Friday, 27 January 2017
Dear You ...
Friday, 29 July 2011
Parasites, Cancer and Chemtrails
I saw a very interesting article today on Facebook about Cancer and the possibility that it’s caused by the evolution of a new parasitic species that has taken up residence inside our bodies.
Apparently, and according to the article in question, this theory isn’t really new. As far back as 1956, Biologist Julian Huxley claimed that growing tumors belonged to a new species. However, it would seem that his theory paled in comparison with the prevailing one that still persists today, which is that cancer is a consequence of genetic mutation.
What I find curious is that, between 1956 and the end of the millennium, death by cancer represented a fairly small percentage of the population. Admittedly, a lot of data regarding cancer wasn’t submitted, filed or reported either during that time, but I’m sure we all agree we use to hear of it less.
It’s documented that in 2005 there were an estimated 1,372.910 US cases of which 570,00 or so were terminal. The forecast for 2011 is 1,596,670 new US cases and 571,950 deaths expected to occur. Those figures don’t look quite right to me; especially considering that in 2004 there were 7.4 million deaths worldwide.
How can we have a 223,760 new US cases of cancer predicted but only 1,950 newly expected deaths? I know we have new drugs and better cancer management, but we’re discovering new cancers all the time. We don’t yet have a cure. So, the percentages of survival seem a little low to me in comparison to the new cases predicted to emerge.
As a matter of interest, in 2007 there were 7.9 million deaths worldwide and in 2010 cancer became the number one killer globally; claiming the lives of well over 8 million people.
Another little fact that I find very curious is that cancer seems to prefer low income underdeveloped countries; claiming 70% of its victims there. Now why is that?
I was under the impression that our modern day stressful, smoke filled, junk food lifestyles were to blame. So, how does cancer find itself so prominent in societies where life is so much simpler than our own?
This brings me back to the article I read today. Parasites!
It’s long been thought that chemtrails infect us with parasites called Morgellons. There is so much information available on the world wide web, I’m not going to go into details here. If you’re interested, just type in chemtrails morgellons in Google and see what you come up with.
However, I found a very interesting video on youtube about a fibre that was found after a chemtrail blast. The strand looks like no more than a fibre of hair. Yet, under microscopic scrutiny, presents itself as the very parasite it is. The frightening thing is, it appears to have some sense of individualism. It shows a certain intelligence of its own.
The link to the youtube viedo is posted below, but I warn you - It’s not for the faint of heart.
So, if it is true that a new species of parasites is to blame for cancer and if it is true that chemtrails are showering us with parasites, can the two not be linked? I leave you to ponder the question, find out the facts and come up with your own theories and answers.
http://www.youtube.com/watch?v=AQsotLwwwuw&feature=related
http://www.cancer.org/acs/groups/content/@nho/documents/document/caff2005f4pwsecuredpdf.pdf
http://www.tiptoptens.com/2011/03/27/10-cancer-facts-and-stats-2011/
Monday, 19 July 2010
A false claim to cure cancer
The company in question, which shall remain nameless, is falsely making miraculous claims that it can heal cancer through the use of natural products. That doesn’t worry so much as the fact that it’s giving people false hope and emptying their wallet at the same time. Worse still, it could discourage people from following appropriate conventional treatments.
I’m a believer in integrated methods of medical intervention; a little of both - Conventional and Natural Methods of Healing.
Anyway, I looked up the products in question and decided to research the ingredients. There is nothing out of the ordinary and nothing that can’t be had from a more balanced every day diet. If our daily intake consisted of more pulses, grains, fibres, water, fresh fruit and vegetables, we wouldn’t need to resort to supplements such as these.
Here’s why. Here are just a few of the ingredients:
IP-6 (Inositol hexaphosphate) - Just as easily found in high fiber foods such as beans, pulses, grains etc.
ß-Sitosterol - Just as easily found in advocados, cumin, black pepper seeds, soya etc.
The one thing you should know about the above is that they are not easily synthesized. It’s also dubious how much is assimilated in the human body due to our digestive system process.
phytosterols Cordyceps sinensis mycelia extract Baker’s yeast (Saccharomyces cerevisiae) extract Agaricus blazeii fruiting body extract Aloe (Aloe barbadensis) leaf gel extract Oat (Avena sativa) seed extract Olive (Olea europaea) - Courtesy of the “Product specific website” - who shall remain unnamed.
Everything seems to be natural.
One word of warning against yeast intake though. It is a well known fact that reducing the amount of yeast in one’s diet can: a) increase life expectancy by up to 50% and b) reduce infections in the body like candida.
Another ingredient that is contained in another product is Colostrum. Colostrum is a cow milk produced in very late pregnancy or even one day after giving birth.
When it’s fed to new born calves, it is known to have a mild laxative effect. It contains many beneficial antibodies that help to eliminate dead red blood cells and it contains a large amount of proteins that are all beneficial to the development of organs and body tissue.
Yet, its beneficial properties and its effects in human consumption are little known and very dubious because of the human digestive process; not to mention the fact that many people nowadays are lactose intolerant.
Colostrum had once been used as an alternative to the modern day antibiotic. In fact, it was one of the original ingredients in an early polio vaccine. Nowadays, there is talk of it being used once again as
Since Colostrum contains IGF-1, the lack of which is associated with malnutrition, dementia, obesity and lean body mass, it is reputed that a supplementation can help with these conditions. However, it seems to be that there is little scientific research and few clinical trials to back these claims.
However, one interesting fact is that within colostrum, scientists discovered Proline-rich Polypeptides (PRP) - These are molecules that transmit signals to the immune system. It was originally believed that these peptides had the capacity to transfer immunity from one immune system to another. However, this is not the case. What is more likely to happen is that the molecules send signals to the immune system to boost it in times of attack from foreign bodies, which means we can better deal with disease.
I did find some research regarding the use of PRP supplements and HIV, herpes, Hodgkins, prostrate cancer and Alzheimer’s. Now, while the research findings seem to stabilise 40% of the patients’ symptoms and condition in the short term, i.e. over a 15 week trial; there are no long term studies. So, we are far from knowing what the long terms effects.
So, please be warned this is not a long term solution for any of the above conditions nor can it claim to be a cure for cancer as this company is falsely promising.
Another warning for any of this company’s products containing Chicken egg yolks - Anyone who is dairy intolerant should avoid taking this ingredient.
In conclusion, this company cannot lay claim to finding a cure for cancer. They cannot lay claim to having a product for transferring one immune system to another. All they have is another marketable natural supplement.
Will it may you feel good? Well, if you’re not dairy intolerant, yes it might. Will it work? That depends on your own immune system and how your body responds to the products.
Please, however, before you part with your hard earned cash, do not think you are buying into a miracle cure.
http://en.wikipedia.org/wiki/Colostrum
http://www.drweil.com/drw/u/QAA400312/consider-cows-colostrum
http://www.sciencedaily.com/articles/c/colostrum.htm
http://www.cancer.org/Treatment/TreatmentsandSideEffects/ComplementaryandAlternativeMedicine/DietandNutrition/inositol-hexaphosphate
http://en.wikipedia.org/wiki/Beta-Sitosterol
http://news.bbc.co.uk/2/hi/health/4583063.stm
http://www.buzzle.com/articles/how-reducing-yeast-in-your-diet-can-cure-candida.html
Thursday, 15 July 2010
Cancer and Massage or Aroma-Massage
We all know someone who has had cancer and if we don’t, chances are we will before our own time is up. Yet, what do we really know about this disease apart from the fact that it’s a silent killer for which there is still no known cure; although nowadays there are a lot of treatments that are proving to be effective in many cases.
Please let me add here that although alternative therapies such as Aromatherapy Massage, Reiki, Ayurveda, Reflexology, Indian Head Massage etc. may bring relief to patients who have cancer, they are by no means a cure. They are complimentary. They can and should only be used, in my opinion, as an integrative part of conventional medicine.
I could go on and on about the benefits of Holistic Therapies but I’m sure you’ve all heard them a million times before. What I will say is that “touch” is extremely important for any human being, but it’s probably more important to cancer patients, or any patient for that matter, who gets poked and prodded around all day by needles and is subjected to chemotherapy or radiotherapy.
