1. ANNOUNCEMENT AND WELCOME

The Chairman welcomed Professor Anne Greenough who was attending the Committee as a guest. She specialises in Child Health at King's College and has been Chair to the JCVI RSV subgroup.

Apologies have been received from Prof Keith Cartwright, Anika Ambler, Natasha Crowcroft, Dr Christopher Verity, Dr Jane Leese and Dr Mair Powell. In addition, John Edmunds will attend the morning session only.

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

2. MINUTES OF THE LAST MEETING HELD ON WEDNESDAY 22 FEBRUARY 2005

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

(i) Clarify typing errors in items 5, 7 (change to SHA's) and 11 (explain metal failures).

With these amendments, the minutes were agreed and would be placed on the JCVI website as final minutes.

3. MATTERS ARISING

There were no substantive matters arising that were not covered elsewhere on the Agenda.

4. PANDEMIC FLU

The Committee was brought up-to-date on the work of the Department, and cross-Government on pandemic influenza.

The revised UK Influenza Pandemic Contingency Plan was published in March this year. Comments have been invited on the document, and it is hoped that a revised Plan would be published in the Autumn. It was also noted that the Department was purchasing a significant stockpile of antiviral drugs to treat those ill with pandemic flu.

DH officials had held meetings with all manufacturers who supply seasonal influenza vaccines to the UK in order to learn of their planning for pandemic influenza vaccine production. DH plan to continue to maintain this dialogue. The Department is currently considering pandemic influenza vaccine strategies. The Department explained that it had placed an advert for some (2 - 3 million doses) of H5N1 vaccine that could be used for research purposes, and to offer to NHS staff if necessary.

DH is also working with its G7 colleagues, WHO and the EU on pandemic preparedness. The UK's level of pandemic influenza preparedness is well advanced compared to many other countries.

The Committee noted that the MRC has indicated that it wants to support R&D on pandemic influenza.

The Committee agreed that, due to the threat that pandemic flu poses, the Committee should devote a significant amount of its next meeting to discuss pandemic flu vaccines and related issues.

In light of the current risk assessment of pandemic flu occurring, as noted above endorsed the DH decision to purchase supplies of H5N1 vaccine.

SEASONAL INFLUENZA CAMPAIGN

Surveillance data showed that the uptake of the seasonal flu vaccine in those aged 65 years and over increased by 0.4% last winter. This increase though small is statistically significant and it occurred despite one of the manufacturers being unable to supply the UK market.

The JCVI influenza subgroup met in April and recommended that people with chronic liver disease; and carers, should be added to the list of risk groups who were recommended to receive seasonal flu vaccine. The Department of Health were planning to send out a CMO letter for the national seasonal influenza campaign around July/August time.

It was noted that the JCVI Influenza sub-group was also considering the evidence to support offering flu vaccine to pregnant women. This matter would be on their agenda for the JCVI influenza sub-group scheduled for September.

The Committee agreed to add chronic liver disease, and carers, to the list of people who should be offered seasonal flu vaccine.

5. GREEN BOOK

The Committee was reminded of the Department's aim to publish the revised text "Immunisation against Infectious Diseases" (also known as 'The Green book') this year. Currently the draft version is being checked for consistency and the remaining chapters including that on "BCG", which will be sent to members for comments shortly.

The Committee approved the progress of the Green book chapters.

6. BCG UPDATE

The JCVI BCG subgroup met on 7 April to discuss a number of issues (detailed below) regarding BCG policy, and the Committee discussed their recommendations.

The BCG subgroup proposed a number of changes to BCG policy in the UK. The key recommendations are:

1. the BCG schools programme should cease at the end of the current school year. This was because TB now occurs in clearly defined risk groups rather than across the whole population;
2. the targeted neonatal BCG vaccination programme- based on individual and geographical risk factors - should be enhanced;
3. children up to 12 months of age (subsequently, amended to under 6 years of aged do not require a tuberculin skin test prior to BCG vaccine), (this point will still need to go the next meeting in October 2005)

The BCG subgroup next meets on 14 July 2005. It was noted that all efforts were being made to ensure the work of JCVI and NICE were continuing in step.

The Committee welcomed the work of the BCG subgroup and agreed with the proposals.

7. RSV (Respiratory Syncytial Virus)

A non-specific interest was declared by Dr Elizabeth Stewart.

Following on from the discussions on this topic at the previous meeting of JCVI, further information and clarification was sought from the JCVI RSV subgroup. Professor Anne Greenough, Chair of the JCVI RSV subgroup, introduced the item and the conclusions of the subgroup on the use the of palivizumab to treat RSV. The Committee were asked to consider the recommendations made by the sub-group.

