NicVAX...what it is, its effectiveness and side effects
Covering Nicvax vaccine clinical trial information, side effects and expected availability date
NicVAX is the brand name of the first ever nicotine vaccine the world will hopefully soon see. To get the best out of the information in this article please first read detailed information on nicotine vaccine in general by clicking on the link.
Short for nicotine vaccine it is a commercial nicotine conjugate vaccine manufactured by a US bio-pharmaceutical company specializing in vaccines called Nabi Biopharmaceuticals.
There are other few companies also working on nicotine vaccines. However, NicVAX is currently way ahead of the process.
It is perhaps the first ever attempt by the scientific community to develop a vaccine against nicotine addiction. Clinical trial work on the vaccine started in the early 2000s with successful laboratory tests. When applied on laboratory rats, the vaccine successfully reduced nicotine reaching the brain by 64%.
Even after this positive laboratory achievement, concerns remained that actual smokers would probably not respond in the same manner as rats let alone its safety for human consumption. As you would imagine, some worried that human beings would simply react by increasing the nicotine intake to counter reduced nicotine brain stimulation.
As any new product to be soon available there were some further concerns from both critics and the general public;
Public health consequences remained unknown.
Some worried society would misinterpret the vaccine to something that would make people (especially teens) invulnerable to addiction.
Current smokers would erroneously believe the nicotine vaccine neutralizes the negative effects of smoking.
The tobacco industry might itself ride on the confusion of the purpose and effects of the vaccine to downplay tobacco health risks.
Access to the nicotine vaccine as a commercial vaccine would be limited especially in developing countries where many are still in the rural areas.
Diverse social-cultural settings might also make the vaccine unwelcome to others.
Indeed this is a mouthful of concerns yet important for a new long awaited vaccine. The vaccine has now entered its third phase of clinical trials after having passed with positive results two other stages after the laboratory rat tests stated above.
In fact as recent as December 2008 the company was in discussions with the European drug licensing and regulators in preparation for a commercial launch in Europe apart from the United States after years of successful trials amongst actual smokers.
Some of the concerns raised above such as access and misconceptions are still yet to be met head-on. However, my observation with such new products is that confusion and suspicion often quickly dissipates within the first few months to a few years of use. It's just the natural way of doing things by human beings. This has however saved us well in the past :)
How it will be administered
NicVAX is administered via an injection into the arm. The injection may last from a few weeks to a year depending on dosage after which the patient will again visit their pharmacist or health service provider for a renewal until they are completely smoke free.
The developers of the vaccine hope to make it possible to increase a smokers anti-nicotine antibodies, for instance, 3 months ahead of the quit date. The increased anti-nicotine antibodies will help you in your most critical time for instance the quit week or hell week as many quitting smokers call it.
NicVAX side effects
Third phase clinical trials of the vaccine are in progress and have at some point involved over 300 heavy smokers. A significant number from a high dosage group in the trials quit smoking and did not relapse for at least 30 days. This group had continued smoking whilst on the vaccine.
The results gathered throughout the clinical trials have been positive concerning possible adverse effects of the vaccine. There were some few reactogenicity events such as muscle ache, headache, discomfort, colds and upper respiratory tract infections. These conditions ranged from mild to moderate in some participants in the trials.
These were resolved swiftly and did not seem to increase with the number of injections patients received. About 10% of all patients involved experienced nausea and fever.
It is indeed a promising treatment to nicotine addiction and might just put a definite arrest to runaway nicotine related mortality now reaching the 10 million mark worldwide.
The key to any successful stop smoking method goes beyond just arresting the urge to smoke. Smoking relapse must be prevented by nipping in the bud the initial nicotine addiction. This is what NicVAX hopes to achieve.
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