An oncology patient’s body is subjected to such harsh procedures and conditions that it becomes almost abused by medical standards. Of course, it’s a necessary part of the medical healing process, yet it’s surprising how many times even relatives find it difficult to touch a body that changes beyond their own recognition of it; unless it’s to feed it, wash it or give it a kiss on the forehead. Sometimes, even the cancer patients themselves feel detached from their own ever-changing body.
A simple yet loving touch from another human being is sufficient to reconnect an oncology patient to his or her own body. A gentle caress, a soft massage, a kind stroke of the hand is enough to bring peace of mind, relaxation, appease fear and depression, create an atmosphere of positivity, create distraction, alleviate tiredness and, of course make them feel safe, secure and loved.
If a Holistic treatment is administered under the proper conditions, with maximum care and abiding by certain cautious guidelines, it can also help to alleviate the feelings of weakness, dizziness and/or sickness after medical treatments like chemotherapy.
Up until recently, in the United Kingdom, Australia and the United States, Oncology wards in mainstream hospitals used Holistic Health Therapies and Aromatherapy Massage as a means of bringing relief to cancer patients. Not to mention that Eastern cultures have been using Holistic concepts of Healing since time began.
Yet, the big question that has sparked controversy and that everyone is trying to answer is:
”Can massage and aroma-massage spread cancer?”
Well, my research leads me to the conclusion that scientifically, there is no evidence to prove that it can; not any more so than exercising anyway. By the same token, there is also no real evidence to prove that it can’t if it misused.
However, if massage or aroma-massage is conducted under appropriate circumstances, abiding by certain conditions and using specific techniques, then it is perfectly safe, but the therapist would have to have medical knowledge, specific oncological knowledge and a great deal of compassion and intuitive knowing.
Why? - Simple -
As we all know our bodies are made up of millions of different cells. Over time, these cells become damaged or old, due to the physical conditions they are subjected to, and they die. They are replaced with new cells. Only, sometimes, the new cells can be damaged to due their DNA content. This means they can mutate and develop abnormally. When this happens, we call the cells cancer cells. This abnormal development of cells may form a mass; a whole bunch of cells clustered together in what is known as a tumour.
When we think or hear the word tumour we automatically panic. However, not all tumours are necessarily harmful, nor are they necessarily cancerous in nature. Hence, we use the terms benign and malignant to determine the two different types of tumours.
If a tumour is benign it basically means the cells do not spread to another part of the body. According to medical research in current standing, benign tumours can be removed safely and upon removal, probably won’t come back. Personally, I think there is a lack of sufficient scientific evidence, in this area, for the latter part of this statement to be true. Reason being, I had a gentleman client who was prone to benign tumours. It seems that the more consultants surgically removed the benign tumours from his body, the more they appeared.
Without his complete medical history, I could not determine the exact locations nor prove or disprove any personal theories. However, this one individual case was enough to raise concern and doubt in my mind, and considering that there are always exceptions to all general theories in science, I think it is a noteworthy fact not to be dismissed.
On the contrary to its counterpart, when a tumour is malignant, something called metastasis occurs. This basically means the cells that have clustered together: start to break off. When these cells break away from the cluster, they travel through the blood system and/or the lymph system into other areas of the body; attacking it or invading it.
The one thing we need to understand about cancer is that there are over 100 different types. They do not all behave the same way. They do not all form tumours. They do not all start in the same areas or necessarily for the same reasons. Moreover, no two individuals will respond to cancer and subsequent cancer treatments in the same way either. Cancer may start in a singular cell in a major organ just as easily as it may start on the skin or in the in the bone marrow or the blood itself.
Some cancer patients may have lumps, others may have red swollen areas. Some may have very subtle signs of the disease. Some cancer patients may have cancer in one area of the body and suffer pain in a completely opposite area. This is where training in Kinesiology comes in very useful.
Anyone who wants to massage or touch a cancer patient should be very aware of any areas that are “off limits.” Any areas that are being treated, any areas that are bruised, swollen, red, or have broken skin are all off limits!
Also, common sense might dictate that directly and harshly massaging a tumour could potentially cause the cells to break away from the cluster and travel into the body. So, in this respect, one has to question whether there is potential danger of causing metastasis through massage. I can see, from this point of view, where the controversy might arise, but, directly massaging a tumour if off limits, so there is no reason for concern. You never massage a tumour!!!
The most important things are that there should be a) thorough communication between the therapist and the cancer patient in a prior interview; b) the therapist should be flexible and have the ability to design new techniques and methods of treatment around the patient’s needs and c) any touch should be loving and compassionate not of technique learnt in a school nor of the ego. The cancer patient and their body should be listened to and paid attention to at all times.
Saturday, 30 January 2010
The H1N1 Vaccine - Know it in detail!
As you know, I am a member of the British Psychological Society and the British Mensa Society. My background is in Psychology and Natural Medicine but within both fields I had to study a part of conventional science; not enough to be qualified to conduct my own scientific laboratory research, but enough to be able to bring you informed research from reliable medical sources - if there is such a thing nowadays. I say that because most scientific research nowadays has some invested interest somewhere, and results are sometimes dependent on who’s funding it.
Just recently, I’ve been engaged in more conversations about the swine flu (Influenza A or Gripe A) and the H1N1 vaccine than I care to mention. Many of my colleagues have had the vaccine and some have suffered adverse reactions to it; from headaches to vomiting. However, the biggest plea I received was from my mother who has also been vaccinated. She asked me to please prove the vaccine was safe and that it couldn’t cause cancer.
So, I decided to carry out my own independent research a) to see what I could come up with and b) to inform everyone, in simple terms, about the pros and cons of the vaccine and the flu itself.
I’ve tried to put together material from as reliable and accurate sources as possible. Please consider it very carefully and make your own formulated opinion. Please also consider that since I am not a laboratory researcher, I can only give you facts and data collated by third party scientists in their own research environments.
I wish I could be the one to give my mother good news but I’m not sure I can. My conclusion is that the vaccine does contain known cancer causing substances that are toxic to humans. However, there is some discrepancy as to what dosages are considered highly toxic. So, at this point nobody can predict what the long term side effects will be. Furthermore, everybody’s body will react in a different way; just as some people can smoke all their lives and never develop cancer, whilst others can’t.
By the same token, I can say that one of the vaccines being manufactured does contain a substance that, in laboratory rats, has been known to act as an anti-chemical carcinogenesis. Whether this works in humans is still unknown since clinical trials, with humans, have not yet been carried out.
I think, in all honesty, only the future will tell.
I’ve tried to do my best to bring you the breakdown of the chemical ingredients in the vaccine, and what they’re used for. The rest is up to you to get more information, be aware, take responsibility and do your due diligence.
Be safe. I value every living being.
Background Information
There is a wealth of information on the Internet about the Influenza A. I am not going to reiterate here. However, the “so-called” swine flu first appeared in 1918. It was responsible for the death of between 50 - 100 million people worldwide. It primarily claimed the lives of healthy adults between the ages of 20 and 40. Why? Because it caused something called a cytokine response - what is this?
It’s a term used to describe when the body’s immune system goes into overdrive at defending our organism against harmful external viruses. Basically, the more healthy a body is, the harder it fights off external threats. The harder it fights, the more it goes into overdrive until it, basically, send the system into tilt.
Weaker immune systems, as found in younger people, children, babies and elderly people have slower and weaker responses, which placed them out of the common death claiming range.
I didn’t find any documented evidence that suggested the 2009 Influenza A claimed any lives due to the cytokine response. However, I did find evidence that there is a mutated version of the Influenza A, which has claimed the lives of (maybe) 6 people worldwide. Whether these facts, figures and data are correct is unknown; since we cannot rely on the Media nowadays to duly and accurately inform us.
However, there are a lot of factors that need to be considered when we look at the 1918 death toll. It was war time. Hygiene standards, on a global scale, were much lower. People suffered with malnutrition in areas that nowadays don’t. Troops were constantly on the move, and in great numbers on a global scale, hence the contamination process was greatly aided and speeded up. There was less awareness about the contamination process itself. Little was known about viral infections in general. We didn’t have micro-medications we have today. The list could go on.
