Attending

Professor Andrew Hall (Chair)
Dr Richard Roberts
Professor Simon Kroll
Professor Brent Taylor
Professor Keith Cartwright
Mrs Vivienne Parry
Professor Paul Griffiths
Professor Jon Friedland
Professor Alan Emond
Dr Paul Jackson
Dr Syed Ahmed
Dr Anthony Harnden
Dr Yvonne Doyle

Ex-Officio

Professor David Hill - NATHNAC
Dr Stephen Inglis - NIBSC
Professor George Griffin

Observers

Lt Colonel David Ross MoD
Dr Rachel Pudney MoD
Wing Comander Green - MoD
Dr Eibhlin Connolly - Ireland
Dr Darina O'Flanagan (NSDC)- Ireland
Dr Susan Hahne -Netherlands

Invited to attend

Professor Elizabeth Miller - HPA
Dr Mary Ramsay - HPA
Dr Natasha Crowcroft- HPA

Department of Health

Dr David Salisbury (Medical Secretary)
Dr Dorian Kennedy (Admin Secretary)
Mr Daniel Eghan (Minutes)
Mrs Joanna Yarwood
Dr Karen Noakes
Miss Jennifer Lamin
Mr Zoltan Bozoky
Ms Beatrice Wilson
Miss Heather Lambert
Miss June Bristol

Welsh Assembly Government

Dr Mike Simmons
Mr Neil Robins
Mr Keith Cox
Mr Mathew Thomas

DHSS Northern Ireland

Dr Lorraine Doherty

Scottish Executive

Dr Elizabeth Stewart

DTI

Mr Derek Flynn

 

1. ANNOUNCEMENT AND WELCOME

The Chairman welcomed all those present. He introduced Dr Anthony Harnden (University Lecturer and Principal in General Practice, Oxford University and Morland House Surgery) as the GP member.

Apologies have been received from Dr Christopher Verity, Dr Daniel Levy-Bruhl and Dr Mair Powell from the MHRA.

The Chairman also noted that the Appointments Commission are still in the process of appointing a nurse member. Nominations are currently being sought.

The Chairman, on behalf of the Committee and the Secretariat, expressed thanks to Professor Keith Cartwright as his period of appointment was coming to an end. In particular, he was thanked for his contribution on pneumococcal and meningococcal vaccines and it was noted that JCVI had been fortunate to have the input from an expert of such high calibre.

Members were reminded of the need to ensure their declarations of interest were up-to-date, and to declare their interests relevant to each agenda item.

2. MINUTES OF THE LAST MEETING HELD ON WEDNESDAY 15 FEBRUARY 2005

The Committee was invited to comment on the draft minutes. The following changes were suggested:
(i) On page 4 in the second sentence delete "the" before "there";
(ii) and on page 5 under item 7 in the 3rd paragraph replace "1994" with "2003";
With these amendments, the minutes were agreed and would be placed on the JCVI website as final minutes.

3. MATTERS ARISING

The Chairman informed the Committee that he had written to the Minister of State for Public Health (Caroline Flint) on a range of issues including Connecting for Health. He hoped for a positive response in due course.

It had been hoped that data from the Netherlands on BCG uptake rates and how babies are identified on their programme would be available for this meeting. However this had proved much more time-consuming due to the details required than it was first thought, and it is expected that it will be available for the October 2006 meeting of JCVI.

4. Seasonal Influenza Vaccination

Professor Keith Cartwright declared a non-personal non-specific interest in GlaxoSmithKline (GSK) but this did not debar him from taking part in the proceedings. Dr Richard Roberts declared a non-personal non-specific interest in Sanofi but this did not debar him from taking part in the proceedings. Simon Kroll declared a non-personal non-specific interest in Chiron but this did not debar him from taking part in the proceedings. Paul Griffiths declared a non-personal non-specific interest in GSK and Sanofi but this did not debar him from taking part in the proceedings.

The Committee was informed that the Department of Health had received a letter from the UK Vaccine Industry Group, which advised that some difficulties were being experienced in manufacturing this winter's seasonal flu vaccine. It is possible that vaccine deliveries would be delayed and/or there may be fewer doses of the vaccine available.

Due to the possibility of shortages or delays, the Committee was asked for advice on the prioritisation of available supplies of vaccine. Following a detailed discussion which emphasised the need to focus on public health protection, the Committee recommended the following prioritisation if supplies of seasonal flu vaccine should be limited:

(i) All those aged 65 and over, and all those aged 6 months and over in the clinical risk group
(ii) Those in long stay residential care homes
(iii) Carers
(iv) Any other groups recommended for immunisation
(v) Poultry workers

JCVI Influenza subgroup

The subgroup provided advice on two issues: the use of flu vaccine for pregnant women; and for those with neurological conditions. This recommendation will be submitted to Ministers shortly.

