Thiomersal FDA Response

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Department of Health and Human Services Public Health Service Food and Drug Administration Rockville, Maryland 20857 September 26 2006 Paul G. King, Ph.D., and Other Representatives for CoMed Coalition for Mercury-Free Drugs 33A Hoffman Avenue Lake Hiawatha, NJ 07034-1922 Re: Docket Number CP2004P-0439/CP1 Dear Dr. King and Others: This letter is in response to your citizen petition dated July 30, 2004. in which you asked the Secretary of Health and Human Services or the Commissioner of the Food
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  Department of Health and Human ServicesPublic Health ServiceFood and Drug AdministrationRockville, Maryland 20857September 26 2006Paul G. King, Ph.D., and Other Representatives for CoMedCoalition for Mercury-Free Drugs   33A Hoffman AvenueLake Hiawatha, NJ 07034-1922Re: Docket Number CP2004P-0439/CP1Dear Dr. King and Others:This letter is in response to your citizen petition dated July 30, 2004. in which you asked   the Secretary of Health and Human Services or the Commissioner of the Food and DrugAdministration (FDA) to take numerous actions pertaining to vaccines and other FDA-   regulated products containing thimerosal or other mercury-based preservatives. Weapologize for the delay in responding to the petition. After review and consideration, wedeny the petition for the reasons stated below in this response.We first address the underlying basis for all the actions you request: your contention that   all licensed and approved products containing thimerosal are unsafe. The first part of ourdiscussion explains how FDA came to the conclusion that those licensed and approved   products are safe. The second part explains why the studies on which you rely do notsupport your contention.Following that science-based discussion on safety. we address your legal arguments. Wereiterate that for the scientific reasons explained above, none of the legal actions or   remedies you seek are warranted. We then explain why your claims that the governmenthas violated people’s rights lack merit and do not support your petition.Here is an outline of our response:1. LICENSED AND APPROVED PRODUCTS ARE SAFEA. Exposure to Mercury through Vaccines is Minimal 1. Thimerosal in routinely recommended pediatric vaccines has been removed or reduced.   2. Adult exposure to thimerosal through vaccines has been reduced.    B. Exposure to Mercury through other Biologics and Drugs is Minimal 1. Most plasma derivative products are thimerosal-free; the few snake and spider antivenoms that contain thimerosal create minimal exposure.   2. Exposure to mercury through phenylmercuric acetate and thimerosal in nasal and ophthalmic drug products is minimal.  C. The Few Products that Still Contain Thimerosal are Safe 1. To be safe means that the benefits outweigh the risks.   2. For the vaccines that still contain thimerosal, the evidence favors rejecting your allegations about risks, and the benefits are lifesaving and well-established    3. For the drug products that still contain phenylmercuric acetate or thimerosal, theamounts of mercury are at levels well below what any evidence suggests could pose   significant risks to human health.  II. THE STUDIES CITED AND RELATED ARGUMENTS DO NOT SUPPORT PETITIONERS’ CONTENTIONSA. The Cell Culture Studies Cited do not Demonstrate Harm in the Human BodyB. The Argument that Thimerosal-Containing Products Harm a “Susceptible Population”    of Humans is not Supported by the Evidence 1. The susceptible population annual studies cited do not prove, or even concludethemselves, that a significant risk exists for susceptible populations among humans.   2. The references cited that report an increase In the autism rate do not link any increaseto vaccines, nor support petitioners’ argument.   3. The mercury excretion studies in humans do not support petitioners’ argument that    thimerosal in vaccines causes autism.  C. Arguments that Thimerosal in the Current Amounts is Insufficient to Quality as aPreservative or an Adjuvant are Flawed; Thimerosal does Meet the United StatesPharmacopeia Standard for a Preservative where it is being used as One, and Thimerosal isnot being used as an AdjuvantD. The Cited Animal and Human Studies on Thimerosal’s Longevity in the Body do notStudy the Consequences of that Exposure.E. The Studies Cited that Recommend Eliminating all Thimerosal from all Products donot Support those Recommendations with Valid Science.F. The Methyl Mercury Studies Cited are Inconclusive and Inapplicable to Human Vaccines  G. The Ashwood, et al, Mcginnis, and Megson Studies Cited, which Hypothesize thatThimerosal Causes Gastrointestinal Illness, Vitamin A Depletion, and other Problems, LackEvidence to Support their TheoriesIII. PETITIONERS’ LEGAL ARGUMENTS LACK MERITA. The Actions and Legal Remedies Requested are Unwarranted on Scientific GroundsB. The Constitutional and Civil Rights Claims do not Articulate any Grounds upon whichFDA Should or Could Grant the PetitionIV. AGENCY CONCLUSIONS DISCUSSION   I. LICENSED AND APPROVED PRODUCTS ARE SAFE  A. Exposure to Mercury through Vaccines is Minimal   The FDA recognizes and supports the goal of reducing exposure to mercury from allsources. Consistent with this goal. FDA has been working with manufacturers for severalyears to facilitate the development of new vaccines without thimerosal as a preservativeand to remove or reduce the thimerosal content of existing, licensed vaccines).