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EDITORIALS:
Graham H Bothamley, Ed Cooper, Delane Shingadia, and Alex Mellanby
Tuberculin testing before BCG vaccination
BMJ 2003; 327: 243-244 [Full text]
*Rapid Responses: Submit a response to this article

Rapid Responses published:

[Read Rapid Response] BCG reactions
Gnanam Duraisamy, 43400 UPM Serdang   (1 August 2003)
[Read Rapid Response] Effect of age on adverse effects
Richard J Roberts   (2 August 2003)
[Read Rapid Response] BCG vaccine needed till what age?
anju aggarwal, M.M.A Faridi,Head of Department, Pediatrics ,University College of Medical Sciences and Guru Tegh Bahadur Hospital ,New Delhi.   (3 August 2003)
[Read Rapid Response] Tuberculin testing before giving BCG
John A Lunn   (12 August 2003)
[Read Rapid Response] Tuberculin testing before BCG vaccination
Julian H Shelley, N/A   (13 August 2003)
[Read Rapid Response] BCG as a diagnostic test for tuberculosis
David A Green   (15 August 2003)
[Read Rapid Response] Tuberculin testing prior to delayed selective neonatal BCG vaccination
Peter I Macfarlane, Michelle Harper-Crouch, and Y S Kaplan   (29 August 2003)
[Read Rapid Response] Vaccination Scars
A L H MOSS   (30 November 2003)
[Read Rapid Response] Tuberculin testing before BCG vaccination
John M Watson, Ian A Campbell, L Peter Ormerod   (20 August 2004)

BCG reactions 1 August 2003
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Gnanam Duraisamy,
Haematologist
University Putra Malaysia,
43400 UPM Serdang

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Re: BCG reactions

BCG was given without a tuberculin test to 12 year olds entering secondary school. In some children, severe keloids are seen over the upper arm (the deltoid area) in these children over 12 years who were given the BCG. Would doing the tuberculin test and not giving the BCG to those with a positive reaction have prevented this scarring? Why does it happen? What can be done to avoid it?

G. Duraisamy

Competing interests:   None declared

Effect of age on adverse effects 2 August 2003
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Richard J Roberts,
Consultant in Communicable Disease Control
National Public Health Service for Wales, Preswylfa, Mold, Flintshire, Wales, CH7 1PZ

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Re: Effect of age on adverse effects

Dear editor

This editorial is usefully provocative.

The authors begin by stating that the evidence base for the current recommendations is not clear. However the evidence base for the authors' suggestion is not clear either. The evidence on complications cited only describes an age related effect for tuberculous skin lesions in those over 15 years of age, and the authors do not state whether the increased frequency of this complication over that age is considered clinically significant.

Is age important, or do the authors' conclusions also apply to children 10-14 years of age (the age at which BCG is given to school children in the United Kingdom living outside high prevalence areas such as the one in which the authors work) or even to adults as well?

Yours sincerely

Competing interests:   None declared

BCG vaccine needed till what age? 3 August 2003
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anju aggarwal,
Lecturer Pediatrics
University College of Medical Sciences and Guru Tegh Bahadur Hospital, New Delhi -110095,
M.M.A Faridi,Head of Department, Pediatrics ,University College of Medical Sciences and Guru Tegh Bahadur Hospital ,New Delhi.

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Re: BCG vaccine needed till what age?

Evidence in literature clearly demonstrates beneficial effect of BCG vaccine. Reactions to BCG vary. Typical sequence of papule, nodule, pustule, ulcer and scar may take 6 weeks to 3 months. Sometimes reaction may be arrested at any of the above mentioned stages.These are called abortive reactions (1).Immunity has been demonstrated in such cases of abortive reactions either by tuberculin test or lymphocyte migration inhibition test.On the other hand reaction may be acclerated if there is prior exposure to tubercular bacilli (2).

Tuberculin testing before BCG vaccine should not be practiced as argued in this editorial.BCG vaccine is beneficial if given before exposure to natural infection. It replaces the natural and potentially harmful primary infection by a benign artificial primary infection.Therefore the age till which BCG vaccine is required should be determined by the epidemiology of tuberculosis in a particular country or geographical area. In India according to the National Immunization schedule BCG vaccine is given at birth and till 5 years of age(3).

