Immunization safety

A 2004 report by the Institute of Medicine s Immunization Safety Review Committee concluded that available evidence favored rejection of a causal relation between thimerosal-containing vaccines and autism. In like manner, a recent retrospective cohort study conducted by the CDC did not support a causal association between early prenatal or postnatal exposure to mercury from thimerosal-containing vaccines and neuropsychological functioning later in childhood. 

Immunization Safety Review Committee. Immunization safety review measles-mumps-rubella vaccine and autism. In Stratton K, Gable A, Shetty P, McCormick M, editors. Institute of MedicineNational Academy of Sciences, 2001 241. 

Clinical immunization safety assessment centers The National Immunization Program of the Centers for Disease Control and Prevention (CDC), Atlanta, GA, USA, is trying to set up a network of Clinical Immunization Safety Assessment Centers (CISA). Based on standardized clinical evaluation protocols the centers will assist health care providers in evaluating patients who may have had an adverse reaction after immunization. Furthermore, the centers will evaluate newly hypothesized syndromes or events identified through the routine VAERS (28). 

In 2001 the Immunization Safety Review Committee of the Institute of Medicine issued a report on thiomersal-containing vaccines and neurodevelopmental disorders (104). The committee concluded that although the hypothesis that exposure to thiomersal-containing... 

Announcing funding for clinical immunization safety assessment centers. www.cdc.gov/od/pgo/funding/ 01112.htm, 27/06/2001. 

Institute of Medicine (lOM) Report. Immunization Safety Review. Vaccinations and sudden unexpected death in infancy. The National Academies Press. http //www. nap.edu/nap-cgi, 20/06/2003. 

Immunization Safety Review. Thimerosal-Containing Vaccines and Neurodevelopmental Disorders. Washington, DC National Academy Press, 2001. 

Institute of Medicine Report. Immunization safety review Vaccines and autism. Immunization Safety Review Committee, Board on Health Promotion and Disease Prevention. Washington DC The National Academy Press, 2004. 

WHO adopted for their revised guidance, the terminology outlined by the Clinical Immunization Safety Assessment (CISA) Network. CISA had redefined terms used to describe causal relationship between vaccine and AEFI. They felt that using the terms consistent with, inconsistent with and indeterminate was favourable, compared to the previously used very likely/certain, probable, possible, unlikely, unrelated and unclassifiable, and would reduce confusion and inconsistency [3 ]. 

GACVS also discussed the association of IS and RV vaccination at their meeting in December 2013. They reviewed recently published data from Australia and the United States. IS cases in Australia were identified from Jxme 2007 to June 2010 using nahonal database resources and active hospital surveillance techniques, and both Rotateq and Rotarix were found to carry similar risk. The estimated relative risk for IS was 5.6 additional cases per 100,000 vaccinated infants. In the United States, data from three vaccine safety reporting systems were reviewed (VAERS, VSD and Post-Licensure Rapid Immunization Safety Monitoring (PRISM) program). Between 2006 and 2012, 584 cases of IS... 

The separation of cells from the culture media or fermentation broth is the first step in a bioproduct recovery sequence. Whereas centrifugation is common for recombinant bacterial cells (see Centrifugal separation), the final removal of CHO cells utilizes sterile-filtration techniques. Safety concerns with respect to contamination of the product with CHO cells were addressed by confirming the absence of cells in the product, and their relative noninfectivity with respect to immune competent rodents injected with a large number of CHO cells. 

The Vaccine Adverse Event Reporting System (VAERS) is a national vaccine safety surveillance program co-sponsored by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). VAERS collects and analyzes information from reports of adverse reactions after immunization. Anyone can report to VAERS, and reports are sent in by vaccine manufacturers, health care providers, and vaccine recipients and their parents or guardians. An example of the VAERS and instructions for completing the form are found in Appendix F. Any clinically significant adverse event that occurs after the administration of any vaccine should be reported. Individuals are encouraged to provide the information on the form even if the individual is uncertain if the event was related to the... 

Hendrix C (2004) Safety, phamacokinetics and antiviral activity of AMD3100, a selective CXCR4 receptor inhibitor, in HlV-1 infection. J Acquir Immune Defic Syndr 37 1253-1262... 

Fischl MA, Richman DD, Saag M, Meng TC, Squires KE, Holden-Wiltse J, Meehan PM (1997) Safety and antiviral activity of combination therapy with zidovudine, zalcitabine, and two doses of interferon-alpha2a in patients with HIV. J Acquit Immune Deflc Syndr Hum Retrovirol 16 247-253... 

Kozlowski A, Charles SA, Harris JM (2001) Development of pegylated interferons for the treatment of chronic hepatitis C. BioDrugs 15 419 29 Krown SE, AeppU D, Balfour HH Jr (1999) Phase II, randomized, open-label, community-based trial to compare the safety and activity of combination therapy with recombinant interferon-alpha2b and zidovudine versus zidovudine alone in patients with asymptomatic to mildly symptomatic HIV infection. J Acquir Immune Defic Syndr Hum Retrovirol 20 245-254 LaFleur DW, NardeUi B, Tsareva T, Mather D, Feng P, Semenuk M, Taylor K, Buergin M, Chinchilla D, Roshke V, Chen G, Ruben SM, Pitha PM, Coleman TA, Moore PA (2001) Interferon-kappa, a novel type I interferon expressed in human keratinocytes. J Biol Chem 276 39765-39771... 

There is much concern for the safety of personnel handling articles contaminated with pathogenic viruses such as hepatitis B virus (HB V) and human immunodeficiency vims (HIV) which causes acquired immune deficiency syndrome (AIDS). Some agents have been recommended for disinfection of HBV and HIV depending on the circumstances and level of contamination these are hsted in Table 10.4. Disinfectants must be able to treat rapidly and reliably accidental spills of blood, body fluids or secretions from HIV infected patients. Such spills may contain levels of HIV as high as lO" infectious units/ml. Recent evidence Irom the Medical Devices Agency evaluation of disinfectants against HIV indicated that few chemicals could destroy the vims in a... 

The single-component bacterial vaccines are listed in Table 15.1. For each vaccine, notes are provided of the basic material fkm which the vaccine is made, the salient production processes and tests for potency and for safety. The multicomponent vaccines that are made by blending together two or more of the single component vaccines are required to meet the potency and safety requirements for each of the single components that they contain. The best known of the combined bacterial vaccines is the adsorbed diphtheria, tetanus and pertussis vaccine (DTPerWac/Ads) that is used to immunize infants, and the adsorbed diphtheria and tetanus vaccine (DTWac/Ads) that is used to reinforce the immunity of school entrants. 

Public confidence in the safely of vaccines and immunization procedures is essential if compliance is to match the needs the community. In this respect public concern and anxiety, in the mid 1970s, over the peroeived safety of pertussis vaccine led to a reduction in coverage of the target group from ca. 80% to ca. 30%. Major epidemics of whooping-cough, with over 100000 notified cases, followed in 1977/1979 and 1981/83. By 1992, public confidence had returned, coverage had increased to 92% and there were only 4091 reported cases. 

Brinkerhoff CR, Sharma RP, Boucier DR. 1981. The effects of Tn-ortho-to y Phosphate (TOTP) on the immune system of mice. Ecotoxicology and Environmental Safety 5 368-376. 

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