Treatise on the A/H1N1 flu vaccines from the United States

Treatise on the A/H1N1 flu vaccines from the United States
Authors: Cynthia Janak, Research Journalist, President of an International Coalition and Dr. True Ott, PhD. ND. Naturopath, Investigative Clinician.
Abstract
Since March, 2009, the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC), through the news media, have created the impression that a “novel” strain of H1N1 (swine) flu virus has appeared and that it will mutate and spread pandemically all across the world. Deemed “unstoppable,” the only way to protect the world’s nearly 7 billion people, according to WHO et al, is to “develop” a vaccine, produce nearly five billion doses of it and vaccinate the entire planet—children and pregnant women first.
The evidence, however, shows that the “novel” H1N1 “virus” strain is a product of bio-weapons research and the patented vaccine has been under development for at least four years. The implication of this research undermines the WHO/CDC/media-created impression that a global cooperative of public health officials and vaccine manufacturers are responding appropriately to a pending public health emergency.
Background
In March, 2009, a new strain of influenza was detected in the country of Mexico and was deemed a “novel” or new and unique virus. Since that time, there have been several admissions reported in the mainstream media that provide foundational clues as to our contention that the H1N1 influenza vaccine was patented to be sold as the antidote for an H1N1 influenza strain created in bioweapons labs.
CNN reported April 24, 2009 that CDC Influenza Division Director Nancy Cox, PhD, said, “The new virus has genes from North American swine and avian influenza, human influenza, and swine influenza normally found in Asia and Europe.” (1) The next day (April 25, 2009) CNN reported that WHO Epidemic and Pandemic Disease spokesman Gregory Hartl said, “The strain of the virus seen in Mexico is worrisome because it has mutated from older strains.” (2) On May 22, 2009, the World Health Organization’s “Weekly Epidemiological Record” noted that, “Most cases [of swine flu] appear to have uncomplicated, typical influenza-like illness and [afflicted individuals] recover spontaneously.” (3) This appears to be patently true, as the CDC admits that reported death rates per thousands of infections are much lower with this “novel virus” than death rates commonly ascribed to “seasonal” influenza.
On June 11, 2009, the WHO Regional Office for Europe announced, “Today WHO raised the level of influenza A(H1N1) pandemic alert to phase 6, as sustained community-level transmission of the virus is taking place in more than one region of the world. The term pandemic means that an influenza virus that is new to human beings has appeared is spreading and is causing disease in many parts of the world. Globally, it is of moderate severity.” (4) Regardless that the epidemiological data, May, 2009, Novartis received a $289 million order from the US Department of Health and Human Services for A(H1N1) vaccine with proprietary adjuvant MF59© (5)
This paper will focus on eight areas: (1) Novartis patent information regarding flu vaccine composition. (2) Individual ingredients involved in the creation of this vaccine. Reports documenting adverse events in regards to ingredients of this vaccine. (3) Genetically modified vaccines and foods and their dangers. (4) Vaccine challenge and re-challenge in regards to multiple vaccinations. (5) Aluminum and thimerosal content of vaccines. (6) Other pandemic influenza vaccines approved by the European Medicines Agency. (7) Mandatory vaccination hazards. (8) Preventative measures.
Novartis patent information – Pub. No.: US 2009/0047353 A1, Pub. Date: Feb. 19, 2009 -
Abstract – The invention seeks to avoid components in split vaccines that could cause an excessive Th2 response. Thus the invention provides an immunogenic composition comprising a split influenza virus antigen and a Th1 adjuvant, wherein the antigen is preferably prepared from a virus grown in cell culture (e.g., it is free from egg proteins.)
Split virions – (Disclosure of the Invention)
0007…the clinical and epidemiological features of ORS are suggestive of hypersensitivity, and so it has been proposed that the vaccine may upset the natural Th1/Th2 balance,
0008 …the invention seeks to minimize the possibility that a split vaccine might cause an excessive Th2 response. In a situation where influenza vaccines have to be produced in a hurry (e.g. after a pandemic outbreak) then pressures on manufacturers might inadvertently result in the release of vaccines that suffer from the same problems as the partially un-split aggregated Canadian batches from 2000-01.
The Split Influenza Virus Antigen
0032 – The influenza virus may be a reassortant strain, and may have been obtained by reverse genetics techniques.
Reverse genetics techniques [e.g. 16 – 20] allow influenza viruses with desired genome segments to be prepared in vitro using plasmids.
… they involve expressing (a) DNA molecules that encode desired viral RNA molecules
(b) DNA molecules that encode viral proteins
… it is also possible to use a helper virus to provide some of the RNA and proteins.
0036 – may include one or more RNA segments
from a A/PR/8/34 virus (typically 6 segments from A/PR/8/34, with HA and N segments being from a vaccine strains, i.e. a 6:2 reassortant).
from a A/WSN/33 virus,
or from any other virus strain useful for generating reassortant viruses for vaccine preparation
0037 – viruses used as the source of the antigens are grown on cell culture.
Mammalian origin
origin include, but are not limited to, hamster, cattle, primate (including humans and monkeys) and dog cells.
Cell types may be used, such as kidney cells, fibroblasts, retinal cells, lung cells, etc.
Hamster cells – BHK21 or HKCC
Monkey cells – African green monkey – kidney cells – Vero cell line.
Dog cells – kidney cells – MDCK cell line.
Thus suitable cell lines include, but are not limited to: MDCK; CHO; 293T; BHK; Vero; MRC-5; PER C6; WI-38; etc.
Preferred
MDCK cells (28-31), derived from Madin Dabry canine kidney;
Vero cells derived from African green monkey (Cercopithecus aethiops) kidney
or PER C6 cells [35] derived from human embryonic retinoblasts.
Less-preferred
Ducks (e.g. duck retina)
Hens e.g. chicken embryo fibroblasts
Examples include avian embryonic stem cells… chicken embryonic stem cells.
0043 – trace amounts of host cell DNA may be present.
Oil-in-Water Emulsion Adjuvants
0100 – Emulsions can include oils such as those from animal or vegetable source.
Vegetable oils include nuts, seeds and grains, peanut oil, soybean oil, coconut oil, and olive oil, the most commonly available exemplify the nut oils
Jojoba oil obtained from the jojobean.
Seed oils include safflower oil, cotton-weed oil, sunflower seed oil, sesame seed oil and the like.