Diagnostic utility of BCG in malnourished children and in situation of non-availbility of tuberculin needs further evaluation and standardization as has been done for tuberculin test (Mantoux) (4).

References.

1.Kaur S, Faidi MM, Agarwal KN. BCG vaccination reaction in low birth weight infants. Indian J Med Res 2002,116:64-69.

2.Udani PM, Parikh UC, Shah PM, Naik PA.BCG test in tuberculosis. Indian J Pediatr 1971,8:43-50.

3.Committee on Immunization, Indian Academy of Pediatrics. In IAP guide book on immunization.2001,pp49.

4.Aggarwal A, Guglani L, Faridi MM. Standardization of Mantoux test. Indian Pediatr 2002,39:404-406. Diagnostic

Competing interests:   None declared

Tuberculin testing before giving BCG 12 August 2003
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John A Lunn,
Former member of the Joint Committee on Vaccination and Immunisation
retired consultant

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Re: Tuberculin testing before giving BCG

Your editorial, "Tuberculin testing before BCG vaccination may not be necessary", BMJ 2003; 243-244 indicates some advantages in not tuberculin testing older children prior to giving BCG. Some potential problems should also be mentioned. In subjects already tuberculin positive the Koch's phenomenon from giving BCG, as a rule, produces a larger and often more unsightly scar. The general public has become more aware that scars in subjects properly selected and properly given BCG are usually circular and 5mm. or less in diameter with a smooth surface. Litigation in the NHS is ever increasing and there are now several examples of compensation being paid to subjects with unsightly BCG scars because of being wrongly selected and/or having BCG incorrectly administered. Your proposals could increase the possibility of litigation due to more unsightly scars. Regarding the number of visits required, especially in the Schools BCG programme, there would still be two needed, one to give BCG and one to identify those with the Koch's phenomenon. Possibly a third to confirm healing of the latter as not all such reactions heal as readily as your editorial implied.

Competing interests:   I am a member of the Dept of Health's working party to develop the disposable Heaf testing device

Tuberculin testing before BCG vaccination 13 August 2003
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Julian H Shelley,
Retired physician
Private house RG14 1RR,
N/A

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Re: Tuberculin testing before BCG vaccination

The conclusion by Bothamley et al (1) that tuberculin testing may not be necessary before BCG vaccination has particular importance in countries with scant medical resources.

As a prelude to vaccinating some 65,000 children in Tanganyika (Tanzania) Gordon and I (2) performed a careful study in a sample of 1750 children from the Marangu area of Kilimanjaro. Prior tuberculin testing and subsequent BCG vaccinations showed an increased number of early reactions and persisting skin lesions in tuberculin (10 TU) positive children, all of which were healed at 7 weeks follow-up. These were judged more irritating than dangerous.

As our paper was published 44 years ago, it is disappointing, to say the least, that this issue has not been resolved.

References:

1. Bothamley GH, Cooper E, Shingadia D, Mellanby A, Tuberculin testing before BCG vaccanination BMJ 2003 327 243-244

2. Gordon CGI, Shelley JH The use of BCG Vaccine in Mantoux-Positive and Mantoux-Negative Persons in East Africa Tubercle 1959 40 425-431

Competing interests:   None declared

BCG as a diagnostic test for tuberculosis 15 August 2003
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David A Green,
Consultant Paediatrician
West Middlesex University Hospital, Twickenham Road, Isleworth, Middlesex TW7 6AF

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Re: BCG as a diagnostic test for tuberculosis

In your recent editorial entitled Tuberculin testing before BCG vaccination(1), the authors state that the use of BCG as a diagnostic test for tuberculosis has been recommended by the World Health Organisation. They quote WHO Technical Report Series 1964: 210. This reference is incorrect and interestingly their later reference Göçmen et al (2) made the same typing error. In fact the WHO Technical Report Series referred to was 290 not 210. The report (3) states that “the committee reviewed recent studies carried out on direct BCG vaccination, that is, vaccination without a prior tuberculin test. These studies have not demonstrated local, regional, focal, or general complications detrimental to the health of the tuberculin reactors among the vaccinated individuals. In countries where BCG vaccination is essential to the effective control of tuberculosis, where cost is of major importance, and where prior tuberculin testing would considerably reduce coverage, direct BCG vaccination is recommended by the committee as a public health procedure.” The report does not actually claim that BCG can itself be used as a diagnostic test. Indeed, in a later section the committee recommended the use of the internationally standardised batch of tuberculin PPD RT 23.

