Attending

Professor Andrew Hall (Chair)
Dr Richard Roberts
Professor Simon Kroll
Professor Brent Taylor
Professor Paul Griffiths
Professor Jon Friedland
Professor Alan Emond
Dr Paul Jackson
Dr Syed Ahmed
Dr Anthony Harnden

Ex-Officio

Professor David Hill - NATHNAC
Dr Stephen Inglis - NIBSC
Professor George Griffin
Dr Claire Cameron - HPS
Professor Mike Richards - Head of Cancer Programme

Observers

Lt Colonel David Ross MoD
Dr Rachel Pudney MoD
Wing Commander Green - MoD
Dr Eibhlin Connolly - Ireland
Dr Darina O'Flanagan (NSDC)- Ireland
Dr Hester De Melker -Netherlands
Dr Chistiane Meyer - Germany
Dr Jeff Koplan-former CDC Director

Invited to attend

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

Department of Health

Dr David Salisbury (Medical Secretary)
Dr Karen Noakes (Minutes)
Mr Zoltan Bozoky
Miss Heather Lambert
Miss Jennifer Lamin
Mrs Josie Senior-St.Juste
Miss June Bristol
Miss Veda Maharaj

Welsh Assembly Government

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

DHSS Northern Ireland Scottish Executive

Dr Lorraine Doherty Dr Elizabeth Stewart

1. ANNOUNCEMENT AND WELCOME

The Chairman welcomed all those present with a special welcome to a number of international observers who were attending this meeting for the first time: Dr Christine Myer, Director of Immunisation from Germany, Dr Hester De Mekler from the Netherlands, Director for the Centre for Infectious Disease Epidemiology (CIE),National Institute for Public Health and the Environment Netherlands and Dr Jeff Koplan, former director of CDC and also former executive secretary US Advisory Committee on Immunisation Practice.

Apologies were received from Dr Mair Powell from the MHRA.

The Committee was informed that a microbiologist had successfully been appointed to replace Professor Keith Cartwright. Dr Ray Borrow, Head of the Health Protection Agency's Meningococcal Reference Unit in Manchester will hopefully take up his position at the next meeting. Interviews were also held to appoint a nurse member. Due to the very high quality of candidates, it has been agreed, with the approval of Ministers, to appoint two members, Anne McCowan and Pauline McDonald.

The Committee was informed that Dr Yvonne Doyle has resigned from the Committee because she was recently appointed as Regional Director of Public Health for the Southwest Regional SHA. The Secretariat will advertise for an NHS public health representative.

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 21 June 2006

The Committee was invited to comment on the draft minutes. The following changes were suggested:

(i) On page 8, delete the 3rd paragraph and replace with " However the committee noted that a dose of Hib could be given to those children being included in the pneumococcal catch up campaign. If in addition a pre-school booster dose was given this would ensure that the vast majority of these children would receive a booster dose at some point. The committee strongly supported this approach to minimise the number of cases predicted by the HPA exercise."

(ii) On page 5, under item 8 in the 1st paragraph insert 'Hep B coverage data in London were encouraging'.

(iii) Dr Martin Donaghy from HPS provided Scottish representation at this meeting and not Dr Elizabeth Stewart as minuted, who had sent her apologies.
With these amendments, the minutes were agreed and would be placed on the JCVI website as final minutes.

3. MATTERS ARISING

Child Health computing problems in London

The Chair informed the committee that he had met with Ministers to discuss concerns relating to NHS Connecting for Health and continued child health computing problems. There were still 10 PCTs in London having problems scheduling immunisation appointments and in providing coverage data. There were backlogs of data, spanning over a year, that will need to be checked to ensure that these children, who appear not to have been immunised, have actually received their immunisations. A group has been set up, which includes representatives from Connecting for Health and DH officials, to look at the current problems and to draw up an Options Appraisal to look at the various software options available.

