A Comparative pharmacokinetic estimate of mercury in U.S. infants following yearly exposures to inactivated influenza vaccines containing thimerosal

Risk Analysis

Volumn 34, Issue 4, 2014, Pages 735-750

  Mitkus, Robert J ^a   King, David B ^a,b   Walderhaug, Mark O ^a   Forshee, Richard A ^a  

^a CENTER FOR BIOLOGICS EVALUATION AND RESEARCH   (United States)

^b Center for Veterinary Medicine   (United States)

Author keywords

MeHg; Modeling; Pharmacokinetics; Safety; Thimerosal

Indexed keywords

ACCIDENT PREVENTION; MERCURY (METAL); MODELS; PHARMACOKINETICS;

DIETARY METHYLMERCURY; INFLUENZA VACCINES; MEHG; ORDERS OF MAGNITUDE; PHARMACOKINETIC ANALYSIS; REGULATORY THRESHOLDS; THIMEROSAL; WORST-CASE ANALYSIS;

VACCINES;

CHILD HEALTH; DISEASE CONTROL; ESTIMATION METHOD; HEALTH CARE; INFLUENZA; METHYLMERCURY; VACCINE;

UNITED STATES;

INFLUENZA VACCINE; MERCURY; THIOMERSAL;

AREA UNDER THE CURVE; BODY BURDEN; CHEMISTRY; COMPARATIVE STUDY; HUMAN; INFANT; UNCERTAINTY; UNITED STATES; VALIDATION STUDY;

AREA UNDER CURVE; BODY BURDEN; HUMANS; INFANT; INFLUENZA VACCINES; MERCURY; THIMEROSAL; UNCERTAINTY; UNITED STATES;

EID: 84897978497     PISSN: 02724332     EISSN: 15396924     Source Type: Journal    
DOI: 10.1111/risa.12124     Document Type: Article

References (54)