It was agreed that pregnant women were at an increased risk of morbidity and mortality from seasonal influenza. It was noted that the most significant risk to the mother and baby is in the later stages of pregnancy. In addition to the benefits to the women themselves the vaccination will benefit the newborn child. The Committee agreed with the advice from the subgroup that influenza vaccination should be routinely offered to pregnant women in their second and third trimester. It was noted that this recommendation was for inactivated flu vaccine, and that vaccines with low reactogenicity profiles would be desirable. It was also noted that thiomersal-free vaccines should be offered where available (in order to be consistent with the wider aim of reducing exposure to mercury). However thiomersal-containing vaccines should be used rather than not providing the vaccine.

The Committee recommended that influenza vaccination should be routinely offered to pregnant women in their second and third trimester. This recommendation will be submitted to Ministers shortly.

In addition, the Committee recognised that attention needed to be given to communicating the benefits to pregnant women and their unborn children, and of any risks.

Neurological disease

JCVI considered advice from the JCVI flu subgroup on extending the definition of neurological risk groups recommended for routine immunisation, following earlier advice that people with Multiple Sclerosis should be offered influenza vaccination.

The Committee recommended that a neurological 'at risk' category be added to the list of groups offered influenza vaccine. This would include Multiple Sclerosis and related conditions (ICD 9 code 340-341), hereditary and degenerative disease of the Central Nervous System (ICD 9 code 330-337) and cerebrovascular disease (ICD code 430-438).

The Committee asked for clarification as to whether the neurological 'at-risk' risk group should be extended to include additional conditions that could equally compromise respiratory function or the handling of respiratory secretions or that could increase the risk for aspiration. Specific conditions mentioned were cerebral palsy and muscular dystrophies.

The Department would carry out further work on the expected benefits and cost effectiveness of the recommendations made by the Committee.

Other business

The Committee also accepted advice from the subgroup that currently there was insufficient scientific evidence to justify adding those suffering from schizophrenia and bi-polar affective disorder to the list of those offered influenza vaccination.

Influenza vaccine for young children

The JCVI flu subgroup briefly updated the Committee on their consideration of the evidence for the universal vaccination of children with inactivated flu vaccine. So far the subgroup had reviewed the work commissioned by the Department to assess the current burden of influenza in England and Wales and to estimate the impact and potential cost effectiveness of introducing a childhood influenza immunisation programme.

The subgroup will review further papers at its forthcoming meeting and present a full discussion at the October 2006 JCVI meeting.

Review of seasonal influenza vaccination programme

The Secretary of State for Health had announced last November a review of the supply and distribution of vaccines for the annual seasonal flu immunisation programme. An update was give by the Department of Health.

The review will proceed in three stages.

• The first stage will be to collect, consider and interpret evidence on the reported vaccine supply shortage that became known in November 2005. Evidence will be gathered from NHS sources and vaccine manufacturers.
• The second stage of the review will be to assess the evidence collected and present findings to relevant DH stakeholders for discussion. The main findings from internal sessions will be summarised and used in the final report. The third and final stage will require the assessors to appraise the evidence and generate options for future supply arrangements. Implications for the Department on its own central contingency supply will be included.

The review will need to develop a series of options for consideration including,

• benefit of maintaining the current method of GP's purchasing their own supplies, with or without new arrangements to minimise any discrepancy between availability and demand;
• further options for switching to central purchase; and
• the benefits and risks of a mixed model depending on the type of primary medical care contract.

Two independent assessors are carrying out the review, with input from the flu and primary care contracting teams.

The findings of the review will be provided to the JCVI flu subgroup and to the main JCVI.

6. PANDEMIC FLU

The Committee was given an oral update on pandemic flu preparation. Of particular interest was the use of pre-pandemic vaccine as a potential strategy to reduce the impact of a flu pandemic.

The Committee was in favour of exploring further the strategy of using pre-pandemic vaccination for significant sections of the population, and asked to be updated on the production issues.

7. SWINE WORKERS AND SWINE FLU

DH presented a paper on swine workers and swine influenza (Myers et al 2006) suggesting that in the United States, occupational exposure to pigs increased workers' risk of swine influenza virus infection, and that this may be a route for the emergence of new human influenza strains.

The Advisory Committee on Dangerous Pathogens (ACDP) had noted at an earlier meeting that the hypothesis that pigs act as the mixing vessel for influenza viruses from which the new pandemic human strain arises is no longer widely held to be correct as there is little evidence that a flu strain dangerous to public health has been produced in this way.

The Committee agreed with ACDP not to vaccinate swine workers with seasonal flu vaccine.