Grain group, corn oil is the most readily available but the oil of other cereal grains such as wheat, oats, rye, rice, teff, triticale and the like…
Fats and oils from mammalian milk are metabolizable and may therefore be used.
Fish oils – For example, cod liver oil, shark liver oils, and whale oil such as spermaceti.
Squalene, the saturated analog to squalene is also a preferred oil.
0107 – A submicron emulsion of squalene, Tween 80, and Span 85, also including an immunostimulatory oligonucleotide.
Emulsion by volume can be about 5% squalene,
About 0.5% polysorbate 80
And about 0.5% Span 85
Pharmaceutical Compositions
0113 – The composition may include preservatives such as thiomersal or 2-phenoxyethanol … (i.e. less than 5mcg/ml) mercurial material e.g. thiomersal-free.
0119 – The inclusion of a preservative is preferred in multidose arrangements.
0144 – Multiple doses will typically be administered at least 1 week apart.
0145 – Vaccines produced by the invention may be administered to patients at substantially the same time as:
Measles vaccine, a mumps vaccine, rubella vaccine, a MMR vaccine, a varicella vaccine, a MMRV vaccine, a diphtheria vaccine, a tetanus vaccine, a pertussis vaccine, a DPT vaccine, a conjugated II. Influenza type a vaccine, an inactivated poliovirus vaccine, a respiratory syncytial virus vaccine, a pneumococcal conjugate vaccine, etc.
Modes for carrying out the invention
Oil-in-Water Emulsion Adjuvant Favouring Th1 Response
Human Trials
0161 – split influenza vaccines were adjuvanted with an oil-in-water emulsion having an organic phase made of two oils (a-tocopherol and squalene). And an aqueous phase of phosphate buffered saline (PBS) containing Tween80 as emulsifying agent.
2.5% sqalene (v/v)
2.5% a-tocopherol (v/v)
0.9% polyoxyethylene sorbitan monooleate (v/v) (Tween80)
References (The contents of which are hereby incorporated by reference.
Page 14 – 15.
1. An immunogenic composition comprising a split influenza virus antigen and a Th1 adjuvant, wherein the antigen is prepared from a virus grown in cell culture and does not include any egg proteins. (see 1.3.3.1.6 and 1.3.3.1.7)
3. The composition of claim 1, wherein the composition is free from ovalbumin, ovomucoid and chicken DNA.
4. The composition of claim 1, wherein the virus is grown on a cell culture of a cell line selected from the group consisting of: MDCK; Vero; and PER.C6. (see 1.3.3.1.7)
8. The composition of claim 1, wherein the adjuvant includes a tocopherol. (see 1.4.1.1.1.2)
9. The composition of claim 8, wherein the tocopherol is DL-[alpha]-tocopherol.
10. The composition of claim 1, wherein the adjuvant is in the form of an oil-in-water emulsion. (see 1.4.1.1.1)
13. The composition of claim 1, wherein the influenza virus antigen is prepared from an influenza virus obtained by reverse genetics techniques.
16. The composition of claim 1, wherein the adjuvant comprises of 3-O-deacylated monophosphoryl lipid A (3dMPL)
19. The composition of claim 1, being substantially free from mercurial material. (see 1.3.6.1)
20. The composition of claim 1, including between 1 and 20 mg/ml sodium chloride.
23. The composition of claim 22, wherein the buffer(s) include: a phosphate buffer; a Tris buffer; a borate buffer; a succinate buffer; a histidine buffer; or a citrate buffer.
30. The composition of claim 11, wherein the emulsion includes squalene, a tocopherol, and polysorbate80.
Individual ingredients referenced in the Novartis patent.
Tocopherol – Vitamin E (not known if tested in a vaccine environment) – Side effects –
… in high doses. An increased risk of bleeding has been proposed, particularly in patients taking blood-thinning agents such as warfarin, heparin, or aspirin; or in patients with vitamin K deficiency. Recent evidence suggests that regular use of high-dose vitamin E supplements may increase the risk of death (from "all causes") by a small amount, http://www.healthline.com/natstandardcontent/vitamin-e-1
Rats treated with weekly oral doses of about 50 mg of a vitamin E concentrate were found to have fatty changes in the liver. In addition, intimal sclerosis of the aorta was seen, with the over-development of collagenous tissue at the base of the aortic valve and in the medial coat of the aorta (Marxs et al., 1947).
Rats given high doses of alpha-tocopherol had elevated liver cholesterol levels and altered tissue fatty acids (Alfin-Slater et al., 1972).
Groups of weanling female Wistar rats were fed diets containing 0, 25, 250, 2500, 10,000, or 25,000 IU vitamin E/kg diet for 8 and 16 months. Vitamin E depressed body-weight gain at concentrations of 10,000 and 25,000 IU/kg diet, and increased relative heart and spleen weights were seen at 8 months and 16 months, respectively. There was an increase in plasma alkaline phosphatase and a decrease in the ash content of bone after 16 months at these two dose levels. Prothrombin time was reduced at 12 months, but not at 9 or 16 months. Urinary excretion of creatine and creatinine was normal at 11 months. No histological examinations were reported (Yang & Desai, 1977).
Squalene - MF59, a proprietary adjuvant containing squalene –
A link between the health problems of Gulf-War veterans and possible presence of squalene in vaccines received by these soldiers has been suggested. One published report has suggested that some army veterans who received anthrax vaccines developed anti-squalene antibodies and that these antibodies caused disabilities. http://www.who.int/vaccine_safety/topics/adjuvants/squalene/en/index.html
Analysis of additional personnel revealed that in all but one case (19/20; 95%), ASA were restricted to personnel immunized with lots of vaccine known to contain squalene. Except for one symptomatic individual, positive clinical findings in 17 ASA-negative personnel were restricted to 4 individuals receiving vaccine from lots containing squalene. ASA were not present prior to vaccination in pre-immunization sera available from 4 AVIP personnel. Three of these individuals became ASA positive after vaccination. These results suggest that the production of ASA in GWS patients is linked to the presence of squalene in certain lots of anthrax vaccine. 2002: Asa Pamela B; Wilson Russell B; Garry Robert F, Antibodies to squalene in recipients of anthrax vaccine. Experimental and molecular pathology 2002;73(1):19-27.
