Attending

1. ANNOUNCEMENT AND WELCOME

The Chairman welcomed everyone to the meeting and reminded members of the need to declare interests when appropriate.

Apologies were received from Professor George Griffin, Professor Jonathan Cohen, Professor Brent Taylor, Dr Richard Roberts, Dr Stephen Inglis, Dr Christopher Verity, Dr Lorraine Doherty from DHSS Northern Ireland, and Dr Mike Simmons from the National Assembly of Wales. Wg Cdr AD Green also sent his apologies and Lt Col Jerry Tuck attended in his place.

2. MINUTES OF THE LAST MEETING HELD ON FRIDAY 6 FEBRUARY 2004

2.1 The minutes were agreed with the following corrections

Paragraph 4.1, penultimate sentence amended to read 'A study in the UK that will be published soon is expected to show that serotype 1 is the prevalent serotype of childhood empyema in the area studied in the UK, the majority of which is caused by pneumococcus'.

Paragraph 4.2(i) change the word 'immunogenicity' to 'immunity'.

Paragraph 4.2(iii) delete the words 'aged 2-3 years' in final sentence and replace it with 'aged 18 months'.

Paragraph 4.3 2nd paragraph after (iv) replace 'Northern Ireland' with 'the Republic of Ireland'.

2.2 Dr Salisbury informed the Committee that as a consequence of the re-structuring of the Department of Health it is expected that some of the staff currently employed by the Department will transfer to the Health Protection Agency. Dr Salisbury reassured the Committee that the re-organisation would not affect the way the Committee functions and the Committee would continue to be serviced in the usual way.

3. MATTERS ARISING

3.1 Childhood Vaccines

Dr Salisbury updated the Committee on the introduction of new vaccines. There were currently delays in availability of infant vaccines but it was proposed to introduce a new pre-school booster vaccine (dTaP/IPV) and a new teenage booster vaccine (Td/IPV) in September. This would result in oral polio vaccine no longer being given to children after their primary vaccinations.

The Committee was also reminded that it had previously advised, in addition to switching from oral polio vaccine to inactivated polio vaccine, that acellular pertussis vaccines should be introduced when the efficacy of acellular vaccines at least matched that of the currently available whole cell pertussis vaccine. The Department would implement this advice, as soon as supplies of licensed vaccines meeting the requirements were available in the UK.

3.2 Annual Report

The aim is to have a final draft in July. Members will have the opportunity to comment on the final draft.

3.3 Hepatitis B

Progress in this area had slowed during the re-organisation of the Department. However, it is hoped that the work needed to take this issue forward could now be carried out. A JCVI Hepatitis B sub-group meeting is also needed.

3.4 Poliomyelitis - global update

Dr Salisbury updated the Committee on the global polio situation. The number of cases in India this year is very low. This is due to the number of national immunisation days already held, and their improved quality.

However, there has been some resistance to the use of OPV vaccine among some communities in Nigeria, due to rumours being circulated that it may adversely affect fertility, or that its use was linked to HIV. The WHO has worked hard with the Nigerian authorities and community leaders to show the rumours to be false, and to rebuild confidence in the vaccine.

3.6 Future JCVI Meetings

The Committee's views were sought on an alternative day for JCVI meetings because Friday was not always convenient. Members' views would be canvassed by e-mail.

4. COVERAGE AND OTHER REPORTS

4.1 The coverage reports for the UK were tabled. At 12 months of age, approximately 91% of UK children are fully up-to-date with their immunisations. Scotland and Northern Ireland are maintaining rates of around 95%. The figures for England are lower due to the uptake rate in London being 82-83%.

4.2 At 24 months, 93-94% of UK children are up to date with all vaccinations, with the exception of MMR. At 2 years, 81.1% (up 1.3% from last quarter 79.8% last quarter) of UK children had had one dose of MMR. By five years of age, 91% of children had had at least one dose of MMR. The committee asked whether there was any information available on how many children were being immunised with single vaccines. This information is not routinely collected and would be difficult to collect.

