Global Vaccine Safety

Safety of BCG vaccine in HIV-infected children

Extract from report of GACVS meeting of 29-30 November 2006, published in the WHO Weekly Epidemiological Record of 19 January 2007

The Committee has reviewed the policy on the use of bacille Calmette–Guérin (BCG) vaccination for children infected with HIV. Data from retrospective studies from Argentina and South Africa indicate there is a substantiated higher risk of disseminated BCG disease developing in children infected with HIV who are vaccinated at birth and who later developed AIDS. The reported risk associated with vaccinating HIV-infected children may outweigh the benefits of preventing severe tuberculosis, especially since the protective effect of BCG against tuberculosis in HIV-infected children is not known.

WHO currently recommends administering a single dose of BCG vaccine to all infants living in areas where tuberculosis is highly endemic as well as to infants and children at particular risk of exposure to tuberculosis in countries with low endemicity. BCG vaccine is contraindicated in people with impaired immunity, and WHO does not recommend BCG vaccination for children with symptomatic HIV infection.

GACVS concluded that the findings indicated there is a high risk of disseminated BCG disease developing in HIV-infected infants and therefore BCG vaccine should not be used in children who are known to be HIV infected.

The Committee recognizes the difficulty in identifying infants infected with HIV at birth in settings where diagnostic and treatment services for mothers and infants are limited. In such situations, BCG vaccination should continue to be given at birth to all infants regardless of HIV exposure, especially considering the high endemicity of tuberculosis in populations with high HIV prevalence. Close follow up of infants known to be born to HIV-infected mothers and who received BCG at birth is recommended in order to provide early identification and treatment of any BCG-related complication. In settings with adequate HIV services that could allow for early identification and administration of antiretroviral therapy to HIV-infected children, consideration should be given to delaying BCG vaccination in infants born to mothers known to be infected with HIV until these infants are confirmed to be HIV negative.