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RESEARCH:
Linda Diggle, Jonathan J Deeks, and Andrew J Pollard
Effect of needle size on immunogenicity and reactogenicity of vaccines in infants: randomised controlled trial
BMJ 2006; 333: 571 [Abstract] [Full text]
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Rapid Responses published:

[Read Rapid Response] Needle size and reactogenicity of vaccines in infants
Stefan D Garner   (18 September 2006)
[Read Rapid Response] Visual messages
richard g wilson   (19 September 2006)
[Read Rapid Response] Nurse-led immunisation clinics are effective
Eileen Marfe, Christine E. Jones, Paediatric SpR   (27 September 2006)
[Read Rapid Response] How long and how deep?
Sabiha Kausar   (29 September 2006)
[Read Rapid Response] Reliability of drug safety data
Marc Girard   (4 October 2006)
[Read Rapid Response] A landmark study
Harish K. Pemde   (25 November 2006)

Needle size and reactogenicity of vaccines in infants 18 September 2006
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Stefan D Garner,
General Practitioner
Peartree Surgery, South Ockendon, Essex RM15 6PR

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Re: Needle size and reactogenicity of vaccines in infants

Editor: Linda Diggle et al BMJ 16 September 2006 reported less local reactions to immunisation of infants using longer needles.

In my early days of general practice in the mid-1980s, I too achieved this, not by changing needles, but by reversing my then procedure of injection (Diphtheria Tetanus and I think Pertussis) followed by oral vaccine (Polio) in to the open-mouthed but struggling infant. Giving mothers the time to press on the injection site for at least 1/2 minute, it seems, brought to an abrupt end to the procession of local 'allergic reactions'. (It worked in adults too)

Competing interests: None declared

Visual messages 19 September 2006
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richard g wilson,
honorary consultant paediatrician
kingston hosp NHST

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Re: Visual messages

The cover of the BMJ Sept 16 could be a powerful advertisement for the wrong message. Long needles are best , but only when injections are given in the right place. How are you going to correct the error in the photograph ?

Competing interests: None declared

Nurse-led immunisation clinics are effective 27 September 2006
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Eileen Marfe,
Senior Sister
Kingston Hospital, KT2 7QB,
Christine E. Jones, Paediatric SpR

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Re: Nurse-led immunisation clinics are effective

To date, there is a paucity of literature concerning issues of increased immunogenicity with administration of vaccines intramuscularly. It was certainly thought provoking to be confronted with such well substantiated evidence in the recent article "Effect of needle size on immunogenicity and rectogenicity of vaccines in infants: randomised controlled trial".

Whilst there are well documented guidelines concerning optimum needle depth when administering immunisations, the subject of reactogenicity has been very clearly examined in this study. It is hoped that all practitioners will consider these findings which will greatly reduce the incidence of induration and swelling following immunisation.

The paediatric immunisation service for high-risk children at this hospital has been developed into a nurse-led service. Immunisations are administered intramuscularly with a 25mm needle. Audits have shown there to be not only improvements in practice, but one recent study, which examined the outcomes of children 48 hours following immunisation, showed only minor ill-effects. There were no reports of swelling or induration at injection site.

Competing interests: None declared

How long and how deep? 29 September 2006
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Sabiha Kausar,
Paediatric SHO
George Eliot Hospital Nuneaton CV10 7DJ

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Re: How long and how deep?

Working as a doctor in paediatrics and having to administer vaccines to neonates and high-risk babies I have been surprised to find that some of my colleagues were unfamiliar with the recommended needle size. There was little awareness amongst colleagues regarding documented guidelines concerning the optimum needle length and insertion depth when administering immunisations.

As injection technique is fundamental to immunisation, in recent years there has been little attention paid to considering exactly where the procedure will place the injected material. I have read this paper with great interest and feel that it highlights an important point that needs to be addressed in the hospital setting as well as primary care.

It would be useful to understand what is happening in clinical practice at the hospital level; what needles are we using, what techniques are we adopting and on what basis are we doing what we do?

Competing interests: None declared

Reliability of drug safety data 4 October 2006
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Marc Girard,
Consultant
78760 Jouars-Pontchartrain (France)

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Re: Reliability of drug safety data

According to Diggle et al (BMJ, 16 Sept 2006, 571-4), use of long needles could significantly reduce vaccine reactogenicity. In their study, the percentage of infants experiencing local reactions after intramuscular injection went up to 61% for a combined vaccine and 42% for a meningococcal vaccine; 2% of the included subjects were withdrawn due to severe local or general reactions. Fairly recently, however, in a plea for “the importance of injecting vaccines into muscle”, Zuckerman5 contended that after intramuscular injection, only… 0.4% of the patients had local adverse effect. Even taking into account potential disparities in the criteria used for reporting or coding, it is extremely difficult to reconcile such conflicting results. And every attempt to do so notwithstanding, an even more crucial question concerns the clinical or epidemiological relevance of estimates which can display such phenomenal fluctuations… For not speaking about prescribers information, and even less: about the “informed” consent of parents who gather information from doctors who received such informative data! Although it was recently pointed out4 5, most of health professionals remain unaware of this worrying lack of reliability of safety data about medicines (from the clinical trials as well as from post-marketing surveillance). Some may think that the above comparison between two estimations of local reactions is a caricature, but this is not the case: while monitoring of iatrogenic hazards is certainly poorer with vaccines than with other drugs1-3 5, examples of irresponsible management of drug safety by manufacturers as well as governmental agencies could easily be extended to a number of non-vaccine products.

References

1. Anon. WHO urges better monitoring of vaccine ADRs. Scip 2006; 13.

2. Bonhoeffer J, Zumbrunn B, Heininger U. Reporting of vaccine safety data in publications: systematic review. Pharmacoepidemiol Drug Saf 2005; 14:101-6.

3. Girard M. Vaccination and auto-immunity: reassessing evidence. Medical Veritas 2005; 2:549-54.

4. Ioannidis JP, Lau J. Completeness of safety reporting in randomized trials: an evaluation of 7 medical areas. JAMA 2001; 285:437- 43.

5. Zuckerman JN. The importance of injecting vaccines into muscle. Different patients need different needle sizes. BMJ 2000; 321:1237-8.

Competing interests: Dr Girard works as an independent consultant for pharmaceutical industry, including vaccine manufacturers and a number of their competitors.

A landmark study 25 November 2006
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Harish K. Pemde,
Associate Professor of Pediatrics
New Delhi India 110085

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Re: A landmark study

Study by Linda Diggle and others is very important one in view of paucity of literature on the issue of length and guage of needle for intramuscular injections for vaccination. Reactogenicity and immunogenicity depend on the vaccine used, and on the injection equipment and the procedure of injection. This study clearly favors the use of longer (25 mm) and wider (guage 23) needle. However, this study was not designed to study the differences caused by needle guage for which a larger sample will be required.

I believe that a study comparing the 25 mm needles of guages 22, 23, and 24 will be useful in deciding the optimum guage for minimum reactogenicity and maximum immunogenicity. I will be happy to collaborate for this study.

Competing interests: None declared