Squalene is a cholesterol precursor, which stimulates the immune system nonspecifically. We demonstrate that one intradermal injection of this adjuvant lipid can induce joint-specific inflammation in arthritis-prone DA rats. Histopathological and immunohistochemical analyses revealed erosion of bone and cartilage, and that development of polyarthritis coincided with infiltration of ß+ T cells. – Our demonstration that an autoadjuvant can trigger chronic, immune-mediated joint-specific inflammation may give clues to the pathogenesis of rheumatoid arthritis, and it raises new questions concerning the role of endogenous molecules with adjuvant properties in chronic inflammatory diseases. (American Journal of Pathology. 2000;156:2057-2065.) © 2000 American Society for Investigative Pathology The Endogenous Adjuvant Squalene Can Induce a Chronic T-Cell-Mediated Arthritis in Rats, Barbro C. Carlson*, Åsa M. Jansson*, Anders Larsson, Anders Bucht* and Johnny C. Lorentzen* , From the Department of Medicine,*Unit of Rheumatology, Karolinska Institutet, Stockholm; the Department of Medical Sciences,University Hospital, Uppsala; and the Department of Biomedicine,Division of NBC Defense, Defense Research Establishment, Umeå, Sweden
Polysorbate80 – surfactant
According to the MSDS sheet at Science lab.com, section 11: Toxicological Information, it was tested for inhalation and ingestion and was shown to be slightly hazardous on skin contact, ingestion and inhalation. However these are minor compared to other potential side effects of its use especially in an intravenous or immunologic setting. In the same section of toxicological information it states that it may cause reproductive effects, it may cause cancer, and may be a mutagenic, (change the genetics), in animals… http://www.sciencelab.com/xMSDS-POLYSORBATE_80-9926645
PubMed.Gov a service of the U.S. Library of Medicine and the National Institute of Health, a report shows that neonatal rats were injected with small doses of polysorbate 80 and the results were major effects on the reproductive organs of the rats, resulting in infertility. http://www.ncbi.nlm.nih.gov/pubmed/8473002?dopt=Abstract
PubMed studied Polysorbate 80 in an intravenous vitamin mix given to a pregnant woman who suffered anaphylactic shock where polysorbate 80 was identified as the causative agent, http://www.ncbi.nlm.nih.gov/pubmed/16400901?dopt=Citation
and yet another study showed two patients who developed hypersensitive reactions to red blood cell growth hormones and subsequent skin testing indicated polysorbate 80 as the culprit. This finding might have implications in the recent increase in the incidence of pure red cell aplasia. http://www.ncbi.nlm.nih.gov/pubmed/15958049?dopt=Abstract
3-O-deacylated monophosphoryl lipid A (3dMPL) - If MPL is immunogenic, it raises the possibility of a dangerous "cross reaction." The human body is full of lipids. Antibodies and immune cells responding to MPL might also respond to other lipids in the body, thus breaking tolerance for endogenous lipids (those native to the human body) and initiating autoimmunity.
Thiomersal – Ethyl mercury
Public concern had been expressed about the health effects of mercury exposure of any sort, and the elimination of mercury from vaccines was considered a feasible means of reducing an infant’s total exposure to mercury in a world where other environmental sources of exposure are more difficult or impossible to eliminate (e.g. certain foods). http://www.medicine.manchester.ac.uk/immunise/elearning/workshop/Appendix4.pdf
Used as a preservative in vaccines, thimerosal has been linked to autism and other neurodevelopmental disorders in children. Thimerosal carries risk of serious adverse effects because it contains mercury, which can be neurotoxic at certain levels. Behind uranium, mercury is the second most toxic substance known to man. http://www.adrugrecall.com/thimerosal/thimerosal.html
Sodium Chloride - also known as common salt, table salt, or halite, is an ionic compound with the formula NaCl.
Tris buffer - TromeThamine, USP is chemically designated 2-amino-2-(hydroxymethyl)-1, 3-propanediol, a solid readily soluble in water, also classified as an organic amine buffer. http://www.drugs.com/pro/tham.html
Animal reproduction studies have not been conducted with tromeThamine. It is also not known whether tromeThamine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. TromeThamine should be given to a pregnant woman only if clearly needed.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Tham Solution is administered to a nursing mother.
have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.
L-Histidine - is an essential amino acid that cannot be formed by other nutrients, and must be in the diet to be available to the body.Most often recognized as a precursor to the allergy symptom producing hormone histamine, both histidine and histamine have essential roles in the body beyond tormenting allergy sufferers.
Sodium borate – Borax
Introduction, Paragraph 5 – Prior to the study reported here, there had been an earlier study that suggested borate exposure was associated with symptoms of acute respiratory irritation, such as dryness of the mouth, nose, or throat; dry cough; nose bleeds; sore throat; productive cough; shortness of breath; and chest tightness. Acute and Chronic Respiratory Effects of Sodium Borate Particulate Exposures, David H. Wegman, Ellen A. Eisen, Xiaohan Hu, Susan R. Woskie, Ralph G. Smith and David H. Garabrant, Environmental Health Perspectives, Vol. 102, Supplement 7: Health Effects of Boron (Nov., 1994), pp. 119-128
Label Precautionary Statements – Harmful – Possible risk of harm to the unborn child, possible risk of impaired fertility, irritating to eyes, respiratory system and skin, target organ(s): Central Nervous System, Kidneys. Material Safety Data Sheet, Copyright 1997, Sigma Chemical Co., Aldrich Chemical co., Inc. Fluka Chemie AG. http://www.palomar.edu/ehs/Chemistry%20MSDS/SODIUM%20BORATE,%20DECAHYDRATE.pdf
Potential Health Effects – Mallinckrodt Baker, Inc., Prepared by: Strategic Services Division, http://www.sefsc.noaa.gov/HTMLdocs/SodiumBorate.htm
Inhalation: Causes irritation to the respiratory tract. Symptoms may include coughing, shortness of breath.
Ingestion: May cause nausea, vomiting, diarrhea, muscular spasms, dullness, lethargy, circulatory depression, central nervous system depression, shock, kidney damage, coma, and death. Estimated lethal dose 15 to 20 grams.
Skin Contact: Causes irritation to skin. Symptoms include redness, itching, and pain. May be absorbed through the skin with possible systemic effects.
Eye Contact: Causes irritation, redness, and pain.
