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Pregnancy and lactation

Please note this information is specifically directed to, and only to be used by, medical professionals seeking additional information on the BRACE trial. In order to be fully understood, this section may require you to have medical or biomedical research training.

BCG vaccination in pregnancy and lactation

BCG vaccination is not recommended for use in pregnancy due to a lack of safety data and theoretical concerns associated with a live vaccine. However, no evidence of adverse effects to the developing foetus have been observed [1-3].

BCG vaccination is not contraindicated in lactating women, although there is limited data on safety and immunogenicity of the vaccine in this group [1]. 

  • Although no harmful effects of the BCG vaccine on the foetus have been observed, BCG vaccination should not be given during pregnancy due to theoretical concerns associated with a live vaccine [2]
  • BCG vaccination is not contraindicated in lactating women, although there is limited data on safety and immunogenicity of the vaccine in this group [1]. 
  • In the 1990s, a number of European countries gave repeat BCG vaccinations in adolescence or early adulthood, including Luxembourg (18-25 years), Portugal (18-20 years), Albania (18 years), Greece (21 years), Hungary (16-17 years), Poland (18 years), Slovakia (16 years), Yugoslavia (15 years), Azerbaijan (25 years), Lithuania (17 years) and Russia (21-22 years) [4].
  • Bulgaria is the only European country that routinely gives BCG vaccine in adolescence, with a catch-up dose given at 17 years if previous doses were missed [5]. Patients are screened for latent TB infection (LTBI) with a tuberculin skin test (TST) prior to the catch-up doses. 

[1]    World Health Organization. BCG vaccines: WHO position paper - February 2018. Wkly Epidemiol Rec 2018;93:73-96.         
[2]    Centers for Disease Control and Prevention. BCG Vaccine Sheet.        
[3]    National Centre for Immunization and Respiratory Diseases. General recommendations on immunization - recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2011;60:1-64.         
[4]    World Health Organization. Bulletin of the World Health Organization. 1998;76:85-91.         
[5]    European Centre for Disease Prevention and Control. Vaccine scheduler.        

This review was done in accordance with the ‘preferred reporting items for systematic reviews and meta-analyses’ (PRISMA) statement. A systematic search of MEDLINE was done in March 2020 using the OVID interface using the following search terms: (exp BCG vaccine OR exp tuberculosis vaccines) AND (exp pregnancy OR exp breast feeding OR exp pregnant women OR exp pregnancy complications/ OR exp prenatal care/ OR exp pregnancy complications, infectious). Reference lists of identified relevant publications were also hand-searched. 

Studies were included if they: 1) assessed the safety of BCG vaccination antenatally or during lactation, or 2) described case reports of BCG vaccination during pregnancy or lactation. The search identified a total of 253 studies, none of which fulfilled the inclusion criteria.