Attending

1. ANNOUNCEMENT AND WELCOME

The Chairman welcomed Gary Freed, Professor of Paediatrics and Child Health Delivery from University of Michigan who is currently carrying out some research in the Department during a sabbatical. Daniel Eghan who has recently joined the Immunisation team, was also introduced.

Apologies were received from Dr Chris Verity and Mrs Joan Sawyer from the Committee, and Jenny Thorne from the Welsh Assembly. Dr Rob George from HPA attended in Professor Miller's absence.

2. MINUTES OF THE LAST MEETING HELD ON FRIDAY 4 JUNE 2004

Paragraph 5.1 of the draft minutes was amended to state that "The Chairman ruled that those members could participate fully in the discussion but not take part in a vote." With this amendment the minutes were agreed. The minutes will be placed on the website as final minutes.

3. MATTERS ARISING

3.1 Membership

The Committee was informed that: Dr Richard Smithson, Professor Lewis Ritchie, and Dr Barbara Bannister had served two terms and had now left the Committee. Both the Minister and the Chairman have written to them thanking them for their work.

Professor Keith Cartwright has been reappointed for a further 2 years having already served two terms. His expertise in pneumococcal disease was considered to be invaluable to the Committee at a time when JCVI is actively considering pneumococcal vaccination policy for children and evaluating initial data from the pneumococcal programme for older people.

Professor Paul Griffiths, Professor Simon Kroll, and Professor Brent Taylor had finished their first term on the Committee and had been reappointed for a second term:

All appointments were made through the Appointments Commission and in accordance with the original Nolan recommendations.

3.2 Dates of future JCVI meetings

The dates of the future JCVI meetings for 2005 will be 23 February, 15 June and 12 October.

3. 3 Hepatitis B

Progress on hepatitis B policy was slower than had been anticipated due to re-structuring of the Department. The JCVI sub-group on Hepatitis will meet before the next main JCVI meeting.

3.4 Annual report

On the final draft of the report, members were thanked for comments received. The report is now being edited and should be on the website in the next few weeks.

3.5 Varicella zoster (shingles)

As the results from a large research study on a candidate vaccine in the US were not yet available, this item was deferred until the next JCVI meeting.

3.6 Staphvax for end stage renal disease

This item was discussed at the last meeting at the request of NICE. The Committee had thought it important that NICE was made aware of the research being carried out by the National Vaccine Evaluation Consortium, funded by the Department, into the use of vaccines to help protect against Staphylococcus aureus infection. The Committee was informed that JCVI's advice had been passed to NICE.

4. INTRODUCTION OF THE NEW VACCINES INTO THE ROUTINE CHILDHOOD PROGRAMME

New childhood vaccines were introduced from Monday 27 September. These included the new "5-in-1" vaccine for babies (which protects against diphtheria, tetanus, pertussis (whooping cough), polio, and Hib disease); the "4-in-1" preschool booster (which boosts protection against diphtheria, tetanus, pertussis and polio); and the "3-in-1" teenager booster (which boosts protection against diphtheria, tetanus and polio). Distribution of the vaccines was planned so that all surgeries would have received their first supplies of the vaccines in the period 27 September to 8 October. A range of information materials (leaflets, PowerPoint presentations etc) had been produced to support the new programme, and the www.immunisation.nhs.uk website had been redesigned and updated to reflect the changes to the programme.

5. COVERAGE AND OTHER REPORTS

The Committee was updated with the routine quarterly vaccine uptake data collected by the HPA.

Similar patterns were seen as before, with uptake levels of all vaccines tending to be higher in Scotland, Northern Ireland and Wales than in England. In England, the recorded uptake levels for all vaccines is significantly lower in London than elsewhere in the country.

The Committee also considered a paper examining trends in vaccination coverage in the UK over the last 10 years. The paper was based on data collected and published by the HPA. The data showed a gradual decline in uptake levels of some antigens, even though figures remain higher than 90% for all vaccines apart from MMR. However there has been an upturn in MMR coverage recorded over the last year.

The Committee welcomed this 'Trends' paper and suggested that such a paper should be presented annually to the Committee.

The Committee expressed concern about how vaccination rates have fallen in some parts of the country. The following factors may contribute to the lower recorded vaccination coverage in London:

• data collection methods in some areas are antiquated and may result in poor capture of the data. Investing resources to ensure data is recorded more accurately would be expected to increase the recorded vaccine uptake.
  