Chronic Exposure: Prolonged or repeated ingestion or skin absorption may cause anorexia, weight loss, vomiting, mild diarrhea, skin rash, convulsions, and anemia.
Aggravation of Pre-existing Conditions:
No information found.
Span 85 – Sorbitan trioleate – (Tween 85) – surfactant –
the hematological examination revealed anemia corresponding to the histological findings of the bone marrow. Biochemical analysis displayed the significant increase and/or decrease of enzyme values in 200.0 mg/kg group. Morphology showed the swelling, vacuolization and granuloma of the spleen, hepatic granuloma, the increase of reticulum cells and granuloma in the bone marrow. Embolism and thrombus were also found in the pulmonary and tail veins probably due to an artifact caused by the i.v. injection. Study on subacute toxicity of intravenous sorbitan trioleate (STO) in Wistar rats. Yamamoto H, Tsutsui K, Shimada K, Yamanishi Y, Imai S., J Toxicol Sci. 1983 Nov;8(4):301-10
*Aluminum salts – Aluminum phosphate and/or aluminum hydroxide
Aluminum phosphate - http://www.webmd.com/
Phosphate salts can irritate the digestive tract and cause stomach upset, diarrhea, constipation, and other problems. Do not take phosphate salts unless prescribed by a healthcare professional if:
You have kidney disease
You have heart disease.
You have high or low calcium blood levels.
You have high phosphate blood levels.
You have a condition which causes the body to retain fluid (edema), including heart failure, liver problems (cirrhosis), and other conditions.
Aluminum hydroxide – Aluminum hydroxide side effects - http://www.drugs.com/mtm/aluminum-hydroxide.html
Aluminum overdose - Seek emergency medical attention.
Symptoms of an aluminum overdose include weight loss, decreased appetite, general feeling of sickness, muscle weakness, kidney failure, and softening of the bones.
Stop taking aluminum hydroxide and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).
Other, less serious side effects may be more likely to occur. Continue to take aluminum and talk to your doctor if you experience constipation. Increased fluid intake may lessen constipation
*QS21 – Saponin –
QS-21 induced mild local erythema, induration, and tenderness lasting 24-72h in all patients at the 100-mcg dose. The 200-pg dose of QS-21 was associated with local tenderness and inflammation lasting 2-10days in all patients as well as mild flu-like symptoms, including low grade fever (<38.5°C), headache, and myalgia lasting 8-24h after most immunizations. No neurological abnormalities or other side effects were observed. [CANCERRESEARCH55, 2783-278 July 1, 1995], GM2-KLH Conjugate Vaccine: Increased Immunogenicity in Melanoma Patients after Administration with Immunological Adjuvant QS-21, Friedheim Helling,2 Shengle Zhang, Ann Shang, Sucharita Adluri, Michele Calves, Rao Koganty, B. Michael Longenecker, Tzy-J. Yao, Herbert F. Oettgen, and Philip 0. Livingston
Histidine and Polysorbate80 - Background: There are no pharmacologic strategies to prevent embolism bubble-induced blood clot formation. The authors conducted experiments to measure thrombin production in sheared whole blood in the presence and absence of bubbles and three surface-active compounds.The time-dependent enhancement of thrombin production presented in figure 1B also appears in the data obtained using quiescent whole blood samples with and without exposure to histamine, as is depicted in figure 2A. Only means ± SDs of the peak fluorescence intensity data (emission wavelength, 460 nm) for each group at each time point are shown. The level of blood activation increased slightly more than 2-fold in the untreated quiescent sample after 30 min. In the histamine-treated sample, thrombin production increased more than 5-fold from the baseline value after 30 min. After the initial time point, significantly more thrombin was formed in the histamine-activated samples (P < 0.004 in all cases). Anesthesiology: Volume 100(1)January 2004pp 77-84, Surfactants Attenuate Gas Embolism-induced Thrombin Production, Eckmann, David M. Ph.D., M.D.*; Diamond, Scott L. Ph.D.†
Genetically modified vaccines and foods and their dangers. The Novartis patent uses VLP’s (virus like particles) which are referenced as split influenza virus antigen, section 1.1 - Abstract. http://www.responsibletechnology.org/GMFree/AboutGMFoods/FAQs/index.cfm
What combinations have been tried?
It is now possible for plants to be engineered with genes taken from bacteria, viruses, insects, animals or even humans. Scientists have worked on some interesting combinations:
Spider genes were inserted into goat DNA, in hopes that the goat milk would contain spider web protein for use in bulletproof vests.
Cow genes turned pigskins into cowhides.
Jellyfish genes lit up pigs’ noses in the dark.
Arctic fish genes gave tomatoes and strawberries tolerance to frost.
Potatoes that glowed in the dark when they needed watering.
Human genes were inserted into corn to produce spermicide.
Current field trials include:
Corn engineered with human genes (Dow)
Sugarcane engineered with human genes (Hawaii Agriculture Research Center)
Corn engineered with jellyfish genes (Stanford University)
Tobacco engineered with lettuce genes (University of Hawaii)
Rice engineered with human genes (Applied Phytologics)
Corn engineered with hepatitis virus genes (Prodigene)
What kinds of traits have been added to food crops?
Although there are attempts to increase nutritional benefits or productivity, the two main traits that have been added to date are herbicide tolerance and the ability of the plant to produce its own pesticide. These results have no health benefit, only economic benefit.
Crops such as Bt cotton produce pesticides inside the plant. This kills or deters insects, saving the farmer from having to spray pesticides. The plants themselves are toxic, and not just to insects. Farmers in India, who let their sheep graze on Bt cotton plants after the harvest, saw thousands of sheep die.
Why do genetically engineered foods have antibiotic resistant genes in them?
The techniques used to transfer genes have a very low success rate, so the genetic engineers attach "marker genes" that are resistant to antibiotics to help them to find out which cells have taken up the new DNA. These marker genes are resistant to antibiotics that are commonly used in human and veterinary medicine. Some scientists believe that eating GE food containing these marker genes could encourage gut bacteria to develop antibiotic resistance.
What are the problems created through genetic engineering of food and crops?
Genetic engineers continually encounter unintended side effects – GM plants create toxins, react to weather differently, contain too much or too little nutrients, become diseased or malfunction and die. When foreign genes are inserted, dormant genes may be activated or the functioning of genes altered, creating new or unknown proteins, or increasing or decreasing the output of existing proteins inside the plant. The effects of consuming these new combinations of proteins are unknown.
