Utility of large-linked databases in vaccine safety, particularly in distinguishing independent and synergistic effects. The Vaccine Safety Datalink Investigators.
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ABSTRACT: The study evaluated possible associations between neurodevelopmental disorders (NDs) and exposure to mercury (Hg) from Thimerosal-containing vaccines (TCVs) by examining the automated Vaccine Safety Datalink (VSD). A total of 278,624 subjects were identified in birth cohorts from 1990-1996 that had received their first oral polio vaccination by 3 months of age in the VSD. The birth cohort prevalence rate of medically diagnosed International Classification of Disease, 9th revision (ICD-9) specific NDs and control outcomes were calculated. Exposures to Hg from TCVs were calculated by birth cohort for specific exposure windows from birth-7 months and birth-13 months of age. Poisson regression analysis was used to model the association between the prevalence of outcomes and Hg doses from TCVs. Consistent significantly increased rate ratios were observed for autism, autism spectrum disorders, tics, attention deficit disorder, and emotional disturbances with Hg exposure from TCVs. By contrast, none of the control outcomes had significantly increased rate ratios with Hg exposure from TCVs. Routine childhood vaccination should be continued to help reduce the morbidity and mortality associated with infectious diseases, but efforts should be undertaken to remove Hg from vaccines. Additional studies should be conducted to further evaluate the relationship between Hg exposure and NDs.Journal of the Neurological Sciences 09/2008; 271(1-2):110-8. DOI:10.1016/j.jns.2008.04.002 · 2.26 Impact Factor
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ABSTRACT: I. Public health importance Immunizations have reduced the incidence of many vaccine-preventable diseases in the United States (and many other countries) by more than 95% compared with the prevaccine era (Table 1). For example, paralytic poliomyelitis has been eliminated from the Western Hemisphere and there has been cessation of indigenous measles virus transmission in the U.S. As the proportion of the vaccinated population increases, however, the number of persons who experience an adverse event following vaccination also increases—due either to reactions caused by the vaccination or coincidental events not caused by the vaccination (e.g., sudden infant death syndrome after diphtheria-tetanus-pertussis [DTP] vaccination). In recent years, the annual number of reports to the national adverse event reporting system has exceeded the total number of reports of routine childhood vaccine-preventable diseases, excluding varicella (Table 1). In the absence of disease, benefits of vaccination may be overshadowed by reports of vaccine adverse events (VAEs), and media attention may result in loss of public confidence in the vaccine and resurgence of vaccine-preventable diseases as experienced by several countries for pertussis. 1-3 Vaccinations are usually administered to healthy persons and often are mandated; therefore, they are held to a higher standard of safety than other medications. 4 However, as with all medications, no vaccine is perfectly safe or effective. Vaccines can induce minor adverse events such as local reaction or fever. Very rarely, they can induce serious adverse events such as seizures, intussusception, or severe allergic reactions. However, until vaccine-preventable diseases are eradicated, vaccines must continue to be used. To ensure that vaccines are as safe as possible and to maintain public confidence in vaccines, close monitoring of the reporting of adverse events, adequate scientific evaluation of possible associations, and appropriate responses to newly identified risks of vaccines are essential. To reduce the occurrence of vaccine adverse events, it is important to improve the understanding of vaccine safety, and, thereby, foster the development and use of safer vaccines. 5 One of the best ways to enhance our understanding of vaccine safety is to improve surveillance for vaccine adverse events (VAEs).
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ABSTRACT: Rotavirus infection produces a serious health burden in the United States, causing an estimated > 100,000 hospitalizations and > 100 deaths annually. This health burden is comparable to that for measles, pertussis, mumps, and varicella before vaccines for these diseases were routinely given to children. Rotavirus vaccines have the potential to significantly reduce a serious public health problem in the United States. However, while development and licensure of vaccines is a major breakthrough, it represents only the first step in disease prevention. Vaccines must be recommended by major immunization advisory committees, financed in both the public and private sectors, and successfully integrated into the existing vaccination schedule. Vaccines must reach all targeted children, and monitoring systems must be established or adapted to better determine vaccine safety and disease impact. Reevaluation of disease prevention strategies must be ongoing and fueled by new information on safety and disease reduction.The Journal of Infectious Diseases 10/1996; 174 Suppl 1:S118-24. DOI:10.1093/infdis/174.Supplement_1.S118 · 5.78 Impact Factor