4.3 The measured uptake of all vaccines is consistently lower in the London region.

4.4 Across the board, uptake in Scotland and Northern Ireland are consistently higher than England for all vaccines. Wales reported that they had areas in Wales where uptake was low. Wales also noted that they were considering carrying out a catch up campaign to identify young people under the age of 19 who have not had two doses of MMR because of the risk of mumps in those without adequate protection.

5. GREEN BOOK CHAPTERS

5.1 The following interests were declared:

Dr Claire Bramley - Non personal specific
The chairman ruled participation was allowed in the discussion but not in any decision making.

5.2 The Committee was invited to consider the revised Green Book chapters on Vaccine Safety and Management of Adverse Events following Immunisation; Surveillance and Monitoring of Vaccine Safety; Vaccine Damage; and Pneumococcal vaccination.

5.3 Dr Salisbury outlined the key changes to each of the chapters. He explained that two draft chapters - Vaccine Safety and Management of Adverse Events Following Immunisation; and Surveillance and Monitoring of Vaccine Safety - aimed to give clearer information and advice on vaccine safety. The type of adverse reaction that may be expected following vaccination, such as a small lump at the site of injection, or a low grade fever, were clearly described. Very rare but important adverse reactions such as anaphylaxis were also clearly identified. Information on the management and treatment of adverse reactions is included, with the advice on the treatment on anaphylaxis being consistent with that given by the UK Resuscitation Council. It was suggested that a little more explanation of why certain adverse reactions occur would be helpful.

5.4 The Surveillance and Monitoring for Vaccine Safety Chapter describes the process of vaccine safety monitoring in the UK. It describes the reporting of adverse reactions suspected to be vaccine-induced via the Yellow Card scheme.

5.5 Vaccine Damage Payments Scheme This chapter has been updated to reflect the recent changes that have been made to the Vaccine Damage Payment (VDP) Scheme, with the main changes being a reduction in the disability threshold from 80 per cent to 60 per cent and an increase in the amount paid out to £100,000.

5.6 Pneumococcal Vaccine

A draft version of this chapter has been available on the Department of Health website since August 2003, following the introduction of the pneumoccocal immunisation programme for older adults. This draft version has now been revised and updated to bring it into line with the new format of chapters, and take into account recent recommendations made by the Committee about pneumococcal vaccine. The Committee suggested that the chapter should clearly identify that those children under five years of age at higher risk of pneumococcal infection should be offered the conjugate vaccine. The risk groups would be expanded to include children under 5 years with previous history of invasive pneumococcal disease and people with CSF leak or shunt.

5.7 Overall the Committee found the revised chapters were very clear and congratulated the authors. JCVI members were invited to send any further comments to the Secretariat within a week.

6. PNEUMOCOCCAL VACCINE

6.1 Pneumococcal conjugate vaccine in children

6.2 The Committee was reminded that at the last meeting they agreed that even though the results from the trials were encouraging there were still some uncertainty in the long-term community protective effect from infant immunisation and the impact serotype replacement might have on the overall benefits on introduction to the programme. The Committee's attention was drawn to a new unpublished cost-benefit analysis of pneumococcal vaccine in children. The results of the study show the cost-benefit analysis is very sensitive to:

· The impact of community protection (herd immunity), in particular vaccinating children against pneumococcus would be expected to reduce the risk of pneumococcal infection in the elderly, thereby bringing greater benefit overall.

· The degree of serotype replacement that may occur, the vaccine only protects against seven strains of pneumococcus. Protecting against those strains leaves opportunity for other strains of pneumococcus to cause infection. The impact of a pneumococcal vaccination programme would be reduced if serotype replacement was significant. Some degree of serotype replacement has been observed in the US.

· Assumptions regarding the current and future burden of pneumococcal disease in the UK.

6.3 With this additional information the Committee agreed that further studies needed to be completed to find the most effective way to implement the vaccine into the UK schedule.

6.6 Pneumococcal vaccination for the elderly

6.7 From April this year, people aged 75 years and over are being offered pneumococcal vaccine. This follows on from the campaign last year to protect those aged 80 and over. No problems with supplies of the adult pneumococcal vaccine are anticipated.