  
• The number of staff vacancies, particularly among health visitors in London, and the relative high turnover of staff in some London boroughs present challenges to implementing effective vaccination programmes.
  
  
• The relationship between the health professional and parent/patient is considered to be very important in all areas of primary care. Competing priorities within primary care, coupled with the staffing issues above, does put pressure on the quality of service that health professionals provide.

It was pointed out that the priority given at the local level to the various services provided is strongly influenced by whether it is a service for which performance indicators have been set. The priority given to immunisation has gone down in some areas because it is not now an area (with the exception of MMR) where performance indicators are set.

The Committee expressed its concern at the low vaccination rates in some areas, and noted that central performance management may help ensure immunisation receives the priority it merits. The Secretariat was requested to take this recommendation forward with the Department.

The Committee also considered a technical paper on the impact that re-organisation in the NHS may have had on the recording of vaccine uptake figures. This paper showed that recent changes in population definitions have had an impact on the COVER programme. During 1998 to 2002, the population measured by the COVER programme tended to be lower than that recorded by ONS. The difference was greatest in 2002 and these results suggest that children not registered with their GP may be 'lost' to the COVER programme. This effect may result in vaccine coverage being over- rather than underestimated. However, it is recognised that other factors, such as antiquated vaccine data recording in some areas, may result in vaccine coverage being under-estimated.

6. GREEN BOOK CHAPTERS

Draft 'Green Book' chapters on Vaccine Storage, Immunisation Procedures, Hepatitis A, Japanese encephalitis and Rabies had been circulated to the Committee. The chapters would be placed on the immunisation website as soon as they had been agreed.

The Committee suggested the chapter on immunisation procedures would benefit from inclusion of information on techniques on holding an infant during immunisation to reduce discomfort. In addition, it was suggested that the draft recommendations on hepatitis A needed to take account of a consensus statement recently published in the Lancet suggesting that two doses of Hep A provided long-term protection.

7. BCG UPDATE

The Committee was informed that BCG policy would be reviewed. A JCVI sub-group will review the evidence and provide advice to the Committee.

8. MENINGITIS

8.1 Long term effectiveness of Meningitis C and Hib conjugate vaccines

The Committee considered the long-term effectiveness of MenC and Hib vaccines. Both vaccines are routinely offered to babies at 2, 3 and 4 months of age. Since the vaccines had been introduced in the UK, the rate of both Hib disease and meningococcal group C infection have plummeted.

The Committee considered a recent paper published by Trotter et al (Trotter et al 2004; Lancet 364; 365 - 366) which suggested that the protection provided by a primary course of MenC in young infants wanes in the second year of life. Similar research has been published on the protection offered by Hib vaccine (Ramsay et al. 2004; Journal of Infectious Disease 188; 481-485).

It was noted that cases of meningitis C in children remained very low in number; and that cases of Hib infection had fallen following the recent Hib booster campaign. Therefore the risk of these infections remains low. It was felt that the issue of waning immunity following a primary course of these conjugate vaccines at 2, 3, and 4 months needed to be examined further. The Committee wanted to consider whether a booster dose of Hib and MenC vaccines was needed to ensure a high level of protection throughout infancy and beyond.

The Secretariat was asked to provide information for the Committee to consider how protection against Hib and MenC can be maintained through infancy and beyond.

8.2 Serological response to ACYW135 polysaccharide meningococcal vaccine in Saudi children aged under 5 years

Current advice for Hajj pilgrims is that children aged 6 months to two years of age should be offered two doses of Meningococcal ACYW135 vaccine, with an interval of three months between each dose. The Committee's attention was drawn to a recent study (unpublished) on the serological response to the meningitis ACYW135 vaccine.

The Committee noted that outbreaks of meningitis, particularly meningitis W135, had previously occurred in association with the Hajj. The Committee also noted that children under 18 months of age in the UK should have already received MenC vaccine during the first year of life, and that other vaccines to protect against A, Y and W135 for this age group were not readily available nor were they likely to provide a better level of protection.

The Committee advised that the recommendation for children over six months of age attending the Hajj should remain unchanged. Parents taking children aged 6-18 months of age to the Hajj should be informed that the recommended MenACYW135 vaccine only provides a low level of protection against meningitis Y and W135.

