach is possible.”

Council Member Mark Levine, chair of the City Council Health Committee, said that “NYC has taken historic action against the mounting crisis of opioid deaths with the opening of the nation’s first overdose prevention centers.”

“This strategy is proven to save lives, and is desperately needed at a moment when fatalities are rising fast,” Levine added. “I applaud the city as well as the providers who offer these lifesaving services for this bold approach to stopping this crisis.”

The city’s OPCs are operated by outreach and education group New York Harm Reduction Educators, which has opened two supervised injection sites at existing facilities in Harlem and Washington Heights. As of December 14, only two weeks into the program, the two sites had registered 350 participants and staff had already reversed 43 overdoses, according to a report from WNYC/Gothamist.

City Leaders Seek Support from Biden Administration

The success of New York’s OPCs has led a group of city leaders to call on the administration of President Joe Biden to support federal authorization of supervised injection sites nationwide. Under the federal Controlled Substances Act, it is illegal to operate, own or rent a location for the purpose of using illegal drugs. 

In an op-ed published on December 15, New York City Health Commissioner Dr. Dave A. Chokshi, Bronx District Attorney Darcel Clark, Brooklyn District Attorney Eric Gonzalez, Queens District Attorney Melinda Katz and Manhattan District Attorney Cy Vance called on Biden to provide legal protection for OPCs to open across the country. 

They noted that in April, New York had joined the cities of San Francisco, Oakland, Philadelphia, Pittsburgh and Somerville, Massachusetts, in a letter to Attorney General Merrick Garland, asking the Justice Department to deprioritize enforcement of federal drug laws against supervised injection sites. But so far, no response has been received from federal officials.

The civic leaders also noted that Biden had recently become the first president to include harm reduction in his drug policy priorities and said that New York’s OPCs could be a model for the nation. Under the American Rescue Plan passed by Congress in March, $30 million was appropriated to state, local and tribal governments and organizations for overdose prevention and harm reduction services.

“It is time to embrace bold strategies in the face of public health crises, even if they may seem radical at first,” they wrote in the BuzzFeed News op-ed. “Thirty years ago, in the midst of the HIV/AIDS epidemic, New York City activists started one of the first syringe service programs in the country and, as a result, reduced HIV transmission among people who inject drugs, averting countless deaths.”

“We urge the Biden administration to endorse overdose prevention centers, empowering state and local jurisdictions to fully leverage their resources and authority to build healthier and safer cities, towns and communities,” the civic leaders concluded.

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U.S. Reports More Than 100,000 Overdose Deaths In One Year

More than 100,000 people succumbed to overdose deaths in the United States in the span of a year, a record death toll that underscores the continuing failure of the War on Drugs to keep the nation safe.

During the 12-month period ending April 2021, 100,306 Americans died of drug overdoses, according to provisional data released by the U.S. Centers for Disease Control and Prevention on Wednesday. Federal officials point to the coronavirus pandemic and the proliferation of powerful synthetic opioids including fentanyl as major contributors to the spike in overdose deaths over the past two years.

“These are numbers we have never seen before,” Dr. Nora Volkow, director of the National Institute on Drug Abuse, told the New York Times. Commenting on the human toll behind the statistics, Volkow noted that a majority of the deaths occurred among people aged 25 to 55.

“They leave behind friends, family and children, if they have children, so there are a lot of downstream consequences,” Dr. Volkow said. “This is a major challenge to our society.”

Overdose Deaths Add to Covid-19’s Toll

During the same time period, approximately 509,000 died from Covid-19 in the United States, according to figures from Johns Hopkins University, while millions were left isolated due to quarantines and business closures. Volkow noted that the pandemic also led to border shutdowns that made powerful synthetic opioids including fentanyl easier to smuggle into the country than naturally produced but less potent and thus more bulky drugs including morphine and heroin.

“What we’re seeing are the effects of these patterns of crisis and the appearance of more dangerous drugs at much lower prices,” Volkow said to CNN. “In a crisis of this magnitude, those already taking drugs may take higher amounts and those in recovery may relapse. It’s a phenomenon we’ve seen and perhaps could have predicted.”

The new data, representing deaths from May 2020 through April 2021, reflects a 28.5 percent increase in the number of fatal overdoses in the United States compared to the same time period one year earlier and the first time deaths have exceeded 100,000 in one year. Synthetic opioids including fentanyl were up 49 percent over the year before, contributing to the vast majority (64 percent) of overdose deaths. Stimulants including methamphetamines were involved in about a quarter of overdose deaths, a jump of 48 percent over the previous year. The data also show more modest increases in the number of overdose deaths caused by natural opioids, cocaine and prescription medications.

Dr. Volkow said that while some drug users intentionally seek out fentanyl, others “may not have wanted to take it. But that is what is being sold, and the risk of overdose is very high.”

The pandemic also decreased the availability and access to treatment for substance use disorders. As the country reopens and life begins to return to normal, overdose deaths are likely to remain high if access to drug treatment and other interventions is not improved, experts says.

“Even if Covid went away tomorrow, we’d still have a problem. What will have an impact is dramatic improvement to access to treatment,” said Dr. Andrew Kolodny, medical director of opioid policy research at the Brandeis University Heller School for Social Policy and Management.

“These are deaths in people with a preventable, treatable condition. The United States continues to fail on both fronts, both on preventing opioid addiction and treating addiction,” he continued, adding that President Joe Biden should act on his campaign promises to address the continuing opioid crisis.

Access to Treatment Saves Lives

The White House Office of National Drug Control Policy on Wednesday released model legislation to serve as a guideline for states to pass laws that increase access to naloxone, a life-saving drug that can reverse opioid overdoses. Other medications including buprenorphine can be prescribed to help those with opioid use disorder, but access to the drugs is also often limited. In October, the U.S. Department of Health and Human Services issued a plan to combat drug overdoses, including federal support for harm reduction and recovery services and provisions that lessen barriers to substance abuse treatment.

“If we really want to turn the corner, we have to get to a point where treatment for opioid addiction is easier to access than fentanyl, heroin, or prescription opioids are,” Kolodny said.

Beth Connolly, director of the Pew Charitable Trusts substance use prevention and treatment initiative, said that improving access to drug treatment and emergency interventions can help bring down the spike in overdose deaths.

“The evidence is really clear that using medications to treat opioid addiction disorders saves lives,” said Connolly. “As we see more and more evidence that (medication) does save lives, that will hopefully reduce stigmatizing and categorizing in favor of supporting individuals.”

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