1. Ball LK, Ball R, Pratt RD. An assessment of thimerosal use in childhood vaccines. Pediatrics, 2001; 107(5):1147-1154.
2. Hinman AR, Orenstein WA, Schuchat A; Centers for Disease Control and Prevention (CDC). Vaccine-preventable diseases, immunizations, and MMWR: 1961-2011. Morbidity and Mortality Weekly Reports Surveillance Summaries, 2011; 60 Suppl 4:49-57.
3. American Academy of Pediatrics and the Public Health Service (AAP and USPHS). Notice to readers: Thimerosal in vaccines: A joint statement of the American Academy of Pediatrics and the Public Health Service. Morbidity and Mortality Weekly Reports Surveillance Summaries, 1999; 48(26):563-565.
4. Institute of Medicine (IOM). Immunization Safety Review: Vaccines and Autism. Washington, DC: National Academy Press, 2004.
5. DeStefano F. Vaccines and autism: Evidence does not support a causal association. Clinical Pharmacology & Therapeutics, 2007; 82(6):756-759.
6. Thompson WW, Price C, Goodson B, Shay DK, Benson P, Hinrichsen VL, Lewis E, Eriksen E, Ray P, Marcy SM, Dunn J, Jackson LA, Lieu TA, Black S, Stewart G, Weintraub ES, Davis RL, DeStefano F; Vaccine Safety Datalink Team. Early thimerosal exposure and neuropsychological outcomes at 7 and 10 years. New England Journal of Medicine, 2007; 357:1281-1292.
7. Tozzi AE, Bisiacchi P, Tarantino V, De Mei B, D'Elia L, Chiarotti F, Salmaso S. Neuropsychological performance 10 years after immunization in infancy with thimerosal-containing vaccines. Pediatrics, 2009; 123(2):475-482.
8. Price CS, Thompson WW, Goodson B, Weintraub ES, Croen LA, Hinrichsen VL, Marcy M, Robertson A, Eriksen E, Lewis E, Bernal P, Shay D, Davis RL, DeStefano F. Prenatal and infant exposure to thimerosal from vaccines and immunoglobulins and risk of autism. Pediatrics, 2010; 126(4):656-664.
9. Hurley AM, Tadrous M, Miller ES. Thimerosal-containing vaccines and autism: A review of recent epidemiologic studies. Journal of Pediatric Pharmacology and Therapeutics, 2010; 15(3):173-181.
10. Barile JP, Kuperminc GP, Weintraub ES, Mink JW, Thompson WW. Thimerosal exposure in early life and neuropsychological outcomes 7-10 years later. Journal of Pediatric Psychology, 2012; 37(1):106-118.
11. Orenstein WA, Paulson JA, Brady MT, Cooper LZ, Seib K. Global vaccination recommendations and thimerosal. Pediatrics, 2013; 131(1):149-51.
12. Kurt TL. ACMT position statement: The IOM report on thimerosal and autism. Journal of Medical Toxicology, 2006; 2(4):170-171.
13. World Health Organization (WHO). Global Advisory Committee on Vaccine Safety. Statement on Thiomersal, 2006. Available at: http://www.who.int/vaccine_safety/committee/topics/thiomersal/statement_jul2006/en/index.html, Accessed on December 1, 2012.
14. World Health Organization (WHO). Global advisory committee on vaccine safety, 2012. Weekly Epidemiological Record, 2012; 87(6):53-59.
15. Brent J. Toxicologists and the assessment of risk: The problem with mercury (commentary). Journal of Toxicology: Clinical Toxicology, 2001; 39(7):707-710.
16. Burbacher TM, Shen DD, Liberato N, Grant KS, Cernichiari E, Clarkson T. Comparison of blood and brain mercury levels in infant monkeys exposed to methylmercury or vaccines containing thimerosal. Environmental Health Perspectives, 2005; 113(8):1015-1021.
17. Pichichero ME, Cernichari E, Lopreiato J, Treanor J. Mercury concentrations and metabolism in infants receiving vaccines containing thiomersal: A descriptive study. Lancet, 2002; 360:1737-1741.
18. Pichichero ME, Gentile A, Giglio N, Umido V, Clarkson T, Cernichiari E, Zareba G, Gotelli C, Gotelli M, Yan L, Treanor J. Mercury levels in newborns and infants after receipt of thimerosal-containing vaccines. Pediatrics, 2008; 121(2):e208-14.
19. Pichichero ME, Gentile A, Giglio N, Alonso MM, Fernandez Mentaberri MV, Zareba G, Clarkson T, Gotelli C, Gotelli M, Yan L, Treanor J. Mercury levels in premature and low birth weight newborn infants after receipt of thimerosal-containing vaccines. Journal of Pediatrics, 2009; 155(4):495-499.
20. Barregard L, Rekic D, Horvat M, Elmberg L, Lundh T, Zachrisson O. Toxicokinetics of mercury after long-term repeated exposure to thimerosal-containing vaccine. Toxicological Sciences, 2011; 120(2):499-506.
21. Rodrigues JL, Serpeloni JM, Batista BL, Souza SS, Barbosa F, Jr. Identification and distribution of mercury species in rat tissues following administration of thimerosal or methylmercury. Archives of Toxicology, 2010; 84(11):891-896.
22. Zareba G, Cernichiari E, Hojo R, Nitt SM, Weiss B, Mumtaz MM, Jones DE, Clarkson TW. Thimerosal distribution and metabolism in neonatal mice: Comparison with methyl mercury. Journal of Applied Toxicology, 2007; 27(5):511-518.
23. Harry GJ, Harris MW, Burka LT. Mercury concentrations in brain and kidney following ethylmercury, methylmercury and thimerosal administration to neonatal mice. Toxicology Letters, 2004; 154(3):183-189.
24. Suzuki T, Miyama T, Katsunuma H. Comparative study of bodily distribution of mercury in mice after subcutaneous administration of methyl, ethyl and n-propyl mercury acetates. Japanese Journal of Experimental Medicine, 1963; 33:277-282.
25. Suzuki T, Takemoto T. Metabolic fate of ethylmercury salts in man and animal. Pp. 209-232 in Morton Miller, Thomas Clarkson (eds). Mercury, Mercurials and Mercaptans. Springfield, IL: Charles C Thomas, 1973.
26. Agency for Toxic Substances and Disease Registry (ATSDR). Toxicological Profile for Mercury. Atlanta, GA: U.S. Department of Health and Human Services, Public Health Service, 1999.