9. POLIOMYELITIS

The Committee was updated on progress to eradicate polio, and was presented with the latest report on the global count of polio cases (see www.polioeradication.org/casecount.asp). Excellent progress was being made in India and Pakistan. However progress in Nigeria had reversed following a vaccine scare in the north of that country. While the number of cases in Nigeria had increased, the polio campaign in Nigeria is now back on track with mass vaccination days taking place in the north of Nigeria.

10. PNEUMOCOCCAL

10.1 Pneumococcal vaccine and the elderly

The HPA provided an update on their enhanced surveillance of the pneumococcal programme for the elderly. Their report focused on preliminary data from individuals aged 80 years and over who were first vaccinated in England from August 2003.

Significant numbers of older people aged 80 years or over received pneumococcal vaccine prior to the introduction of the universal programme because they fell within one of the at risk groups. The new programme had resulted in a 26% increase in coverage in this age group so that by 31st March 2003, 62% people aged 80 years and over had been immunised.

The initial data suggested that pneumococcal vaccine had not yet resulted in a decrease in invasive pneumococcal disease in this age group. Further analysis of the data were required, and surveillance of disease in these groups will continue. As the programme is rolled out, the surveillance is being extended to cover the new target groups.

A paper was tabled describing the impact of introducing pneumococcal vaccination for all individuals aged over 65 years in Scotland. Overall uptake was 66%, and preliminary results suggest that there may have been a decrease in invasive disease in the over 65s, in contrast to all other age groups, for which increases were recorded. Surveillance data continue to be analysed and vaccination details for cases of invasive pneumococcal disease have been sought.

10.2 Pneumococcal vaccine and children

The Committee has considered evidence on pneumococcal vaccine for children on a number of occasions. Introducing this vaccine may result in babies receiving three separate injections per visit to the surgery where other established vaccine schedules are taken into account, and a question had been asked about the acceptability of this.

There is not a significant amount of research available in the scientific literature about the acceptability of multiple injections. However, the available evidence suggests that parents are willing to accept additional injections if they believe that these are of benefit to their child. It is also clear that the healthcare professionals may need additional support and training on this issue. It was noted that in the US, multiple injections per visit were common.

The Committee recommended that there were no medical reasons not to offer pneumococcal vaccine alongside the other primary immunisations. However it recognised that some parents may have concerns, and that health professionals may need additional information and training. The Committee noted that the Department was planning to seek the views of parents and health professionals on the information that would reassure them about this issue, and would prepare materials based on this research.

The Chairman summarised that the Committee had examined all the evidence regarding the benefits of the pneumococcal vaccine in children. The Committee recommended that it agreed in principle to the introduction of pneumococcal vaccine for children, subject to further consideration of the following: the number of doses required and their timing to protect children; the price at which the Department is able to secure the vaccine; and guarantees of the supply of the vaccine. The Committee also recommended that the introduction of the vaccine would need to be accompanied by a well-designed surveillance programme to monitor the impact of the programme, including monitoring for evidence of serotype replacement.

11. RSV

The RSV subgroup would be reconvened to consider any new evidence on the use of palivizumab in the prevention of RSV, and would advise the Committee accordingly.

12. HORIZON SCANNING PAPER ON ROTAVIRUS

As part of Committee's regular horizon scanning activity, the Committee considered a paper on the epidemiology and burden of disease of rotavirus and the availability of a vaccine against the disease.

Rotavirus infection is the single most common cause of gastroenteritis in children in the world, and is estimated to be responsible for over 400,000 deaths in children under 5. In the UK, rotavirus infection can occur at any age but is commonly seen in infants between 6 and 12 months. It is not believed to lead to fatalities in the UK, but does to result in a large number of GP consultations and hospitalisations each year.

The development of a cost effective vaccine against rotavirus would be of great benefit to the developing world, and progress to this end is being made. A rotavirus vaccine may also be of benefit to the UK as it would reduce the incidence of hospitalisations and GP visits in young children. However, work was needed to update the burden of rotavirus disease in the UK and to assess the cost-benefit of introducing a rotavirus vaccine in the UK.

The Committee asked for the subject to be kept under review.

13. PERTUSSIS REVIEW

The Committee recalled that in 2001 a pertussis booster was introduced to the routine UK schedule. The Committee reviewed the epidemiology of the disease before and after the introduction of the pre-school booster.