8. COVER DATA

An update was given to the Committee by the HPA on vaccine coverage data. In general, vaccination coverage was stable or slightly increased on the previous quarter. The MMR vaccination uptake is lower than is desirable but continues to increase. Hep B coverage data were encouraging.

It was noted that Wales had achieved a coverage for DTP vaccine of 95%.

Scotland presented the uptake as being high, apart from MMR, and with an upward trend. Scotland had prepared some publicity materials entitled "Never Too Late" designed for children who may not have received MMR vaccine.

Child Health Computing problems in London

The HPA updated the Committee about concerns of the possible impact that child health computing problems may be having on the immunisation programme in some parts of London. The HPA noted that vaccination uptake data for London could not be provided at the moment due to difficulties in IT systems.

The DH were first made aware of problems with the Child Health interim system last autumn. This occurred following the HPA's announcement that, the quarterly COVER stats due for that quarter could not be produced by 10 PCTs in the London area, who were using an Interim Child Health Application (CHIA). This system is supplied by BT.

Actions that have been taken so far were that the DH Immunisation Team has made contact with all of the 10 PCTs affected (at Child Health Team level) in order to collect and compare their experiences with CHIA. The aim of this approach was to engage more effectively with the various bodies involved and to provide support for an appropriate way forward.

A report detailing the findings of the visits was sent by the Immunisation team to those involved in the project. Various meetings were also set up with the CfH CHIA team together with HPA, BT, and SHA representatives.

In addition, two joint external review meetings have been held with Dr David Elliman and Professor Brent Taylor, chaired by Dr David Salisbury together with representatives from the above groups.

The improved joined up working arrangements and approach initially gave a sense that progress was being made and issues with CHIA were being taken forward. Progress on clearing the outstanding immunisation backlogs has been good and CfH advise that all PCT's will have cleared their backlogs before the next COVER quarter is due. There has also been renewed commitment from the SHA and CfH Project team to review and improve communications and engagement with those using the system.

The Committee expressed great concern over the reported problems, and the impact that these could have on vaccination programmes. The Chairman noted that he hoped to discuss some of these issues with the Minister for State.

9. HPV vaccine

Professor Keith Cartwright declared a non-personal non-specific interest in GSK but this did not debar him from taking part in the proceedings. Dr Richard Roberts declared a non-personal non-specific interest in Sanofi but this did not debar him from taking part in the proceedings. Dr Ahmed Syed declared a non-personal non-specific interest in Sanofi and GSK but this did not debar him from taking part in the proceedings. Dr Stephen Inglis declared a non-personal non-specific interest in GSK, Merck and Sanofi but this did not debar him from taking part in the proceedings.

The JCVI HPV subgroup met about a month ago. The sub-group aimed to provide advice to the main JCVI Committee in October 2006. HPV is the cause of cervical cancer and genital warts. Two vaccines are in development which aim to provide protection against the most prevalent strains of HPV virus, and may reduce the rate of cervical cancer by 70%-80%.

There are currently two HPV vaccines in development, by GSK and by Sanofi Pasteur MSD.

The Sanofi Pasteur candidate vaccine is a quadrivalent vaccine which provides protection against HPV types 6, 11, 16 and 18. The GSK candidate vaccine is a bivalent vaccine providing protection against HPV types 16 and 18.

Both products have shown promising result in clinical trials, showing good safety profiles and a high degree of efficacy. Evidence suggests that protection lasts for at least 4 - 5 years after administration, and work is on-going to test how much longer protection might last.

The Committee was grateful for the update, and looked forward to a further meeting of the JCVI HPV sub-group and a more detailed consideration at a future main JCVI meeting.

10. BCG subgroup

Professor Keith Cartwright declared a non-personal non-specific interest in GSK but this did not debar him from taking part in the proceedings. Dr Richard Roberts declared a non-personal non-specific interest in Sanofi but this did not debar him from taking part in the proceedings. Dr Ahmed Syed declared a non-personal non-specific interest in Sanofi and GSK but this did not debar him from taking part in the proceedings. Dr Paul Griffiths declared a non-personal non-specific interest in GSK, and Sanofi but this did not debar him from taking part in the proceedings.

The BCG subgroup met to consider the differences between national policy as outlined in Immunisation Against Infectious Disease (The 'Green book') and forthcoming guidance from the National Institute of Clinical Excellence (NICE) on TB.

One outstanding issue, that had caused some confusion for health professionals was the definition of those who had lived for a prolonged period in a country with an annual incidence of 40 per 100,000 or greater. The definition differs between travel advice, the advice for new entrants and advice for Mantoux testing. In addition members of the committee questioned the evidence for BCG vaccination of those older than 15 years. The Committee agreed that the BCG subgroup should meet again to discuss this issue and whether the cut off should be a 3 month or 1 month stay and that the recommendation should be consistent where possible.

