Vaccination safety

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... 

Peng MM. Jick H A population-based study of the incidence, cause, and severity of anaphylaxis in the United Kingdom. Arch Intern Med 2004 164 317-319. Bohlke K, Davis RL, DeStefano F. et al Vaccine Safety Datalink Team. Epidemiology of anaphylaxis among children and adolescents enrolled in a health maintenance organization. J Allergy Clin Immunol 2004 113 536-542. 

Vaccine safety is monitored by the FDA and CDC through a passive reporting system that allows anyone, health professionals or lay public, to report any event. Health care professionals are bound by federal regulation to report certain adverse events (Table 83-2). Additionally, any serious, life-threatening or unusual reactions should also be reported. The Vaccine Adverse Event Reporting System (VAERS) can be found at http //vaers.hhs.gov. 

Kosten T., Rosen M., Bond J. et al. Human therapeutic cocaine vaccine safety and immunogenicity. Vaccine. 20 1196, 2002. 

United States Adopted Name Council United States Department of Agriculture United States Environmental Protection Agency United States Pharmacopoeia Vaccine Adverse Event Reporting System Vaccine Safety Data Link World Health Organization... 

In response to continued concerns about vaccine safety, the National Childhood Vaccine Injury (NCVI) Act of 1986 established a no-fault compensation process for people injured by them. The NCVI also mandated that the Institute of Medicine (lOM) reviews scientific evidence of vaccine-related ADRs in children. In 1996, the Department of Health and Human Services (HHS) made changes to the NCVI, which lessened its usefulness. In response to the problems this generated, the Vaccine Injured Children s Compensation Act of 2001 was introduced in Congress.This bill, however, also has its problems, and in April 2001, the bill was referred to the House subcommittee on health, where it still... 

Gust, D. A., Strine, T. W., Maurice, E., Smith, P., Yusuf, H., Wilkinson, M., Battaglia, M., Wright, R., and Schwartz, B. (2004). Underimmunization among children Effects of vaccine safety concerns on immunization status. Pediatrics 114, el6-e22. 

In practice, c may vary according to the extent to which companies invest in a production process that ensures continuous supply and is not subject to stoppages due, for example, to violations in vaccine safety standards. That c may vary inversely with the probability of a supply disruption complicates the task of determining an appropriate c ... 

Institute lor Vaccine Safety Johns Hopkins School of Public Health http //www. 

Klinman DM, Takeno M, Ichino M, Gu M, Yamshchikov G, Mor G, Conover J. DNA vaccines safety and efficacy issues. Springer Semin Immunopathol 1997 19 245-56. 

Verdier F, Morgan L. Predictive value of pre-chnical work for vaccine safety assessment. Vaccine 2001 20 S21-S23. 

Kennedy RC, Shearer MH, Hildebrand W. Nonhuman primate models to evaluate vaccine safety and immunogenicity. Vaccine 1997 15 903-8. 

Vaccine safety Nurses, Physicians, Pharmacists, immunizer Assistants, Medicai Screeners... 

The WHO has recommended that individuals with clinical (symptomatic) AIDS or other clinical manifestations of HIV-infection should not receive BCG (108). The Global Advisory Committee on Vaccine Safety has noted that there has been repeated reference to local or disseminated BCG infection several years after BCG immunization in HIV-infected persons (109). However, the Committee has not recommended a change in immunization policy (BCG immunization recommended in asymptomatic HIV-infected persons not recommended in symptomatic HIV-infected persons), but surveillance for BCG-immunized, HIV-infected persons should be continued for 5-7 years. 

Global Advisory Committee on Vaccine Safety, 11-12 June 2003. Wkly Epidemiol Rec 2003 78(32) 282-4. 

Associated Press. Press release, 15 April 1999. Hepatitis vaccine safety questioned in the United States. http //www. who.int/vaccines-diseases/safety/hottop/HBV Press.html (accessed 2 August 2000). 

