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Does the Anti-Smoking Vaccine Have a Future? Not Right Now


After the failure of a fourth anti-nicotine experimental vaccine, the leading medical journal "Addiction" tells researchers and investors to cut their losses and spend more wisely.

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Anti-smoking vaccines

The four top anti-smoking vaccines have failed costly Phase III trials. Photo via Shutterstock.

Enough is enough, say the editors of the journal Addiction as far as further investment in experimental anti-smoking vaccine goes.

The August issue of the field’s most influential medical authority has an editorial titled “Nicotine Vaccination—Does It Have a Future?” that urges public and private researchers to admit failure for the time being—or at least raise the bar much higher for which candidates get bankrolled.

“We already have varenicline [Chantix], and a recent study has found that adding bupropion [Wellbutrin] to varenicline improves outcomes in heavy smokers. Moreover, we also have the very low-cost drug, cytosine [Tabex], as an option. This raises a serious question as to whether substantial further investment in nicotine vaccines will be worthwhile from either commercial or public health perspectives,” the editorial reads in what passes for a stern voice in the exceedingly cautious jargon of medicine.

The editorial was triggered by the failure of NicVAX, the most advanced experimental anti-nicotine vaccine, in two major Phase III clinical trials, as reported in the August Addiction. Both studies were funded by the Dutch government. This marks the first time that public funds were used to bankroll the testing of a commercial product (NicVAX is owned by Nabi Biopharmaceuticals)—a decision the practical Dutch made based on a cost/benefit public health analysis.

“It raises issues about how the promotion surrounding nicotine vaccines has raised expectations concerning smoking cessation and whether, if an effective vaccine were found, it would be ethical to give it to minors and young adults,” the editors write.

Nicotine is famously known as the world’s most addictive drug. Although a plethora of public health measures over a period of decades has succeeded in significantly reducing the overall smoking rate in the US, only one out of four current smokers is able to quit for good. Again and again studies using every available smoking-cessation method—whether pill, a patch, a pat on the back or all three—fail to help more than 20% to 25% of smokers get beyond a 12-month abstinence before relapse.

So it was with NicVAX. In one study, smokers given the vaccine plus Chantix plus behavioral support fared no better than those who got Chantix and behavioral support but no vax. In the other study, NicVAX was shown to have no effect on brain responses or working memory—two measurements indicating that the nicotinic antibodies produced by the vaccine have little activity. Basically, after close to a decade in development and hundreds of millions of dollars, NicVAX is a dud.

But not a lonely dud. NicVAX joins three other anti-nicotine vaccines—NIC002, Niccine and TA-NIC—in the vast burial ground of pharmacological failures. Given that record, the editors of Addiction argue that although the theory of a treatment vaccine for smokers is unquestionably sound, science lacks the technological sophistication to pull it off.

The journal contains a third paper by the Dutch researchers in which they step back to assess the entire two-decade-long anti-nicotine vaccine project. “It raises issues about how the promotion surrounding nicotine vaccines has raised expectations concerning smoking cessation and whether, if an effective vaccine were found, it would be ethical to give it to minors and young adults,” the editors write.

All addiction vaccines are currently unable to clear the same hurdle: basically, how to get effective antibodies to the psychoactive chemical—whether nicotine, cocaine or alcohol—into the brain. Vaccine development is a high-stakes gamble that attracts high-rolling investors. Addiction is telling investors to take their money elsewhere. Stop throwing good money after bad on clinical trials of “promising” addiction vaccines that make big claims but do not deliver.

Does nicotine vaccination have a future? Maybe, probably, but not right now.