After 50 Years of Failed Attempts, Is a Drug Vaccine Close?

In the early 1970s, a graduate student at Rockefeller University in New York City pitched an idea to his mentor, the physician who had given the world methadone maintenance: What if you could create a vaccine to train the immune system to intercept a drug before it reached the brain?

The mentor, Vincent P. Dole, MD, was skeptical. Methadone already existed and was being used successfully. They also already had naloxone. Why would anyone choose a vaccine that took weeks to work over a pill that worked right now?

The graduate student was Thomas Kosten, MD, now a professor of psychiatry at Baylor College of Medicine in Houston. Despite his mentor’s skepticism, Kosten spent the next five decades pursuing the idea. He built a cocaine vaccine at Yale University, New Haven, Connecticut, first testing it in humans in 2000. It went through three phases of clinical trials only to be rejected by the FDA. The vaccine worked in two-thirds of recipients, but the agency required an intent-to-treat analysis. When the responders were pooled with the nonresponders, the signal vanished. 

“My commercial partner at that point said, ‘Well, nice talking to you. Bye.’ That was it,” Kosten said. (Medscape, USA, 18.09.2026)

https://www.medscape.com/viewarticle/after-50-years-failed-attempts-drug-vaccine-close-2026a1000yux