Of course, there would also be conspiracy theorists who would have us believe the H1N1 was a laboratory manufactured virus, as a type of biological warfare; specifically designed to eliminate a certain age group of the population in order to end, and win, the war. Personally, I do not believe this as there were too many casualties on all sides.
The 1918 Influenza A didn’t just disappear as many would have us believe. It apparently weakened itself over time, as many viruses do, but lay dormant somehow; somewhere. It reappeared again in 1937.
The scandalous facts about the 1937 outbreak is that scientists in the UK and the United States used patients, they describe as “feebleminded” at various psychiatric institutions as human guinea pigs for live anti-viral testing. Yes, you read it correctly. Scientists injected about a third of the patients, across various institutions at various locations, with a vaccine containing “live” Influenza A virus; no doubt without written consent. http://aje.oxfordjournals.org/cgi/pdf_extract/35/1/55
If you follow the link above, to the article written in 1941, what amazes me is how scientists report patients were inoculated, and I quote, 5 to 10 weeks before the onset of an Influenza epidemic. We have two choices here: a) we can think that any serious Influenza, at that time was considered an Influenza A, or that somehow the relaunch of the Influenza A (of which by definition of gene content there is only one associated with the Swine flu) was premeditated in a bid to use more humans as guinea pigs.
In 1946/47, there was another outbreak of Influenza that apparently started in Japan. People were inoculated with a milder strain of the H1N1 vaccine but it proved to be a complete failure. Even nowadays, the H1N1 vaccine will not protect you from the swine flu nor any of its mutations thereof.
In 1957, 1968, 1976, 1977 there were more minor outbreaks of various types of Influenza; including the H1N1 that struck people who hadn’t had it previously. Of course, then, closer to the 21st century we’ve had the Avian Influenza and now we have the new H1N1 again.
An interesting fact I came across is that in 2008, in a bid to study the Avian Influenza virus, scientists exhumed the body of a man who died during the 1918/1919 pandemic. He was buried in a lead coffin, which could have very well preserved the H1N1 virus. I’ll leave it to you to think what you will.
So, I come to the modern day 2009 Influenza A. You’ve all heard about it. You all know what it is and how it can affect you. You all know what steps you can take to avoid contamination and spreading. So, I’m not going to go into any details here. What I will say though is that more people have died from a common flu than from the Influenza A.
It’s the Media hype that has blown it out of control and disseminated fear into our minds with a little help from the pharmaceutical companies who have an invested interest in making billion and billions of dollars; not just in the short term, with the vaccines, but in the long term as well, with the potential side effects the vaccines could have in a large proportion of individuals that have it.
Current Manufacturers of the Influenza A (H1N1) vaccine
To date, I have found 5 major manufacturers of the Influenza A vaccine. They are: Sanofi Pasteur, Novartis Vaccines and Diagnostics Limited, CSL Limited, ID Biomedical Corporation of Qebec and MedImmune, LLC. The vaccine produced by ID Biomedical Corporation of Qebec is being distributed by Glaxo Smithkline Beecham.
As a matter of curiosity, I went digging around for financial reports for all the pharmaceutical companies mentioned above. As with all businesses, they suffered losses due to the economic crisis the world has been facing. Stocks had fallen. Yet, they are rising again slowly since the advent of the “hearsay” Influenza A epidemic.
As anyone who deals in stocks and shares will know, the more a rumour is spread, the more likely it is a product will sell. The more likely it is that a product will sell, the more likely it is a company will find investors or the more likely it is prices of stock will go up and the company makes money all round.
Far be it for me to be a sceptic, but in a world where economic growth is at an all time slow and world markets show no sign of immediate recovery, perhaps the banks and the big boys behind wall street, (and most of the global power), found a window of opportunity to increase their bank balances, recover their losses and guarantee an income for the coming years.
How? Simple, develop a vaccine that, theoretically, does little or nothing against the Influenza A, yet injects people with toxic substances that in the long term might have detrimental effects on their health, and ensure they require more medication in the future. More medication equals more guaranteed income for the pharmaceutical companies. I hate to say this but it’s also a way to control the population count.
I’d like to just say here that I am not in any way a conspiracy theorist. I look at the given facts before coming to any conclusions. The facts, in this case, are exemplified by the Polio vaccine first introduce in 1955. By 1961, the vaccine was declared unsafe for human consumption because it was thought to be contaminated with a substance called SV40, a carcinogen that came from infected monkeys.
Yet, that very same vaccine continued to be used well into the year 2000 on a global scale. Hundreds of millions of people worldwide have potentially been exposed to this silent killer. In some, the effects have become apparent. Sufferers in whom cancer has already developed, relatives of people who died and/or some people who have become or became paralysed, because of the vaccine, have carried out lawsuits. You can find more information on the net by searching for links between polio vaccines and paralysis lawsuits.
With the new H1N1 vaccine, as far as I am aware, the pharmaceutical companies have a clause that stipulates they cannot be brought into a court of law should anyone suffer any side effects. This clause alone begs the question: “Why?”
It’s my humble opinion we do not question enough what we allow medics to put into our bodies. We do not investigate enough. We place too much trust in the hands of our doctors and the Media. It doesn’t take a medical degree to ask what something is and what it is used for, and nowadays we have no excuse. Information is everywhere.
Prior to the current manufacturers of the vaccine H1N1, Baxter International Inc. developed a vaccine that contained H5N1 (avian flu virus) and H3N2 (seasonal flu viruses.) In experiments, ferrets were found to die from the vaccine, which suggested the H5N1 virus was live. If this substance had been injected into humans it could have had disastrous consequences.
Human beings could have acted as incubators for a new crossbreed virus that could have then been transmitted from one being to another. The vaccine went out. It was discovered by pure accident. However, it is now said that all known batches of the Baxter vaccine have been recalled.
Human errors happen. Accidents happen. Researchers, scientists, doctors, nurses; nobody is infallible. It’s our responsibility to safeguard ourselves from others’ errors.
H1N1 Vaccine - “Known” Ingredients
This is the list of ingredients contained within the vaccines that I’ve been able to find so far. As you will see, different pharmaceutical companies are using slightly different ingredients. I have no idea if there are other “unmentioned” ingredients as I cannot get my hands on all the packaging labels that come with the actual vaccines (as of yet.)
Sanofi Pasteur
Formaldehyde, Gelatin, Sucrose, Thimerosal, Sodium chloride, Sodium phosphate, Chick embryo cells, Triton X-100, Polyethylene glycol.
Novartis Vaccines and Diagnostics Limited,
Beta-propiolactone, Neomycin, Polymyxin B, Thimerosal, Mercury, Chick embryo cells, Egg protein, Nonylphenol ethoxylate.
CSL Limited,
Beta-propiolactone, Polymyxin B, Sucrose, Thimerosal, Mercury, Sodium chloride, Sodium phosphate-monobasic, Ovalbumin (egg), Chick embryo cells, Neomycin sulphate, Calcium chloride, Sodium phosphate- dibasic anhydrous, Potassium phosphate- monobasic, Sodium taurodeoxycholate, Triton X-100.
ID Biomedical Corporation of Qebec
Formaldehyde, Thimerosal, Mercury, Ovalbumin (egg), Egg protein, Virus: Influenza virus antigens, Sodium deoxycholate.
MedImmune, LLC.
Gentamicin Sulfate, Gelatin, Monosodium Glutamate (MSG), Sucrose, Potassium phosphate, Chick embryo cells, Potassium phosphate- monobasic, Arginine.
Please note that anyone suffering with egg allergies should not go anywhere near the vaccine.
Know these ingredients - What are they?
I am not going to describe every ingredient in detail, as I am sure you know what many of them are; like sucrose (sugar), gelatin (which can cause allergies in some people), ovalbumin (egg or egg protein), sodium (salt) and so on. However, I am going to bring to your attention the most important ones that need very careful reflection.