(1)    Under the FDA Modernization Act (FDA MA) of 1997, FDA conducted a comprehensivereview of the use of thimerosal in childhood vaccines. Conducted in 1999, this reviewfound no evidence of harm from the use of thimerosal as a vaccine preservative, otherthan local hypersensitivity reactions. However, as a precautionary measure, and becausethe elimination or reduction of mercury in vaccines was a feasible means of reducing aninfant’s total exposure to mercury in a world where other environmental sources are   challenging to eliminate, the Public Health Service (including FDA, the National Institutesof Health, the Centers for Disease Control and Prevention (CDC), and the Health Resources   and Services Administration) established the goal of removing thimerosal as soon aspossible as a preservative from vaccines routinely administered to infants.1. Thimerosal in routinely recommended pediatric vaccines has been removed or reduced.     The FDA’s efforts have been successful. Since 2001, all vaccines routinely recommendedfor children 6 years of age and under (Diphtheria and Tetanus Toxoids and acellularPertussis Vaccine (DTaP), hepatitis B, Haemophilus b conjugate (Hib), pneumococcalconjugate, Inactivated Polio Vitus Vaccine (IPV), Measles. Mumps and Rubella Vaccine(AMR), rotavirus, and varicella) manufactured for the U.S. market have contained nothimerosal or only trace amounts, with the exception of the inactivated influenza vaccine.  In 2004, the Advisory Committee on Immunization Practices first recommended theinactivated influenza vaccine for routine use in children 6 to 23 months of age and hassince updated the recommendation to children 6 to 59 months of age.As to those influenza vaccines. FDA has approved preservative-free formulations (whichcontain either no, or only trace amounts of, thimerosal) for two licensed inactivatedinfluenza vaccines that are indicated for children. These influenza vaccines continue to bemarketed in both the preservative-free and thimerosal-preservative-containingformulations. Sanofi Pasteur’s Fluzone is approved for use in children down to 6 months of age. However, during the last influenza season (2005-2006), Sanofi Pasteur had a capacityto manufacture only approximately 7 million doses of thimerosal-preservative freeinfluenza vaccine. For the 2006-2007 influenza season. Sanofi Pasteur has stated that itwill produce approximately 11 million doses of thimerosal-preservative-free influenza   vaccine. Novartis’ Fluvirin is approved for individuals 4 years of age and older. For the2006-2007 influenza season, Novartis has stated that it will produce approximately 3   million doses of thimerosal-preservative-free influenza vaccine for the U.S. market. Inaddition, GlaxoSmithKline’s (GSK) Fluarix contains less than 1.25µg/mercury/dose and is   approved for individuals I8 years of age and older. Last season GSK producedapproximately 8 million doses of Fluarix. The live attenuated influenza vaccine (FluMist,manufactured by Medlmmune) contains no thimerosal, and is approved for individuals 5 to49 years of age. Medimmune estimates that it will distribute approximately 3 million dosesof FluMist in the 2006-2007 season. Clinical studies to evaluate the safety and efficacy of FluMist in children less than 5 years of age have recently been completed and are underFDA review.Based on an estimated annual birth cohort in the United States of 4 million, there would beapproximately 20 million infants and children between the ages of 6 to 59 months, most of whom would need two doses each. The amount of thimerosal-preservative-free vaccineavailable is well below the amount needed for this age group alone, let alone for theapproximately 180 million Americans for whom the vaccine is recommended. FDA is indiscussions with manufacturers of influenza vaccine regarding their capacity to increasethe supply of thimerosal-preservative-free vaccine.Prior to the initiative to reduce or eliminate thimerosal from childhood vaccines, themaximum cumulative exposure to mercury via routine childhood vaccinations during thefirst 6 months of life was 187.5 micrograms. With the introduction of thimerosal-preservative-free formulations of DTaP, hepatitis B, and Hib, the maximum cumulativeexposure from the routinely recommended childhood vaccines decreased to less than threemicrograms of mercury in the first 6 months of life. With the addition in 2004 of influenzavaccine to the recommended vaccines, an infant could receive a thimerosal-containinginfluenza vaccine at 6 and 7 months of age. This would result in a maximum exposure of 28 micrograms during the first 7 months of life via routine childhood vaccinations. This
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