What are the potential dangers of eating GM foods?
There are a number of dangers that broadly fall into the categories of potential toxins, allergens, carcinogens, new diseases, antibiotic resistant diseases, and nutritional problems.
Hasn’t research shown GM foods to be safe?
The only feeding study done with humans showed that GMOs survived inside the stomach of the people eating GMO food. No follow-up studies were done.
Various feeding studies in animals have resulted in potentially pre-cancerous cell growth, damaged immune systems, smaller brains, livers, and testicles, partial atrophy or increased density of the liver, odd shaped cell nuclei and other unexplained anomalies, false pregnancies and higher death rates.
What indications are there that GM foods are causing problems?
Soon after GM soy was introduced to the UK, soy allergies skyrocketed by 50 percent.
In March 2001, the Center for Disease Control reported that food is responsible for twice the number of illnesses in the U.S. compared to estimates just seven years earlier. This increase roughly corresponds to the period when Americans have been eating GM food.
What about GM hormones in milk?
Milk from rBGH-treated cows contains an increased amount of the hormone IGF-1, which is one of the highest risk factors associated with breast and prostate cancer, but no one is tracking this in relation to cancer rates.
Is there any documented instance of adverse effects of GMOs on people?
One epidemic was rare, serious, and fast acting, and therefore more easily discovered. Called EMS, it was traced to a GM brand of the food supplement L-tryptophan. In the 1980's, the contaminated brand killed about 100 Americans and caused sickness or disability in about 5,000-10,000 others.
Why are children particularly susceptible to the effects of GM foods?
Children face the greatest risk from the potential dangers of GM foods for the same reasons that they also face the greatest risk from other hazards like pesticides and radiation, these include:
Young, fast-developing bodies are influenced most.
Children are more susceptible to allergies.
Children are more susceptible to problems with milk.
Children are more susceptible to nutritional problems.
Children are in danger from antibiotic resistant diseases.
Vaccine challenge and rechallenge in regards to vaccinations. With the proposed pandemic vaccine program citizens will receive 3 injections approximately 3 weeks apart. Challenge is the first injection and rechallenge are subsequent injections.
Case reports - two published case reports of neurological disease following challenge and rechallenge with hepatitis B vaccine. Immunization Safety Review: Hepatitis B Vaccine and Demyelinating Neurological Disorders (2002), Board on Health Promotion and Disease Prevention (HPDP), Institute of Medicine (IOM), page 39
The first pertains to a woman diagnosed with leukoencephalitis7 following each of her second and third shots of recombinant hepatitis B vaccine (Konstantinou et al., 2001).
The second case report pertains to sensorineural deafness (Biacabe et al., 1997). Although the patient appears to have suffered hearing loss twice after vaccination, the time frame is too short to be suggestive of an immunemediated reaction.
…tabulation prepared by CDC of case reports submitted to the Vaccine Adverse Events Reporting System (VAERS) between 1990 and 2001 lists eight cases stating evidence of rechallenge adverse events. These included a variety of clinical descriptions, including neuropathy, MS, and brachial neuritis.
Reports included 125 cases of MS, 15 cases of brachial neuritis, 83 cases of optic neuritis, 46 cases of peripheral neuritis, 91 cases of GBS, 30 cases of ADEM or demyelinating disease not otherwise specified, and 109 cases of myelitis. Most of these reports were included in only one outcome category, but some (73) were classified in more than one.
The published medical literature provides case reports of several demyelinating diseases following hepatitis B vaccination. These range, for example, from optic neuritis in a 28-year-old man (Albitar et al., 1997), to GBS in a 45-year-old woman (Creange et al., 1999), and transverse myelitis in a 40-year-old health care worker (Tartaglino et al., 1995).
Bases for the early immune response after rechallenge or component vaccination in an animal model of acute Mycoplasma pneumoniae pneumonitis, CIMOLAI N. (1) ; MAH D. G. (1) ; TAYLOR G. P. (1) ; MORRISON B. J. (1) ; 1) Division of Medical Microbiology, Department of Pathology, The University of British Columbia, Vancouver, CANADA
Abstract - The pathology of Mycoplasma pneumoniae pulmonary infection for a hamster model was examined after whole bacterium rechallenge or component vaccination. Animals which, after an initial infection, were rechallenged with either live or heat-killed M. pneumoniae inocula developed severe early recall lesions in the first 3 days. In contrast, animals infected once develop maximum histopathology at approximately 10-14 days. A severe perivascular inflammatory cellular infiltrate developed in the rechallenged groups, and pulmonary pathology could also be elicited by rechallenge with bacterial growth medium components.
Gastrointestinal co-morbidity, autistic regression and Measles-containing vaccines: positive re-challenge and biological gradient, Medical Veritas, Volume 3, Issue 1, April, 2006, By Gary S. Goldman, Ph.D., page 796
Challenge re-challenge refers to a situation where re-exposure of an individual to an agent (e.g., a drug or a toxin) elicits a similar adverse reaction to that seen following the initial exposure. The secondary reaction associated with re-challenge may either reproduce the features associated with the primary challenge, or may lead to worsening of the condition that was provoked or induced by the initial exposure. Alternatively, the risk of an adverse outcome may increase with increasing exposure.
Influenza Vaccine and Neurological Adverse Events: VAERS 7/1990 – 1/2003, Institute of Medicine (IOM), 3/13/03, Penina Haber, Department of Health and Human Services, CDC http://www.iom.edu/Object.File/Master/7/075/haber.pdf
Positive Re-challenge, page 25
Same adverse event occurred previously after the same vaccine
•Positive re-challenge COSTART code added end of 1994
•Four GBS reports: 1994, 2000, 2001 & 2002
•Four reports of paresthesia, myasthenia and hypotonia
•One report of neuralgia
•The above five reports aggravated / severe following 2nd dose
Summary – page 26
•Influenza vaccine most common “ exposure” annually (70 millions N x 3 next vaccine >Hep B)
•Reporting rate for influenza vaccine to VAERS is low vs. all other vaccines
•Annual variation in GBS reports after flu vaccination
•Diagnoses verified in 81%
–Non random distribution onset intervals
–Prevalence antecedent illness: 18%
–Several other neurological outcomes after flu vaccination have PRR =>2
–Controlled studies needed to further assess causality
Drug Injury, Liability, Analysis and Prevention, Second Edition, James T. O’Donnell, Pharm.D., M.S., FCP, ABCP, FACN, CNS, R.Ph.,
Chapter 10, Evaluation of Medical Causation, Donald H. Marks, M.D., Ph.D.
