Thursday, May 17, 2007

Vaccine FAQ's

Vaccine FAQ’s some basic information ( a series of posts)
So some of you know me some of you don’t so let me say a few words of intro first. There is a lot of misunderstanding of basic vaccinology on DU. I understand, it’s a somewhat complex field. I have numerous years of experience working as a technician in biotechnology lab- bench work is my passion. My work experience is now considered the equivalent of having a Master’s in biotechnology. I have extensive experience in diagnostics, as well as QA/QC type regulatory experience that makes me VERY familiar with the process the FDA uses to approve vaccines and other biologics. However, I recently discovered that my real passion is for vaccine development, it’s a fascinating field for a science orientated person like me. I also had the honor of working at NIH directly underneath one of the world’s foremost experts on malaria vaccines. His passion and dedication to the field infected me with the same enthusiasm. This self same scientist even once infected himself with the malaria parasite in order to produce the needed infected red blood cells for testing. Suffice to say, it was not a pleasant experience for him. That’s the level of dedication I often found in the scientists working both at NIH and at several private biotech companies I worked for. And while many of them made very good money, none of them were really driven by money or greed. It was the passion for science and the desire to help improve mankind that drives the vast majority. The purpose of this post will be to inform all of established scientific facts about this misunderstood field. I am not trying to influence anybody’s personal opinions, merely to inform. All this information is easily found in basic biology, and/or immunology text books. For those who wish to fact check or just learn more, instead of just trying to click on a link to a short article on the internet I would instead go to the library and read one of these types of textbooks. There are many on the subject. Now on to the basic biology of vaccines:
1) There are two basic types of vaccines: virus (attenuated, live etc) that are made directly with the antigen (i.e. virus) and recombinants which are made with small bits of the virus…bits that through extensive testing are determined to be the most likely to provoke the most useful antibody response. Recombinants are considered to be the wave of the future because since its only small bits and not actual virus they are less likely to have side effects.
2) A vaccine is neither a chemical or drug but something entirely different. It is designed to train the immune system into making antigen specific antibodies . Once the vaccine enters the bloodstream it is attacked by the immune system. A good vaccine provokes enough of a response that the immune system will remember it on encountering it again, but not enough that they person actually get sick. Sometimes that happens and people have side effects similar to the actual disease. Sometimes it takes more than one exposure so that the immune system remembers it. Those vaccines require boosters. Vaccines DO NOT linger in the body the way a chemical does. Once the immune system is done “attacking” the vaccine, the now defunct complex of antibody-vaccine(waste product) is removed from the body by the spleen, the same way the body removes the killed virus/bacteria/pathogen of any infection we pick up.
3) Adjuvants. This is actually a technology that has been quite widely accepted and used for years. Some of them have very frightening complex chemical names. In truth, they are small molecules that are attached to the vaccines to “boost” the effect of the vaccine. A good adjuvant can make the need for boosters much less. Some adjuvants work better than others with certain vaccines. A lot of pre-clinical trial work in vaccine R+D is determining what adjuvant works best with a particular vaccine. Since it is attached (or conjugated is the technical term) directly to the vaccine, like the vaccine it is bound tightly in the antibody-vaccine complex which is eventually taken out of the system within a short period of time by the spleen.
4) Side effects- all vaccines have side effects. The thing with vaccines is that they work really really well. However since they stimulate the immune system, autoimmune problems can sometimes result from a vaccine. And sometimes people have undiscovered allergies to some of the compounds and that can cause difficulties as well. As mentioned above sometimes somebody just can’t handle some of the very potent vaccines (the live virus ones usually) and they get sick. Mostly its minor, flu like symptoms aches etc, minor fevers. Sometimes for unknown reasons the reactions are far more severe. No one can predict how individuals are going to react to a vaccine. However the serious reactions are very very small in terms of percentages of overall population. Cold comfort perhaps to the few individuals that have suffered a bad reaction but true none the less. The golden rule on vaccines are this: only healthy individuals are vaccinated. Anything less than healthy is asking for trouble. In fact, it is my OPINION that many of the serious side effects that individuals suffer are due to previously undetected underlying health issues. But that’s only speculation on my part.
Now some of the popular “myths” about vaccines:
1) Vaccines cause autism due to mercury in them. There are two points here a) the scientific community in general does not believe there is any link between vaccines and autism (for various reasons I won’t go into here). This is a scientific consensus. Are there some in the community who believe there is a link? Sure. But the vast majority are skeptical. The mercury in the vaccines was part of the preservative called thimerosol. Preservatives are necessary to keep the vaccines potent enough for storage for a certain amount of time. Thimerosol has been removed from almost all vaccines with the exception of flu vaccines. However thimerosol free flu vaccines are available as well.
My old boss was one who wouldn’t even have thimerosol in the lab for use in non-vaccine related buffers. It is therefore now a non-issue
2) adjuvants are unsafe neurotoxins. Untrue as mentioned before they are an established technology. Before any vaccine+adjuvant gets approved for clinical trials they undergo YEARS of animal testing (usually in both mice, rats, rabbits and monkeys). And its not a few animals but hundreds for each candidate vaccine. Both safety (toxicity) and efficacy (potency) studies are conducted in these animal studies.
3) Vaccines are rushed onto the market before safety testing is finished. For the most part, wrong. Besides the years of animal studies done prior to clinical studies, the clinical trials themselves (usually conducted under very strict regs called Good Laboratory Practices and/or Good Manufacturing Practices) are long (usually in the 10 year area) where again both safety and efficiency are checked. Clinical trials are long enough to establish safety. Sometimes though when the data indicates a problem with the vaccine the study will be ended and the candidate vaccine withdrawn. This happens on a fairly regular basis but usually is not reported in the MSM. Some non-FDA approved vaccines have been rushed onto the market for use by the government from time to time. The anthrax vaccine of the mid to late 90’s is an example of this. Non-FDA approved vaccines are used in private industry for people doing experimental work. But all the vaccines used in the general population and distributed by pharmaceutical companies/biotech firms MUST be FDA approved and therefore must go through the GLP compliant clinical trials, after having extensive pre clinical testing.
4) Vaccines are huge money makers for Pharmaceuticals. Incorrect. Vaccine development and particularly production have such high costs of development and don’t have a large profit margin that many biotech’s and pharma’s do not feel the rewards are worth the risks of investing in a long drawn out research project. The UN is constantly begging Pharmas to invest more in the manufacturing of vaccines as there are constant shortages for them in the third world . Polio might be extinct in this country but it is a HUGE problem in Africa and there is not nearly enough vaccine to go around. In fact most vaccines are made by companies in Europe because laws and regs there with the funding is set up so that making the vaccines is not as expensive. The reason why there has been flu vaccine shortages in the past few years is because only 2 companies make it, and one had production issues that made them not be able to make any.
That’s the basics. Are there problems in the industry. Absolutely. I and other sensible techs/scientists often know what companies are more profit minded than science minded and avoid them like the plague (Pfizer has a real bad reputation in the professional community for example). Are there dishonest scientists? Sure and I have encountered them and fought them to the detriment of my career. Most scientists are more motivated by ego and reputation than greed though. The ability to publish and professional reputations are the big motivations for scientists . Some will massage or manipulate data to protect their intellectual reputations. Very few are motivated by simple greed although there are a few. But the vast majority of scientists and techs are dedicated and hard working and motivated to improving this world. That’s why the vast majority are registered democrats….

Note to science geeks: I am aware that I have very much simplified some very complex science in an effort to communicate and inform

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