The Minister of State for Public Health and the Minister of State for Delivery and Reform met with representatives from Connecting for Health and DH officials on 17th October to discuss two issues: 1) Immunisation; 2) Communicable disease reporting through pathology departments. While there was some disagreement as to whether the problems were managerial, software or operational, all agreed that a solution needed to be found quickly and that once agreed, PCTs should come in line with the recommendations as quickly as possible. Ministers were clear that the solution must meet the needs of immunisation services. Ministers also advised, following lessons learnt from CHIA, that the solution must not be short-sighted and must meet future functional requirements. It was noted that a new system, RIO, was currently being put in place as an interim measure but that the required functionality would not be available for another 3 years.

BCG

The BCG subgroup had agreed via correspondence to standardise the advice given for the definition of a 'prolonged period' for risk groups recommended for vaccination.

For:

1) new entrants under 16 years of age who were born in or who lived for a prolonged period in a country with an annual TB incidence of 40/100,000 or greater; or

2) those under 35 years of age who were going to live or work with local people for a prolonged period in a country where the annual incidence of TB is 40/100,000 or greater.

The definition of 'prolonged period' would be at least 3 months. BCG vaccination would not be recommended for anyone 16 years or older staying in the UK, unless they were at a continued, increased risk. Those at increased risk are:

• Healthcare workers who have contacts with patients or clinical materials
• Laboratory staff who have contact with patients, clinical materials or derived isolates
• Veterinary staff and staff such as abattoir workers who handle animal species known to be susceptible to TB
• Prison staff working directly with prisoners
• Staff of care homes for the elderly
• Staff of hostels for homeless people and facilities accommodating refugees and asylum seekers.

Hib

There remains a small cohort of children who had missed out on the Hib catch-up campaign in 2003 and who would now be too old to receive a routine Hib-MenC booster at 12 months. Analysis of a catch-up programme for this cohort suggested that this was not cost-effective. Although this cohort of children has fallen outside the current immunisation policy to receive a Hib booster, Treasury demands that each new intervention must be shown to be cost effective on its own merit. The Committee continued to support the need to look at the cost-effectiveness of adding the Hib component to the pre-school booster over a time limited period. An economic analysis from the Department would be circulated to members.

New JCVI subgroups

The JCVI had proposed that subgroups be set up to look at rotavirus vaccines and varicella zoster vaccines. This had not yet been possible they but would be set up shortly.

4. INFLUENZA

Flu vaccination for children

The minutes of the influenza subgroup for 6 September 2006 were reviewed. This meeting had looked at the issue of childhood vaccination. At the present time the subgroup did not recommend the vaccination of young children based on two concerns.

(i) At least one of the subunit influenza vaccines currently available shows poor immunogenicity in young children.
(ii) There is an absence of published clinical trial data showing vaccine efficacy in children under 6 years of age.

The subgroup noted that the European Medicines Agency (EMEA) has a Committee looking at this issue. The Committee for Medicinal Products for Human Use (CHMP) is conducting a review of published and unpublished evidence on the immunogenicity of influenza vaccines in children. The JCVI Secretariat will liaise with this Committee on findings.

Members noted that if the modelling was correct (based on an assumption that the vaccine was efficacious in young children), almost all influenza A could be reduced across all ages. Concern was raised that the mixing patterns used in the model were based on data from 15 years ago and that lifestyles and hence mixing patterns between age groups are different now. The introduction of paediatric influenza vaccination programmes in the US and Canada would mean that more recent data will start to accrue that will refine the model. It was noted that the US and Canadian guidelines make reference to the lack of evidence that the vaccine is effective in young children as part of their recommendations.

