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Venue: Room 102A/124A, Skipton House

Please note that this version was agreed at the meeting on 7 February.

Attending:

Professor Michael Langman (Chairman)
Professor Keith Cartwright
Dr David Goldblatt
Professor Andrew Hall
Mrs Joan Sawyer
Dr Christopher Verity
Dr Barbara Bannister
Dr Huw Joynson
Dr Richard Smithson
Professor Lewis Ritchie
Dr Michael Raworth
Professor Paul Griffiths
Professor Simon Kroll
Professor Jonathan Cohen

Ex-officio:

Professor Brian Duerden PHLS
Professor Angus Nicoll CDSC
Dr Steven Inglis NIBSC
Dr Claire Bramley SCIEH

Observers:

Dr A Croft (MOD)
Wg. CDR Andy Green
Major (Dr) Pauline McDonald
Dr Angela Williams
Dr Jan Van Wijngaarden
Dr John Devlin

Invited to attend:

Dr Natasha Crowcroft (CDSC)
Dr Elizabeth Miller (CDSC)
Dr Mary Ramsay (CDSC)
Dr Darina O'Flanagan
Dr Ambler
Dr Arlene King

Department of Health:

Dr David Salisbury (Medical Secretary)
Dr Jane Leese
Dr Hugh Nicholas
Dr Dorian Kennedy (Administrative Secretary)
Mr Robert Anderson
Mrs Loraine Gershon
Mrs Debby Webb
Dr Arlene Reynolds
Dr Karen Noakes
Richard Griffiths (minutes)
Mrs Pam Gardiner
Ms Jo Yarwood
Mrs Judith Moreton

Medicines Control Agency:

Dr Phil Bryan
Dr Teresa Pepper
Dr Peter Arlett

Scottish Executive:

Dr Elizabeth Stewart

National Assembly for Wales:

Dr Mike Simmons

DHSS Northern Ireland:

Dr Lorraine Doherty

Apologies were received from:

Professor Goldberg
Professor G Griffin
Professor Brent Taylor
Dr Kit Harling

1. Announcements and welcome

The Chairman welcomed Mrs Vivienne Parry and Professor Brian Duerden to their first meeting. Mrs Parry is the newly appointed lay member for the Committee. Professor Duerden is the new Director of the Public Health Laboratory Service and is an ex-officio Member.

Dr Arlene King from the Bureau of Infectious Diseases in Canada was also welcomed and attending the meeting as an observer.

On behalf of the Committee, the Chairman also congratulated Professor Angus Nicoll on his award of CBE.

The Chairman reminded members that they should declare any conflicts of interest at the start of each item. Members were also asked to notify the Secretariat of any changes in their interests so that their declarations could be amended on the website.

2. Minutes and Open Minutes of the meeting of the Joint Committee on Vaccination and Immunisation held on 3 May.          Paper JCVI(02) 52 a and b

The minutes were agreed subject to the following changes:

Dr Christopher Verity was welcomed to his first meeting of the Committee; and the entry about the Chairman’s declaration of interests in Section 4 (Varicella) should be amended to read "which did not prevent full participation in the meeting"

The Open Minutes were agreed and it was also agreed that these could be published on the JCVI Website.

3. Matters arising

Applications for the position of paediatrician on the Committee were being processed in accordance with the requirements of the Commissioner for Public Appointments. The Secretariat was aiming for an appointment to be made prior to the next meeting of JCVI.

There had been difficulty in recruiting a Public Health Specialist of sufficient expertise and experience. Members were asked to suggest appropriate Public Health Specialists who may be interested membership.

4.  Coverage and other reports         Paper JCVI (02) 53

In England immunisation coverage for diphtheria, tetanus and polio at 12 months remains stable at 91%, and likewise at 90% for pertussis and Hib. MMR uptake at 24 months has stabilised and may have increased slightly over the last quarter.

In Scotland the uptake rates are around 95% at 12 months of age for all antigens, and MMR is 88.6% at 24 months.

In Wales uptake of diphtheria, pertussis and Hib at 12 months was slightly below 95% for the last quarter; uptake of MMR at 24 months was about 84%.

In Northern Ireland rates of primary immunisations remain high at 95%, and MMR is currently stable at about 90%.

The Committee considered its working practices in light of the OST Code of Practice for Scientific Advisory Committees.

