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Serious adverse events associated with bacille Calmette-Guérin vaccine in Canada

Shelley L Deeks1, Michael Clark, David W Scheifele

  • 1Immunization and Respiratory Infections Division, Community Acquired Infections Division, Public Health Agency of Canada, Health Canada, Ottawa, Ontario.

The Pediatric Infectious Disease Journal
|June 4, 2005
PubMed

Insights

Serious adverse events, including disseminated disease and death, continue to occur following Bacille Calmette-Guérin (BCG) vaccination in Canadian First Nations and Inuit children. This highlights ongoing risks associated with BCG vaccine use in these vulnerable populations.

Area of Science:

  • Pediatric infectious diseases
  • Vaccine safety and surveillance
  • Immunology

Background:

  • Targeted Bacille Calmette-Guérin (BCG) vaccination is administered to neonates in select First Nations and Inuit (FNI) communities in Canada.
  • Concerns regarding serious adverse events linked to BCG vaccine necessitated a causality assessment.

Purpose of the Study:

  • To review and assess the causality of serious adverse events associated with BCG vaccination in Canadian pediatric populations.
  • To evaluate the incidence and nature of adverse events reported through active and passive surveillance systems.

Main Methods:

  • Utilized data from the Immunization Monitoring Program Active (IMPACT), a pediatric hospital-based surveillance network (1993-2002).
  • Employed the Canadian Advisory Committee on Causality Assessment (ACCA) to review reported BCG-related adverse events.
  • Analyzed data from the Vaccine-Associated Adverse Event Surveillance (VAAES) Program, a national passive reporting system (1987-2002).

Main Results:

  • IMPACT identified 21 pediatric cases, with 18 in FNI infants; 6 cases of disseminated BCG disease occurred, 5 in FNI infants who died, all with immunodeficiencies and concurrent infections.
  • ACCA determined 14 cases were very likely vaccine-associated, including the 6 disseminated BCGs; 5 were probably and 1 possibly associated.
  • The VAAES program reported 157 adverse events, but no additional serious systemic events like disseminated BCG or osteomyelitis were identified.

Conclusions:

  • Serious complications associated with BCG vaccine continue to be observed in Canada.
  • The incidence of disseminated BCG disease among FNI children exceeded expected rates reported in existing literature, indicating a disproportionate risk.
Abstract

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