Review of the seasonal influenza programme 2006/07

The Department were alerted on the 12 June that manufacturers were encountering delays in their production of seasonal flu vaccine, due to the low yield of one of the recommended strains (H3N2) for inclusion in the vaccine. This could have resulted in either a low yield and thus fewer vaccines for the year or a delay in production but with the final quantity of vaccines as projected. Following this advice a CMO letter was issued on the 29 June, earlier than in previous years, to alert the profession to this news. This was a Europe wide situation. In the US, where a change of strain does not necessitate submission of further clinical data to regulators, a change of strain was made for inclusion in the flu vaccine. In September, the Department was informed that the overall quantity of vaccines would not be affected but that there would be a delay of several weeks with some vaccine deliveries continuing into December. As far as the Department knows, manufacturers are keeping to these projections. A second letter was sent out to the profession in September from the Director of Immunisation. The Department will continue to monitor vaccine coverage through the sentinel surveillance schemes and on a national basis each month.

Flu vaccination and poultry workers

Despite a bid being placed, the Department does not have a contingency stock of seasonal flu vaccine for 2006/07. The JCVI recommend that in the case of H5N1 avian influenza outbreaks occurring in the UK, poultry workers should be recommended seasonal influenza vaccination. There are 75,000 poultry workers in England but no central register so it would be difficult to vaccinate this cohort in a GP practice setting with seasonal flu vaccine that is available within the NHS. However, poultry workers could be identified via their employers and vaccinated by occupational health departments. A number of Health Protection Units have retained stocks of last year's flu vaccine which is similar in composition to the 2006/07 vaccine. The committee were asked for their advice on whether the 2005/06 flu vaccine could be given to poultry workers on the basis that:

(i) The poultry worker is at risk of exposure to H5N1

(ii) The 2005/06 flu vaccine has been tested and the shelf life of the vaccine has been extended beyond one year.

(iii) There is no current 2006/07 vaccine available

The Committee concluded that:

The chances of reassortment between avian and human influenza viruses in the UK is remote compared to the chances of reassortment occurring in other parts of the world where H5N1 is more common.

Based on advice from colleagues from NIMH and NIBSC, that the strains in the two seasonal vaccines are similar, vaccination with the 2005/06 flu vaccine to protect against the human strains circulating in the 2006/07 season would be better than no vaccination at all.

In addition, anti N1 antibodies from seasonal influenza vaccines have been shown, in animal studies, to provide some protection against H5N1.

The Committee recommended, as an interim measure that if there was a risk that poultry workers may become infected with H5N1 flu virus, then in order to prevent reassortment with a human strain, supplies of seasonal flu vaccine should be diverted from the NHS if possible. If there are not supplies left, the vaccination with the 2005/06 flu vaccine would be better than no vaccination.

The Department would explore options for recovering excess seasonal flu vaccines from GP practices.

It was noted that in Ireland, poultry workers were asked to register and obtain flu vaccination from their GP practice. In Northern Ireland there is a poultry worker vaccination programme. In Germany and the US, poultry workers were included as part of the routine flu vaccination programme.

Review of the Arrangements for the seasonal influenza programme in England

Interim findings of the independent review of the 2005/06 influenza programme were shared with the Committee. Two independent reviewers were asked to look at the supply and procurement of influenza vaccine. They examined the available evidence base, looking at payment data, the Quality and Outcomes Framework (QOF), vaccine uptake and supply data. Based on an initial sift, a number of interviews were carried out with key internal and external stakeholders in the context of last year's influenza programme; the reviewers will consider how improvements could be made to the seasonal influenza vaccination programme.

Members noted the findings and commented that this review focused on the downstream end of the influenza programme but that the front end (i.e. vaccine production) was important too. Vaccine production is fraught with difficulties; for instance this year the National Institute for Biological Standards and Control (NIBSC) had to provide new reagents for the US market due to the change in strain as well as maintaining stocks of reagents for European manufacturers. In future years, as a result of recent funding from the Department, NIBSC will provide an additional service in producing flu strains for use, by manufacturers, in vaccine production.In future years, as a result of expected additional capital investment from the Department and contributory funding from a consortium of manufacturers, NIBSC will provide additional support for production of new virus strains for vaccine production.

