CA Health Authorities Distributed Flu Vaccine To Public Health Agencies Statewide With Mercury-Containing Preservative That's Been Reduced or Eliminated From Other Childhood Vaccines As Precautionary Measure
Feds Have Authorized Use In Flu Vaccine And Local Health Agencies Including LB, Are Using It
Some Alternate Flu Vaccines Contain Reduced Or Only Trace Amounts of Thimerosal And May Be Available Thru Some Private Doctors
(January 2, 2003) -- CA's Dept. of Health and Human Services distributed flu vaccine to public health departments statewide, including Long Beach, which includes a mercury-containing preservative -- thimerosal -- that has been reduced or eliminated from routinely recommended childhood vaccines as a precautionary measure. Its use in flu vaccine is federally authorized and lawful.
There are alternate forms of the flu vaccine that contain only trace amounts of thimerosal (considered thimerosal free by FDA) which the Centers for Disease Control and Prevention (CDC) web site says are available in limited amounts. A version by one manufacturer is approved for persons aged three years and older; another is approved for children ages six months and older and pregnant women. Some private physicians may have these; others don't, and patients are free to ask...if they know about them.
The CDC web site states in part, "There is no convincing evidence of harm to anyone, including infants and pregnant women, caused by the small amount of thimerosal in flu vaccines. The Advisory Committee on Immunization Practices (ACIP) has concluded that the benefits of flu vaccine outweigh any hypothetical risks posed by thimerosal." The CDC adds:
Thimerosal is a very effective preservative that has been used since the 1930s to prevent contamination in some multi-dose vials of vaccines (preservatives are not required for vaccines in single dose vials). Thimerosal contains approximately 49% ethyl mercury. There is no convincing evidence of harm caused by the low doses of thimerosal in vaccines, except for minor reactions like redness and swelling at the injection site. However, in July 1999 the Public Health Service (PHS) agencies, the American Academy of Pediatrics (AAP), and vaccine manufacturers agreed that thimerosal should be reduced or eliminated in vaccines as a precautionary measure.
Today, all routinely recommended licensed pediatric vaccines that are currently being manufactured for the U.S. market contain no thimerosal or only trace amounts...
Dr. Loring Dales, MD, Section Chief for Immunization with CA's Dept. of Health and Human Services, told LBReport.com that flu vaccine distributed to public health agencies statewide by his agency does contain thimerosal. Dr. Dales indicated that to the extent there has been concern over thimerosal, it's focused mainly on children, and flu vaccine is not licensed at all for children under six months of age. Flu vaccine efforts are now focused mainly on seniors...although the American Academy of Pediatrics has encouraged flu shots for all healthy children from 6 months to 2 years old.
Thimerosal information is not included on the federally designed vaccine information statement routinely given to patients.
Dr. Dales noted the CDC and the Advisory Committee on Immunization Practices do not include a precaution or contraindication on use of thimerosal with pregnant women. He added that the FDA has licensed and continues to license thimerosal-containing vaccine for pregnant women.
Dr. Dales said he wasn't sure if the alternative versions of flu vaccine with reduced or trace amounts of thimerosal were available soon enough or in sufficient quantities to allow statewide distribution this year.
There has been controversy over the record of some federal agencies on thimerosal and their interpretation of data, particularly as the number of vaccinations recommended for young children has increased. On December 10, 2002 the House Committee on Government Reform held a hearing that featured testimony from some physicians critical of federal agencies on thimerosal, followed by officials who defended their agencies' records.
Long Beach City Health Officer, Dr. Darryl Sexton, M.D., told LBReport.com:
"We are going to make sure that the information about thimerosal's inclusion will be available, if it's not clear already, and [also point out] that there is not flu vaccine completely without thimerosal but there are some that have some only trace amounts."
The following were found on the CDC web site:
Source for below: www.cdc.gov/nip/vacsafe/concerns/thimerosal/faqs-mercury.htm
What is mercury?
Mercury is a metal, a naturally occurring chemical element found everywhere in the environment. It becomes airborne when rocks erode and soil decomposes, or when coal, oil or natural gas is burned as fuel, or mercury-containing garbage is incinerated. In the atmosphere, mercury is transported by wind either as a vapor or as particles. It can fall to the ground with rain and snow, landing on soil or bodies of water. Mercury takes three major forms: metallic, inorganic, and organic.
Metallic mercury is a shiny, silver-white metal that is liquid at room temperature. It is the purest form of mercury in that it is not combined with other elements. Metallic mercury is the familiar liquid metal used in thermometers, dental fillings, batteries, and some electrical switches. Mercury easily evaporates into the air and the vapors can be very dangerous to breathe.