Dr Neal Halsey, head of the Institute for Vaccine Safety at John Hopkins University, explained that the poor sales had resulted from public misperception and the promotion of false concerns (5). Lyme disease researchers consider the Lyme vaccine story in the USA to have been a setback in Ljme disease prevention. Vaccines meeting the specific epidemiological situation in Europe are under development. Lyme disease prevention and prophylaxis has been reviewed (6). 

FDA. Vaccines and Related Biological Products Advisory Committee. LYMErix. Lyme Disease Vaccine Safety Update, 31 January 2001. http7/www.fda.gov/ohrms/dockets / ac/01/briefing/368ob2.htm (accessed 10 February 2001). 

A Vaccine Safety Datalink project has been used to compare adverse events after MMR immunization either at... 

The 1994 report of the Institute of Medicine concluded that the evidence was inadequate to accept or reject a causal relation between MMR and encephalopathy, and it is known that the incidence of encephalitis after measles immunization of healthy children tends to be lower than the observed incidence of encephalitis of unknown cause. Two large studies have been negative. In a study analogous to the British Childhood Encephalopathy Study there were no increased risks of either encephalopathy or neurological sequelae after measles immunization (19). A retrospective case-control study through the CDC Vaccine Safety DataUnk assessing the risk for 300 000 doses of MMR found not a single case of encephalitis/ encephalopathy within 30 days of the administration of MMR (20). In contrast, the review mentioned above (18) reported an association between measles vaccine and encephalopathy. However, the conclusion of the report of the Institute of Medicine is still valid, namely that evidence is stiU inadequate to accept or reject a causal relation between measles vaccine and these diseases. 

Rhodes PH, Swint E, Jackson LA, Barlow WE, Immanuel VH, Benson PJ, Mullooly JP, Drew L, Mendius B, Lewis N, Fireman BH, Ward JI, Vadheim CM, Marcy SM, Jing J, Wuhson M, Lugg M, Osborne P, Wise RP. MMR2 immunization at 4 to 5 years and 10 to 12 years of age a comparison of adverse clinical events after immunization in the Vaccine Safety Datalink project. The Vaccine Safety DataUnk Team. Pediatrics 1997 100(5) 767-71. 

Black S, Shinefield H, Ray P, Lewis E, Chen R, Glasser J, Hadler S, Hardy J, Rhodes P, Swint E, Davis R, Thompson R, Mullooly J, Marcy M, Vadheim C, Ward J, Rastogi S, Wise R. Risk of hospitalization because of aseptic meningitis after measles-mumps-rubella vaccination in one- to two-year-old children an analysis of the Vaccine Safety Datalink (VSD) Project. Pediatr Infect Dis J 1997 16(5) 500-3. 

A critical examination (4) of a report (5) of several children whose chronic bowel and behavioral abnormalities were linked to measles, mumps, and rubella (MMR) immunization can be used as an example to underline Halsey s comments. Without effective and credible systems for the detection of vaccine-associated adverse events through pharmacovigilance, for distinguishing causal reactions from coincidental reactions by pharmacoepidemiological or other studies, and for risk communication, vaccine safety concerns may confuse the media and the public. 

Reports on adverse events after the administration of the two hepatitis B vaccines licensed in the US (Engerix-B and Recombivax HB) have been compared in two different surveillance systems VAERS and Vaccine Safety Datalink (VSD) (8). VSD is a computerized record linkage system designed to allow more rigorous evaluation of... 

Improving monitoring of vaccine safety through postlicensure studies... 

The success of vaccines is not only impressive and convincing but also makes immunization its own worst enemy. When a naturally occurring disease becomes less common, concerns about vaccine safety increase, particularly since no vaccine can be regarded as being completely safe, although some are very much safer than others. Progress in the development, manufacture, and control of modern vaccines has contributed to the safety of current vaccines. However, it is absolutely necessary to know what the true... 

Congress ordered an in-depth investigation into the safety of the anthrax vaccine. The lOM was asked to initiate a comprehensive study and to report on the safety and efficacy of the vaccine in an effort to answer the questions raised by Congress, the Department of Defense, and the public. Because of immediate concerns over anthrax vaccine safety issues, the lOM provided on 30 March 2000 a letter report to the Department of... 

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