27. Aschner M, Ceccatelli S. Are neuropathological conditions relevant to ethylmercury exposure? Neurotoxicity Research, 2010; 18(1):59-68.
28. Saghir SA, Mendrala AL, Bartels MJ, Day SJ, Hansen SC, Sushynski JM, Bus JS. Strategies to assess systemic exposure of chemicals in subchronic/chronic diet and drinking water studies. Toxicology and Applied Pharmacology, 2006; 211(3):245-260.
29. Creton S, Billington R, Davies W, Dent MP, Hawksworth GM, Parry S, Travis KZ. Application of toxicokinetics to improve chemical risk assessment: Implications for the use of animals. Regulatory Toxicology and Pharmacology, 2009; 55(3):291-299.
30. Centers for Disease Control and Prevention (CDC). Advisory Committee on Immunization Practices (ACIP) recommended immunization schedules for persons aged 0 through 18 years and adults aged 19 years and older: United States, 2013. Morbidity and Mortality Weekly Reports Surveillance Summaries, 2013; 62 Suppl 1(1):2-8.
31. Food and Drug Administration (FDA), 2013. Available at: http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm093830.htm. Accessed on September 5, 2013.
32. Environmental Protection Agency (EPA). Methylmercury (MeHg) (CASRN 22967-92-6). Integrated Risk Information System, 2001. Available at: http://www.epa.gov/iris/subst/0073.htm. Accessed on December 1, 2012.
33. World Health Organization (WHO). Methylmercury. Pp. 132-140 in Safety Evaluation of Certain Food Additives and Contaminants. Report of the 61st Joint FAO/WHO Expert Committee on Food Additives. Geneva: World Health Organization, International Programme on Chemical Safety. WHO Technical Report Series Vol. 922, 2004.
34. Food and Drug Administration (FDA). Action level for mercury in fish, shellfish, crustaceans, and other aquatic animals. Federal Register, 1979; 44:3990.
35. NHANES (National Health and Nutrition Examination Survey Data). Hyattsville, MD: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Health Statistics (NCHS), 2008. Available at: http://www.cdc.gov/nchs/nhanes/nhanes2007-2008/BMX_E.htm. Accessed on March 1, 2011.
36. Mitkus RJ, King DB, Hess MA, Forshee RA, Walderhaug MO. Updated aluminum pharmacokinetics following infant exposures through diet and vaccination. Vaccine, 2011; 29(51):9538-9543.
37. 203Hg) compounds in man. Archives of Environmental Health, 1969; 19:478-484.
38. Ward KW, Smith BR. A comprehensive quantitative and qualitative evaluation of extrapolation of intravenous pharmacokinetic parameters from rat, dog, and monkey to humans. I. Clearance. Drug Metabolism and Disposition, 2004; 32(6):603-611.
39. Ward KW, Smith BR. A comprehensive quantitative and qualitative evaluation of extrapolation of intravenous pharmacokinetic parameters from rat, dog, and monkey to humans. II. Volume of distribution and mean residence time. Drug Metabolism and Disposition, 2004; 32(6):612-619.
40. Lunn DJ, Thomas A, Best N, Spiegelhalter D. WinBUGS: A Bayesian modelling framework: Concepts, structure, and extensibility. Statistics and Computing, 2000; 10:325-337.
41. Plummer M. JAGS: A program for analysis of Bayesian graphical models using Gibbs sampling. Proceedings of the 3rd International Workshop on Distributed Statistical Computing (DSC 2003), Vienna, Austria, March 20-22, 2003.
42. Raftery AE, Lewis SM. How many iterations in the Gibbs sampler? Pp. 763-773 in Bernardo JM, Berger JO, Dawid AP, Smith AFM (eds). Bayesian Statistics 4. Oxford: Oxford University Press, 1992.
43. Carlin BP, Louis TA. Bayesian Methods for Data Analysis, 3rd ed. Boca Raton, FL: Chapman & Hall/CRC, 2008.
44. Gelman, Carlin, Stern, Rubin. Bayesian Data Analysis, 2nd ed. Boca Raton, FL: Chapman & Hall/CRC, 2003.
45. Björkman L, Mottet K, Nylander M, Vahter M, Lind B, Friberg L. Selenium concentrations in brain after exposure to methylmercury: Relations between the inorganic mercury fraction and selenium. Archives of Toxicology, 1995; 69(4):228-234.
46. R Development Core Team. R: A Language and Environment for Statistical Computing. Vienna, Austria: R Foundation for Statistical Computing, 2008. Available at: http://www.R-project.org
47. Sánchez G. Fitting bioassay data and performing uncertainty analysis with BIOKMOD. Health Physics, 2007; 92(1):64-72.
48. Magos L. Neurotoxic character of thimerosal and the allometric extrapolation of adult clearance half-time to infants. Journal of Applied Toxicology, 2003; 23(4):263-269.
49. Clarkson TW, Magos L. The toxicology of mercury and its chemical compounds. Critical Reviews in Toxicology, 2006; 36:609-662.
50. Clarkson TW, Vyas JB, Ballatori N. Mechanisms of mercury disposition in the body. American Journal of Industrial Medicine, 2007; 50(10):757-764.
51. Simmons-Willis TA, Koh AS, Clarkson TW, Ballatori N. Transport of a neurotoxicant by molecular mimicry: The methylmercury-L-cysteine complex is a substrate for human L-type large neutral amino acid transporter (LAT) 1 and LAT2. Biochemical Journal, 2002; 367(Pt 1):239-246.
52. World Health Organization (WHO). Environmental Health Criteria 101: Methylmercury. Geneva: International Program on Chemical Safety, 1990.
53. Gibaldi M, Perrier D. Pharmacokinetics. New York: Marcel Dekker, 1982.
54. Renwick AG, Lazarus NR. Human variability and noncancer risk assessment: An analysis of the default uncertainty factor. Regulatory Toxicology and Pharmacology, 1998; 27(1 Pt 1):3-20.