It is highly unlikely that a randomised placebo controlled trials of RSV prophylaxis funded by commercial companies will be carried out as palivizumab is already widely used by some countries for example the United States. It is also extremely unlikely, even if such a study was funded by alternative sources, that sufficient infants would be recruited as many countries give prophylaxis routinely to many of the high risk groups.

Professor Neil McIntosh had previously drawn attention to an observational report of increased mortality following use of Palivizumab (Thomas J. Moore, Sheila R. Weiss, Carol J. Blaisdell. Reported Fatal and Serious Adverse Events Associated with Palivizumab, Late Breaker Platform Session. Pediatric Academic Societies' Annual Meeting, 2002). There was, however, no comparison with appropriate controls and the randomised trial (n=1500) showed no excess in mortality.

Since the subgroup had met in 2002, new data has come available on the effect of RSV hospitalisation on prematurely born infants with chronic lung disease. It had now been demonstrated by following these children up to 5 years of age, that RSV infection in these infants resulted in long-term respiratory problems later in life.
The subgroup recommended that RSV prophylaxis should be given to all children under 2 years who had chronic lung disease with oxygen dependency. This replaced the previous recommendation that babies with chronic lung disease and who were oxygen dependent at home should be prophylaxed.

The number of babies who would need prophylaxis is about 0.3% of births which is approximately 2,000 per year. Long term follow up of these children is recommended to assess if this use will be cost effective.
A number of studies have shown that infants with pulmonary hypertension are at a greater risk from RSV infection. Data on the prophylaxis of this group of children with palivizumab was limited. With the available information, the sub-group recommended that infants less than 6 months of age who have left to right shunt haemodynamically significant congenital heart disease and/or pulmonary hypertension.

It was noted that these recommendations would expand the use of the product in the NHS.

The Committee was advised by the RSV subgroup that the following children should be recommended for palivizumab prophylaxis;

1. Children under 2 years of age with chronic lung disease, on home oxygen or who have had prolonged use of oxygen.
2. Infants less than 6 months of age who have left to right shunt haemodynamically significant congenital heart disease and/or pulmonary hypertension.
3. Children under 2 years of age with severe congenital immuno-deficiency.

The Committee accepted the recommendations of the subgroup, with the definition of chronic lung disease as oxygen dependency for at least 28 days from birth.

8. HEPATITIS B REPORT

The Committee considered advice in the Report provided by the JCVI subgroup on hepatitis B. The Committee was grateful to the sub-group for its work, and noted that the report gathered together the available evidence very well.

The Committee considered the current selective Hep B infant programme, and agreed that efforts could be made to enhance its implementation.

There was further potential for improving uptake of antenatal screening, and for ensuring that babies born to infected mothers completed the full course of Hep B vaccine. The Committee also noted the evidence from modelling studies that offering Hep B vaccine to the prison population may contribute significantly to controlling hepatitis B in the population. It was also suggested that more emphasis was needed on the importance of immunising people travelling abroad, particularly young children visiting relatives in high and intermediate endemicity countries.

The Committee requested consideration be given to the use of Hep B vaccine in areas where the disease is more prevalent. A paper on methods of enhancing the hepatitis B targeted programme was requested and will be presented at the next JCVI meeting.

9. VARICELLA

Recent data based on modelling studies were discussed, which suggested an increased incidence of varicella in adults over time if there was an infant vaccination programme. The findings implied benefits for herd immunity from natural infection against herpes zoster in adults.

In older adults it was noted that vaccination of this age group led to a reduction in the incidence of zoster.

The Committee considered that the available modelling studies required amplification and confirmation particularly where adult disease data were concerned.

10. PNEUMOCOCCAL PROGRAMME UPDATE

An oral update was given explaining that this pneumococcal immunisation programme was introduced in August 2003. In England, the programme was introduced in 3 phases. From August 2003, pneumococcal polysaccharide vaccine was offered to all people aged 80 years and over. In April 2004 the vaccine was offered to all those 75 years and over and from April 2005 to all those 65 years and over.

As part of the enhanced surveillance scheme to support this programme, vaccine uptake data is being collected annually using the web based collection system. Data has also been collected on the number of people immunised prior to the immunisation programme (who may have been offered the vaccine because they were in a medical risk group or whose GP practice may have implemented an age based policy).

Based on data captured so far (deadline for this data collection is the end of July 2005) vaccine uptake for those aged 75-79 years was 30.7% for the period 1 April 2004 to 31 March 2005. Data collected last year showed that a further 33.73% people in this age group had been immunised prior to 1 April 2004. The total number of people immunised so far is therefore approximately 64%. 20% of people 80 years and over were immunised between 1 April 2004 to 31 March 2005. Data collected previously showed that 26% people were immunised in the first year of the programme and that 36% has been immunised previously. The total number of people 80 years and over immunised so far is therefore approximately 82%. This data is provisional.

The Committee agreed the ongoing need for good quality surveillance to monitor the impact of the programme.