B. Riddell’s criteria, Page 146
4. De-challenge - De-challenge is the disappearance or improvement of AE after the treatment is withdrawn and is a positive indication of relatedness. AEs can, however, persist after treatment is withdrawn, which indicates either that there was no relatedness or that the AE was a persistent injury.
5. Re-challenge – Re-challenge is the re-introduction of a treatment, which is then associated with the same or a similar AE, and is a good indication of causation. An AE that does not recur can signal a lack of causation, but it might also indicate that tolerance has developed. Because just the potential association of a treatment and an adverse reaction may pre-effect its re-introduction (re-administration of penicillin to a person with a history would be ill-advised, for example), it is not always possible to use a re-challenge test on a patient.
10.7. Daibert v. Merrell Dow Pharmaceuticals, Inc., and the Evolution of Causation, Page 148
D. Challenge, de-challenge, and re-challenge studies – Challenge, de-challenge and re-challenge studies are useful in suggesting causation. In some cases, however, only a second challenge will result in an AE. Sometime the AE after a challenge is long-lasting and does not exhibit a de-challenge response after the treatment is stopped. Re-challenge can be considered positive when a similar, but not identical, treatment is applied (for example, when another member of the same drug class, a nearly identical vaccine, or a drug with to a shared vaccine component is used).
Aluminum and Thiomersal content of vaccines that are authorized to be co administered with the pandemic flu vaccine. http://www.fda.gov
Vaccines to be administered along with flu vaccines. (see 1.3.6.4.1) Partial list.
Measles vaccine - Tradename: ATTENUVAX, Manufacturer: Merck & Co., Inc, License #0002
propagated in chick embryo cell culture, Medium 199 (a buffered salt solution containing vitamins and amino acids and supplemented with fetal bovine serum) containing SPGA (sucrose, phosphate, glutamate, and human albumin) as stabilizer and neomycin.
Each dose of the vaccine is calculated to contain sorbitol (14.5 mg), sodium phosphate, sucrose (1.9 mg), sodium chloride, hydrolyzed gelatin (14.5 mg), human albumin (0.3 mg), fetal bovine serum (<1 ppm), other buffer and media ingredients and approximately 25 mcg of neomycin. The product contains no preservative.
Mumps vaccine – Not listed
Rubella vaccine - Tradename: MERUVAX II, Manufacturer: Merck & Co., Inc, License #0002
propagated in WI-38 human diploid lung fibroblasts.
The growth medium is Minimum Essential Medium (MEM) [a buffered salt solution containing vitamins and amino acids and supplemented with fetal bovine serum] containing human serum albumin and neomycin. Sorbitol and hydrolyzed gelatin stabilizer are added to the individual virus harvests.
Each dose of the vaccine is calculated to contain sorbitol (14.5 mg), sodium phosphate, sucrose (1.9 mg), sodium chloride, hydrolyzed gelatin (14.5 mg), human albumin (0.3 mg), fetal bovine serum (<1 ppm), other buffer and media ingredients and approximately 25 mcg of neomycin. The product contains no preservative.
MMR vaccine - Tradename: M-M-R II, Manufacturer: Merck & Co., Inc, License #0002
propagated in chick embryo cell culture, propagated in WI-38 human diploid lung fibroblasts.
Medium 199 (a buffered salt solution containing vitamins and amino acids and supplemented with fetal bovine serum) containing SPGA (sucrose, phosphate, glutamate, and recombinant human albumin) as stabilizer and neomycin.
Minimum Essential Medium (MEM) [a buffered salt solution containing vitamins and amino acids and supplemented with fetal bovine serum] containing recombinant human albumin and neomycin. Sorbitol and hydrolyzed gelatin stabilizer are added to the individual virus harvests.
Each dose of the vaccine is calculated to contain sorbitol (14.5 mg), sodium phosphate, sucrose (1.9 mg), sodium chloride, hydrolyzed gelatin (14.5 mg), recombinant human albumin (≤0.3 mg), fetal bovine serum (<1 ppm), other buffer and media ingredients and approximately 25 mcg of neomycin. The product contains no preservative.
Varicella vaccine - Tradename: Varivax, Manufacturer: Merck & Co, Inc, License #0002
Introduced into human embryonic lung cell cultures, adapted to and propagated in embryonic guinea pig cell cultures and finally propagated in human diploid cell cultures (WI-38). Further passage of the virus for varicella vaccine was performed at Merck Research Laboratories (MRL) in human diploid cell cultures (MRC-5) that were free of adventitious agents. This live, attenuated varicella vaccine is a lyophilized preparation containing sucrose, phosphate, glutamate, processed gelatin, and urea as stabilizers
approximately 18 mg of sucrose, 8.9 mg hydrolyzed gelatin, 3.6 mg of urea, 2.3 mg of sodium chloride, 0.36 mg of monosodium L-glutamate, 0.33 mg of sodium phosphate dibasic, 57 mcg of potassium phosphate monobasic, 57 mcg of potassium chloride. The product also contains residual components of MRC-5 cells including DNA and protein and trace quantities of neomycin and bovine calf serum from MRC-5 culture media. The product contains no preservative.
MMRV vaccine - Tradename: ProQuad, Manufacturer: Merck & Co, Inc, License #0002
propagated in chick embryo cell culture, WI-38 human diploid lung fibroblasts, propagated in MRC-5 cells
21 mg of sucrose, 11 mg of hydrolyzed gelatin, 2.4 mg of sodium chloride, 1.8 mg of sorbitol, 0.40 mg of monosodium L-glutamate, 0.34 mg of sodium phosphate dibasic, 0.31 mg of human albumin, 0.17 mg of sodium bicarbonate, 72 mcg of potassium phosphate monobasic, 60 mcg of potassium chloride; 36 mcg of potassium phosphate dibasic; residual components of MRC-5 cells including DNA and protein; <16 mcg of neomycin, bovine calf serum (0.5 mcg), and other buffer and media ingredients. The product contains no preservative.
