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Assessing Biological, Structural, and Ethical Barriers to Implementation of Opioid Vaccination

Given the diverse public health challenges facing the United States today, the opioid overdose epidemic is among the most pressing. Nearly 50,000 individuals died in the past year due to opioid overdose, and around 500,000 individuals have died due to opioid overdose overall. These staggering numbers of deaths have unfortunately occurred despite the availability of effective treatments for both overdose reversal and opioid use disorder. Unfortunately, less than 20% of individuals who may qualify for such treatments actually access them. Given the clear ongoing need for new solutions, vaccination against both prescription and illicit opioids has been proposed as an alternative method to address this crisis. Indeed, following on from promising pre‐clinical work in both rodents and non‐human primates, the first clinical trials to test opioid vaccines have now been registered. Considering that previous vaccines directed against small molecules such as nicotine ultimately failed to reach the market, and that even approved treatments for opioid use disorder face barriers to dissemination and widespread use, we undertook a concerted, human subject investigation into three separate domains of translational barriers that could impact the ultimate success of the opioid vaccine approach. We first investigated biological barriers to success, specifically using ELISA to assess the blood of individuals who were either chronic opioid users or matched controls to look for development of endogenous anti‐opioid antibodies that could ultimately suppress immune responses to vaccination. We next assessed structural barriers to implementation, surveying current and future healthcare providers about present use and perceived structural challenges to the use of interventions for opioid use disorder. Finally, we assessed ethical barriers to implementation of vaccine‐based therapeutics for substance use disorders, also using a targeted survey approach. Overall, this investigation identified limited evidence of endogenous antibody formation in chronic prescription opioid users, identified some structural difficulties arising from injectable formulations and cost concerns, and identified ethical concerns regarding compulsory use of vaccination, as well as potential use in protected classes of individuals. Nevertheless, opioid vaccination was reported to be a helpful potential addition for the treatment of opioid use disorder and overdose.