NEW YORK (USA) VIETA I VACCINI AL MERCURIO

Il Senato di New York ha vietato la somministrazione di vaccini contenenti “tracce di mercurio” a bambini di meno di 3 anni e a donne incinte.
La decisione prende di mira (senza nominarlo esplicitamente) il thimerosal, un antibatterico al mercurio, prodotto dalla Eli Lilly, che viene aggiunto da decenni ai più comuni vaccini.
Esso è ritenuto responsabile di migliaia di casi di autismo infantile, essendo il mercurio un potente neurotossico.

La fonte della notizia – In-Pharma, sito ufficiale delle industrie farmaceutiche USA – si premura di precisare che “dal 2000 [sic] i vaccini per bambini sono disponibili in versioni che non contengono mercurio (‘Thiomersal-free’) o che lo contengono solo in tracce…eccettuate le fiale multidose destinate al Terzo Mondo” [sospiro di sollievo].

La sostanza è già stata vietata nello Iowa ed in California, ed il divieto sta per essere sancito anche da Delaware, Florida, Maryland, Massachusettes, Minnesota, Missouri, Nevada, North Carolina, Ohio, Oregon, Pennsylvania, Rhode Island, Tennessee, Utah e Washington.

Questa notizia viene fornita a beneficio speciale di una lettrice che, avendo letto a mia firma la notizia sul Thimerosal e la sua pericolosità, mi ha accusato di esagerare per “antiamericanismo”.
Evidentemente molti Stati in USA sono antiamericani.

di Maurizio Blondet
Da: http://www.effedieffe.com/fdf/giornale/interventi.php?id=510&parametro=scienze
In: http://www.effedieffe.com/fdf/giornale/giornale.php
 

Contenuto in timerosal e in mercurio dei vaccini in commercio in Italia  Tabella 1

* La scheda tecnica non lo menziona nella “Lista degli eccipienti”, ma dichiara altresì che ne sono contenute tracce non dosabili alla voce “Avvertenze speciali e opportune precauzioni di impiego”
** Erroneamente l’Informatore farmaceutico riporta 500 mg 

Legenda:
T: Tetano
DT: Difterite-Tetano
DTP: Difterite-Tetano-Pertosse cellulare
DTPa: Difterite-Tetano-Pertosse acellulare
Pa: Pertosse acellulare
Hep B: Epatite B
IPV: Polio per via intramuscolare (tipo Salk)
HiB: Haemophilus Influentiae di tipo b
Hep A: Epatite A

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National Immunization Program Thimerosal and Vaccine - Questions/Answers - July 15, 1999
Q 1. What is Thimerosal ?
A. Thimerosal is a very effective preservative that contains mercury and has been used in some vaccines and other products since the 1930s. Thimerosal is the most widely used preservative in vaccines. The FDA estimates that it is used in more than 30 licensed vaccines and biologics. Mercury is excreted from the body over time. 

Q 2. Why is Thimerosal used in vaccines ? 
A. Thimerosal is used as an extra safeguard against contamination. It may be used during processing or added to the final container to prevent contamination when multi-dose vials are opened. Before Thimerosal was marketed in the United States, a number of safety studies were conducted, first on animals and then on humans. Thimerosal is an important preservative that protects vaccine against bacterial contamination. It is very effective in killing bacteria used in several vaccines and in preventing bacterial contamination, particularly in opened multi-dose containers. Some but not all of the vaccines recommended routinely for children in the United States contain thimerosal. Disease outbreaks have occurred following contamination of multi-dose vaccine vials in the United States and from other countries. For example, in April, 1995, three infants died in India from toxic shock syndrome after administration of contaminated measles vaccine at one health center. 

Q3. Can all vaccines be made Thimerosal-free, or within accepted guidelines? If so, how quickly ? 
A. All vaccines either do not contain thimerosal or contain thimerosal within FDA guidelines. To further increase the margin of safety that already exists, clinicians can use the inherent flexibility in the current immunization schedule to fully vaccinate children and meet even the most conservative guidelines for cumulative mercury exposure. Clinicians and parents can take advantage of the flexibility within the existing schedule for infants born to Hepatitis B surface antigen (HbsAg)-negative women to postpone the first dose of hepatitis B vaccine from birth until two to six months of age when the infant is considerably larger. Pre-term infants born to HBsAg-negative mothers should similarly receive hepatitis B vaccine, but ideally not until they reach term gestational age and a weight of at least 2.5 kilograms. Because of the substantial risk of disease, there is no change in the recommendations for infants of HbsAg-positive mothers or of mothers whose status is not known. Also, in populations where HbsAg screening of pregnant women is not routinely performed, vaccination of all infants at birth should be maintained, as is currently recommended. Public Health Service agencies are working with private physician groups and vaccine manufacturers to expedite the process to reduce or eliminate thimerosal from vaccines used in the United States.