Diphtheria vaccine – Not Listed
Tetanus vaccine (booster) – Manufacturer: Sanofi Pasteur, Inc, License #1725
grown in a peptone-based medium and detoxified with formaldehyde
Each dose contains the preservative thimerosal [(mercury derivative), 25 μg mercury/dose]. This product does not contain an aluminum-containing adjuvant.
Tetanus Toxoid Adsorbed - Manufacturer: Sanofi Pasteur, Inc, License #1725
medium containing an extract of bovine muscle tissue and detoxified with formaldehyde.
contains the preservative thimerosal [(mercury derivative), (25 μg mercury/dose)].
0.25 mg of aluminum.
Pertussis vaccine – Not Listed
DPT vaccine - Tradename: Tripedia, Manufacturer: Sanofi Pasteur, Inc. License #1725
contains a trace amount of thimerosal [(mercury derivative), (≤0.3 μg mercury/dose)] from the manufacturing process. Each 0.5 mL dose also contains, by assay, not more than 0.170 mg of aluminum and not more than 100 μg (0.02%) of residual formaldehyde. The vaccine contains gelatin and polysorbate 80 (Tween-80),
DPT vaccine - Tradename: Infanrix, Manufacturer: GlaxoSmithKline Biologicals, License #1617
VERO cell line (See 1.3.3.1.4)
Lactose, sodium chloride (NaCl), Medium 199 (as stabilizer containing amino acids, mineral salts, vitamins and other substances), aluminium hydroxide, aluminium phosphate, water for injections. potassium chloride, disodium phosphate, monopotassium phosphate, polysorbate 20 and 80, glycine, formaldehyde, neomycin sulphate, polymyxin B sulphate are present as residuals from the manufacturing process.
DPT vaccine – Tradename: DAPTACEL, Manufacturer: Sanofi Pasteur, Ltd. License #1726
Other ingredients per 0.5 mL dose include 1.5 mg aluminum phosphate (0.33 mg of aluminum) as the adjuvant, ≤5 μg residual formaldehyde, <50 ng residual glutaraldehyde and 3.3 mg (0.6% v/v) 2-phenoxyethanol (not as a preservative). The vial stopper is composed of dry natural latex rubber.
Influenza Virus Vaccine – Tradename: AFLURIA, Manufacturer: CSL Limited, License No. 1764
propagated in the allantoic fluid of embryonated chicken eggs
The multi-dose formulation contains thimerosal, added as a preservative; each 0.5 mL dose contains 24.5 mcg of mercury.
contains sodium chloride (4.1 mg), monobasic sodium phosphate (80 mcg), dibasic sodium phosphate (300 mcg), monobasic potassium phosphate (20 mcg), potassium chloride (20 mcg), and calcium chloride (1.5 mcg). From the manufacturing process, each dose may also contain residual amounts of sodium taurodeoxycholate (≤ 10 ppm), ovalbumin (≤ 1 mcg), neomycin sulfate (≤ 0.2 picograms [pg]), polymyxin B (≤ 0.03 pg), and beta-propiolactone (< 25 nanograms).
Influenza Virus Vaccine - Tradename: Fluvirin, 2009-2010 FORMULA Manufacturer: Novartis Vaccines and Diagnostics Limited, License #1750
propagated in the allantoic cavity of embryonated hens’ eggs
thimerosal, a mercury derivative used during manufacturing, is removed by subsequent purification steps to a trace amount (≤ 1 mcg mercury per 0.5-mL dose).
The 5-mL multidose vial formulation contains thimerosal, a mercury derivative, added as a preservative. Each 0.5-mL dose from the multidose vial contains 25 mcg mercury.
may also contain residual amounts of egg proteins (≤ 1 mcg ovalbumin), polymyxin (≤ 3.75 mcg), neomycin (≤ 2.5 mcg), betapropiolactone (not more than 0.5 mcg) and nonylphenol ethoxylate (not more than 0.015% w/v).
Inactivated Poliovirus vaccine - Tradename: IPOL, Manufacturer: Sanofi Pasteur, SA, License #1724
grown in vero cells, a continuous line of monkey kidney cells cultivated on microcarriers.1,2 newborn calf serum,
present are 0.5% of 2-phenoxyethanol and a maximum of 0.02% of formaldehyde per dose as preservatives. Neomycin, streptomycin and polymyxin B are used in vaccine production, and although purification procedures eliminate measurable amounts, less than 5 ng neomycin, 200 ng streptomycin and 25 ng polymyxin B per dose may still be present. The residual calf serum protein is less than 1 ppm in the final vaccine.
Other pandemic influenza vaccines approved by the EMEA (European Medicines Agency) and their ingredients. http://www.emea.europa.eu/htms/human/pandemicinfluenza/vaccines.htm
Baxter – Celvapan
Celvapan is a Vero cell-derived, monovalent, whole virion, inactivated vaccine containing 7.5 μg/dose of Haemagglutinin (HA). The whole virions of Influenza type A as the active ingredient is inactivated both by formaldehyde and UV-irradiation and purified on a sucrose density gradient.
The Active Substance is the Vero cell-derived, formaldehyde- and UVinactivated and sucrose gradient purified whole virions of influenza virus.
Additional components of the active Substance are
Tween 80,
Sodium Chloride and
Tris-buffer (TBS, containing Trometamol).
