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UNITED
STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES PETITION FOR THE IMMEDIATE SUSPENSION
) AND EXPEDITED REVOCATION OF ALL ) VACCINES CONTAINING THIMEROSAL
) FOR WHICH THERE IS AN EXISTING THIMEROSAL- ) FREE FORMULATION ) PETITION I.
Petitioners
This
petition is brought by Kathi Williams, co-founder and Vice-President of the
National Vaccine Information Center (NVIC), on behalf of members of NVIC who
support the withdrawal of mercury-containing vaccines from vaccine stocks.
NVIC is a non-profit nationwide organization dedicated to preventing
vaccine injuries and deaths through public education, improving the safety of
vaccines. oversight of vaccine policies, and protecting the informed consent
rights of citizens. NVIC, formerly known as Dissatisfied Parents Together (DPT)
participated prominently in the development of the National Childhood Vaccine
Injury Act., 42 U.S.C. Sec. 300aa-10 et seq. (1988 & 1998 Supp),
and has remained deeply involved in monitoring the implementation of the
National Vaccine Injury Compensation Program created by the Act.
NVIC has member parents whose children have received vaccines
containing Thimerosal and have been diagnosed with mercury toxicity and brain
damage. II.
The Need for Action On
October 1, 2001, the Institute of Medicine’s Immunization Safety Review
Committee released a report entitled Thimerosal
Containing Vaccines and Neurodevelopmental Outcomes.
The report stated, “ …the
committee recommends the use of Thimerosal-free DTaP, HIB, hepatitis B
vaccines in the United States, despite the fact that there might be remaining
supplies of Thimerosal-containing vaccine available. The committee could not
explore mechanisms by which this could be accomplished. However,
the committee is concerned that, because of meeting schedules and other
requirements- for example the development of official statements on this issue
by advisory groups such as the Red Book Committee of the AAP or the ACIP –
might delay action. The removal of Thimerosal as a preservative from vaccines
on the recommended childhood immunization schedule does not eliminate exposure
to Thimerosal from other vaccines, such as DT or influenza, that some infants,
children and pregnant women receive. Therefore, the committee recommends
that full consideration be given by
appropriate professional societies and government agencies to removing
Thimerosal from vaccines administered to infants, or pregnant women in the
United States.” [1] Currently
every vaccine recommended for children is available without the preservative
Thimerosal. Allowing Thimerosal-containing vaccines to remain in use, when
Thimerosal-free versions are currently available, unnecessarily exposes
American children to a heightened risk of serious adverse reactions.
For these reasons, and as set forth below, Thimerosal-containing
vaccines should be delicensed and removed from the market immediately. A.
Background Thimerosal
has been used in some vaccines as a preservative since the 1930’s.
Thimerosal is effective in killing bacteria in opened multi-dose bottles. The
Food and Drug Administration Modernization Act of 1997 called for an FDA
review of all mercury containing food and drugs which included a review of
vaccines that contain Thimerosal. This
review was completed in 1999. The FDA recognized that some children could be
exposed to a cumulative level of mercury over the first 6 months of life that
exceed the federal guidelines on methyl mercury.
Thimerosal contains 49.6% mercury by weight and is metabolized to ethyl
mercury and thiosalicylate. All
guidelines for safe mercury intake are related to methyl-mercury, not
ethyl-mercury. Methyl mercury is associated with neurotoxicity in high doses.
The Center for Biologic Evaluation and Research (CBER) at the FDA had to
assume that the toxicity of the two compounds were equivalent. CBER realized
that Thimerosal was present in over 30 licensed vaccines in the United States.
According to CBER calculations a 6-month old baby that received all the
vaccines on schedule would receive 75 micrograms of mercury from three doses
of DTaP, 75 micrograms of mercury from three doses of Hib and 37.5 micrograms
from three doses of hepatitis B vaccine. The total of 187.5 micrograms exceeds
the suggested safe limits published by the EPA.[2] Due
to any potential risk, the Public Health Service and the American Academy of
Pediatrics and the vaccine companies that produce vaccines agreed that
Thimerosal-containing vaccines should be removed as quickly as possible. A
recommendation was made to forgo the infant dose of hepatitis B vaccine at
birth if the mother tested negative for hepatitis B disease, in an effort to
provide a wider margin of safety. Pre-term
babies were not to be vaccinated with hepatitis B until they reached term
gestational age and the weight of at least 5.5 pounds. [3] C. Thimerosal Removed from Over the Counter Products
Thimerosal is
found in over-the counter products such as opthalmic solutions and skin
ointments. The FDA has already evaluated the safety and effectiveness of many
of the over the counter (OTC) uses of mercury compounds as part of its OTC
drug review. Many have been found to be not generally recognized as safe and
effective. [4]
For many years Thimerosal was used in latex paint to prevent mold from
growing in the can. Thimerosal has been eliminated from latex paints, and
Merthiolate, a concentrated form of Thimerosal used as an antiseptic, is no
longer used because of serious toxic effects from these products in infants.[5]
The American Academy of Pediatrics state: “Mercury in all forms is
toxic to the fetus and children, and efforts should be made to reduce exposure
to the extent possible to pregnant women and children as well as the general
population.”[6] D. Risks of Mercury Exposure in Pregnant WomenIn
March 2001, the FDA issued a Consumer Advisory to pregnant women regarding
eating fish that contain high levels of methyl mercury. The Advisory stated,
“ While the primary danger from methyl mercury in fish is to the developing
nervous system of the unborn child, it is prudent for nursing mothers and
young children not to eat these fish as well.”[7]
Unborn babies are
more sensitive to the effects of mercury. Premature babies are also more
vulnerable because the brain is not developed as in a full-term baby.