Q4. What could happen if parents ignored recommendations to use thimerosal-containing vaccines during this transition period ?
A. Children would be at very real risk from illnesses that can be prevented with safe and effective vaccinations. High rates of vaccination led to declines of 95% to 100% in the occurrence of vaccine preventable diseases in the United States. Despite this, the pathogens responsible for most vaccine preventable diseases still circulate and rates of disease would increase if vaccine coverage dropped. For example, if vaccination coverage among infants dropped from 95% to 70%, an additional 2,500 cases of pertussis would be expected to occur. Moreover, the risk of death from pertussis is greatest in young children. A second severe vaccine preventable disease among young children is Haemophilus influenzae type b (Hib). Before vaccine was introduced, this pathogen was the leading cause of meningitis and other severe invasive infections among children; now cases of invasive Hib disease have virtually disappeared. If vaccination for Hib declined to 70%, 2,000 excess cases would occur with 1,200 cases of meningitis, resulting in about 100 deaths and 180 children who would suffer mental retardation and hearing loss.

Q5. Why isn&Mac226;t the federal government just recommending not using vaccines with thimerosal in them if there is concern ?
A. Making vaccines safer and more effective is a constant goal for the federal government; and, that is the purpose of the action we&Mac226;re taking now. There is a significant safety margin incorporated into all acceptable mercury exposure limits. Furthermore, there are no data or evidence of any harm caused by the level of exposure that some children may have encountered in following the existing immunization schedule. Today, we&Mac226;re discussing a minimal, if any, risk from minute levels of mercury-containing thimerosal versus the large and devastating risk of childhood diseases like bacterial meningitis and whooping cough if parents and physicians abandon vaccination during this transition period. Any missed vaccinations puts children at risk from disease.

Q6. How much mercury did my 6-month-old get in the last six months from vaccines? How dangerous is that ?
A. Each dose of vaccine given your child met FDA requirements and should not be a concern to you now--your choice to vaccinate your baby was a sound one. The mercury levels being discussed are well within the safety margins; however, we are working toward further increasing the margin of safety that already exists. It is important that we limit the cumulative amount of mercury children are exposed to, but parents should not abandon vaccination as a means to do that.

Q7. If there are vaccines that are mercury-free, why shouldn't I just ask for those ?
A. The American Academy of Pediatrics, the Advisory Committee on Immunization Practices for CDC and the Surgeon General all recommend that parents do not let their child miss a vaccination when safe and effective vaccines are available. Today, we are discussing a minimal, if any, risk from cumulative levels of mercury from some vaccines versus the large and devastating risk of childhood diseases like bacterial meningitis and whooping cough if parents and physicians abandon vaccination during this transition period. Clinicians and parents can take advantage of the flexibility within the existing schedule for infants born to Hepatitis B surface antigen (HbsAg)-negative women to postpone the first dose of hepatitis B vaccine from birth until two to six months of age when the infant is considerably larger. Pre-term infants born to HBsAg-negative mothers should similarly receive hepatitis B vaccine, but ideally not until they reach term gestational age and a weight of at least 2.5 kilograms. Because of the substantial risk of disease, there is no change in the recommendations for infants of HbsAg-positive mothers or of mothers whose status is not known. Also, in populations where HbsAg screening of pregnant women is not routinely performed, vaccination of all infants at birth should be maintained, as is currently recommended. Public Health Service agencies are working with private physician groups and vaccine manufacturers to expedite the process to reduce or eliminate thimerosal from vaccines used in the United States. The American Academy of Pediatrics, the Advisory Committee on Immunization Practices for CDC and the U.S. Surgeon General want parents to be fully informed about children&Mac226;s vaccines and if you have questions or concerns, we encourage you to speak to your child&Mac226;s trusted health care provider.

Q8. I&Mac226;ve heard that children may be getting toxic levels of mercury from vaccines. Is that true ?
A. Everyone is exposed to mercury, even in some foods and household products. As part of an ongoing assessment of mercury in the environment and in products, many agencies have developed guidelines for acceptable levels of mercury--levels many times below any amount known to cause harm. Some children, depending on which vaccines they receive and the timing of those vaccines, are exposed to cumulative levels of mercury close to the safety ranges of guidelines. To further increase this margin of safety, clinicians and parents can take advantage of the flexibility within the existing immunization schedule. It&Mac226;s important to understand that these highest acceptable levels include a "safety cushion" to take into account all the variables that people face in their exposures to mercury. No children are getting toxic levels of mercury from vaccines.