5. PANDEMIC INFLUENZA

An update on pandemic flu vaccines was provided. Sleeping contracts for pandemic flu vaccine, whereby countries reserve the capacity for a manufacturer to produce flu vaccine in the event of a pandemic, have gone out to tender. There are a number of interested parties and advice will be provided to Ministers shortly. 3.5 million vaccine doses of H5N1 vaccine are being delivered in 2 consignments. One consignment of H5N1 vaccine is cell culture based with an alum adjuvant. The other is grown on eggs but uses the newly developed MF59 adjuvant. Deliveries of H5N1 vaccine will be completed by the end of the year.

The Department is also considering pre-pandemic flu vaccines. Modelling studies have indicated that even a poorly matched flu vaccine (such as a pre pandemic vaccine) may downsize a pandemic to seasonal flu activity. Discussions are underway with manufacturers and the chair of JCVI will be invited to join these discussions and consider the available evidence with respect to cross protection. The Chief Scientist will also join these discussions.

It was noted that there is already some human data on the immunogenicity of these vaccines. There is a lack of safety data thus any further trials would still need to be in volunteers and could not immediately be given to a particular risk group such as poultry workers.

Those invited to attend from other countries noted that similar discussions were taking place in their Departments.

The JCVI Committee stated that they continued to agree to the use of pre-pandemic vaccines as stated at the meeting in June of this year.

6. CHILDHOOD PROGRAMME UPDATE

The CMO letter announcing the new childhood immunisation programme was provided for information. The Department noted that the programme was running smoothly and that there had been few queries regarding supply issues.

7. ANNUAL COVER REPORT

The annual COVER report was presented to the Committee. It was noted that this collection was complex and that over 9,000 data points were produced each quarter.

Vaccine coverage is high in Scotland, Wales and Northern Ireland. It is in England, particularly London where coverage is lower. Vaccine coverage for pre-school boosters is lower than for the primary immunisations. This may be a data quality problem but is also likely to be an issue of how vaccines are delivered to older children. Data is not collected on the school leaving dose. Consideration needs to be made as to how vaccine coverage would be monitored if additional vaccines were recommended for older children.

MMR vaccine coverage by 24 months has risen in 2005/06 and is estimated to be 84.9% for the UK, a 3% increase compared to 2004/05. Sentinel surveillance at 16 months indicated that the trend is likely to continue.

There have been problems in providing neonatal Hepatitis B coverage data with many Primary Care Organisations (PCOs) providing poor or no coverage data.

Northern Ireland, Scotland and Wales noted that overall vaccination rates were stable and also noted an upward trend in MMR coverage.

The Committee recommended that the COVER group investigate whether the school leaving dose could be added to the collection.

8. IMMUNISATION WEB PROGRAMME GROUP

Over the last 6 months, work for the immunisation web programme group has mostly centred around pandemic planning and enhancements to the web portal. In addition the Pneumococcal vaccination data collection was completed successfully by the HPA in July 2006, 87% of practices provided returns through the DH web platform, approximately a third of returns were received through automatic uploads to the site. This is the highest ever response to the pneumococcal survey.

Work is also underway to assess the requirements for a national Pandemic call centre. Work on the Leaflet, COVER and Bar Code projects are also now progressing as funds have been released for this work.

9. ARTICLES FOR INFORMATION

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

• Longer Needles for Infant Immunization may cause fewer local reactions, Medscape Medical News 2006

The findings of the paper were already covered in the next edition of the Green book.

• Report of the European Academies Science Advisory Council (EASAC) on Vaccines: Innovation and Human Health, The Royal Society 2006

The committee commented that this report underplays the regulatory roles already carried out in Europe. The emphasis should be to strengthen what already exists rather than start up new organisations. There is already a network of organisations in Europe, which play a comparable role to the FDA. The Committee agreed to accept the report but for the Chair to write to the authors of the paper highlighting this issue.

• Vaccine Damage Payment Scheme

The report was noted by the Committee.