Formaldehyde
As many of you probably already know, Formaldehyde is a colourless and odourless substance that was once used in building materials; in resin form for insulating foam, as an adhesive and to treat textiles. Its primary function was to act as a fungicide, sterilizer and germicide. It’s also used in morgues and laboratories (in liquid form) as embalming fluid and to preserve bodies. Formaldehyde is actually naturally present in the atmosphere in very small quantities because every living organism produces and emits a tiny amount of it.
Different people have different reactions to over-exposure to Formaldehyde and, of course, the severity of symptoms depends on the amount of exposure.
According to the U.S Goverment’s National Cancer Institute website information and the International Agency for Research on Cancer (World Health Organization) - http://www.cancer.gov/cancertopics/factsheet/risk/formaldehyde - http://monographs.iarc.fr/ENG/Monographs/vol88/index.php - studies have been carried out, on a global scale, since the 1980s to see just what the effects of Formaldehyde are.
In 1980, Formaldehyde was found to cause nasal cancer in rats. In 1987 Formaldehyde was declared a cancer causing substance for humans (carcinogen) and found to be associated with different types of cancers. In fact, in 1988 and again in 2003, scientists in the United States and the United Kingdom found a serious relationship between over-exposure to Formaldehyde and deaths caused by lung cancer in industries where Formaldehyde was being used as a chemical agent. (http://monographs.iarc.fr/ENG/Monographs/vol88/mono88-6B.pdf) - In Denmark, Formaldehyde was associated with lung, kidney, colon and nasal cancer in a study carried out by Hansen and Olsen. http://www.springerlink.com/content/w632326683541334/ The list and studies go on. I suggest you follow the links if you’re interested in the full research findings.
Pregnant women who were exposed to Formaldehyde have been known to give birth to deformed babies. There were known cases studied in China, UK and US. In fact, just recently I was talking to a friend about the UK being one of the first countries in the world to pay compensation to mothers, of deformed babies through exposure to Formaldehyde, who sought legal action.
Why would the World Health Organization, any Government or any Health organisation knowingly approve that we be injected with a substance, (no matter in how much of a small dosage), that they themselves officially declared as a carcinogen?
Tween 80 (also known as Polysorbate 80)
First of all, Tween 80 is a drug used to trick the blood brain barrier to open up so that nano-drugs can be carried through into the brain. However, in 2005, it was discovered that this drug can cause hives, breathing problems and a sharp enough drop in blood pressure to actually be fatal. Aside from this, it was found to cause infertility in mice.
I quote: http://www.whale.to/v/tween_80.html
According to the World Intellectual Property Organization, which is part of the United Nations, scientists from the organization are developing vaccines specifically to damage fertility as a method of contraception. A suggested ingredient for the vaccine is tween 80 (polysorbate 80): “In a preferred embodiment the vaccine comprises oil, preferably a biodegradable oil such as squalene oil. Typically, the vaccine is prepared using an adjuvant concentrate which contains lecithin in squalene oil. The aqueous solution glycoprotein is typically a phosphate-buffered saline (PBS) solution, and additionally preferably contains Tween 80.” (Fertility Impairing Vaccine And Methods of Use’ This application claims the benefit of U. S. Provisional Application No. 60/070,375, filed January 2,1998, U. S. Provisional Application No. 60/071,406, filed January 15,1998.) Exploring Vaccines
You will see, from what I have highlighted in red and orange that a couple of questions arise:
a) Are the pharmaceutical companies trying to control the number of future births; on a global scale?
b) Or, are they trying to subsequently cash in on fertility treatments? Think about this, with each treatment costing between 2,000 to 5,000 US dollars, just how much would they stand to cash in on if a third of the global population was sterile? After all, is it not nearly every couple’s dream to have a child?
Thimerosal and Mercury
Thimerosal is a type of Mercury used as a preservative. So, I am shocked to find that the H1N1 has both Thimerosal and Mercury contained within the vaccine. Both elements have been declared dangerous to health and linked to autism in children, cardiovascular disease in adults, brain tissue damage and other malfunctions of the nervous system.
For years, the FDA in the United States has admitted that Mercury is toxic. For years, it has been reviewing what quantities can be excreted from the body safely. Yet, regardless of the amount of research carried out, the answer is: we still don’t know. Scientists still don’t know. For years the FDA has been campaigning to remove Thimerosal altogether from vaccines. Yet, pharmaceutical companies are still selling vaccines with Mercury and Thimerosal, and the FDA are still approving them. Why?
You can read full reports on Thimerosal and Mercury here:
http://www.naturalnews.com/011764.html
http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/UCM096228
Triton X-100
Commonly used as a spermicide. Also used as a detergent and a solvent for vinyl record cleaning.
Polyethylene glycol
I find the inclusion of this ingredient very interesting. Apparently, to date, it is a known anti-chemical carcinogenesis in laboratory rats. However, whether or not it can prevent the development of cancer in humans is not yet known because, (as far as I could find out), there haven’t been any human clinical trials yet.
I have to wonder, though, if the inclusion of this substance in the H1N1 vaccine is part of a live clinical trial. Think what you will.
Squalene - Although it’s not on the official packaging, we know it’s being used.
Squalene is an oil that derives from sharks’ liver primarily and some plants as well. It’s used in cosmetics because it’s easily absorbed through the skin and doesn’t leave an oily after-feeling. In medicine, it’s added to vaccines to stimulate the immune system’s response because it enhance the production of what are known as CD4 memory cells. However, squalene has never been approved for this usage by the FDA.
I quote: http://www.novaccine.com/vaccine-ingredients/results.asp?sc=27
"Animals injected with squalene always develop painful, incurable, autoimmune diseases like multiple sclerosis, rheumatoid arthritis or systemic lupus according to investigative journalist Gary Matsumoto, former reporter for NBC and Fox News. (Gary Matsumoto, Vaccine A: The Covert Government Experiment That's Killing Our Soldiers and Why GIs Are Only the First Victims, Basic Books, 2004) Dangers of squalene have been known since 1956 when Dr. Jules Freund, creator of this oil-based adjuvant, warned that animals injected with his formulation developed terrible, incurable conditions: allergic aspermatogenesis (stoppage of sperm production), experimental allergic encephalomyelitis (the animal version of MS), allergic neuritis (inflammation of the nerves that can lead to paralysis) and other severe autoimmune disorders. Squalene (MF 59) was added to the anthrax vaccine. This vaccine caused tens of thousands of U.S. Iraq Desert Storm soldiers to suffer permanent neurological damage called “Gulf War Illness.” (Jane Bergermeister, Adjuvants to be added to H1N1 vaccine by Baxter and WHO programme body for “endless loop of self-destruction, 2009) Squalene (MF 59) enzyme is not approved for human consumption but waived for use in the H1N1 vaccine. It also potentially causes “undiscovered side effects” according to Jefferson, Mercola and others. "
Deborah Dupre, Examiner.com -- 8/18/2009
Mono Sodium Glutamate
Mono Sodium Glutamate is known as an excitotoxin. It’s an additive that’s been used in food for centuries; to make it taste better. The truth behind it is, it kills off certain neurons in the brain by overstimulating them.
Russell Blaylock, an American neurosurgeon, has made a very convincing connection between continuous exposure to Mono Sodium Glutamate, in adults, to (and I quote) an accelerated onset and degeneration in Alzheimer's disease, Parkinson's, and ALS as well as headaches, seizures, strokes and AIDS dementia.
http://curezone.com/foods/msg.asp http://www.russellblaylockmd.com/
Polyethylene glycol
Usually used as a laxative or as a substance to coat suppositories with. It is also found in cosmetics because of its lubricant nature.
Nonylphenol ethoxylate
Mainly used in detergents, as emulsifiers and found in some pesticides, Nonylphenol ethoxylate is a man-made chemical that was officially declared dangerous to the environment by the European commission and the WWF. It was found to have serious detrimental effects on the female reproductive organs in aquatic species and also found to lower the sperm count in male species. Just how it affects humans is still relatively unknown.
In 1992 the Paris Commission urged the European parliament to recommend that the use of Nonylphenol ethoxylate be completely phased out of domestic cleaning substances by the year 2000. You can read the full International report here:
http://www.ngo.grida.no/wwfneap/Publication/briefings/Nonylphenol.pdf
As far as I discovered, in 2003, the product was banned in Europe by the European Parliament. Here’s the Directive:
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:178:0024:0027:EN:PDF
Gentamicin Sulfate
This is an antibiotic. However, in some people it can cause side-effects of vomiting, nausea, increased salivation, joint pain, visual disturbances, dry eyes, tinitus, vertigo etc.