Q9. Are there vaccines available to prevent childhood diseases without exposing them to mercury ?
A. Yes, although you may discover that these vaccines are not immediately available from your health care provider. The American
Academy of Pediatrics, the Advisory Committee on Immunization Practices for CDC and the Surgeon General all recommend that parents do not let their child miss a vaccination when safe and effective vaccines are available. Today, we have a minimal, if any, risk from minute levels of mercury-containing thimerosal in some vaccines versus the large and devastating risk of childhood diseases like bacterial meningitis and whooping cough if parents and physicians abandon vaccination during this transition period. The American Academy of Pediatrics, the Advisory Committee on Immunization Practices for CDC and the U.S. Surgeon General want parents to be fully informed about children&Mac226;s vaccines and if you have questions or concerns, we encourage you to speak to your child&Mac226;s trusted health care provider.

Q10. Why are the Public Health Service and AAP making these recommendations now ?
A. Although mercury is found in the environment, in food and in household products, exposure to mercury is of concern and, when possible, should be avoided. The Public Health Service agencies, the American Academy of Pediatrics, and vaccine manufacturers agree that thimerosal should be reduced or eliminated in vaccines to make already safety vaccines even safer and to allow for new vaccines to be added to the schedule in the future. Some children, depending on which vaccines they receive and the timing of those vaccines, are exposed to cumulative levels of mercury close to the safety ranges of guidelines. The mercury levels being discussed are within the safety margins; however, we are working toward further increasing the margin of safety that already exists. It is important that we limit the cumulative amount of mercury children are exposed to, but parents should not abandon vaccination as a means to do that.

Q11. Why are chemicals and other substances added to vaccines ?
A. Many things in today's world, including foods and medicines, have chemicals added to them to prevent the growth of germs and reduce spoilage. Chemicals are added to vaccines for similar reasons, to inactivate a virus or bacteria and to stabilize it, helping to preserve the vaccine and prevent it from losing its potency over time. Some additives are used in the production of vaccines. Vaccines may include suspending fluid (e.g., sterile water, saline, or fluids containing protein); preservatives and stabilizers (e.g., albumin, phenols, and glycine);  and adjuvants or enhancers that help the vaccine improve its immunogenicity (ability to protect against disease).

Q12. I understand some people are sensitive to thimerosal and must avoid it. Do they have problems with thimerosal-containing vaccines ?
A. Most patients do not develop reactions to thimerosal given as a component of vaccines even when they&Mac226;ve had a patch or intradermal tests for thimerosal that indicated hypersensitivity. Hypersensitivity to thimerosal usually consists of local, delayed reactions.

Q13. How can I find out what chemical additives are in specific vaccines ?
A. Ask your health care provider or pharmacist for a copy of the vaccine package insert. The package insert lists ingredients in the vaccine and discusses any known adverse reactions.

Q14. What is mercury ?
A. Mercury is a metal, a chemical element found everywhere. As such, it is neither created, nor destroyed -- the same amount of mercury has existed since the earth was formed. Two major forms of mercury exist in nature, an inorganic form (the mercury used in thermometers) and the organic form. Humans and wildlife are exposed to both, but the metallic mercury is quickly released from the body. The organic form tends to accumulate in humans, and particularly in large predator fish. Humans are usually exposed to organic mercury from eating fish which have accumulated it in their muscle tissue. Very high levels of mercury are toxic. Because mercury is everywhere, it is not possible to prevent all exposure to mercury. Federal agencies, including the Agency for Toxic Substances and Disease Registries and the Food Administration have established guidelines for levels of mercury exposure considered safe. In addition, uses and releases of mercury have been reduced very substantially in recent decades in the U.S. and most other industrialized countries.

Q15. Who is most vulnerable to mercury ?
A. Two groups are most vulnerable to methyl mercury: the fetus and pregnant women. Premature babies are more vulnerable because they tend to be very small and their brain is not as developed as a full term  baby. Children may be at higher risk of mercury exposure than are adults because they eat more per pound of body weight and because they may be inherently more sensitive than adults since their nervous systems are still developing. The guidelines for mercury exposure are based on amount of mercury per weight. This helps estimate reference level of exposure according to the person's weight.