• No evidence of persisting measles virus in peripheral blood mononuclear cells from children with autism spectrum disorder. Yasmin D'Souza; Eric Fombonne and Brian J Ward Pediatrics 118:1664-1675 2006

The results from this study were recently presented at an international conference on autism and have now been published. One of the co-authors of the paper had in the past reported unpublished data that supported the presence of measles virus RNA in the tissues of autistic children. The findings now came to the conclusion that this was not the case. The research group took the same methodology as the research groups from Dublin and Japan who had reported the presence of measles virus in autistic children. They replicated the study and found the same positive results. However they looked at these positive signals in depth and with further analysis and more specialist PCR tests and found the results to be false positives. The Department had asked three independent experts to provide critiques of this research. The Committee's views were obtained by correspondence: the study reinforced previous statements that there was no evidence that MMR played a causal part in autism.

10. HPV VACCINES

The minutes of the HPV subgroup were reported. The subgroup was unable to put forward recommendations to the main JCVI at this time. The subgroup in general favoured vaccination of girls at the age of 11 or 12 years with HPV vaccine. However, cost effectiveness in the UK setting has not yet been determined and this information will be essential in formulating policy and would be needed before a recommendation could be made by the main JCVI Committee.

The results of the modelling did not support the vaccination of boys since the benefit from the additional herd immunity in the prevention of additional cervical cancer cases was unlikely to justify the cost. However the likely impact of the vaccine on genital warts if a quadrivalent vaccine were to be chosen remained to be investigated. There may also be concerns about exclusion of boys from vaccination from the male gay community who are at risk from anal cancer resulting from HPV16/18 infection.

The choice of vaccine, assuming two were licensed, was dependent on a number of issues

(i) Is there greater cross-reactive protection against non-vaccine HPV types for one vaccine than the other?

(ii) Is there any evidence of a difference in duration of immunity/protection between the vaccines?

(iii) Is there a possibility that one company might commit to producing vaccine with multiple types if it was successful in securing the UK contract?

The subgroup advised that there was insufficient information to decide on whether a catch-up campaign should be conducted at the time of introduction and what age range this might cover. Additional information was required on age specific infection rates by single years of age from 11-20 years. This information was being collected by the Health Protection Agency and would be available around January 2007. Serological samples from the Preston collection were being tested for the four HPV types contained in the vaccines. This information would then be used in both the Imperial College and HPA models. A cost effectiveness analysis should take into account:

(i) Whether or not the vaccine protects against genital warts;

(ii) Whether booster doses are needed later in life;

(iii) Whether or not a catch-up campaign is conducted at the time of the programme to include 11-16 year olds, 11-18 years olds or 11-25 year olds.

In parallel with the cohort models already being developed by the HPA and Imperial College, an individual model was being developed which would allow additional serotypes to be fitted into the model and for the complexity of the screening programme with the addition of HPV testing.

Professor Mike Richards, Head of the Cancer Programme noted the importance of looking at the impact HPV vaccination would have on the screening programme. As well as including the screening programme in cost effectiveness studies, an important communication message was to ensure that women appreciated the continued importance of attending for screening in a post vaccination era.

The Committee noted that it was important to maintain links with countries who have already introduced HPV vaccine in order to detect any implementation issues. They also recommended that religious groups and homosexual groups should be consulted for their views on these issues.

The Health Protection Agency planned to do both prospective and retrospective serological testing in groups such as homosexuals. The Committee also noted that if HPV vaccination was introduced, it would be important to continue typing cancers to look at vaccine efficacy and to monitor where there has been type replacement.

11. HEPATITIS B VACCINE

A paper was presented that looked at options for a targeted approach to the vaccination of infants at an increased risk from Hepatitis B. Three options were presented:

(i) the TB approach

It has been suggested that PCOs with higher risks of TB transmission are also likely to have higher risks for hepatitis B transmission and that a simple approach would be to offer immunisation against hepatitis to all babies born in the 26 PCTs already identified for universal BCG immunisation.