Pertussis is a serious infection that has resulted in 53 deaths in England and Wales over the last 8 years. The UK vaccination programme has been successful in reducing the incidence of pertussis. The incidence of disease is now at an all time low, and an epidemic peak that would have been expected in 2000-01 did not occur, which may indicate a lengthening of the inter-epidemic cycle or that transmission has been interrupted. The main burden of morbidity and mortality continues to be in infants under 3 months of age. Although an encouraging reduction in pertussis incidence has been seen in the last two years, it is too soon to evaluate the impact of the booster dose.

The Committee welcomed the review and asked to be kept updated on the issue.

14. HIB VACCINATION CATCH UP CAMPAIGN-FURTHER ANALYSIS OF COVERAGE AND THE IMPACT OF THE CAMPAIGN

The recent Hib campaign had been hugely successful, with the rate of Hib disease plummeting in the under 4 year old target population, with a decline also seen in older age groups.

The Committee noted that coverage for the Hib catch-up campaign was around 72% in infants and 63% in older children. However, results showed that Hib coverage varied widely between Primary Care Trusts (PCT) and Strategic Health Authorities. PCTs with high coverage for routine immunisations tended to have higher coverage for the Hib campaign. Coverage in London was noted to be lower than other areas. It was commented that inclusion of immunisation targets in performance management of PCTs may help those with low vaccination uptake rates.

15. OPENESS

The Committee reviewed its policy on openness. It was content with the policy to increase the openness of the work of the Committee, and agreed that a greater use of statements on key policy issues may help explain the position of the Committee to the public.

The Committee reviewed papers and concluded that the declaration of interests should be explained in plain English.

16. ARTICLES FOR INFORMATION

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

(i) Hung C-C. et. al.(2004). Clinical experience of the 23-valent capsular polysaccharide pneumococcal vaccination of HIV-1-infected patients receiving highly active antiretroviral therapy: a prospective observational study. Vaccine, 22; 2006-12.

(ii) Chen W. et.al. (2004). No evidence for links between autism, MMR and measles virus. Psychological Medicine, 34;543-553

(iii) Bradstreet J.J et.al.(2004). Detection of measles virus genomic RNA in cerebrospinal fluid of children with regressive autism: a report of three cases. Journal of American Physicians and Surgeons, 9 (2; 38-45..

(iv) Jick H & Kaye J.A. (2004). Autism and DPT vaccination in the United Kingdom. New England Journal of Medicine, June 24;2722-73.

(v) Fombonne E. et.al. (2004). Validation of the diagnosis of autism in general practitioner records. BioMedCentral Public Health (http://www.biomedcentral.com/1471-2458/4/5).

(vi) Goldman G.S. &, Yazbak F.E. (2004). An investigation of the association between MMR vaccination and autism in Denmark.. Journal of American Physicians and Surgeons, 9 (3); 70-75.

(vii) Stott C. et.al. (2004). MMR and Autism in Perspective: the Denmark Story. Journal of American Physicians and Surgeons, 9 (3); 89-91..

(viii) Heron J. et.al (2004). Thimerosal exposure in infants and developmental disorders: A prospective cohort study in the United Kingdom does not support a causal association. Pedriatrics, 114 (3); 577-583.

(ix) Andrews N. et.al. (2004). Thiomersal exposure in infants and developmental disorders: a retrospective cohort study in the United Kingdom does not support a casual association. Pediatrics, 114 (3); 584-591.

(x) Parker SK. et.al. (2004). Thiomersal-containing vaccines and autistic spectrum disorder: a critical review of published original data. Pediatrics, 114 (3); 793-804.

(xi) Smeeth L. et.al. (2004). MMR vaccinations and pervasive developmental disorders: a
case-control study. Lancet, 364; 963-969.

Committee members did not find any evidence, which altered its previous opinions.

18. ANY OTHER BUSINESS

The Committee considered a request from Northern Ireland for advice on prioritising individuals for flu vaccine in light of the supply problems with the vaccine. The Committee agreed with the suggestion that children under 14 years of age in at risk groups, and individuals aged over 75 years should be given priority. It was agreed that the JCVI sub-group on influenza would need to meet soon, and should also cover avian flu.

19. DATES OF FUTURE MEETINGS AGREED

Wednesday 23 February 2005
Wednesday 15 June 2005
Wednesday 12 October 2005

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