You can see the full description on the packaging details here:
http://medical-dictionary.thefreedictionary.com/gentamicin+sulfate
Other Internet Sources:
CDC - Emerging Infectious Diseases
http://www.cdc.gov/ncidod/eid/vol12no01/05-1254.htm
United States Government National Cancer Institute
http://www.cancer.gov/cancertopics/factsheet/risk/formaldehyde
International Agency for Research on Cancer (World Health Organization)
http://monographs.iarc.fr/ENG/Monographs/vol88/index.php
(http://monographs.iarc.fr/ENG/Monographs/vol88/mono88-6B.pdf)
United States Department of Labor
Occupational Safety and Health Administration
http://www.osha.gov/SLTC/formaldehyde/
Formaldehyde and cancer morbidity among male employees in Denmark
http://www.springerlink.com/content/w632326683541334/
Warnings: (Courtesy of the following websites:)
http://www.rumormillnews.com/cgi-bin/archive.cgi?read=150745
FLU VACCINE RECOMMENDATIONS FOR ALL PREGNANT WOMEN (CDC)
The Advisory Committee on Immunization Practices (ACIP): Vaccination of pregnant women is recommended by the Centers for Disease Control Advisory Committee on Immunization Practices (ACIP). < http://www.cdc.gov/vaccines/pubs/vis/default.htm#flu > http://www.cdc.gov/vaccines/pubs/vis/default.htm#flu
FDA approved manufacturers package insert: Manufacturers warnings
Sanofi Pasteurs Fluzone package insert, WARNING www.vaccinesafety.edu/package_inserts.htm" TARGET="_blank">http://www.vaccinesafety.edu/package_inserts.htm>www.vaccinesafety.edu/package_inserts.htm>
8.1 Pregnancy Category C: Animal reproduction studies have not been conducted with Fluzone vaccine. It is also not known whether Fluzone vaccine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Fluzone vaccine should be given to a pregnant woman only if clearly needed.
8.2 Nursing Mothers: It is not known whether Fluzone vaccine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Fluzone vaccine is administered to a nursing woman.
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility: Fluzone vaccine has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.
NOTE: CDC does not require providers to inform pregnant women of the Thimerosal (mercury) content.
Appendix A - Sanofi Pasteur Packaging Insert -
Courtesy of the FDA -
http://www.fda.gov/downloads/biologicsbloodvaccines/vaccines/approvedproducts/ucm182404.pdf
sanofi pasteur 449/454 Influenza A (H1N1) 2009 Monovalent Vaccine
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use Influenza A (H1N1) 2009 Monovalent Vaccine safely and effectively. See full prescribing information for Influenza A (H1N1) 2009 Monovalent Vaccine.
Influenza A (H1N1) 2009 Monovalent Vaccine Manufactured by Sanofi Pasteur Inc. Suspension for Intramuscular Injection Initial US Approval: 1980
----------------------------RECENT MAJOR CHANGES------------------------------ Indications and Usage ( 1 ) [9/2009] Dosage and Administration ( 2.2 ) [9/2009]
----------------------------INDICATIONS AND USAGE------------------------------- Influenza A (H1N1) 2009 Monovalent Vaccine is an inactivated influenza virus vaccine indicated for active immunization of persons 6 months of age and older against influenza disease caused by pandemic (H1N1) 2009 virus. (1)
--------------------------DOSAGE AND ADMINISTRATION------------------------- Based on currently available information the vaccination regimen is as follows:
Children ▪ 6 through 35 months of age (0.25 mL dose, intramuscular injection): - Two 0.25 mL doses approximately one month apart. (2.2) ▪ 36 months through 9 years of age (0.5 mL dose, intramuscular injection): - Two 0.5 mL doses approximately one month apart. (2.2) ▪ 10 years of age and older - A single 0.5 mL dose, intramuscular injection. (2.2) Adults - A single 0.5 mL dose, intramuscular injection. (2.2)
---------------------DOSAGE FORMS AND STRENGTHS--------- Influenza A (H1N1) 2009 Monovalent Vaccine, a sterile suspension for intramuscular injection, is supplied in four presentations: ␣ Prefilled syringe, 0.25 mL, no preservative; distinguished by a pink syringe
plunger rod (3) ␣ Prefilled syringe, 0.5 mL, no preservative (3) ␣ Single-dose vial, 0.5 mL, no preservative (3) ␣ Multi-dose vial, 5 mL, contains thimerosal, a mercury derivative, added as a
10 September 2009_v0.3 LE5860-5862
-------------------------------CONTRAINDICATIONS------------ ␣ Severe hypersensitivity to egg proteins or any component of the vaccine
or life-threatening reactions after previous administration of any influenza vaccine. (4, 11)
-----------------------WARNINGS AND PRECAUTIONS--------------------- ␣ If Guillain-Barré syndrome (GBS) has occurred within 6 weeks of
previous influenza vaccination, the decision to give Influenza A (H1N1) 2009 Monovalent Vaccine should be based on careful consideration of the potential benefits and risks. (5.1)
␣ Immunocompromised persons may have a reduced immune response to Influenza A (H1N1) 2009 Monovalent Vaccine. (5.2)
------------------------------ADVERSE REACTIONS-------------- Adverse reaction information is based on studies conducted with seasonal trivalent Influenza Virus Vaccine. ␣ Most common (≥10%) local reactions were soreness at injection site,
tenderness, pain, and swelling. (6) ␣ Most common (≥10%) systemic events were malaise, headache, and
myalgia. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Sanofi Pasteur Inc., Discovery Drive, Swiftwater, PA 18370 at 1-800-822-2463 (1-800-VACCINE) or VAERS at 1-800-822-7967 or http://vaers.hhs.gov.
------------------------------DRUG INTERACTIONS-------------- ␣ Do not mix with other vaccines in the same syringe or vial. (7.1) ␣ Immunosuppressive therapies may reduce the immune response to
Influenza A (H1N1) 2009 Monovalent Vaccine. (7.2)
-----------------------USE IN SPECIFIC POPULATIONS------- Information in this section is based on seasonal trivalent Influenza Virus Vaccine manufactured by Sanofi Pasteur Inc. (Fluzone vaccine). ␣ Safety and effectiveness of Influenza A (H1N1) 2009 Monovalent
Vaccine have not been established in pregnant women or nursing mothers
or children <6 months of age. (8.1, 8.3, 8.4) ␣ Antibody responses to Fluzone vaccine were lower in the geriatric
population than in younger adults. (8.5) See 17 PATIENT_COUNSELING_INFORMATION.
preservative. Each 0.5 mL dose contains 25 mcg mercury. (3, 11 ) _______________________________________________________________________________________________________________________________________
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION
2.1 Preparation for Administration
2.2 Recommended Dose and Schedule 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS
5.1 Guillain-Barré Syndrome 5.2 Altered Immunocompetence 5.3 Preventing and Managing Allergic Reaction 5.4 Limitations of Vaccine Effectiveness
6 ADVERSE REACTIONS
6.1 Clinical Trial Experience 6.2 Post-Marketing Experience 6.3 Other Adverse Events Associated with Influenza Vaccines
7 DRUG INTERACTIONS
7.1 Concomitant Administration with other Vaccines 7.2 Immunosuppressive Therapies
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use
11 DESCRIPTION 12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action 13 NON-CLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES
14.1 Immunogenicity in the Adult and Geriatric Population
14.2 Immunogenicity in Children 15 REFERENCES 16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
16.2 Storage and Handling 17 PATIENT COUNSELING INFORMATION
*Sections or subsections omitted from the full prescribing information are not listed.
