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Vaccine SafetyAdvisory Committee on Causality Assessment (ACCA)There is little question that vaccines have had a tremendous impact on the incidence of childhood infectious diseases. However, during the years before 1965 when many vaccines were being introduced, the systematic monitoring for adverse events associated with drug products was not being undertaken. It required an international disaster, the discovery of phocomelia (a congenital malformation or birth defect) associated with thalidomide use in pregnancy, to stimulate the creation of formal surveillance programs.(1) Canada is a world leader in the postmarketing surveillance of vaccine products. The Canadian Adverse Events Following Immunization Surveillance System (CAEFISS) (which is distinct from the monitoring program for other drug products) is maintained by the Immunization and Respiratory Infections Division, Public Health Agency of Canada. The Division receives case reports of events suspected to be due to the administration of a vaccine that are submitted voluntarily by health care providers through their provincial public health authorities on an Adverse Event Following Immunization Report Form Continually improving the capacity of spontaneous reporting systems to detect new and rare events is a challenge, especially in a climate of under reporting. Two activities have been added to supplement the CAEFIS spontaneous reporting system to address the need for more active surveillance and to more fully evaluate and interpret case reports of new or serious adverse events. The first, started in 1990, is an active, pediatric hospital-based surveillance program known as the Immunization Monitoring Program ACTive (IMPACT) This group is composed of specialists in pediatrics, public health, epidemiology, infectious diseases, immunology, neurology and adverse event surveillance. The committee meets for two days once a year and meets by regular teleconferences 9-10 times a year to review selected cases. Should an emergent concern require intervention, additional ad hoc teleconferences are arranged. Cases that are reviewed are stripped of all identifiers and distributed to each member in advance. Selection criteria for case review include deaths, hospitalization for more than 3 days, life threatening events such as anaphylaxis, and other serious adverse events including meningitis/encephalitis, encephalopathy, and Guilain-Barre Syndrome. Every year, ACCA reviews approximately 60 to 70 cases submitted to the reporting system as a result of both passive and active surveillance activities. Each case is reviewed using the WHO-UMC In addition, ACCA is in a position to recommend increased education in certain areas such as the recognition and diagnosis, management, and reporting of cases of anaphylaxis. Summary reports of the case evaluations done by ACCA are made available to the Provincial/Territorial Epidemiologists (responsible for immunization programs), to the IMPACT surveillance program and for review by the Canadian Pediatric Society Committee on Immunization and Infectious Diseases. The functioning of ACCA has attracted attention internationally. Representatives from the U.S. Centers for Disease Control and Prevention (CDC) as well as the U.S. Vaccine Injury Compensation Program attend ACCA meetings. Together with the participation of practitioners who report suspected adverse events, and the IMPACT surveillance program that maintains active, hospital-based surveillance, the Advisory Committee on Causality Assessment (ACCA) is a key component in the postmarketing surveillance of vaccine products and is contributing to public and health provider confidence in immunization programs. References
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Last Updated: 2006-05-03 | ![]() |