6.8 Scotland and Northern Ireland introduced this vaccine to individuals aged 65 years and over in 2003/04. Initial estimates suggests that uptake in Scotland may be 60 - 70%. It was noted that the vaccine uptake data for the campaign for older people in 2003/04 in England would be available in time for the next meeting of JCVI.

7. Respiratory Syncytial Virus (RSV)

In November 2002, the JCVI recommended that babies under 2 years of age with severe chronic lung disease, who are on home oxygen during the respiratory syncytial virus (RSV) season, should be offered palivizumab to protect them against RSV. It further recommended that treatment should be considered on a case-by case basis for babies with rare conditions such as multiple congenital abnormalities or severe immunodeficiency.

The Committee asked that the JCVI RSV sub-group be contacted to determine whether they were aware of any new relevant information that might influence the recommendation. If needed, the subject would be reviewed.

8. Influenza

8.1 The Committee was updated on the success of the influenza immunisation campaign last winter. The overall vaccine uptake for those aged 65 and over was 71% in England, 1% higher than the 70% target set at the start of the campaign.

8.2 The Committee agreed that the 2004/05 programme should focus on the at-risk groups in younger age groups as well as those aged 65 years and over. It was noted that GPs are now required to set up disease based registers which will enable 'at risk' groups to be targeted more effectively. It was noted that the Department could work through the Royal College of General Practitioners and the Royal College of Paediatrics and Child Health to encourage GPs to have accurate 'at risk' registers particularly for vulnerable children. The Committee accepted the recommendation of the Influenza Panel that, at GPs discretion, main carers of an elderly or disabled person should be recommended influenza vaccine, if maintaining the cared person at home would be jeopardised by the carer catching flu.

8.3 The Committee also briefly commented on the risk of influenza to pregnant women and to the developing fetus. The JCVI Flu Panel would consider the available evidence at its next meeting.

8.4 The Committee supported the proposal to fund a study by the HPA on the potential benefits of routinely immunising young children. It was agreed that findings should be presented to JCVI in one year.

9. MENINGOCOCCAL DISEASE

9.1 The Committee was reminded that in 2000, 45 cases of W135 meningococcal infection were identified in UK residents and eight people died. Some had recently returned from the Hajj but the infection also spread to people in the community. In 2001, 38 cases and 10 deaths related to the Hajj were reported in the UK.

9.2 In 2001, the Department of Health launched an awareness campaign to alert all pilgrims travelling to Saudi Arabia for Hajj and Umrah, about the risk of meningococcal W135 infection and advising vaccination against the disease. Since then, no deaths from W135 infection have been reported in the UK linked to the Hajj. There was however one cluster last year in one family. The Department will continue to run its awareness campaign for those attending the Hajj in 2005, it has also awarded a Section 64 grant to the Association of British Hujjaj, a voluntary organisation working for the welfare of British pilgrims. They will be organising seminars and events around the country regarding health management and prevention of communicable diseases specifically targeted at British Hujjaj (pilgrims) and hard to reach groups. This grant will support efforts to increase awareness of the need for immunisation.

10. BCG

10.1 The Committee was reminded that the BCG vaccine supplied by SSI and currently used in the UK was different to that supplied previously by Evans. There has been an increased reporting rate of suspected adverse reactions, mainly vaccination site reactions including abscesses. There has also been a notable increase in reporting of immediate vasovagal reactions to the injection, including syncope. This increase may be due to a combination of the new vaccine being more immunogenic than the previously used vaccine, the need for more precise immunisation technique, and an increased reporter base (nurses were included as reporters to the Yellow Card Scheme at the time when the vaccine was introduced). The Committee on Safety of Medicines had reviewed the evidence and concluded that no new safety signals had been identified. The Department was developing a BCG vaccination training video demonstrating the intradermal vaccination technique, which would be circulated to help staff who administer the vaccine.

