No vaccine for opioid addiction has been tested in humans
"It's a long process, and it takes years," one doctor says
Health and Human Services Secretary Tom Price this week touted the potential for a vaccine to help with opioid addiction, but those on the front lines say such products are nowhere close to a reality.
The research may be exciting, say experts working on a vaccine, but they caution against people getting their hopes up for a loved one currently in need, because the vaccines are years away from production. Even with President Donald Trump declaring the opioid epidemic an emergency on Thursday, experts say, the move does little to bring addiction vaccines to the market quicker.
In fact, no vaccine for opioid addiction has been tested in humans. There would have to be phase 1, phase 2 and phase 3 trials before any such product could reach the US Food and Drug Administration for approval, assuming it showed promising results.
“It’s a long process, and it takes years,” said Dr. Ivan Montoya, acting director of the Division of Therapeutics and Medical Consequences at the National Institute on Drug Abuse.
Dr. Thomas R. Kosten, a professor of psychiatry at Baylor College of Medicine who has worked on addiction vaccines for over two decades, said Price is a bit too optimistic.
“He may be a physician, but he’s not terribly well-informed about addictions,” Kosten said. “I can’t imagine the vaccine would be on the market before the Trump administration is over.”
Kosten worked on a cocaine vaccine for more than 16 years before a study showed that “it just didn’t work well enough for us to continue.” He is now working on what he hopes could be a fentanyl vaccine, but “there’s quite a ways to go.” Fentanyl is a synthetic opioid about 50 to 100 times more potent than morphine – and is one of the most potent and lethal drugs available.
“There are no opiate vaccines that have been in people at this point,” Kosten said.
He emphasized that any addiction vaccine would be therapeutic, not preventative, meaning it would be used for people already struggling with addiction. Doctors won’t “mass-immunize a whole bunch of kids,” he said. “That’s not at all what they’re designed for.”
Montoya said that some of the vaccines in initial testing have showed promise in animals, but “sometimes, the translation from animals is not necessarily the same in humans. So we have to do the human studies.”
His agency funds research on the development of innovative approaches for substance-abuse disorder, including the funding for vaccine research. The biggest challenge in creating an effective opioid vaccine, he said, is being “able to fight it in the bloodstream before it gets to the brain.”
The most exciting thing about the concept of an addiction vaccine, he said, is the ability to use one’s immune system to fight drug abuse: “We don’t have to modify the brain to produce the effect. You take advantage of your own immune system and prevent access of the drug to the brain.”
His ideal vaccine would be one that treats multiple opioids. “One vaccine would cover, say, fentanyl, heroin and Oxycontin,” Montoya said. “That is our dream.”
It’s a dream, he acknowledged, that is years down the road.
Since 1999, the number of American overdose deaths involving opioids has quadrupled, the Centers for Disease Control and Prevention says. From 2000 to 2015, more than 500,000 people died of drug overdoses, and opioids account for the majority of those.
During a news conference on the epidemic Tuesday, Price listed several initiatives the government is leading to help combat the growing crisis. He applauded research being done by the National Institutes of Health: “One of the exciting things that they’re actually working on is a vaccine for addiction, which is incredibly exciting.”
Why would the secretary tout something that may never come to fruition?
Montoya would say only that maybe Price “saw the mechanism and got excited about the approach.”
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“I’m a scientist. I don’t get into the political aspect,” he said. “My interest as a scientist is to get as much support from the government to advance science as efficiently as possible.”
Grant Smith, deputy director of national affairs for the nonpartisan nonprofit Drug Policy Alliance, said he wishes the administration would focus more on the here and now – to help the millions of Americans currently caught up in the opioid epidemic.
“I think a lot of people are going to needlessly die if steps are not taken now to eliminate barriers to the full range of medication-assisted treatments and make naloxone (the antidote used to save people) as widely available in every community, as President Trump’s bipartisan opioid commission has recommended,” Smith said.