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The following is the handout distributed at a neurotoxicology conference in

Colorado last weekend. SAFE MINDS presented a paper and a fairly high

ranking person from the FDA attended and presented something as well.

Heidi

Mercury in Vaccines:

Cause for Concern

The Question

Should infants be given vaccines with mercury or vaccines without mercury?

Today, infants and young children are being given vaccines containing

mercury, even though vaccines without mercury are readily available for all

CDC-recommended pediatric immunizations. Given the known toxicity of

mercury and its harmful effects on the developing brain even at low doses,

prudent medical practice suggests the use only of vaccines without mercury

to meet immunization requirements.

The Facts

Mercury: one of the most dangerous chemicals on earth and a known

neurotoxin, mercury (Hg) is especially harmful to the developing brain1.

Thimerosal: a preservative comprised of 49.6% ethyl mercury by weight,

thimerosal is routinely used in vaccines and other biologic products2.

Harmful substance: since the 1970's, researchers and clinicians have

described the harmful effects of thimerosal on humans3. In 1982, an expert

FDA panel concluded that thimerosal was an ineffective bactericide and

unsafe, and it recommended that thimerosal be removed from all

over-the-counter products4.

Exposure from vaccines: in 1999, under Congressional mandate, the FDA

calculated the amount of mercury in pediatric vaccines from thimerosal. By

the age of 2 years, a child could receive 237.5 mcg/Hg in repeat, acute

doses if following the CDC's recommended immunization schedule. The FDA

concluded that the amount exceeds Federal safety guidelines5.

Neurodevelopmental effects: in July 2000, a study commissioned by the CDC

utilizing the Vaccine Safety Datalink database of 400,000 children found a

statistically significant association between exposure to thimerosal in

vaccines and attention deficit disorder, speech delay, tics, and

neurodevelopmental disorders in general. A dose response relationship was

observed6.

Toxic dose: SAFE MINDs, a non-profit organization investigating the role of

thimerosal in neurodevelopmental disorders, has calculated using a

biokinetic model that the amount of mercury in vaccines is predicted to

result in hair Hg concentrations exceeding the EPA/NAS safety guideline of 1

ppm from birth to age 12 months, with several peak elevations above 5 ppm in

some cases, and, for the smallest babies, peak concentrations of 10 ppm7. A

level of 5 ppm is indicative of toxicity8 and levels of 10 ppm have been

associated with neurological deficits in children exposed prenatally9.

Sensitive populations: sensitive groups may be even more vulnerable to the

thimerosal in vaccines10. Using studies measuring blood Hg concentrations

in newborns after a vaccine injection11 and hair Hg concentrations of

neurodevelopmentally delayed children12, it can be estimated that some

proportion of children will have blood levels exceeding 20 ppm and hair

levels exceeding 10 ppm7. Blood levels of 15-30 ppm and hair levels of 10-20

ppm have been associated with neurological deficits in children13.

Non-thimerosal vaccines: vaccines without thimerosal are readily available

for all recommended childhood immunizations. At a June 2000 meeting of the

Advisory Committee on Immunization Practices, manufacturers stated that they

have enough vaccine supply to immunize all children 6 months and under with

thimerosal-free vaccines14. In sworn testimony before Congress,

Bernier of the CDC testified that there were sufficient supplies of

non-thimerosal vaccines to fully immunize all children15.

Thimerosal vaccines: despite the availability of non-thimerosal

alternatives, vaccines which contain thimerosal are still available on the

market, either because some manufacturers continue to make vaccines with

thimerosal (diphtheria, pertussis, and tetanus products) 16 or because

older, thimerosal-containing versions are still stocked for use17. Other

biologic products routinely given to pregnant women, such as immune globulin

injections and flu vaccines, are still manufactured with thimerosal18.

The Answer

When all infants can be fully immunized with thimerosal-free products,

prudent medical practice would dictate that the FDA support these products

and require that thimerosal-containing vaccines be discontinued; that is,

children should be vaccinated without thimerosal rather than be vaccinated

with thimerosal. Additionally, given the known dangers of mercury to the

developing brain and the toxic levels of Hg to which most children in the

past decade were exposed through vaccinal thimerosal, the possible role of

this exposure in the increasing numbers of children with neurodevelopmental

delays should be investigated thoroughly.

____________________________________

1son, T. The Toxicology of mercury. Crit Rev Clin Lab Sci 1997; 34(3):

369-403. 2Egan, W. M. Thimerosal in Vaccines. Presentation to the FDA,

September 14, 1999. 3Fagan et al. Organ mercury levels in infants with

omphaloceles treated with organic mercurial antiseptic. Arch Disease Child

1977; 52: 962-964; Haeney, M.R. et al. Long-term parenteral exposure to

mercury in patients with hypogammaglobulinaemia. Br Med J 1979; 2: 12-14;

Matheson D.S. et al. Mercury toxicity (acrodynia) induced by long-term

injection of gammaglobulin. J Pediatr 1980; 97: 153-155. 4Food and Drug

Administration. Mercury-containing drug products for topical antimicrobial

over-the-counter human use; establishment of a monograph. Federal Register

1982; 47(2): 436-442 5Hepatitis B Control Report. Uproar over little-known

preservative, thimerosal, jostles U. S. hepatitis B vaccination policy.

Summer 1999; 4(2). 6Verstraeten, T. Risk of neurological and renal

impairment associated with thimerosal-containing vaccines. National

Immunization Program, CDC. Presented to ACIP, July 1999. 7Redwood, L.,

Bernard, S. Predicted mercury concentration in hair from infant

immunizations: cause for concern. Neurotoxicology Conference 2000 Sept 25.

8Katz, S.A., Katz, R.B. Use of hair analysis for evaluating mercury

intoxication of the human body: a review. J App Tox 1992; 12(2): 79-84.

9Grandjean,P. et al. Cognitive performance of children prenatally exposed

to " safe " levels of methylmercury. Environ Res 1998; 77: 65-172. 10Stern,

A. H. Re-evaluation of the reference dose for methylmercury and assessment

of current exposure levels. Risk Analysis 1993; 13: 355-364. 11 Stajich

,G.V. et al. Iatrogenic exposure to mercury after hepatitis B vaccination in

preterm infants. J Ped 2000; 36 12Bernard, S. et al. Autism: a novel type

of mercury poisoning. Coalition for SAFE MINDs 2000 13National Research

Council, Committee on the Toxicological Effects of Methylmercury. The

Toxicological Effects of Methylmercury. National Academy Press 2000 14ACIP

meeting, Atlanta, June 2000. 15Bernier, R.. Testimony before the House

Committee on Government Reform, July 2000. 16Egan, W., FDA, personal

communication. 17CDC, personal communication. 18Manufacturers'

product inserts.

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