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1 FULL PRESCRIBING INFORMATION:
2 1. INDICATIONS AND USAGE
3 Influenza A (H1N1) 2009 Monovalent Vaccine is an inactivated influenza virus vaccine 4 indicated for active immunization of persons 6 months of age and older against influenza disease 5 caused by pandemic (H1N1) 2009 virus. 6
7 2. DOSAGE AND ADMINISTRATION
8
2.1. Preparation for Administration
9 Inspect Influenza A (H1N1) 2009 Monovalent Vaccine syringes and vials visually for particulate 10 matter and/or discoloration prior to administration. If either of these conditions exist, the vaccine 11 should not be administered. 12
13 Shake the syringe and single-dose vials well before administering the vaccine and shake the 14 multi-dose vial each time before withdrawing a dose of vaccine. 15 16 2.2. Recommended Dose and Schedule
17 Clinical studies are ongoing with Influenza A (H1N1) 2009 Monovalent Vaccine to determine 18 the optimal dosage, number of doses and schedule. 19 20 Available data show that children 9 years of age and younger are largely serologically naive to 21 the pandemic (H1N1) 2009 virus. (1) Based upon these data Influenza A (H1N1) 2009
22 Monovalent Vaccine should be administered as follows:
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1 2 Children 3 Children 6 through 35 months of age should receive two 0.25 mL intramuscular doses 4 approximately 1 month apart. (1) 5 6 Children 36 months through 9 years of age should receive two 0.5 mL intramuscular doses 7 approximately 1 month apart. (1) 8 9 Children 10 years of age and older should receive a single 0.5 mL intramuscular dose. (1)
10 11 The preferred sites for intramuscular injections are the anterolateral aspect of the thigh in infants 12 or the deltoid muscle of the upper arm in toddlers and young children. 13 14 The vaccine should not be injected into the gluteal region or into areas where there may be a 15 major nerve trunk. 16 17 Adults 18 Persons 18 years of age and older should receive a single 0.5 mL intramuscular dose. 19 20 In adults, the preferred site for intramuscular injection is the deltoid muscle. 21
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1 The vaccine should not be injected into the gluteal region or into areas where there may be a 2 major nerve trunk. 3
4 3. DOSAGE FORMS AND STRENGTHS 5 Influenza A (H1N1) 2009 Monovalent Vaccine is a sterile suspension for intramuscular
6 injection. [See Description (11)] 7 8 Influenza A (H1N1) 2009 Monovalent Vaccine is supplied in 4 presentations:
Prefilled syringe, 0.25 mL, no preservative, for 6 through 35 months of age; distinguished by a pink syringe plunger rod; Prefilled syringe, 0.5 mL, no preservative, for 36 months of age and older; Single-dose vial, 0.5 mL, no preservative, for 36 months of age and older;
Multi-dose vial, 5 mL, for 6 months of age and older, contains thimerosal, a mercury derivative, added as a preservative. Each 0.5 mL dose contains 25 micrograms (mcg) mercury.
17 4. 18 Do not administer Influenza A (H1N1) 2009 Monovalent Vaccine to anyone with a known severe hypersensitivity to egg proteins or any component of the vaccine or life-threatening reactions after previous administration of any influenza vaccine. [See Warnings and Precautions 21 (5) and Description (11)]
5. WARNINGS AND PRECAUTIONS
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CONTRAINDICATIONS
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1 5.1. Guillain-Barré Syndrome
2 Recurrence of Guillain-Barré syndrome (GBS) has been temporally associated with the 3 administration of influenza vaccine. The decision to give Influenza A (H1N1) 2009 Monovalent 4 Vaccine to individuals who have a prior history of Guillain-Barré syndrome should be based on 5 careful consideration of the potential benefits and risks. 6 7 5.2. Altered Immunocompetence
8 If Influenza A (H1N1) 2009 Monovalent Vaccine is administered to immunocompromised
9 persons, including those receiving immunosuppressive therapy, the immune response may be 10 diminished. 11 12
5.3. Preventing and Managing Allergic Reaction
13 Appropriate medical treatment and supervision must be available to manage possible 14 anaphylactic reactions following administration of the vaccine. 15 16 5.4. Limitations of Vaccine Effectiveness
17 Vaccination with Influenza A (H1N1) 2009 Monovalent Vaccine may not protect all recipients. 18
19
6. ADVERSE REACTIONS
20 Sanofi Pasteur’s Influenza A (H1N1) 2009 Monovalent Vaccine and seasonal trivalent Influenza
21 Virus Vaccine (Fluzone®) are manufactured by the same process. The following sub-sections
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1 summarize safety data from clinical experience with seasonal trivalent inactivated influenza 2 vaccines, including Fluzone vaccine. 3
6.1. Clinical Trial Experience
4 Adverse event information from clinical trials provides the basis for identifying adverse events 5 that appear to be related to vaccine use and for approximating the rates of these events. However, 6 because clinical trials are conducted under widely varying conditions, adverse event rates 7 observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trial 8 of another vaccine, and may not reflect the rates observed in practice. 9
10 Adults and Geriatrics 11 In placebo-controlled studies among adults, the most frequent side effect of vaccination is soreness 12 at the vaccination site (affecting 10%–64% of patients) that lasts <2 days, local pain and swelling. 13 These local reactions typically are mild. Fever, malaise, myalgia, and other systemic symptoms can 14 occur following vaccination and most often affect persons who have had no prior exposure to the 15 influenza virus antigens in the vaccine (e.g., young children). These reactions begin 6–12 hours 16 after vaccination and can persist for 1–2 days. Placebo-controlled trials demonstrate that among 17 older persons and healthy young adults, administration of split-virus influenza vaccine is not 18 associated with higher rates of systemic symptoms (e.g., fever, malaise, myalgia, and headache) 19 when compared with placebo injections. (2) 20
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1 Children 2 The 2003-2004 formulation of Fluzone vaccine was studied in 19 children 6 to 23 months of age 3 and in 12 children 24 to 36 months of age, given in 2 doses one month apart. Local reactions and 4 systemic events were solicited for 3 days after each dose. Most local and systemic reactions were 5 mild. The proportions of local and systemic reactions in children were similar to the proportions 6 in adults. No reported local or systemic reaction required a therapeutic intervention other than 7 analgesics. (3) 8 9
6.2. Post-Marketing Experience
10 The following additional events have been reported during post-approval use of Fluzone vaccine. 11 Because these events are reported voluntarily from a population of uncertain size, it is not always 12 possible to reliably estimate their frequency or establish a causal relationship to vaccine 13 exposure.
14 15 Blood and Lymphatic System Disorders: Thrombocytopenia, lymphadenopathy 16 17 Immune System Disorders: Anaphylaxis, other allergic/hypersensitivity reactions (including 18 urticaria, angioedema) 19 20 Nervous System Disorders: GBS, convulsions, myelitis (including encephalomyelitis and 21 transverse myelitis), facial palsy (Bell’s palsy), optic neuritis/neuropathy, brachial neuritis, 22 syncope (shortly after vaccination), dizziness, paresthesia
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1 2 Vascular Disorders: Vasculitis, vasodilation/flushing 3 4 Respiratory, Thoracic and Mediastinal Disorders: Dyspnea, pharyngitis, rhinitis 5 6 Skin and Subcutaneous Tissue Disorders: Stevens-Johnson syndrome 7 8 General Disorders and Administration Site Conditions: Fever, pain, pruritis, asthenia/fatigue, 9 pain in extremities, chest pain
10 11
6.3. Other Adverse Events Associated with Influenza Vaccines
12 Anaphylaxis has been reported after administration of influenza vaccines. Although Influenza A 13 (H1N1) 2009 Monovalent Vaccine contains only a limited quantity of egg protein, this protein 14 can induce immediate hypersensitivity reactions among persons who have severe egg allergy. 15 Allergic reactions include hives, angioedema, allergic asthma, and systemic anaphylaxis. [See 16 Contraindications (4)]
17 18 The 1976 swine influenza vaccine was associated with an increased frequency of Guillain-Barré 19 syndrome (GBS). Evidence for a causal relation of GBS with subsequent vaccines prepared from 20 other influenza viruses is unclear. If influenza vaccine does pose a risk, it is probably slightly 21 more than 1 additional case/1 million persons vaccinated. 22
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1 Neurological disorders temporally associated with influenza vaccination such as encephalopathy, 2 optic neuritis/neuropathy, partial facial paralysis, and brachial plexus neuropathy have been 3 reported. 4
5 Microscopic polyangitis (vasculitis) has been reported temporally associated with influenza 6 vaccination. 7
8
7. DRUG INTERACTIONS
9
7.1. Concomitant Administration with Other Vaccines
10 There are no data on the concomitant administration of Influenza A (H1N1) 2009 Monovalent 11 V accine with seasonal trivalent influenza vaccines. 12 13 Influenza A (H1N1) 2009 Monovalent Vaccine should not be mixed with any other vaccine in 14 the same syringe or vial.
