As anyone who knows me or anyone who follows my posts knows, I am not a political person; what I do care about though are human beings, life in general, human rights and our safety. If the days and countless hours spent on this can help someone somewhere; I’ll be very happy.
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.
Confidential/Proprietary Information Page 1 of 19
Revised: September 2009
sanofi pasteur 10 September 2009_v0.3 449/454 Influenza A (H1N1) 2009 Monovalent Vaccine LE5860-5862
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:
Confidential/Proprietary Information Page 2 of 19
sanofi pasteur 10 September 2009_v0.3
449/454 Influenza A (H1N1) 2009 Monovalent Vaccine
LE5860-5862
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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sanofi pasteur 10 September 2009_v0.3 449/454 Influenza A (H1N1) 2009 Monovalent Vaccine LE5860-5862
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
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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.
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1 2 3 4
5
Sanofi Pasteur Inc.
Swiftwater PA 18370 USA
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Influenza A, Gripe A and H1N1 Vaccine - My research report