Inorganic mercury compounds are formed when mercury combines with other elements such as chlorine, sulfur, or oxygen. Because these compounds usually take the form of white powders or crystals, they are also known as "mercury salts." Inorganic mercury salts are used in products such as antiseptic creams and ointments. Other inorganic mercury compounds are used as antibacterials. These include thimerosal, which has been used in small amounts as a preservative in some vaccines and some prescription and over-the-counter medicines. Thimerosal contains ethylmercury, which is a form of organic mercury that biotransforms to inorganic mercury.
Organic mercury compounds are formed when mercury combines with carbon. The most common of these compounds, methylmercury, is mainly produced by microorganisms in water and soil. Methylmercury is of particular concern because it can accumulate in certain edible freshwater and saltwater fish, especially in larger and older fish, to levels that are much greater than levels in the surrounding water.
Humans and wildlife are exposed to all three forms of mercury. Most environmental mercury consists of the metallic and inorganic forms, which are quickly released from the body once exposure has occurred. The organic form tends to accumulate in humans, usually because they have been exposed to it by eating fish that have built up high levels of this form of mercury in their muscle tissue. Because mercury is everywhere, it is not possible to prevent all exposure to it. Very high levels of mercury are toxic.
How are recommended limits for mercury exposure established?
Several Federal agencies, including the Agency for Toxic Substances and Disease Registries (ATSDR), the Food and Drug Administration (FDA), and the Environmental Protection Agency (EPA), have established guidelines for levels of mercury exposure that are thought to be safe. Federal safety standards for mercury are based on research that has been performed on methylmercury. There are more data on methylmercury than on a related form called ethylmercury because methylmercury is more easily bound to tissue than ethylmercury, and remains there a longer time. Methylmercury is also believed to be more toxic than ethylmercury (Magos, 2001) and is the form of mercury of greatest public health concern (Mahaffey, 1999).
Recommended limits on methylmercury exposure are not "set lines" below which there is safety and above which adverse health effects will immediately occur (Mahaffey, 1999). There is a significant safety margin incorporated into all acceptable mercury exposure limits. Such guidelines are meant to be starting points for evaluation of mercury exposure, and should not be viewed as absolute levels above which harm can be expected to occur.
What happens if your exposure exceeds the recommended levels?
The nervous system is very sensitive to all forms of mercury. Methylmercury and metal vapors are often 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 include irritability, shyness, tremors, changes in vision or hearing, attention, language, and memory problems.
Effects of short-term exposure to high levels of metallic mercury vapors may include lung damage, nausea, vomiting, diarrhea, increases in blood pressure or heart rate, skin rashes, and eye irritation.
It is important to keep in mind that being exposed to more than the recommended mercury limits does not necessarily mean you will experience adverse health effects. There is a significant safety margin incorporated into all acceptable mercury exposure limits; they should not be viewed as absolute levels above which harm can be expected to occur.
Who is most vulnerable to mercury?
Unborn babies (developing fetus) are more sensitive to the effects of many chemicals, including mercury. Premature babies are also more vulnerable because they tend to be very small and their brain is not as developed as that of 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. Thus, the Food and Drug Administration (FDA) and Environmental Protection Agency (EPA) recommend that women who are pregnant or may become pregnant, nursing mothers, and young children limit consumption of freshwater fish to one meal per week (six ounces of cooked fish per adult; two ounces of cooked fish per child).
How can mercury affect children?
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 breastfeeding may be greater than the possible adverse effects of mercury in breast milk.
If a pregnant woman ingests mercury at high levels, harmful effects that may be passed from the mother to the developing fetus include brain damage, mental retardation, lack of coordination, blindness, seizures, and an inability to speak. Children poisoned by mercury may develop nervous and digestive system problems and kidney damage.
What is thimerosal?
Thimerosal is a very effective preservative that has been used in some vaccines and other products since the 1930’s. Thimerosal contains approximately 49% ethylmercury. There is no evidence of harm caused by the low doses of thimerosal in vaccines, except for minor reactions like redness and swelling at the injection site. However, in July 1999 the Public Health Service (PHS) agencies, the American Academy of Pediatrics (AAP), and vaccine manufacturers agreed that thimerosal should be reduced or eliminated in vaccines as a precautionary measure. Today, all routinely recommended licensed pediatric vaccines that are currently being manufactured for the U.S. market contain no thimerosal or only trace amounts.
Source for below: www.cdc.gov/nip/Flu/thimerosal.htm
1. What is thimerosal?
Thimerosal is a very effective preservative that has been used since the 1930s to prevent contamination in some multi-dose vials of vaccines (preservatives are not required for vaccines in single dose vials). Thimerosal contains approximately 49% ethylmercury. There is no convincing evidence of harm caused by the low doses of thimerosal in vaccines, except for minor reactions like redness and swelling at the injection site. However, in July 1999 the Public Health Service (PHS) agencies, the American Academy of Pediatrics (AAP), and vaccine manufacturers agreed that thimerosal should be reduced or eliminated in vaccines as a precautionary measure.