Q16: What is the ATSDR level for mercury exposure ?
A: The minimal risk level, or MRL, is 0.3 micrograms per kilograms of body weight per day (ug/kg/d) for ingestion of methylmercury. Mercury occurs in the environment in several forms: elemental, inorganic and organic mercury. Methylmercury is the most common form of organic mercury. People can be exposed to methylmercury by eating fish or shellfish that come from mercury-contaminated waters.
MRLs are health guidance values established by ATSDR and are intended for use by health assessors as screening tools when determining whether further evaluation of potential human exposure at hazardous waste sites is warranted. They are not intended for use in determining clean-up levels or for other regulatory purposes.

Q17: Why is this level different from EPA&Mac226;s ?
A: Both agencies recognize Mercury as a neurotoxicant, a toxin which affects the nervous system of humans. Further, both agencies recognize that fetuses and women of reproductive age are among the groups at high risk from Mercury exposure. And, both agencies agree on the Minimal Risk Levels for exposure to two of the three forms of Mercury&Mac246;Elemental Mercury by inhalation, and Inorganic Mercury by oral means. The agencies do differ in the MRL for Methyl Mercury (Organic Mercury). The difference between the two agencies is extremely small. In the Toxicological Profile for Mercury, ATSDR uses exposure to 0.3 micrograms per kilogram of body weight per day as the Minimal Risk Level (the level at which scientists would not expect to see any adverse health effects, but at which they would see the need for additional investigation). EPA considers the level to be 0.1 micrograms/kilogram/day. A microgram is one millionth of a gram. A gram is 0.035 ounce.

Q18: What is the safety margin built into this level ? 
A: The ATSDR value (mrl of 03 mcg/kg/d) has a significant safety margin built into it. The value is approximately ten times below the highest exposure levels found in participants in the Seyschelles Study (a recent study evaluating individuals who were exposed to methyl mercury). Even at the highest exposure levels recorded in the Seyschelles Study, no participants experienced adverse health effects.

Q19: What happens if your exposure exceeds the recomended levels ?
A: The nervous system is very sensitive to all forms of mercury. Methylmercury and metal vapors are more harmful than other forms, because more mercury in these forms reaches the brain. Exposure to high  levels of metallic, inorganic, or organic mercury can permanently damage the brain, kidneys, and developing fetus. Effects on brain functioning may result in irritability, shyness, tremors, changes in vision or hearing, and memory problems. Short-term exposure to high levels of metallic mercury vapors may cause effects including lung damage, nausea, vomiting, diarrhea, increases in blood pressure or heart rate, skin rashes, and eye irritation.

Q20: How can mercury affect children ?
A: Very young children are more sensitive to mercury than adults. Mercury in the mother's body passes to the fetus and can pass to a
nursing infant through breast milk. However, the benefits of breast feeding may be greater than the possible adverse effects of mercury in
breast milk. Mercury's harmful effects that may be passed from the mother to the developing fetus include brain damage, mental retardation, and lack of coordination, blindness, seizures, and an inability to speak. Children poisoned by mercury may develop problems of their nervous and digestive systems and kidney damage.

Q21. Which population groups have the highest levels of mercury ?
A. Groups that tend to have higher exposure include subsistence and frequent recreational fishers, people of Asian origin, and some Native
American groups. The typical U.S. consumer eating fish from restaurants and grocery stores are not in danger of consuming harmful levels of mercury from fish and are not advised to limit fish consumption. Everyone is exposed to mercury, even in some foods and household
products.

Q22. How can parents learn more about children&Mac226;s immunizations ?
A. To learn more about children's immunizations, vaccinations, or baby shots from a CDC information specialist, please call CDC&Mac226;s National Immunization Information Hotline: 1-800-232-2522, for English,
1-800-232-0233, for Spanish.

This page last reviewed July 15, 1999.
Centers for Disease Control and Prevention National Immunization Program
(su "VIA" del 08.03.2000)

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Thimerosal Toxicity

The various mercury guidelines are based on epidemiological and laboratory studies of methyl mercury, whereas thimerosal is a derivative of ethyl mercury. Because they are different chemical entities - ethylversus methylmercury - different toxicological profiles are expected. There is, therefore, an uncertainty that arises in applying the methylmercury-based guidelines to thimerosal. Lacking definitive data on the comparative toxicities of ethyl- versus methylmercury, FDA considered ethyl- and methyl-mercury as equivalent in its risk evaluation . There are some data and studies bearing directly on thimerosal toxicity and these are summarized in this Section .