An HPA paper describing surveillance of the impact of pneumococcal conjugate (PNC-7) programme for children in England and Wales.

The Committee commended the paper as a valuable way of enhancing the data.

11. VACCINE TRACKING PROGRAMME (VTP)

Department of Health presented the vaccine tracking programme. So far 295 PCT’s out of 303 have used the VTP web portal and nearly 45 % of GP practices have logged on. The portal was set up to collect and manage aggregate data from the annual Flu and Pneumococcal immunisation returns.

Other projects being managed as part of the Programme include:

• a service for PCTs/CHIS to provide leaflets to parents and guardians, so far 25 PCT’have taken up this service.
• project to manage children's immunisation information for COVER. The first stage, to replicate HPA's current functionality and incorporate it within the Vaccine Tracking Programme, was completed in April. Currently this is awaiting review and testing by HPA.
• Initial analysis of the current processes for the Barcoding project has started,
• the team are also looking at options to create a surveillance tool for pandemic flu based on the web portal, already in place. The aim being to enable fast (real time) and accurate reporting as well as a management tool to facilitate appropriate analysis and management of the data submissions.

Regular communications have been set up at a policy and development level with NHS Connecting For Health to ensure integrated approach with the two sets of work.

The Committee was pleased with progress of the vaccine tracking programme.

12. HORIZON SCANNING

The Department of Health presented a paper reviewing the current status of the development of vaccines against Rotavirus, Human papillomavirus, Group B streptococcus and Meningococcal B diseases.

The Committee found the paper very useful and agreed that further papers updating them on other vaccines (such as Epstein-Barr Virus and Cytomegalovirus) would be valuable, and should be presented in the same format. It was suggested that attaching copies of key review papers on each vaccine would be very useful.

A copy of a review paper by Paul Heath and Robert Feldman on Group B streptococcus immunisation was provided for the committee at the request of the National Screening Committee (NSC) for Group B streptococcal (GBS) disease. This paper was provided firstly, to update JCVI on the progress of the development of a GBS vaccine and secondly, to make them aware of the legal and regulatory issues surrounding licensing of a GBS vaccine in the UK.

The Committee noted the paper, in particular, the key regulatory and legal issues surrounding the licensing of a GBS vaccine. The committee felt that the NSC for GBS should continue pushing forward with the aspects relating to screening. The committee appreciated the importance of the legal and regulatory issues which needed to be overcome.

13. MMR

Department of Health gave an oral update on MMR London catch up campaign. The final data is not complete but a substantial number of children have been immunised further details should be available by the October meeting.

The current position of mumps is about 30,000 cases with about 2,000 cases per week. The estimated increase on coverage is by 3% which suggest the amount of measles vaccine used is more than mumps.

The Committee noted the update on MMR and on single antigens.

14. FREEDOM OF INFORMATION

A proposal was made by the Department of Health (DH) secretariat to the Committee suggesting that declaration of interests for existing members be narrowed down to 3 years, where previously there was no time limit.

The Committee felt that it should be in line with the Committee on Safety of Medicines (CSM), whose policy was thought to be 1 year. The DH secretariat will confirm this with CSM for the next meeting. The Committee was also informed of FOI requests that had been made for JCVI minutes.

15. POLIO CONTAINMENT

The minutes of the UK Working Party for the Laboratory Containment of Polio Virus were presented for information. The Working Party continues to meet biannually to steer activities on this important work. The UK recently completed their report to the World Health Organisation on their Phase I activities for the laboratory containment of wild polioviruses which included compiling an inventory of every organisation in the UK with a laboratory and those organisations that are storing material that contains, or potentially contains, poliovirus. The next stage of the process was to write to those organisations holding wild poliovirus and determine whether they planned to keep or destroy this materials. The Health and Safety Executive (HSE) are drawing up proposals to include an onsite audit of the inventory. The Working Party meets again in September.

The Committee noted the Polio containment report.

16. ARTICLES FOR INFORMATION

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

(i) Coverage data for October to December 2004 (England, Scotland, Wales and Northern) Ireland and other reports.

(ii) Honda H, Shimizu Y and Rutter M. Article by Honda in the Journal of Child Psychology and Psychiatry - MMR in Japan 2005.

(iii) Introduction of Pneumococcal vaccine for individuals aged 65 and over (issued CMO letter 31 March 2005).

(iv) Vaccination services reducing inequalities in uptake 1 March 2005 (Department of Health)

(v) Protecting the Health of England's children: the benefit of vaccines (Health Protection Agency)

17. AOB

It was agreed that a meeting between Nathnac and DH would be helpful to exchange information about the supply of travel vaccines.

18. DATES OF FUTURE MEETINGS AGREED

Wednesday 19 October 2005 confirmed
Wednesday 22 February 2006 confirmed
Wednesday 21 June 2006 confirmed

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