15 16 If Influenza A (H1N1) 2009 Monovalent Vaccine is to be given at the same time as another 17 injectable vaccine(s), the vaccine(s) should always be administered at different injection sites. 18 19 7.2. Immunosuppressive Therapies
20 If Influenza A (H1N1) 2009 Monovalent Vaccine is administered to immunosuppressed persons 21 or persons receiving immunosuppressive therapy, immunologic response may be diminished. 22
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1
8. USE IN SPECIFIC POPULATIONS 2 Sanofi Pasteur’s Influenza A (H1N1) 2009 Monovalent Vaccine and seasonal trivalent Influenza
3 Virus Vaccine (Fluzone vaccine) are manufactured by the same process. Available information 4 for Fluzone vaccine is provided in this section. 5
8.1. Pregnancy
6 Pregnancy Category C: Animal reproduction studies have not been conducted with Influenza A 7 (H1N1) 2009 Monovalent Vaccine or Fluzone vaccine. It is also not known whether these 8 vaccines can cause fetal harm when administered to a pregnant woman or can affect reproduction 9 capacity. Influenza A (H1N1) 2009 Monovalent Vaccine should be given to a pregnant woman
10 only if clearly needed. 11 12
8.3. Nursing Mothers
13 It is not known whether Influenza A (H1N1) 2009 Monovalent Vaccine or Fluzone vaccine is 14 excreted in human milk. Because many drugs are excreted in human milk, caution should be 15 exercised when this vaccine is administered to a nursing woman. 16
17
8.4. Pediatric Use
18 Safety and effectiveness in pediatric subjects below the age of 6 months have not been 19 established. The immune response and safety of Fluzone vaccine was evaluated in 31 children 20 between the ages of 6-26 months. [See Adverse Reactions (6.1), Clinical Studies (14)] 21 22
8.5. Geriatric Use
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1 Immune response to Fluzone vaccine in subjects older than 61 years of age were lower when 2 compared to immune responses in adults 19-59 years of age. [See Clinical Studies (14)] 3
4
11. DESCRIPTION 5
6 Influenza A (H1N1) 2009 Monovalent Vaccine, an inactivated influenza virus vaccine, for 7 intramuscular use, is prepared from influenza viruses propagated in embryonated chicken eggs. 8 The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza 9 virus is concentrated and purified in a linear sucrose density gradient solution using a continuous
10 flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, polyethylene 11 glycol p-isooctylphenyl ether (Triton® X-100), producing a “split virus”. The split virus is further 12 purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. 13
14 Influenza A (H1N1) 2009 Monovalent Vaccine is formulated to contain 15 mcg hemagglutinin 15 (HA) of influenza A/California/07/2009 (H1N1) v-like virus per 0.5 mL dose. Gelatin 0.05% is 16 added as a stabilizer. Each 0.5 mL dose may contain residual amounts of formaldehyde (not 17 more than 100 mcg), polyethylene glycol p-isooctylphenyl ether (not more than 0.02%), and 18 sucrose (not more than 2.0%).
19
20 There is no thimerosal used in the manufacturing process of the single-dose presentations of
21 Influenza A (H1N1) 2009 Monovalent Vaccine. The multi-dose presentation of Influenza A
22 (H1N1) 2009 Monovalent Vaccine contains thimerosal, a mercury derivative, added as a
23 preservative. Each 0.5 mL dose of the multidose presentation contains 25 mcg mercury.
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1 2 Influenza A (H1N1) 2009 Monvalent Vaccine is a sterile clear to a slightly opalescent 3 suspension. 4 5 Antibiotics are not used in the manufacture of Influenza A (H1N1) 2009 Monovalent Vaccine. 6 7 All presentations of Influenza A (H1N1) 2009 Monovalent Vaccine do not contain latex. 8
9
12. CLINICAL PHARMACOLOGY
10
12.1. Mechanism of Action
11 Influenza illness and its complications follow infection with influenza viruses. Global 12 surveillance of influenza identifies yearly antigenic variants. For example, since 1977, antigenic 13 variants of influenza A (H1N1 and H3N2) viruses and influenza B viruses have been in global 14 circulation. Specific levels of hemagglutinin inhibition (HI) antibody titer post-vaccination with 15 inactivated influenza virus vaccines have not been correlated with protection from influenza 16 virus infection. In some human studies, antibody titer of ≥1:40 have been associated with 17 protection from influenza illness in up to 50% of subjects. (4) (5) 18 19 Antibodies against one influenza virus type or subtype confer limited or no protection against 20 another. Furthermore, antibodies to one antigenic variant of influenza virus might not protect 21 against a new antigenic variant of the same type or subtype. Frequent development of antigenic
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1 variants through antigenic drift is the virologic basis for seasonal epidemics and the reason for 2 the usual change of one or more new strains in each year's influenza vaccine. 3
4
13. NON-CLINICAL TOXICOLOGY
5
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
6 Neither Fluzone vaccine nor Influenza A (H1N1) 2009 Monovalent Vaccine have been evaluated 7 for carcinogenic or mutagenic potential, or for impairment of fertility. 8
9
14. CLINICAL STUDIES 10 Sanofi Pasteur’s Influenza A (H1N1) 2009 Monovalent Vaccine and seasonal trivalent Influenza
11 Virus Vaccine (Fluzone vaccine) are manufactured by the same process. Data in this section 12 were obtained in clinical studies conducted with Fluzone vaccine. 13 14
14.1. Immunogenicity in the Adult and Geriatric Population
15 In an observational study of the immunogenicity of Fluzone vaccine in a geriatric population 16 (median age: 72.0 range: 61 to 86 years of age) compared with younger adults (median age: 38.0 17 range: 19 to 59 years of age; racial distribution was 2 Asian, 11 Black, 106 Caucasian, and 2 18 other; no gender data were available), the following results were obtained using a single-dose of 19 the year 1999–2000 formulation of Fluzone vaccine. (See Table 1.) Antibody levels were 20 obtained on the day of and just prior to vaccination and approximately 21 days after vaccination. 21 (4)
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1 Table 1: Geometric Mean Titer (GMT) and Percentage (%) Achieving an HI Titer ≥1:40 2 (N = 58-62) in Adults and the Elderly (after vaccination with Fluzone vaccine)
3 N = Number of participants 4 5
14.2. Immunogenicity in Children
6 In a study using 2 doses of Fluzone vaccine (2003-2004) in 31 healthy children 6–36 months of 7 age (3 Black, 23 Caucasian, 2 Hispanic, and 3 other; 15 were male and 16 were female), the 8 following immunogenicity results were obtained on day 0 before vaccination and approximately 9 14 days after dose number 2. (See Table 2.)
1 15. REFERENCES
Centers for Disease Control and Prevention. Serum Cross-Reactive Antibody Response to a Novel Influenza A (H1N1) Virus After Vaccination with Seasonal Influenza Vaccine. MMWR 2009;58(19):521-524.
Centers for Disease Control and Prevention. Prevention and Control of Influenza: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2009;58(RR08):1-52.
Sanofi Pasteur Inc. Data on file, 071107.
Hannoun C et al. Immunogenicity and protective efficacy of influenza vaccination. Virus Res 2004;103:133-138
Hobson D, et al. The role of serum hemagglutinin-inhibiting antibody in protection against challenge infection with influenza A2 and B viruses J Hyg Camb 1972;70:767-777.
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1 16. HOW SUPPLIED/STORAGE AND HANDLING
2
16.1. How Supplied
3 Single-dose prefilled syringe, without needle, 0.25 mL, package of 10 prefilled syringes per 4 carton – Product No. NDC 49281-650-25. 5 6 Single-dose prefilled syringe, without needle, 0.25 mL, package of 25 prefilled syringes per 7 carton – Product No. NDC 49281-650-70.
