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Rapid response to:


Effect of BCG vaccination against Mycobacterium tuberculosis infection in children: systematic review and meta-analysis

BMJ 2014; 349 doi: (Published 05 August 2014) Cite this as: BMJ 2014;349:g4643

Rapid Response:

We welcome the findings of Roy et al. regarding the effectiveness of the BCG vaccine in preventing Mycobacterium tuberculosis (TB) infection in immunocompetent children.(1) However, we urge health care professionals responsible for the prescribing and administration of BCG vaccinations to be mindful of significant contraindications that pose risks to immunocompromised patients.(2)

Our characterisation of primary care-related paediatric safety incidents from the England and Wales National Reporting and Learning System (NRLS) includes 1790 vaccine-related incidents from 2005-2013.(3) Although under-reporting is commonly cited as the Achilles’ heel of the NRLS, incidents involving unsafe delivery of the BCG vaccine feature frequently.(4) Our exploration has identified 99 reports of BCG-related incidents in children at risk of TB exposure– either by living in or having family members from areas with a high prevalence of TB. A recurring theme is the administration of BCG vaccines to infants of HIV-positive mothers in whom full assessment of their HIV status had not been completed.(5) There is a risk of disseminated BCG disease in children infected with HIV.(2) Public Health England’s “Green Book” provides clear guidance on this, recommending that BCG should only be administered after two “appropriately timed negative postnatal PCR blood tests for HIV infection”. (6) Poor communication between health services–maternity care, child health and general practice– is frequently described as contributing to such incidents. Typically, infants are sent appointments by child health services as a result of deficiencies or discrepancies between maternal and child health records. This creates a situation whereby healthcare professionals are unaware of a child’s vulnerability.

Vaccine errors remain a threat to patient care.(7) Contraindications to BCG must be explicitly referenced within the unified forms and there is a need for better linkage of maternal and child health records that are accessible in primary and secondary care settings. We caution healthcare professionals not to rely solely on medical records but to consider – double-check – and fully explore with parents (including use of translation services if needed) the child’s suitability for the vaccine prior to administration.

1. Roy A, Eisenhut M, Harris RJ, Rodrigues LC, Sridhar S, Habermann S, et al. Effect of BCG vaccination against Mycobacterium tuberculosis infection in children: systematic review and meta-analysis. BMJ. 2014(349):g4643.

2. Hesseling AC, Marais BJ, Gie RP, Schaaf HS, Fine PE, Godfrey-Faussett P, et al. The risk of disseminated Bacille Calmette-Guerin (BCG) disease in HIV-infected children. Vaccine. 2007;25(1):14-8.

3. National Institute for Health Research. Characterising the nature of primary care patient safety incident reports in England and Wales: mixed methods study. Available from:

4. Vincent C, Aylin P, Franklin BD, Holmes A, Iskander S, Jacklin A, et al. Is health care getting safer? BMJ. 337:a2426.

5. Public Health England. Tuberculosis. In: Immunisation against infectious disease [Internet]. 2003 [cited 13th Aug 2014]: [391-409]. Available from:

6. Public Health England. Contraindications and special considerations: the green book, chapter 6. In: Immunisation against infectious disease [Internet]. 2013 [cited 14th Aug 2014]: [41-48]. Available from:

7. Derrough TF, Kitchin NR. Occurrence of adverse events following inadvertent administration of childhood vaccines. Vaccine. 2002;21(1-2):53-9.

Competing interests: ACS and AE are co-chief investigators of a NIHR HS&DR grant to characterise patient safety incident reports in primary care. PR is a research assistant employed to work on the study. AJ has no conflicts of interest. PH is the former Associate Director of the National Patient Safety Agency responsible for the development of recommendations from patient safety incident reports received by the National Reporting and Learning System.

16 August 2014
Philippa Rees
Intercalated MPhil Medical Student
Huw Evans, MB BCh, Academic F2 Doctor, Cochrane Institute for Primary Care and Public Health, Cardiff University. Sukhmeet Panesar, MD MPH, Honorary Fellow, Centre for Population and Health Sciences, University of Edinburgh. Meirion Llewelyn, PhD FRCP, Consultant in Infectious Diseases, Royal Gwent Hospital, Newport. Adrian Edwards, PhD MRCP MRCGP, Professor of General Practice & Institute Director, Cochrane Institute for Primary Care and Public Health, Cardiff University. Andrew Carson-Stevens MB BCh MPhil, Clinical Lecturer in Healthcare Improvement, Cochrane Institute for Primary Care and Public Health, Cardiff University.
Cochrane Institute for Primary Care and Public Health, Cardiff University
Cochrane Institute of Primary Care and Public Health, 3rd Floor Neuadd Meirionnydd, School of Medicine, Cardiff University, CF14 4YS.