Opioid vaccines hold the potential to counteract the plague of opioid-affiliated deaths that have swept the United States in recent years, according to the Government Accountability Office (GAO).
While clinical trials have begun, numerous barriers remain to use.
The matter of what exactly is involved in opioid vaccines is the first step. They are primarily medical therapies designed to block such drugs from entering the central nervous system, barring them from hitting receptors and causing those effects most associated: psychotropic effects, addiction, and overdose. Triggered antibodies bind opioid molecules and deny them entry. The vaccines themselves come with no potential for abuse, according to GAO. Patients would also require minimal medical supervision. In addition to patients, first responders could also make use of them.
Further, like all effective vaccines, these act as bodily teachers. The immune system learns to identify targeted opioids as dangerous foreign substances in the future, even without the vaccine. For potentially years after, the body naturally forms antibodies to counteract opioids.
In 2017 alone, GAO estimated more than 10 million people abused opioids, such as heroin and fentanyl, leading to more than 47,000 overdose deaths. Opioid vaccine studies re first proposed as far back as the 1970s. As of 2019, the Food and Drug Administration (FDA) has yet to approve any opioid vaccines for use, and clinical trials have thus far failed. However, three early-stage trials are currently underway.
These vaccines are designed against specific opioids, which could, in turn, be quickly altered to decrease their efficacy. The vaccines also are less effective in otherwise immune-compromised patients, and there is the potential for them to be developed for use against legal opioids, which could interfere with medical care. GAO also noted that neither the mechanism of these vaccines is well understood, nor is there a concrete answer to those who would question the role of patient consent in these vaccine uses. Further complicating matters is the issue of insurance. In numerous cases insurance has already refused payment to those who use over-the-counter naloxone to counter overdoses, and nothing is stopping them from doing the same to an opioid vaccine.
Going forward, GAO asks that those considering these vaccines question the available means of making successful commercial opioid vaccines, the standards the FDA should set for clinical trials, when and to whom they should be administered, and what insurance coverage options they could have.