Is a Nicotine Vaccine the Magic Bullet
for Smoking Cessation?

By Joseph J. Wang
Health Law & Policy Institute

The latest innovation in the fight against smoking may be a shot in the arm. Researchers at Nabi, a pharmaceutical company based in Florida, are working closely with scientists at the University of Houston-Clear Lake and the University of Minnesota to develop a vaccine for the prevention and treatment of nicotine addiction in humans. The National Institute on Drug Abuse is funding part of the research, and clinical trials are set to start by 2002. (See the NIDA News Release at http://www.nida.nih.gov/MedAdv/99/NR-1217.html.)

Unlike the Nicoderm patch or Nicorette gum, the nicotine vaccine, NicVAX, would be administered via a shot in the doctor's office. NicVAX works by keeping nicotine away from the brain. It does so by eliciting an immune response causing the body to produce nicotine-specific antibodies that bind to nicotine molecules forming a large antibody/nicotine complex. This complex would be too large to cross the blood-brain barrier and allow nicotine to exert its chemical effect on the brain. As such, NicVAX would not only be effective for smoking cessation, but also for the prevention and treatment of addiction to other tobacco products such as chewing tobacco. Research is now underway to develop vaccines for other drugs like heroin and cocaine.

NicVAX has the potential to be a very powerful form of nicotine addiction treatment. Because less nicotine reaches the brain, smokers get less of a "kick" from the nicotine. Individuals who want to quit smoking could use NicVAX as a way to make smoking less rewarding for them and smoke less and less over time. NicVAX would also have long-lasting effects, up to a year per shot, so that smokers who quit would be less likely to relapse and resume smoking at a later time. And because it acts in the blood system and does not affect neurochemistry, NicVAX would cause fewer side effects and be safer overall.

From a public health standpoint, NicVAX could lower the incidence and prevalence of smoking by neutralizing the addictive properties of nicotine. First-time or occasional smokers might never get hooked. For those who are hooked already, it would offer a relatively easy way to end an expensive and unhealthy behavior. NicVAX could have tremendous impact in the protection, promotion, and maintenance of public health.

NicVAX seems like the magic bullet for smoking cessation, but is it? Will the nicotine vaccine be safe and effective or will it pose serious health risks to the individual? Will the vaccine really lower the incidence and prevalence of tobacco use? And if it works, who would pay for the cost of the vaccine, and are there other barriers to access of this potentially important innovation?

So far, NicVAX has only been tested on laboratory rats in which nicotine reaching the brain was reduced by 64%. Although this result shows great promise, there is a possibility that humans would not respond to the vaccine the exact same way rats do. For example, people might feel the need to smoke more to compensate for the reduced levels of nicotine in the brain. Even if NicVAX would take the "kick" out of smoking, it may do little to reducing the craving for cigarettes. Also, until clinical trials are concluded, researchers will not know whether NicVAX is an effective treatment safe for human consumption.

The public health consequences are also unknown. Young adults who feel smoking is cool may be more inclined to pick up the habit. They may misinterpret the prophylactic purpose of the nicotine vaccine and believe that it will make them invulnerable to addiction, enabling them to quit cold turkey at any time. Current smokers may be misled as to the therapeutic value of the vaccine and conclude that it will neutralize the ill effects of smoking. If misconceptions about the vaccine are common, the tobacco industry might itself promote the vaccine to downplay the health risks associated with tobacco use.

Even if NicVAX was shown to be effective in preventing and treating nicotine addiction, access to it might be limited. Experimental drugs such as NicVAX might not be covered under health insurance. Those who do not have health insurance and cannot afford to pay for NicVAX out-of-pocket will lose out too. Non-financial barriers may also restrict access. NicVAX may not be available in rural areas of the country (geographic barriers). Taking time off work to visit a health care provider may not be an option for some (temporal barriers). Culture and belief systems may make vaccination unacceptable for others (sociocultural barriers).

Until clinical trials conclude and NicVAX is available to the public, we cannot know for certain whether a nicotine vaccine is the magic bullet for smoking cessation. What we do know is that a nicotine vaccine promises to help individuals who want to quit smoking quit. Whether they want to is an entirely separate question.

08/17/00