The other studies quoted (2,4,5,6) do however make a strong case for the use of BCG as a diagnostic test for tuberculosis. In each of them it performed better than tuberculin testing.

It is your responsibility when publishing an Editorial to ensure that references are verified against the original documents and that these documents are not misquoted.

REFERENCES

1. Bothamley GH, Cooper E, Shingadia D, Mellanby A. Tuberculin testing before BCG vaccination. BMJ 2003; 327: 243-244

2. Göçmen A, Kiper N, Ertan Ü, Kalayci Ö, Özçelik U. Is the BCG test of diagnostic value in tuberculosis? Tubercle Lung Dis 1994;75: 54-7.

3. World Health Organisation. WHO expert committee report on tuberculosis. Geneva: WHO, 1964: 290 ( Technical Report Series).

4. Udani PM, Parikh UC, Shah PM, Naik PA. BCG test in tuberculosis. Indian J Pediatr 1971;8: 143-50.

5. Kapoor RK, Wakhlu I, Gupta PK, Saksena PN. Diagnostic utility of BCG test in children. J Indian Medical Ass 1982;78: 177-80.

6. Bhandari NR, Bhambal SS, Beohar V. Diagnostic value of BCG test in childhood tuberculosis. Indian Pediatrics 1984;21: 555-9.

Competing interests:   None declared

Tuberculin testing prior to delayed selective neonatal BCG vaccination 29 August 2003
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Peter I Macfarlane,
consultant paediatrician
Dept of Child Health, Rotherham General Hospital, Rotherham S60 2UD,
Michelle Harper-Crouch, and Y S Kaplan

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Re: Tuberculin testing prior to delayed selective neonatal BCG vaccination

Dear Sir/Madam

The editorial by Bothamley et al(1) questions Department of Health advice(2) about whether prior tuberculin testing before BCG vaccination is helpful or necessary. This question is of current relevance for the U.K. selective neonatal BCG programme, because supply of percutaneous BCG (for administration by multiple puncture gun) was withdrawn in August 2002. In many districts using this method this has created a cohort of infants eligible under current recommendations for neonatal BCG vaccination, who became more than 3 months old before an alternative (intradermal) BCG vaccination supply was restored. The hypothetical risk from going ahead with BCG vaccination in these infants is that some may have acquired tuberculosis infection during this time and that giving BCG may result in problems due to an ‘accelerated’ BCG response or one of its variants.

The editorial does not however cite any evidence concerning this. We are therefore writing to report on the results of Heaf testing in this group of infants in our district.

Under current DoH recommendations(2) ,7.3% of Rotherham newborns are eligible for neonatal BCG vaccination (1999 data).

Multiple puncture percutaneous BCG vaccination ceased in our district in mid August 2002. Amongst the backlog of unvaccinated infants which accumalated before the intradermal programme was recommenced, were 67 infants who were by then 3 or more months old. All were recalled (after more than 1 attempt in some instances) to a BCG Clinic to receive Heaf testing and then reading and intradermal BCG a week later. 65 were Heaf grade 0 and 2 were grade 1 .

Our evidence therefore supports the editorial recommendation that prior tuberculin testing in the context of 'delayed' neonatal BCG vaccination in infants older than 3 months of age is unnecessary because no cases of tuberculin positivity (heaf grade 2 or more) were uncovered.

However, this conclusion may not be applicable to older children receiving BCG at Secondary school, as Heaf positivity would be expected to be higher at this age. In our district (1990 data), 6% of 12-14 year olds were Heaf positive grade 2-4, of which 23% were grade 3 or 4, and 77% were grade 2 (62% after previous BCG vaccination, 15% unvaccinated).