8
9 Single-dose prefilled syringe, without needle, 0.5 mL, package of 10 prefilled syringes per carton 10 – Product No. NDC 49281-650-50. 11 12 Single-dose prefilled syringe, without needle, 0.5 mL, package of 25 prefilled syringes per carton 13 – Product No. NDC 49281-650-90.
14 15 Single-dose vial, 0.5 mL, package of 10 vials per carton – Product No. NDC 49281-650-10. 16 17 Multi-dose vial, 5 mL, one vial per carton. The vial contains ten 0.5 mL doses – Product No. NDC 18 49281-640-15. 19 20 Vial stoppers and syringe plungers do not contain latex. 21 22 16.2. Storage and Handling
Confidential/Proprietary Information Page 17 of 19
sanofi pasteur 10 September 2009_v0.3 449/454 Influenza A (H1N1) 2009 Monovalent Vaccine LE5860-5862
1 Store all Influenza A (H1N1) 2009 Monovalent Vaccine presentations refrigerated at 2° to 8°C 2 (35° to 46°F). DO NOT FREEZE. Discard if vaccine has been frozen. 3 4 Between uses, return the multi-dose vial to the recommended storage conditions at 2o to 8oC (35o 5 to 46oF).
6 7 Do not use after the expiration date shown on the label. 8
9 17. 10 •
PATIENT COUNSELING INFORMATION
Inform vaccine recipients or guardians that Influenza A (H1N1) 2009 Monovalent Vaccine contains killed viruses and cannot cause influenza. Inform vaccine recipients or guardians that there are two influenza vaccine formulations for this influenza season, the monovalent vaccine against influenza disease caused by pandemic (H1N1) 2009 virus and seasonal trivalent influenza vaccine.
Instruct vaccine recipients or guardians to report any severe or unusual adverse reactions to their health care provider.
11 12 • 13 14 15 • 16 17 18 19 20 21 22 23 Manufactured by:
Product information as of September 2009.
Confidential/Proprietary Information Page 18 of 19
sanofi pasteur 449/454 Influenza A (H1N1) 2009 Monovalent Vaccine
10 September 2009_v0.3 LE5860-5862
5860-5862
1 2 3 4
5
Sanofi Pasteur Inc.
Swiftwater PA 18370 USA
Confidential/Proprietary Information Page 19 of 19
Influenza A, Gripe A and H1N1 Vaccine - My research report
Friday, 29 January 2010
Can we make miracles happen?
Most of the time, we’d rather pussy foot around the subject; whispering behind corners, feeling sorry for our loved ones and ourselves, feeling a little helpless and maybe even feeling somewhat like useless bystanders rather than approach the matter in an openly and natural manner.
We put the lives of our loved ones, and our lives, in the hands of doctors and specialists or Gods of our chosen faith hoping that someone or something somewhere will make a miracle happen. In some contrived way, I guess we hope that if a miracle happens then we’ll never have to deal with what actually is and what potentially might yet come.
We forget though that doctors and specialists can make wrong predictions. They are only human. They are not infallible. They do not have all the answers. The human body is the most complex machine there is. Even in this day and age, we still do not know how it works in a concise manner. Moreover, we still don’t know how much the power of the mind can influence the body.
Linsey gave you her story in an earlier post, last year in November, on my wall. To give you a very brief lowdown. She had both kidneys removed along with part of her spleen, pancreas, one adrenal gland and some lymph nodes. By law of average, her chances of survival were very slim from thereon in, (according to her doctors), but she’s still here. Thank goodness! She’s living proof that doctors’ predictions can be wrong. She’s also living proof that the mind and the will are stronger than any disease. That is a miracle!
In November, she told us the cancer has now spread to the liver and that time is running out. I have to question if this diagnosis is just another obstacle to be overcome. Linsey tells me to be a realist and says you can’t avoid the facts staring you in the face. She quite openly speaks about the songs to be sung at the party we’re suppose to have at her funeral. However, after her recent visit to Madeira, something in me can’t help but question whether she can continue to make miracles happen.
Linsey had always wanted to come to Madeira to visit me but with one thing and another, it hadn’t ever been possible. Yet, in a very moment when the impossible seems truly impossible, it not only became possible but very much a reality. Linsey came to Madeira with her husband Paul.
Linsey told you she’d arrived at the airport in Madeira with her pride hurt because she got here in a wheelchair; meaning with airport assistance. Yet, what I saw was a beautiful, brave young woman who’d gotten on a plane despite being warned her blood pressure was too low to travel. She’d had dialysis that morning; prior to the trip. She was warned against travelling. Yet, against all odds, she was determined to make it - and she did. That was a miracle.
Even the rain that had been falling for two months stopped in time for her arrival. That was another small miracle from up above. Or, was it the collective prayers said by a beautiful group of friends of mine who'd been rooting for Linsey to have a perfect time on the island?
I’d arranged a room for Linsey and Paul in the hotel where I work. Yet, my beautiful colleagues, without being asked, took it one step further and made her experience even more perfect by upgrading her to a suite; giving her what she describes as her “Pretty Woman” moment. The text I got said she felt like a movie star. Is it another little miracle or is it the collective wish of beautiful people who’s only wish was to help fulfill someone’s dream and make it perfect.
There were times she felt tired and needed to rest back at the hotel, but they were nothing compared to the effort she put into walking more than she’d apparently walked in the last two months. That was another miracle of mind over matter.
There were times I noticed the tiredness and frustration in her eyes that she was desperately trying to hide with a smile, but they paled in comparison to the radiant glow and the emotions she showed when she saw the dolphins around the boat we went out on. When we were given the all clear to go in the sea and swim with them, wild horses couldn’t have held her back. She was the second person off the boat and in the sea. All the apprehensions, fears, anxiety and nerves she’d felt the day before, about the trip, had gone. It was another miracle of mind over matter.
The sea may have been cold but it had calmed down considerably in comparison to what it had been over the previous two months, and we had plenty of sunshine; another miracle from above? Or, more answered prayers? Of course, we mustn’t forget the miracle itself of actually swimming with dolphins in the wild.
Within that same miracle, there was another one. Whilst Linsey and I floated there hand in hand, just the two of us, watching the dolphins swim under us, next to us and in front of our faces, the dolphins apparently were circling around us. As Linsey questions in her note, were they protecting us? Or, could it be that they knew this was her lifetime dream and that they alone could make it come true?
We heard them communicating to one another or were they actually speaking to us, as well, in their own way. They put on a show that marvelled even our gracious biologist and captain who hadn’t seen the dolphins in such a joyful mood for quite some time. Were we witnessing another miracle in the making? I believe so.
The biggest joy for me was watching Linsey eat. Seeing her eat a little more than she apparently normally manages to eat was, for me, a miracle in itself. I was willing each mouthful to go down and stay on her. I never thought I’d hear myself say that!
The bravest moment of all was when she had to face having dialysis in Madeira; with unknown doctors and nurses. It was the first time she’d had dialysis abroad. Like she said “Needs must”. She could have walked away and waited till she got home but she didn’t. No matter how scary it got at one point, she stuck it out and faced it head on.
Yet, no matter how scary it was to face for the first time, it’s also a symbol and testimony to the fact that Linsey and people with needs like Linsey don’t have to hide and be house bound or country bound simply because they need treatments.
It’s not easy. It’s painful. It’s scary. Yet, for the love of her husband and her little girls, she gets out of bed every morning and chooses to fight to live. I know she would like to climb mountains (metaphorically speaking) but just being awake and there to give them her love every day is a miracle; just like it is for any one of us.
Surviving the way she has for this long may be a miracle; then again it may not. It could just be the sheer determination, will-power and love driven resolve of a young woman who has so much to live for. My point is, when we find a window of joy that is bigger than the fears and the illnesses themselves, no matter what they may be, our mind can drive us with an incredible strength that even we’re unaware of. It can push us beyond what the physical body is experiencing and maybe, just maybe, it’s enough to hold on to to make miracles happen.