Today, all routinely recommended licensed pediatric vaccines that are currently being manufactured for the U.S. market contain no thimerosal or only trace amounts...
2. Does the influenza vaccine contain thimerosal?
Yes, the majority of influenza vaccines distributed in the United States currently contain thimerosal as a preservative. However, some contain only trace amounts of thimerosal and are considered by the Food and Drug Administration (FDA) to be preservative-free. Manufacturers of preservative-free flu vaccine use thimerosal early in the manufacturing process. The thimerosal gets diluted as the vaccine goes through the steps in processing. By the end of the manufacturing process there is not enough thimerosal left in the vaccine to act as a preservative and the vaccine is labeled ‘preservative-free’.
3. Can I get an influenza vaccine that does not contain thimerosal?
For the 2002-2003 flu season, a limited number of individually packaged doses of preservative free, reduced thimerosal-content influenza vaccine are available from Evans Vaccines and Aventis Pasteur. The Evans reduced thimerosal-content vaccine is approved for use in persons over the age of 3 years. In September 2002, the FDA approved Aventis Pasteur’s Fluzone® Preservative-free: Pediatric Dose, Influenza Virus Vaccine for use in children 6 months of age and older. Fluzone® is packaged in 0.25 ml dose syringes for persons under 3 years of age, and in 0.50 ml dose syringes for persons 3 years and older (including pregnant women).
4. Is it safe for children to receive an influenza vaccine that contains thimerosal?
Yes. There is no convincing evidence of harm caused by the small doses of thimerosal in vaccines, except for minor effects like swelling and redness at the injection site due to sensitivity to thimerosal. Most importantly, since 1999, newly formulated thimerosal preservative-free childhood vaccines (Hepatitis B, Hib, and DTaP) have been licensed. With the newly formulated childhood vaccines, the maximum total exposure during the first six months of life will now be less than three micrograms of mercury. Based on guidelines established by the FDA, the Environmental Protection Agency (EPA) and the Agency for Toxic Substances and Disease Registry (ATSDR), no child will receive excessive mercury from childhood vaccines regardless of whether or not their flu shot contains thimerosal as a preservative.
Recent research suggests that healthy children under the age of 2 are more likely than older children and as likely as people over the age of 65 to be hospitalized with flu complications. Therefore, vaccination with reduced or standard thimerosal content flu vaccine is encouraged when feasible in children, including those that are 6-23 months of age.
5. Is it safe for pregnant women to receive an influenza vaccine that contains thimerosal?
Yes. A study of influenza vaccination examining over 2,000 pregnant women demonstrated no adverse fetal effects associated with influenza vaccine. Case reports and limited studies indicate that pregnancy can increase the risk for serious medical complications of influenza. One study found that out of every 10,000 women in their third trimester of pregnancy during an average flu season, 25 will be hospitalized for flu related complications.
Additionally, influenza-associated excess deaths among pregnant women have been documented during influenza pandemics. Because pregnant women are at increased risk for influenza-related complications and because a substantial safety margin has been incorporated into the health guidance values for organic mercury exposure, the benefits of influenza vaccine with reduced or standard thimerosal content outweighs the theoretical risk, if any, of thimerosal.
[references omitted. Click to link]
Source for below: www.cdc.gov/nip/Flu/Provider.htm
The Advisory Committee on Immunization Practices (ACIP) issued the 2002 influenza recommendations on April 12, 2002. One of the principal changes from the preceding year concerned the use of influenza vaccine for healthy young children. Because young, otherwise healthy children are at increased risk for influenza-related hospitalizations, the ACIP decided this year to encourage influenza vaccination of children 6 - 23 months when feasible. However, they did not make a full recommendation for annual vaccination of this group because of several concerns they felt needed to be addressed before this could be done. These concerns include increasing efforts to educate parents and providers regarding the impact of influenza and the potential benefits and risks of vaccination among young children, clarification of practical strategies for annual vaccination of children since most will require two doses in the same season, and reimbursement issues.
The ACIP will address these and other issues in future meetings and will provide updated information as these concerns are addressed. The possibility of additional studies on the effectiveness of influenza vaccine in 6-23 month old children will also be discussed. A full recommendation could be made in the next 3 years. Vaccination of children over 6 months of age who have certain medical conditions continues to be strongly recommended.
Another addition to the ACIP recommendations this year is an encouragement for influenza vaccination of household contacts and out-of-home caretakers of children under two years of age. Because children under 6 months of age are not eligible for influenza vaccination themselves, but have high rates of influenza-related hospitalizations, ACIP particularly encourages vaccination of their close contacts.