11. HIB

11.1 Update on the Hib booster campaign

11.2 Initial coverage data from the recent Hib booster campaign was presented. Coverage in the 1-3 year old age group was 64%, and was 72% in the younger (6-12 months) age group. The disease incidence was reduced (by 87%) in the 1-4 year olds. However, there was little change in the rate of disease in children aged under 1 year or over 4 years of age. There was no evidence yet of a herd immunity effect but this would not be expected until later this year.

11.3 There were concerns that there was a wide range of levels of uptake within a PCT. There was some discussion as to whether any action should be taken in the areas where uptake was low similar to what was done with MMR low uptake areas.

11.4 Further work is required to analyse the coverage data with follow-up of the lowest reports to verify the data. Further action will be needed if the coverage was as low as reported from some localities.

11.5 It was noted that the UK was not the only country to experience an increase in Hib circulating in the community. It was recognised that the JCVI would need in the future to review the evidence of whether an additional dose of Hib vaccine should be offered in the routine immunisation schedule and, if so, as what age.

11.4 Hiberix end of campaign safety review

The Committee was updated by the MHRA on the safety of the vaccine during the campaign. Two hundred and eighty reports were received containing 435 suspected adverse reactions (ADRs) associated with Hiberix vaccine. The vast majority of the ADRs reported were non-serious, previously recognised reactions. No new safety issues were identified.

12. TRAVEL VACCINES

12.1 Cholera

The National Travel Health Network and Centre (NaTHNaC) presented a paper on the new vaccine against cholera (vaccine brand name: DukoralTM) which was now licensed in the UK. The oral vaccine is well tolerated, with side effects being limited to mild gastrointestinal events. The vaccine has good protective efficacy against Vibrio cholerae O1 (in the range 61% to 86%). In children aged 2 to 5 years of age, protection wanes rapidly after 6 months. [No interests were declared]

The Committee agreed with the recommendation from NaTHNac, based on a risk assessment of acquiring cholera, that:

Vaccination against cholera could particularly be considered for the following categories of travellers:

• Relief or disaster aid workers
• Persons with remote itineraries in areas where cholera epidemics are occurring and there is limited access to medical care.

The appropriateness of cholera vaccination apart from the above is a matter for the individual to discuss with their doctor. Individual risk assessment based on the area of travel and any underlying health conditions is key.

JCVI does not recommend the use of Dukoral^TM for protection against travellers' diarrhoea.

12.2 Recall of Rabies Vaccine

The Committee was informed that a single batch (X0071-6) of rabies vaccine (Aventis Pasteur MSD) was recalled from the UK market on 5 April 2004. This was because another, different, single batch of rabies vaccine failed the test for viral inactivation during processing. Although the affected batch had not been released, the company was withdrawing all batches produced at the same time, even though these had passed the test for viral inactivation, purely as a precaution. One batch released onto the UK market was affected by the recall. MHRA provided the Committee with a paper on how this recall was handled. The Committee will be presented with a paper on how the Health Protection Agency handled issues relating to clinical management following the recall.

13. YELLOW CARD DATA

The Committee was provided with a paper by MHRA outlining the suspected ADRs received during 2003 (as compared to 2001 and 2002) in association with DTwP+/-Hib, OPV, MenC, MMR, BCG, DTaP, HepB, HepA and influenza vaccine. With the exception of the DTaP/Hib and reduced efficacy issue and possible nephrotic syndrome relapse associated with MenC (both of which had been presented at previous JCVI meetings) no significant safety issues had been identified.

14. VACCINE DAMAGE PAYMENT SCHEME

A summary paper on claims received through the vaccine damage payment scheme was provided for information. The only point of note was an increase in the number of claims received which cited DTP and neurological reactions which was thought to follow recent media articles. It was noted that this information was provided to the department for their information only and that the DH could not influence decisions made on these or any other claims

15. STAPHVAX FOR END STAGE RENAL DISEASE

15.1 The Committee's view was sought on a NICE briefing paper on the prevention of Staphylococcus aureus infections for end stage renal disease discussed at the last Advisory Committee for Topic Selection (ACTS) meeting. The Committee agreed that this was an important step in dealing with hospital acquired infections in this risk group. However, the Committee was very keen that properly controlled studies were conducted to assess the efficacy and safety of the vaccine in this patient group. It was also important to understand what types of Staphylococcus aureus the vaccine protects against. [No interests were declared].

