Scientific advice and evidence in emergencies - Science and Technology Committee Contents

Memorandum submitted by the Royal College of Paediatrics and Child Health (SAGE 20)

  Our comments relate to the first case study: Swine Flu pandemic in 2009.

  The Royal College of Paediatrics and Child Health believes that the response to the H1N1 pandemic with regard to the production of vaccine and the stock piling of Tamiflu was appropriate. The CMO had to act assuming the worst case scenario. The papers published from Australia and the US had shown that this flu was very virulent with a high mortality, particularly among the young. However, it proved to be less transmissible than had been predicted and numbers of affected cases were therefore less than expected. It is conceivable, if not likely, that a H1N1 pandemic will recur at some point; in this respect, the response may represent a very good dress rehearsal.


  In September/October 2009, constituent parts of the NIHR worked together to support a key study comparing the Baxter H1N1 vaccine and GlaxoSmithKline H1N1 vaccine in children six months to 12 years of age. The study was funded by Health Technology Assessment and the Lead Applicant was Professor Liz Miller, Health Protection Agency, and the Chief Investigator was Professor Andrew Pollard, University of Oxford.

  Usually such studies take many months, even years, to develop from an agreed protocol through regulatory and ethical approvals (both national and at each local participating site), recruitment of staff, then participants and completion of the study. In the context of the H1N1 pandemic, the Department of Health gave high priority to relevant H1N1 studies and the relevant governance bodies fast-tracked their approvals assessments as a result. The NIHR had in the summer of 2009 made contingency plans to allow the research networks to support priority H1N1 studies.

  In this case, the trial was a collaboration between the lead site, The Oxford Vaccine Group at the University of Oxford, Centre for Infections at the Health Protection Agency and other sites, namely: St George's Vaccine Institute, London, University of Southampton, Wellcome Trust Clinical Research Facility, Bristol Children's Vaccine Centre, and Royal Devon and Exeter NHS Foundation Trust. The study was adopted into the NIHR MCRN Portfolio following review by the MCRN Study Assessment Committee which was completed within 48 hours.

  Research staff within the MCRN Local Research Networks (LRNs) and Comprehensive Local Research Networks (CLRN) were mobilised to undertake this study. Support from senior management within participating Trusts facilitated access to Trust resources to ensure swift and efficient study set up and running (eg pharmacy, Research & Development, laboratories, space in Out Patients, PALS, security, cleaning, Finance, HR, Public Relations departments).

  This trial required the recruitment and follow-up of a large number of study participants (see Table 1) within a short time frame (one month for recruitment). This was achieved by close collaboration between the study team and (C)LRN-funded staff during an intense recruitment period when children and families were recruited outside normal working hours. Key to success was the ability to achieve approvals and training (eg nurse contracts and training) to allow staff to work in new sites or facilities (eg schools, primary care sites) to facilitate recruitment, vaccination and follow-up. As a result of this tremendous collaboration, recruitment to the study was not only fully achieved but in a very short period of time. This is unprecedented in a complex research study involving so many children. As a result of this study, the Department of Health was able to institute a timely and evidence-based vaccination programme for children.

Table 1

SiteLRN/area Recruitment
OxfordSouth Central Area 275
SouthamptonSouth Central Area 277
St GeorgesSENCE133


  The RCPCH is committed to ensuring that all advice to Paediatricians during a Swine Flu pandemic is evidence-based, appropriate and consistent, in order to best serve the interests of children and young people.

  During the recent Swine Flu emergency, the Department of Health issued some helpful guidance for paediatric services. The use of algorithms was particular helpful. However, at the time the College had concerns that the Swine Flu paediatric hospital pathway did not make clear under which circumstances the advice should be followed.

  The College feels it is important that all guidance issued in an emergency is produced with a summary document and that any key information is highlighted, so as not to be missed by health professionals. It is also essential that any guidance issued is consistent with existing best practice. For this reason, the College feels it would be of benefit for the Department of Health to work closely with the College from the outset to produce paediatric guidance in an emergency to ensure consistency with other evidence based guidance and meets the College's standards for endorsement.

Dr Jan Dudley

Clinical Standards Committee Chair, RCPCH

  With thanks to:

  Brian Gennery, Joint RCPCH/NPPG Standing Committee on Medicines member

  Dr William van't Hoff, Joint RCPCH/NPPG Standing Committee on Medicines Chair

  Linda Haines, Head of Science and Research, RCPCH

  Rita Ranmal, Clinical Standards Co-ordinator, RCPCH

  Susan Mitchell, Head of Health Services, RCPCH

  Royal College of Paediatrics and Child Health

14 September 2010

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