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 breastfeeding. If a pregnant woman ingests mercury at high levels,
harmful effects that may be passed on 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. E. Influenza Vaccine
The only
vaccine licensed for influenza in the United States is made from killed
influenza viruses. The vaccine contains 1:10,000 Thimerosal.[9] The
Flu Vaccine is licensed for children 6 months and older. The current
recommendation for influenza vaccine includes children in many categories,
including those that have chronic disorders, including asthma, have required
regular medical follow-up or hospitalization during the preceding year because
of chronic disease, children on long-term aspirin therapy and women who will
be in the second or third trimester of pregnancy during the influenza season. F. Europe Changes ProtocolIn
June 1999, the Agency for the Evaluation of Medicinal Products (EMEA)
completed an 18-month investigation into the risks of Thimerosal containing
vaccines. EMEA concluded that even though there was no evidence of harm caused
by the level of exposure (less than the United States), it would be prudent to
promote the general use of vaccines without Thimerosal.[2]
G. Federal Advisory Panel Makes New RecommendationInspections
of 225 clinics, pediatrician’s offices and family practice offices in
mid-September 2001,showed approximately 5.5% of all doses of DTaP, Hib and
hepatitis B vaccines still contain Thimerosal.
The Advisory Commission on Immunization Practices (ACIP) will issue a
recommendation in January 2002 to remove all Thimerosal-containing vaccines
from the shelves by March 31, 2002.[10] H: Chairman of Government Reform Committee Asks for a RecallOn
July 18, 2000, The Government Reform Committee of the House of Representatives
held a hearing on the risks of mercury in medicine. Following that hearing,
the chairman of the committee, Congressman Dan Burton wrote a letter to Donna
Shalala, Secretary of Health and Human Services and said, “ Our children are
the future of this country. As a Government we have a responsibility to do
everything within our power to protect them from harm, including ensuring that
vaccines are safe and effective. Every day that mercury-containing vaccines
remain on the market is another day HHS is putting 8,000 children at risk.
Given that Thimerosal-free vaccines are available and the known risk of
mercury toxicity, to leave Thimerosal-containing vaccines on the market is
unconscionable.”[11] Approximately
one year later Congressman Burton renewed his request to HHS to recall all
childhood vaccines containing Thimerosal stating that we could not leave these
products on the shelves until they were used up. “If there is even the
slightest chance that a vaccine with mercury could contribute to autism
spectrum disorders, learning disabilities, attention deficit disorders or any
other neurological condition, then we should act quickly to stop all potential
exposure to Thimerosal.”[12]
NOTICE UNDER SECTION 2131 Petitioners
hereby give notice of intent to commence suit under Section 21341 of the
Public Health Service Act against the Secretary of HHS, the Commissioner of
the FDA, and other governmental officials to compel the actions requested
above if there is a failure or refusal within the next 60 days to take the
proposed actions or otherwise to act more effectively to protect the health of
America’s children.
Conclusion The
Secretary of the Department of Health and Human Services and the Commissioner
of the Food and Drug Administration should take action to order the immediate
suspension and the expedited revocation of all vaccines containing Thimerosal,
for which there is a Thimerosal-free replacement available.
Certification Under 21 U.S.C. Sec.
10.30(b)(E) The
undersigned certifies that, to the best knowledge and belief of the
undersigned, this petition includes all information and views on which the
petition relies, and that it includes representative data and information
known to the petitioners which are adverse to the petition. Environmental
Impact Statement Under 21 U.S.C. Sec. 10.30(b)(C) The
petitioners hereby state that the relief requested in this petition will have
no environmental impact and that, therefore, an environmental assessment is
not required under 21 U.S.C. Sec. 25.24 [1] The Institute of Medicine October 1, 2001, Immunization Safety Review Thimerosal Containing Vaccines and Neurodevleopmental Outcomes [6]
Goldman, Lynn. July, 2001, Technical Report: Mercury in the Environment:
Implications for Pediatricians, Pediatrics. [7]
Food And Drug Administration. March 2001,
An Important Message for Pregnant Women and Women of Childbearing Age
who May Become Pregnant, About the Risks of Mercury in Fish.
Consumer Advisory. [8] The Centers for Disease Control - National Immunization Program. July 7,2001. Mercury and Thimerosal FAQ http://www.cdc.gov/nip/vacsafe/concerns/thimerosal/faqs-mercury [9] Wyeth Laboratories. May 16, 1996, Product Insert, Flu Shield. [10]
American Academy of Pediatrics. November 2001, Vaccines with Thimerosal: Out
of Offices by March 31, Pediatric News [11] Congressman Dan Burton’s Office. October 25, 2000,Chairman Burton Requests Vaccine Recall, [12] The Committee on Government Reform. October 3, 2001, Press Release |