15.2 The Committee thought it important that NICE was informed that the Department of Health was funding work through the National Vaccine Evaluation Consortium on the use of this vaccine prior to elective surgery. Reducing the risk of Staphylococcus aureus infection in those undergoing surgery would be of great benefit. However, rigorous studies were needed to assess the vaccine for this use.

16. EXECUTIVE SUMMARY OF THE IOM REPORT, IMMUNISATION SAFETY REVIEW: VACCINES AND AUTISM.

The Committee's attention was drawn to the report published on 17 May by the US Institute of Medicine (IOM). The IoM report concluded that there was no good evidence of a causal link between MMR and autism, or between thiomersal in vaccines and autism.

17. ARTICLES FOR INFORMATION

The Committee's attention was drawn to the articles provided for information, in particular the recent publications on MMR, thiomersal and autism. None were considered to affect current recommendation for immunisation.

The Lancet Vol 363 March 6, 2004 (commentaries).
Expert Rev Vaccines. 2004 Feb; 3(1): 19-22 DeStefano F, Thompson WW. MMR vaccine and autism: an update of the scientific evidence.

Pediatrics.2004 Feb;113(2):259-66, DeStafano F, Bhasin TK, Thompsom WW, Yeargin-Allsop M, Boyle C. Age at first measles-mumps-rubella vaccination in children with autism and school-matched control subjects: a population-based study in metropolitan Atlanta.

An assessment of the impact of thiomersal on childhood developmental disorders. David Geier and Mark Geier. Pediatrics Rehabilitation April-June 2003; 6(2); 97-102

A comparative evaluation of the effects of MMR immunization and mercury dose from thiomersal-containing childhood vaccines on the population prevalence of autism. David A Grier and Mark Grier. Med.Sci. Monit 2004; 10(3): 133-139

A case control of mercury burden in children with autistic spectrum disorders. Bradstreet et.al. Journal of American Physicians and Surgeons 2003;8(3): 76-79.

Correspondence - Journal of American Physicians and Surgeons 2003; 8(3) 68-70.

The toxicology of mercury - current exposures and clinical manifestations. Clarkson TW, Magos L and Myers GJ. NEJM 2003; 349: 1731-7

NEJM 2004; 350: 945-947

Addressing parents concerns: Do vaccines contain harmful preservatives, adjuvants, additives or residuals? Offit P and Jew RK. Pediatrics 2003; 112(6); 1394-1401

The evidence for the safety of thiomersal in newborn and infant vaccines. C John Clements. Vaccine.2003.11.017

Thiomersal in vaccines: a regulatory perspective WHO Consultation, Geneva, 15-16 April 2002. I Knezevic, E Griffiths, F Regigel. R Dobbelaer. Vaccine 22 (2004) 1836-1831

The European Agency for the Evaluation of Medicinal Products Public Statement on Thiomersal in vaccines for human use- recent evidence supports safety of thiomersal-containing vaccines

Childhood Vaccination and Type 1 Diabetes. Anders Hviid, Michael Stellfeld, Jan Wohlfahrt, and Mads Melbye. N Engl J Med 2004;350: 1398-404
Validation of the diagnosis of autism in general practitioner records. Eric Fombonne, Lisa Heavey, Liam Smeeth, Laura C Rodrigues, Claire Cook, Peter G Smith, Linyan Meng and Andrew J Hall. BMC Public Health 2004, 4:5.

The Genetics of Autism. Rebecca Muhle, Stephanie V Trentacoste and Isabelle Rapin. Pediatrics vol.113 No5 May 2004.

18. AOB
There was a request for varicella zoster (shingles) vaccine to be considered at the next meeting.

19. DATES OF FUTURE MEETINGS
Friday 1 October 2004

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