Elsevier

Vaccine

Volume 36, Issue 24, 7 June 2018, Pages 3408-3410
Vaccine

WHO Report
BCG vaccine: WHO position paper, February 2018 – Recommendations

https://doi.org/10.1016/j.vaccine.2018.03.009Get rights and content

Abstract

This article presented the World Health Organization’s (WHO) recommendations on the use of on Bacille Calmette-Guérin (BCG) vaccine excerpted from the BCG vaccines: WHO position paper – February 2018 published in the Weekly Epidemiological Record [1]. This position paper replaces the 2004 WHO position paper on Bacille Calmette-Guérin (BCG) vaccine [2] and the 2007 WHO revised BCG vaccination guidelines for infants at risk for human immunodeficiency virus (HIV) infection [3]. It incorporates recent developments in the tuberculosis (TB) field, provides revised guidance on the immunization of children infected with HIV, and re-emphasizes the importance of the birth dose. This position paper also includes recommendations for the prevention of leprosy.

Footnotes to this paper provide a number of core references including references to grading tables that assess the quality of the scientific evidence, and to the evidence-to-recommendation tables. In accordance with its mandate to provide guidance to Member States on health policy matters, WHO issues a series of regularly updated position papers on vaccines and combinations of vaccines against diseases that have an international public health impact. These papers are concerned primarily with the use of vaccines in large-scale immunization programmes; they summarize essential background information on diseases and vaccines, and conclude with WHO’s current position on the use of vaccines in the global context. Recommendations on the use of cholera vaccines were discussed by the Strategic Advisory Group of Experts (SAGE) in October 2017; evidence presented at these meetings can be accessed at: http://www.who.int/immunization/sage/meetings/2017/october/presentations_background_docs/en/

Section snippets

WHO position

Bacille Calmette-Guérin (BCG) vaccination is recommended in countries or settings with a high incidence of Tuberculosis1 (TB) and/or high leprosy burden.2 BCG vaccination may also be considered in settings where Buruli ulcer occurs. The available live attenuated vaccines are safe and effective, particularly to prevent the most severe forms of TB such as childhood TB meningitis and miliary TB disease, and also provide protection against leprosy.

Universal vaccination strategy at birth

In countries or settings with a high incidence of TB1 and/or high leprosy burden,2 a single dose of BCG vaccine should be given to all healthy neonates at birth [4],2 for prevention of TB and leprosy [5], [6]. If BCG vaccine

Selective vaccination strategy for risk groups at birth [7]

Countries with low incidence of TB3 or leprosy may choose to vaccinate neonates selectively in groups at high risk for TB and/or leprosy. High-risk groups to be considered for vaccination include the following:

  • Neonates born to parents (or other close contacts/relatives) with current or previous TB or with leprosy.

  • Neonates born in households with contacts to

Switching from universal to selective vaccination of risk groups at birth

Countries with declining rates of TB are encouraged to evaluate the epidemiology of TB periodically and consider whether a switch from universal vaccination to selective risk group vaccination would be appropriate. Before switching to selective BCG vaccination, countries should also consider the impact of a switch on prevention of leprosy. Since leprosy tends to occur in geographically defined clusters, an epidemiological assessment at national and subnational levels should be carried out.

When

Vaccination of older age groups

BCG vaccination of unvaccinated, tuberculin skin testing (TST) negative or IFN-ɣ release assay (IGRA) negative school children may provide long term protection (up to 20 years or longer). BCG vaccination of older age groups is recommended for the following:

  • Unvaccinated TST- or IGRA-negative older children, adolescents and adults from settings with high incidence of TB and/or high leprosy burden.

  • Unvaccinated TST- or IGRA-negative older children, adolescents and adults moving from low to high TB

Revaccination [8]

Studies have shown minimal or no evidence of any additional benefit of repeat BCG vaccination against TB or leprosy. Therefore, revaccination is not recommended even if the TST reaction or result of an IGRA is negative. The absence of a BCG scar after vaccination is not indicative of lack of protection and is not an indication for revaccination.

Vaccination of special populations, contraindications and precautions

BCG vaccination is contraindicated for individuals known to be allergic to any component of the vaccine.

Pregnant and lactating women – As a precaution, in the absence of adequate evidence on safety, BCG vaccination is not recommended during pregnancy. Although data on safety and immunogenicity of BCG vaccines in lactating women are limited, BCG vaccines may be administered to lactating women.

Immunocompromised and HIV-infected persons [9] – BCG vaccination is contraindicated for persons with

Administration of BCG vaccines

As reconstituted BCG vaccine does not contain a preservative, all opened multi-dose vials must be discarded at the end of the immunization session, or within 6 h, whichever comes first. The standard dose of BCG vaccine is 0.05 mL of the reconstituted vaccine for infants aged less than 1 year, and 0.1 mL for those aged one year and older. BCG vaccines must be administered by intradermal injection. Correct intradermal administration can be verified by bleb formation. BCG vaccine should be

Co-administration with other vaccines

BCG vaccine can be safely co-administered with other routine childhood vaccines.

Monitoring

Currently, childhood TB cases are reported to WHO in 2 age ranges: 0–4 years and 5–14 years. To better understand the effectiveness of BCG vaccination at different ages, reporting of TB cases by age in years should be encouraged, and if possible by months for infants aged <1 year. The status of BCG vaccination among TB cases should be recorded, preferably with information about the product/batch used. A similar reporting of leprosy cases is encouraged.

Research priorities

The development of new vaccines is a high research priority. There is a need for vaccines that would provide greater protection than BCG, preventing all forms of TB including drug-resistant TB, as well as reactivation of TB, and that would be effective in all age groups including HIV-infected persons and perform consistently in all populations. The development of more effective vaccines against leprosy is also encouraged.

The implementation of BCG vaccination of HIV-infected children, including

References (9)

  • World Health Organization (WHO). BCG vaccines: WHO position paper, February 2018, Weekly epidemiological record, No. 8,...
  • WHO. BCG Vaccine, January 2004, Weekly epidemiological record, No. 4, 79; 2004. p....
  • WHO. Revised BCG vaccination guidelines for infants at risk for HIV infection, May 2007, Weekly epidemiological record,...
  • WHO. Evidence to recommendation table: Need for vaccination at birth vs at 6 weeks Available at...
There are more references available in the full text version of this article.

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