Article Text

Disregarding the restrictive vial-opening policy for BCG vaccine in Guinea-Bissau: impact and cost-effectiveness for tuberculosis mortality and all-cause mortality in children aged 0–4 years
  1. Sanne M Thysen1,2,3,4,
  2. Ane Baerent Fisker1,2,3,
  3. Stine Byberg2,3,
  4. Peter Aaby2,3,
  5. Partho Roy5,
  6. Richard White5,
  7. Ulla Griffiths6,
  8. Rebecca C Harris5
  1. 1 OPEN, Institute of Clinical Research, University of Southern Denmark, Odense, Denmark
  2. 2 Bandim Health Project, Bissau, Guinea-Bissau
  3. 3 Research Centre for Vitamins and Vaccines, Bandim Health Project, Statens Serum Institut, Copenhagen, Denmark
  4. 4 Center for Global Health (GloHAU), Aarhus University, Aarhus, Denmark
  5. 5 TB Centre for Mathematical Modelling of Infectious Diseases, London School of Hygiene and Tropical Medicine Faculty of Epidemiology and Population Health, London, UK
  6. 6 Health section, UNICEF, New York, New York, USA
  1. Correspondence to Dr Sanne M Thysen; s.thysen{at}


Objective BCG vaccination is frequently delayed in low-income countries. Restrictive vial-opening policies, where a vial of BCG vaccine is not opened for few children, are a major reason for delay. During delays, children are unprotected against tuberculosis (TB) and deprived of non-specific effects of BCG. We assessed the potential effect and cost-effectiveness of disregarding the restrictive vial-opening policy, on TB and all-cause mortality, in children aged 0–4 years in Guinea-Bissau.

Methods Using static mathematical models, we estimated the absolute and percentage change in TB and all-cause deaths, in children aged 0–4 years, between the current BCG vaccine restrictive-opening policy scenario, and a non-restrictive policy scenario where all children were vaccinated in the first health-facility contact. Incremental cost-effectiveness was estimated by integration of vaccine and treatment costs.

Findings Disregarding the restrictive BCG vial-opening policy was estimated to reduce TB deaths by 11.0% (95% uncertainty range (UR):0.5%–28.8%), corresponding to 4 (UR:0–15) TB deaths averted per birth cohort in Guinea-Bissau, resulting in incremental cost-effectiveness of US$ 911 per discounted life-year gained (LYG) (UR:145–9142). For all-cause deaths, the estimated reduction was 8.1% (UR: 3.3%–12.7%) corresponding to 392 (UR:158–624) fewer all-cause deaths and an incremental cost-effectiveness of US$ 9 (UR:5–23) per discounted LYG.

Conclusions Disregarding the restrictive BCG vial-opening policy was associated with reductions in TB deaths and all-cause deaths and low cost-effectiveness ratios. Our results suggest that it would be cost-effective to disregard the restrictive vial-opening policy. Other settings with similar practice are also likely to gain from disregarding this policy.

  • child health
  • epidemiology
  • paediatrics
  • public health
  • tuberculosis

Data availability statement

Data are available on request. Data are available on a collaborative basis, contact

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Data availability statement

Data are available on request. Data are available on a collaborative basis, contact

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  • Handling editor Lei Si

  • Twitter @Sthysen, @AneFisker

  • Contributors SMT, ABF and RCH conceived the idea for the study. SMT and RCH developed the research method and the mathematical models with input from ABF, UG, PR and RW. SMT, ABF, SB and PA contributed to the original data collection. SMT extracted the data. SMT conducted the analyses, and wrote the manuscript with input from ABF, UG and RCH. All authors reviewed the manuscript and approved the final version for submission.

  • Funding This work was supported by European Union FP7 support for OPTIMUNISE (Health-F3-2011-261375), and by the Augustinus Foundation. The Bandim Health Project received support from the Danish National Research Foundation via Research Centre for Vitamins and Vaccines (DNRF108). RW is funded by the Wellcome Trust (218261/Z/19/Z); NIH (1R01AI147321-01); EDTCP (RIA208D-2505B); UK MRC (CCF17-7779 via SET Bloomsbury); ESRC (ES/P008011/1); BMGF (OPP1084276, OPP1135288, INV-001754) and the WHO (2020/985800-0).

  • Disclaimer The sponsors had no role in designing the study, the data collection, data analysis, data interpretation or writing the paper.

  • Competing interests RCH reports employment at Sanofi Pasteur, unrelated to the subject of this research.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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