Guideline

BCG vaccines: WHO position paper – February 2018

Year of Publication

2018

Issuing Institution

World Health Organization

Links

Recommendations

4 included recommendations

In countries or settings with a high incidence of TB and/or leprosy, a single dose of BCG vaccine should be given to neonates at birth, or as soon as possible thereafter, for prevention of TB and leprosy. If it cannot be given at birth, it should be given at the earliest opportunity thereafter and should not be delayed. Any delay in vaccination may lead to opportunities for known or unknown exposure to TB or leprosy infected contacts. Co-administration of BCG with the hepatitis B birth dose is safe and strongly recommended. In order to avoid missed opportunities for neonatal vaccination, BCG multi-dose vials should be opened and used despite any wastage of unused vaccine. If the birth dose was missed, catch-up vaccination of unvaccinated older infants and children is recommended since evidence shows it is beneficial. Catch-up vaccination should be done at the earliest convenient encounter with the health-care system to minimize known or unknown exposure to TB or leprosy infected contacts.

Status

Updated

Recommended

Certainty of evidence

Low

Countries with a low incidence of TB or leprosy may choose to selectively vaccinate neonates in recognized risk groups for developing disease. High-risk groups to be considered for vaccination include the following:Neonates to parents (or other close contacts/relatives) with previous TB or leprosy; Neonates in households with contacts to countries with high incidence of TB and/or leprosy; Neonates in any other locally identified risk group for TB and/or leprosy. In a few countries with low TB incidence, BCG vaccination is largely replaced by intensified case detection, contact tracing and supervised early treatment.

Status

Updated

Context specific recommendation

Only in specific contexts

Studies show minimal or no evidence of any additional benefit of repeat BCG vaccination against TB or leprosy. Therefore, revaccination is not recommended even if the tuberculin skin testing reaction or result of an Interferon-Gamma Release Assay is negative. The absence of a BCG scar after vaccination is not indicative of a lack of protection and is not an indication for revaccination.

Status

Updated

Not recommended

Certainty of evidence

Low

Children who are HIV-infected when vaccinated with BCG at birth are at increased risk of developing disseminated BCG disease. However, if HIV-infected individuals, including children, are receiving ART, are clinically well and immunologically stable (CD4 % >25% for children aged <5 years or CD4 count ≥200 if aged >5 years) they should be vaccinated with BCG. • In general, populations with high prevalence of HIV infection also have the greatest burden of TB; in such populations the benefits of potentially preventing severe TB through vaccination at birth are outweighed by the risks associated with the use of BCG vaccine. Therefore, it is recommended that in such populations: • Neonates born to women of unknown HIV status should be vaccinated as the benefits of BCG vaccination outweigh the risks. • Neonates of unknown HIV status born to HIV-infected women should be vaccinated if they have no clinical evidence suggestive of HIV infection, regardless of whether the mother is receiving ART. • Although evidence is limited, for neonates with HIV infection confirmed by early virological testing, BCG vaccination should be delayed until ART has been started and the infant confirmed to be clinically and immunologically stable (CD4% >25%).

Status

Maintained

Recommended