Deeks Shelley L, Clark Michael, Scheifele David W, Law Barbara J, Dawar Meenakshi, Ahmadipour Nooshin, Walop Wikke, Ellis C Edward, King Arlene
Immunization and Respiratory Infections Division, Community Acquired Infections Division, Public Health Agency of Canada, Health Canada, Ottawa, Ontario.
Pediatr Infect Dis J. 2005 Jun;24(6):538-41. doi: 10.1097/01.inf.0000164769.22033.2c.
Targeted Bacille Calmette-Guérin (BCG) vaccination is offered to neonates in some First Nations and Inuit (FNI) communities in Canada. Serious adverse events associated with BCG vaccine prompted a review to assess causality.
The Immunization Monitoring Program Active (IMPACT), a pediatric hospital-based active surveillance network, reported admissions for BCG-related adverse events between 1993 and April 2002. The Canadian Advisory Committee on Causality Assessment (ACCA) reviewed the reports to assess causality. Data between 1987 and September 2002 from the Vaccine-Associated Adverse Event Surveillance (VAAES) Program, a passive national reporting system, were also reviewed.
IMPACT identified 21 pediatric cases; 19 were Canadian-born, and 18 were FNI. Six disseminated BCG cases were identified; 5 were FNI infants who subsequently died. All had immunodeficiencies and concurrent infections. Other adverse events included 2 cases of osteomyelitis, BCG abscesses and lymphadenitis. ACCA reviewed the 21 cases and determined that 14 were very likely associated with the vaccine, including the 6 disseminated BCGs; 5 were probably associated and 1 was possibly associated with the vaccine; 1 was unclassifiable. The VAAES program identified 157 adverse events. No additional serious systemic adverse events (disseminated BCG or osteomyelitis) were identified.
Serious BCG vaccine-associated complications continue to occur in Canada. The numbers of FNI children with disseminated disease was greater than expected from reported rates in the literature.
在加拿大的一些原住民和因纽特人（FNI）社区，会为新生儿提供针对性的卡介苗（BCG）接种。与卡介苗疫苗相关的严重不良事件促使进行了一项审查以评估因果关系。
免疫监测项目主动监测（IMPACT）是一个以儿科医院为基础的主动监测网络，报告了1993年至2002年4月期间与卡介苗相关不良事件的住院情况。加拿大因果关系评估咨询委员会（ACCA）对这些报告进行了审查以评估因果关系。还审查了1987年至2002年9月期间来自疫苗相关不良事件监测（VAAES）项目的数据，该项目是一个全国性的被动报告系统。
IMPACT确定了21例儿科病例；19例出生于加拿大，18例为FNI。确定了6例播散性卡介苗病例；5例为FNI婴儿，随后死亡。所有病例均有免疫缺陷并伴有并发感染。其他不良事件包括2例骨髓炎、卡介苗脓肿和淋巴结炎。ACCA审查了这21例病例，确定其中14例极有可能与疫苗相关，包括6例播散性卡介苗病例；5例可能相关，1例可能与疫苗相关；1例无法分类。VAAES项目确定了157例不良事件。未发现其他严重的全身性不良事件（播散性卡介苗或骨髓炎）。
在加拿大，与卡介苗疫苗相关的严重并发症仍在发生。FNI社区中患有播散性疾病的儿童数量高于文献报道率的预期。
