Fatal opioid overdoses are claiming the lives of tens of thousands of Americans every year, leading experts to describe it as the worst crisis the US has ever faced. However, there may be a solution on the horizon in the form of a new vaccine. This groundbreaking vaccine would be given to high-risk drug users months or even years before an overdose occurs, effectively teaching the immune system how to prevent opioids from cutting off oxygen to the brain.
The vaccine would likely be administered through a series of injections, and it works by neutralizing opioids in the bloodstream with antibodies. Unlike the already approved Narcan, which is administered during an overdose, the fentanyl vaccine would be a proactive measure to prevent overdoses from happening in the first place.
Human trials for the vaccine are expected to begin in early 2024. The researchers, led by molecular biologist Jay Evans at the University of Montana, have also developed a second vaccine that targets heroin overdoses. Both heroin and fentanyl bind to opioid receptors in the brain, causing the brain to be starved of oxygen and leading to neuron death during an overdose.
Animal studies have shown promising results, particularly with the addition of a small molecule called an adjuvant. However, more research is needed to ensure the safety and efficacy of the vaccines in humans before they can be widely administered.
The fentanyl epidemic in the US has reached alarming levels, with approximately 150 Americans dying from the synthetic opioid every day, according to the US Centers for Disease Control and Prevention (CDC). In 2022, over two-thirds of the 107,081 reported drug overdose deaths in the US were attributed to synthetic opioids like fentanyl.
Jay Evans and his team at the University of Montana have been collaborating with other institutions to develop these anti-opioid vaccines. They have focused on creating adjuvants, substances that enhance the vaccine response and provide stronger and more durable immunity.
The vaccine works by stimulating T-cells in the immune system to create antibodies that bind to fentanyl in the bloodstream, preventing it from crossing the blood-brain barrier and causing harm. The first vaccine will target heroin, followed by a fentanyl vaccine in Phase I clinical trials. The trials will start with the lowest, potentially ineffective dose, gradually escalating to ensure safety and effectiveness.
If successful, Phase 2 trials will determine the number of doses needed and the time required between doses. Phase 3 will involve a large cohort study to evaluate the benefits and risks of the vaccine, ultimately leading to FDA approval.
It is important to note that the development and approval of these vaccines will take time, as there are many regulatory steps to navigate. However, the researchers are hopeful that these vaccines will be a game-changer in combating opioid overdoses and saving lives.
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