Allergic responses to thimerosal are described in the clinical literature, with these responses manifesting themselves primarily in the form of delayed-type local hypersensitivity reactions, including redness and swelling at the injection site (Cox and Forsyth 1988 ; Grabenstein 1996). Such reactions are usually mild and last only a few days.
Some authors postulate that the thiosalicylate component is the major determinant of allergic reactions (Goncalo et al. 1996) .
In a clinical setting, however, it is usually not possible to determine whether local reactions are caused by thimerosal or other vaccine components.

The earliest published report of thimerosal use in humans was published in 1931 (Powell and Jamieson 1931) .
In this report, 22 individuals received 1% solution of thimerosal intravenously for unspecified therapeutic reasons. Subjects received up to 26 milligrams thimerosal/kg (1 milligrams equals 1,000 micrograms) with no reported toxic effects, although 2 subjects demonstrated phlebitis or sloughing of skin after local infiltration. Of note, this study was not specifically designed to examine toxicity; 7 of 22 subjects were observed for only one day, the specific clinical assessments were not described, and no laboratory studies were reported.

Several cases of acute mercury poisoning from thimerosal-containing products were found in the medical literature with total doses of thimerosal ranging from approximately 3 mg/kg to several hundred mg/kg.
These reports included the administration of immune globulin (gamma globulin) (Matheson et al. 1980) and hepatitis B immune globulin (Lowell et al . 1996), choramphenicol formulated with 1000 times the proper dose of thimerosal as a preservative (Axton 1972), thimerosal ear irrigation in a child with tympanostomy tubes (Rohyans et al. 1994), thimerosal treatment of omphaloceles in infants (Fagan et al . 1977), and a suicide attempt with thimerosal (Pfab et al . 1996) .
These studies reported local necrosis, acute hemolysis, disseminated intravascular coagulation, acute renal tubular necrosis, and central nervous system injury including obtundation, coma, and death. (IOM)

Several animal studies have evaluated the toxicity of thimerosal. In 1931 Powell and Jamieson reported acute toxicity studies in several animal species. Maximum tolerated doses not associated with death of the animals were 20 mg thimerosal/kg (rabbits) and 45 mg/kg (rats) . Blair evaluated the administration of thimerosal intranasally for 190 days and observed no histopathological changes in the brain or kidney (Blair et al . 1975) .
Magos et al. directly compared the toxicity of ethyl- versus methylmercury in adult male and female rats administered 5 daily doses of equimolar concentrations of ethyl- or methylmercury by gavage (Magos et al 1985). Magos concluded that ethylmercury, the mercury derivative found in

http://www.fda.gov/cber/vaccine/thimerosal.htm  -  9/27/2006

Thimerosal in Vaccines Page 6 of 15

thimerosal, is less neurotoxic than methylmercury, the mercury derivative for which the various guidelines are based .

One final piece of data regarding thimerosal is worth noting . At the initial National Vaccine Advisory Committee-sponsored meeting on thimerosal in 1999, concerns were expressed that infants may lack the ability to eliminate mercury.
More recent NIAID-supported studies at the University of Rochester and National Naval Medical Center in Bethesda, MD examined levels of mercury in blood and other samples from infants who had received routine immunizations with thimerosal-containing vaccines. [Pichichero ME, et al. Lancet 360:1737-1741 (2002)] Blood levels of mercury did not exceed safety guidelines for methyl mercury for all infants in these studies.
Further, mercury was cleared from the blood in infants exposed to thimerosal faster than would be predicted for methyl mercury; infants excreted significant amounts of mercury in stool after thimerosal exposure, thus removing mercury from their bodies. These results suggest that there are differences in the way that thimerosal and methyl mercury are distributed, metabolized, and excreted . Thimerosal appears to be removed from the blood and body more rapidly than methyl mercury.
NIAID is sponsoring a follow-up study with larger numbers of infants in Buenos Aires where thimerosal-containing vaccines are still administered to children.
Tratto da: http://www.fda.gov/ohrms/dockets/dockets/04p0349/04p-0349-ref0001-10-Tab-07-CBER-Thimerosal-in-Vacinnes-vol6.pdf

vedi anche Dati ISTAT sui Vaccini Pag. 6  -  Pag. 7  -  Pag. 8  -  Pag. 9  -  Pag. 10  -  Pag 11  -  Pag. 12  -  Pag. 13  - Pag 14  - Pag 15  - Pag. 16  -  Pag. 17  -  Pag. 18  -  Pag.19  -  Pag. 20  -  Pag. 21

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