The 131st Annual Meeting (November 15-19, 2003) of APHA

The 131st Annual Meeting (November 15-19, 2003) of APHA

4263.0: Tuesday, November 18, 2003 - Board 9

Abstract #64176

A review of adverse events associated with BCG vaccine in Canada

Shelley L Deeks, MD, MHSc, FRCPC1, Michael Clark, MSc candidate2, David W Scheifele, MD, FRCPC3, Barbara J Law, MD, FRCPC4, Meenakshi Dawar, MD, MHSc, FRCPC2, Wikke Walop, PhD1, and Arlene S King, MD, MHSc, FRCPC1. (1) Population and Public Health Branch, Health Canada, Tunney's Pasture, Building #6, PL 0603E-1, Ottawa, ON K1A 0K9, Canada, 613-952-6628,, (2) First Nations and Inuit Health Branch, Health Canada, Tunney's Pasture, PL 1920D, Ottawa, ON K1A 0L3, Canada, (3) for Members of the Immunization Monitoring Program, Active, University of British Columbia, BC's Children's Hospital (L427), 4500 Oak St., Vancouver, BC V6H 3N1, Canada, (4) for Members of the Advisory Committee on Causality Assessment, University of Manitoba, Health Sciences Centre, 511 John Buhler Research Centre, 715 McDermot Ave., Winnipeg, MB R3E 0W3, Canada

Currently in Canada, routine BCG vaccination is provided to neonates in some First Nations and Inuit (FNI) communities. Serious adverse events have occurred among infants receiving BCG, prompting a review to assess causality.

The Immunization Monitoring Program, Active (IMPACT), a pediatric hospital-based active surveillance network, identified 21 case reports pertaining to BCG vaccination between 1993 and April 2002; 19 were from children born in Canada and 18 were FNI children. Six cases of disseminated BCG infection were reported, 5 of whom died. All fatal cases were in FNI infants. All had congenital or acquired immunodeficiencies and other concurrent infections. Other adverse events included osteomyelitis, BCG abscess, lymphadenitis and cellulitis.

The Canadian Advisory Committee on Causality Assessment (ACCA) reviewed the 21 cases to assess causality and determined that 14 were very likely/certainly associated with the vaccine, including the 6 disseminated BCG cases; 5 were probably associated with the vaccine; 1 was possibly associated with the vaccine and 1 was unclassifiable due to insufficient information.

Between 1987 and September 2002 there were 157 BCG vaccine-associated adverse events reported to the Vaccine-Associated Adverse Events Surveillance (VAAES) system, a passive reporting system. Four additional serious cases, not captured by IMPACT, were reported through VAAES; all children recovered. There were no additional cases of disseminated BCG.

This review reveals that complications of BCG vaccination can be severe, especially in immunocompromised infants. As children are vaccinated in the neonatal period, it is often difficult to elicit a history or detect an immunosuppressive condition.

Learning Objectives:

Keywords: Tuberculosis, Native Populations

Presenting author's disclosure statement:
I do not have any significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.

Tuberculosis and Outbreaks: Poster Session

The 131st Annual Meeting (November 15-19, 2003) of APHA