(ii) the antenatal approach

In this approach, immunisation would be offered to all infants born in PCOs with a higher local prevalence of hepatitis B. Antenatal screening for HBsAg is the only readily available source of local hepatitis B prevalence data.

(iii) the Dutch approach

In March 2003, the National Vaccination programme in the Netherlands was extended to include vaccination for children of families in which one or both parents come from countries where hepatitis B is common.

The representative for the Netherlands Health Department reported that the system was working well and there was high vaccination coverage. The selective programme appeared to be acceptable to the public. Vaccine coverage is currently available at Municipal level and next year will be available at individual level so that vaccine uptake in specialist groups can be measured. A cost effectiveness analysis of the programme measured against universal vaccination will be available at the end of the year.

The three options were discussed.

It was recognised that the PCO geographical area of birth and of residence is different in some cases. For example, for Eastern Leicester PCT, there are 9359 births annually with only 2758 of these resident within that area. This could dilute the "expected" higher antenatal hepatitis B prevalence among residents living in Eastern Leicester. If the "TB approach" was used, some PCTs such as Greenwich, Croydon and Lewisham would not recommend universal hepatitis vaccination although they have a high antenatal prevalence rate.

It was noted that the antenatal data was obtained by provider units and based on only 6 months data. The number of units with antenatal prevalence rates above any given threshold are likely to rise when we have more complete data. Slough and Ascot have the same provider but are likely to have very different populations in terms of risk from hepatitis B. The recent PCT mergers now mean that as each PCT covers a wider area, there may be greater variability of areas of high and low prevalence within a PCT.

Of the 613,028 live births registered in England in 2005, 21% were to mothers born outside the UK. Excluding mothers who were born in the Irish Republic, Australia, Canada, New Zealand, the USA and European Union, around 16% of these births would likely be candidates for immunisation if the Dutch approach was used. In addition, of births to mothers born in the UK, around 4.2% had fathers who were born in the New Commonwealth, non EU countries and the rest of the world (making the same exclusions as above).

Based on a small study looking at the incidence of hepatitis B in ethnic minority children born to UK and non UK born parents, the Committee considered that it would be sufficient to recommend vaccination for those infants whose parents (and not their grandparents) came from a country where hepatitis B is common. There is no current evidence to suggest that those whose grandparents came from a country where hepatitis B is common but whose parents were born in the UK are at increased risk.

With each of these options there are issues around providing information to the NHS on countries of increased prevalence, to help ascertain which children would be eligible for immunisation and methods of identifying individual infants for immunisation based on their parentage.

The Committee favoured the "Dutch approach" as opposed to a policy that targets by area. It could prove difficult to satisfactorily implement a policy targeted by area at a time when PCTs are undergoing restructuring. In addition the "Dutch approach" has been tried and tested, although there were some concerns as to whether children for whom immunisation was recommended could be as easily identified as in Holland. The Committee noted that selective programmes can be difficult to implement. It felt that in PCTs, where a majority of the population would be recommended for hepatitis B vaccination (such as in London and some other metropolitan areas), it would be easier to recommend a universal policy The Committee recommended that a small group be convened to discuss how to define PCTs that would be recommended to carry out a universal vaccination policy. This could be based on ethnicity of the population and/or antenatal prevalence. The group should report to JCVI at its next meeting.

12. ANY OTHER BUSINESS

The committee noted that any changes to the risk groups recommended flu vaccination should be made early to allow providers the time to order sufficient flu vaccine supplies. It was noted that the Department was still looking at the cost benefits associated with recommending flu vaccination for pregnant women and individuals with neurological disease.

Tetanus vaccination policy and whether a 5-dose schedule was sufficient was raised as an item for discussion. The Secretariat noted that a discussion paper detailing all available evidence would have to be provided at a future meeting.

13. DATES OF FUTURE MEETINGS

• 14 February 2007 - confirmed
• 20 June 2007 - confirmed
• 17 October 2007 - confirmed

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