GlaxoSmithKline Biologicals – Pandemrix
Split influenza virus, inactivated,
propagated in eggs, haemagglutinin
AS03 adjuvant composed of
squalene (10.68 milligrams),
DL-α-tocopherol (11.86 milligrams) and
polysorbate 80 (4.85 milligrams)
Excipients:
It contains 5 micrograms thiomersal
Suspension vial
Polysorbate 80
Octoxynol 10
Thiomersal
Sodium chloride (NaCl)
Disodium hydrogen phosphate (Na2HPO4)
Potassium dihydrogen phosphate (KH2PO4)
Potassium chloride (KCl)
Magnesium chloride (MgCl2)
Water for injections
Emulsion vial:
Sodium chloride (NaCl) 8
Disodium hydrogen phosphate (Na2HPO4)
Potassium dihydrogen phosphate (KH2PO4)
Potassium chloride (KCl)
Water for injections
Novartis – Focetria
Influenza virus surface antigens [purified viral proteins] (haemagglutinin and neuraminidase)
propagated in eggs
expressed in microgram haemagglutinin
Adjuvant MF59C.1 containing
squalene 9.75 milligrams
polysorbate 80 1.175 milligrams
sorbitan trioleate 1.175 milligrams
List of excipients
Sodium chloride,
Potassium chloride,
Potassium dihydrogen phosphate,
Disodium phosphate dihydrate,
Magnesium chloride hexahydrate,
Calcium chloride dihydrate,
Sodium citrate,
Citric acid,
Water for injections
GlaxoSmithKline Biologicals – Daronrix
Pandemic influenza vaccine (whole virion, inactivated, adjuvanted)
propagated in eggs
haemagglutinin
adjuvanted by aluminium phosphate 0.45 milligrams Al3+
and aluminium hydroxide, hydrated 0.05 milligrams Al3+
Thiomersal 50 micrograms
List of excipients
Sodium chloride
Disodium phosphate dodecahydrate
Potassium dihydrogen phosphate
Potassium chloride
Magnesium chloride hexahydrate
Thiomersal
Water for injections
GlaxoSmithKline Biologicals – Prepandrix
Prepandemic influenza vaccine (split virion, inactivated, adjuvanted)
propagated in eggs
haemagglutinin
AS03 adjuvant composed of
squalene (10.68 milligrams),
DL-α-tocopherol (11.86 milligrams) and
polysorbate 80 (4.85 milligrams)
contains 5 micrograms thiomersal
Suspension vial:
Polysorbate 80
Octoxynol 10
Thiomersal
Sodium chloride (NaCl)
Disodium hydrogen phosphate (Na2HPO4)
Potassium dihydrogen phosphate (KH2PO4)
Potassium chloride (KCl)
Magnesium chloride (MgCl2)
Water for injections
Emulsion vial:
Sodium chloride (NaCl)
Disodium hydrogen phosphate (Na2HPO4)
Potassium dihydrogen phosphate (KH2PO4)
Potassium chloride (KCl)
Water for injections
GlaxoSmithKline Biologicals – Not Named
Prepandemic influenza vaccine (split virion, inactivated, adjuvanted)
propagated in eggs
haemagglutinin
AS03 adjuvant composed of
squalene (10.68 milligrams),
DL-α-tocopherol (11.86 milligrams) and
polysorbate 80 (4.85 milligrams)
Excipients:
It contains 5 micrograms thiomersal
Suspension vial:
Polysorbate 80
Octoxynol 10
Thiomersal
Sodium chloride (NaCl)
Disodium hydrogen phosphate (Na2HPO4)
Potassium dihydrogen phosphate (KH2PO4)
Potassium chloride (KCl)
Magnesium chloride (MgCl2)
Water for injections
Emulsion vial:
Sodium chloride (NaCl)
Disodium hydrogen phosphate (Na2HPO4)
Potassium dihydrogen phosphate (KH2PO4)
Potassium chloride (KCl)
Water for injections
Mandatory mass vaccination hazards.
Children
Medical history will not be available.
Medical family history will not be available
The right to informed consent of the parents would be minimal if at all
May have an allergy that would cause an adverse anaphylactic reaction
Vaccine does have Mercury used as a preservative. Mercury is a neurotoxin.
Pregnant women
Medical history will not be available
Medical family history will not be available
Clinical trials presently being conducted do not include pregnant women so safety to the fetus will not be known.
Mercury is known to pass through the placenta to the fetus and could cause neurological damage to the fetus.
Adults with chronic illnesses
Could have a compromised immune system
Could have a compromised renal system
Have the potential for more severe adverse events than a healthy individual
First responders – Medical and Police personnel
Long term safety of vaccine will not be known
Medical history will not be taken into account before vaccination
Could have an undiagnosed pre-existing condition that would surface after vaccination
Young female adults and female adults
Consideration will not be given as to where they are in their menstrual cycle
Consideration will not be given to whether they are on birth control –promotes blood clots (see 1.4)
Could be in early stages of pregnancy
Fertility safety will not be assessed
Preventive measures that are easily implemented in the general public with little cost to our health system and safe for the citizens.
Education of the public on a massive scale – Informational television and radio ads.
Cover nose and mouth with tissue.
Wash hands often
Avoid touching eyes, nose or mouth.
Avoid contact with people who are sick
Follow public health advice regarding school closures, avoiding crowds and other social distancing measures.
Eat a diet rich in fruits and vegetables
Take a quality vitamin supplement daily
Additional supplementation of vitamin C and D3 daily.
Wear a face mask when going into public places
Wear gloves in public
Stay home if you believe you may have the flu
CDC: Swine flu viruses in U.S. and Mexico match, CNN, April 25, 2009 -- Updated 0437 GMT (1237 HKT) http://edition.cnn.com/2009/HEALTH/04/24/swine.flu/index.html
To see actual statement delivered in the Press Briefing Transcripts, CDC Briefing on Public Health Investigation of Human Cases of Swine Influenza, April 23, 2009, 3:30 p.m. EST, http://www.cdc.gov/media/transcripts/2009/t090423.htm
COX: Thank you very much. The virus that has caused these infections is viruses are actually very interesting. They contain genetic segments as Dr. Schuchat said from four different virus sources.
So we have some gene segments that are North American swine influenza viruses. Some gene segments North American avian influenza viruses. One gene segment from a human influenza virus and two gene segments that are normally found from swine influenza viruses in Asia and in Europe.
More cases of swine flu reported; WHO warns of 'health emergency', CNN, updated 11:36 p.m. EDT, Sat April 25th, 2009, http://www.cnn.com/2009/HEALTH/04/25/swine.flu/index.html
Weekly epidemiological record, WHO, May 22nd, 2009, No. 21, 84, 185-196 http://www.who.int/wer/2009/wer8421.pdf
Influenza A (H1N1): pandemic alert phase 6 declared, of moderate severity, WHO/Europe outbreak update, 11 June 2009, 16:00 GMT http://www.euro.who.int/influenza/AH1N1/20090611_11
Novartis successfully demonstrates capabilities of cell-based technology for production of A(H1N1) vaccine, Novartis, Media release, June 12, 2009 07:15 CET http://www.novartis.com/newsroom/media-releases/en/2009/1322241.shtml