Yours sincerely

DR P I MACFARLANE
Consultant Paediatrician

SISTER MICHELLE HARPER-CROUCH
Children’s Outpatient Department

DR Y S KAPLAN
Senior Clinical Medical Officer

References

1: Bothamley GH, Cooper E, Shingadia D, Mellanby A. Tuberculin testing before BCG Vaccination. BMJ 2003; 327:243-244

2: 1996 immunisation against infectious disease. London: DoH, 1996:219-41

Competing interests:   None declared

Vaccination Scars 30 November 2003
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A L H MOSS,
Consultant Paediatric Plastic and Reconstructive Surgeon
St Georges Hospital, Blackshaw Road, Tooting, London, SW17 0QT

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Re: Vaccination Scars

Sir, The development of significant scarring following BCG is not being highlighted enough although mentioned in previous 'Rapid Responses' (1,2). The reasons for hypertrophic/keloid scarring can include a severe local response, vaccine placed in wrong place and/or secondary bacterial infection.

However, the deltoid area is a well known anatomical site for bad scarring. Added to this, certain ethnic groups (eg Afro-Caribean, Oriental) also have a tendency to this reaction.

Having developed this scar, it can be very difficult to deal with both from symptoms of itchiness as well as appearance. Prevention would be better than cure if the siting of vaccinations change to less visible areas eg upper inner arm (3). Policies must change.

References

1. Duraisamy G. BCG reactions. BMJ. Rapid response 1/8/03

2. Lunn JA. Tuberculin testing before giving BCG. BMJ Rapid response. 12/8/03

3. Moss ALH. Needling doubts about where to vaccinate. BMJ.1988. 297:980

Competing interests: None declared

Tuberculin testing before BCG vaccination 20 August 2004
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John M Watson,
Head, Respiratory Diseases Department
Health Protection Agency Communicable Disease Surveillance Centre, London NW9 5EQ,
Ian A Campbell, L Peter Ormerod

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Re: Tuberculin testing before BCG vaccination

Bothamley and colleagues have made an interesting suggestion about the role of tuberculin testing in children over three months old (1). The main reason for tuberculin testing before BCG immunisation is to detect prior tuberculin sensitivity, which may be due to previous infection by Mycobacterium tuberculosis or to previous immunisation. This is done in order to identify, as best as one can, those who do not stand to benefit from the immunisation and who are at risk of accelerated reaction to the vaccine. The extent to which these accelerated or more severe reactions are prevented by prior tuberculin testing will be dependent on the population being tested. Some population sub-groups, particularly household contacts of respiratory tuberculosis and children in ethnic minority groups born abroad, are at substantial risk of tuberculosis, and high levels of prior infection up to and above 10% are well documented. On the other hand in many areas where tuberculosis is uncommon, the risk of prior infection by M. tuberculosis in children involved in routine schools’ BCG programme must be very low. In their Editorial, Bothamley and colleagues provide only very limited information about the likelihood of more severe reactions in those who are already tuberculin positive. More information on this topic, along with an understanding of the prevalence of prior tuberculosis infection or immunisation, is necessary to form a judgement of the approach they advocate.

The occurrence of an accelerated reaction to BCG in children who have concurrent tuberculosis has, as the authors point out, been suggested before as an indicator of the presence of active disease but might it not be an indicator simply of prior infection with tuberculosis rather than active disease? Is there evidence on how to differentiate between the two conditions, one of which requires chemoprophylaxis and the other chemotherapy?

In any case it would presumably be necessary for a second clinic visit to take place as a matter of routine in order to detect these accelerated reactions. Thus there would be no reduction in clinic visits.

The tuberculin test is a virtually harmless diagnostic aid whilst BCG is a vaccination to prevent disease. Until there is more evidence on the benefit as opposed to harm of BCG vaccine when used as a diagnostic tool, it would be prudent to use it for its original purpose only.

IA Campbell, LP Ormerod, JM Watson.
Chairman and members of the Joint Tuberculosis Committee of the British Thoracic Society

References

1 Bothamley GH, Cooper E, Shingadia D, Mellanby A. Tuberculin testing before BCG vaccination. BMJ 2003; 327: 243-4.

Competing interests: None declared