11. HIB

The HPA reported on an assessment of the likely impact of a catch up programme for Hib for children who have been born since the booster campaign of 2003, but who will be above the age of one by the time the routine booster dose is introduced. This is being considered because of the continuing occurrence of cases, albeit in small numbers, in this age group.

Modelling suggests that a catch up programme for Hib, conducted in children being scheduled for the catch up of pneumococcal vaccine, has the potential to prevent up to 113 cases of invasive Hib and 5 deaths. The cost of such a catch up for the whole of the relevant cohort was reported as not being effective based on calculations conducted by the department.

The estimate of the benefit of a catch-up programme for Hib may have been exaggerated since it had been assumed that all invasive cases would be of meningitis, with the associated rates for deaths and sequelae. If the data were adjusted for other causes of invasive disease, such as epiglottitis, then the case for a catch-up campaign becomes less secure

The committee strongly supported minimises the number of cases predicted by the HPA exercise.

12. ROTAVIRUS VACCINE

An oral update was give by DH. Rotavirus is a viral infection that may cause diarrhoea, vomiting, fever and dehydration. A vaccine against rotavirus has recently been licensed in the US.

The Committee wanted to examine the potential use of rotavirus vaccines in the UK, and agreed that a sub-group on the issue is set up.

13. VARICELLA

The Committee recognised that varicella was an area of increasing importance with recent evidence that vaccine prevented shingles in the elderly. However this is a complex area because of the potential impact of chidhood infection on transmission dynamics at older ages. It was agreed that a sub-group should be setup in the near future to consider the issues.

The Committee also noted that questions had arisen as to whether Health Care Workers who had refused varicella vaccination or who were contraindicated to receive varicella vaccine should be allowed to continue to work. The Committee noted that other protective measures could be put in place for these individuals but it was for trusts to decide whether they were happy for these arrangements to be in place.

14. VACCINATION AGAINST PNEUMOCOCCAL INFECTION IN PEOPLE WITH HYDROCEPHALUS

DH presented a paper on Cerebrospinal Fluid Shunts (CSF shunts) following a meeting with the chair of the Infection in Neurosurgery Working Party. The British Society for Antimicrobial Chemotherapy and the Association for Spina Bifida and Hydrocephalus disagree that the placement of a CSF shunt predisposes to pneumococcal meningitis, or to cerebrospinal fluid leak.

The paper explained that there is no evidence of increased risk in these individuals. The committee agreed to remove the section from the Green Book that refers to people with CSF shunts, or those about to receive one as an example of those at risk of pneumococcal meningitis because of CSF leak or surgical breach of the mucous membranes of the upper respiratory tract.

15. COMMUNICATIONS APPROACH TO THE BMA GENERAL PRACTITIONERS COMMITTEE

DH gave an oral update and explained that progress had been made on vaccination issues with the BMA. NHS employers have worked on a mandate on the introduction of the pneumococcal vaccine.

16. Any other business

Human Tetanus Immunoglobulin
The Committee was informed of a short-term shortage in human tetanus immunoglobulin caused by production problems. Reserve supplies of human tetanus immunoglobulin are available for the treatment of those people with tetanus. DH had contacted NHS contacts providing information on the situation and advice of the use of combined tetanus, low dose diphtheria and polio vaccine (Revaxis) in the absence tetanus immunoglobulin.

Manufacturers have confirmed that sufficient supplies to treat tetanus prone wounds, where clinically indicated, will be available by mid July 2006.

Tetanus vaccination
It was suggested that current tetanus immunisation policy may need to be revised as it is now more likely that older people would have received 5 doses of tetanus vaccine earlier in life. The Committee may wish to consider whether a further dose of tetanus vaccine should be offered at the time of tetanus prone injury. The Committee agreed to discuss this via correspondence.

Asplenia or splenic dysfunction
The Committee agreed that as there was a lack of evidence that conjugate vaccines produce a long term protective response, individuals with splenic dysfunction receiving Hib, MenC and PCV vaccination should be offered further doses of vaccines and that:

• Unimmunised individuals, over 1 year of age should receive two doses of conjugate vaccine, 2 months apart
• Vaccinated individuals who develop splenic dysfunction after the age of two years should be offered an additional dose of the conjugate vaccines following diagnosis

16. ARTICLES FOR INFORMATION

The committee's attention was drawn to the following papers for information.

• Vaccine damage update
• FOI (released requests)
• Foresight report (Office of Science and Innovation)

DATES OF FUTURE MEETINGS

• 18 October 2006
• 14 February 2007
• 20 June 2007
• 17 October 2007
  

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