The Committee confirmed that it needed to liaise with other committees, in particular the Committee on Safety of Medicines. Some members of CSM were also members of JCVI, though this was through their individual expertise and not through ex-officio cross membership. It would be appropriate for formal cross-representation between the two committees to be drawn up. This could be, for example, the chair of JCVI being an ex-officio member of CSM, and vice versa. The Secretariat agreed to follow this up with the CSM. It was also noted that JCVI needed to be kept abreast of the work of the new group being set up by the CMO to look at ‘emerging pathogens’.

For horizon scanning, the key areas to be examined were new and emerging diseases, including changing epidemiology; new vaccines in development; and new approaches for stimulating immune responses. Where appropriate, a small group may be helpful.

The Committee should review the range of its balance and expertise annually. A template giving the range of expertise currently covered by the Committee should be published, once finalised, on the website.

The Committee’s workload should be reviewed annually, and that a Forward Work Plan would be prepared on a regular basis. It was recognised that the reactive nature of much of the Committee’s work meant that any forward planning would not necessarily be comprehensive.

New members of the Committee should meet with the Chair, in addition to the Secretariat, before their first meeting. This would provide opportunity to discuss fully what is expected as members of the Committee, and cover other relevant issues such as the rules about conflicts of interest, advice on dealing with the media, etc.

The Chair and members of the Committee would be appraised, with the Chair and members having one appraisal per four-year term. The Chair will be appraised by the Department of Health, and the Chair would appraise members. A standard form would be used in this process that would be sent for information to members.

It was agreed that it was appropriate for the Chair to continue to represent the Committee to the media, although there might be times when the Chair called upon individual members to assist with this task. Members were reminded that they were free to discuss issues with the media on a personal basis.

The current procedure that requires minutes of meetings being approved at the following Committee meeting before becoming public caused significant delays. In order to be more timely, minutes would be agreed by correspondence and published on the website within six weeks of the meeting where possible.

A note of meetings of JCVI sub-groups should be provided on the website.

The Committee would publish an Annual Report on its activities. It was agreed that this would help in making the work of the Committee more open. Consideration would need to be given to publicising the document.

The Committee discussed in detail criteria for information that needed to be kept confidential, and what information should be released into the public domain. Pre-published research information, and individual’s medical records, should remain confidential. However the Committee wanted to consider in more detail what other personal information should be kept confidential; more detail on the breadth of issues covered by the term ‘Commercial – in – confidence’; and more detail on the need for some issues to be kept confidential due to concerns over national security.

The Committee holding meetings that were open to the public. While the Committee has recognised the need for increased openness, concerns were raised by members that holding meetings in public might adversely affect the quality of the Committee’s decision-making.

The Secretariat was asked for a paper on the above two issues for further consideration at its next meeting.

6. Core Principles for Immunisation Policy       JCVI(02)55

This paper was presented following a recommendation in the "Report by the MMR Expert Group to the Scottish Executive", which stated that:

"The Joint Committee on Vaccination and Immunisation should develop and publish core principals for immunisation policy in order to provide all interested parties with a clear framework against which future policy options might be assessed in an open and transparent manner."

The Committee agreed that developing core principals could be a useful aid to transparency regarding the Committee’s working practices and its independence. However the core principles for the Committee could only cover issues within its remit, and it was noted that that the Committee was responsible for providing advice, and it was the responsibility of Government for implementing policy.

The Secretariat will prepare a further paper containing draft Core Principles. These could include: membership with expertise to cover the broad area of vaccines, immunisation and the role of immunisation in the are of the individual and public health; the provision of un-biased and up-to-date expertise and advice; proper scrutiny of the likely advantages and any possible disadvantages from vaccines for individuals and the population as a whole.

7. Haemophilus influenzae Type b (Hib) immunisation

The following interests were declared:

The Chair said that those with non-personal/non-specific interests could take full part in the discussion. All those with personal interests could take part in the discussion but not participate in the decision-making.

The Committee examined a wide range of evidence regarding the incidence of Haemophilus influenzae type b (Hib) disease. The Committee agreed that the introduction of Hib vaccine into the Childhood immunisation programme in 1992 had led to a very significant and important decrease in the incidence of Hib disease in all age groups.

In reviewing the evidence, the Committee noted that there was a relatively small, but significant increase in incidence of Hib disease since 1999. However studies carried out had not been able to identify carriers of the disease.

There may be a number of reasons for the rise in Hib cases. These include children with only low levels of antibodies through immunisation or because of waning immunity with time. This effect will be exacerbated in the vaccine-induced absence of natural boosting that previously occurred as a consequence of community carriage. When carriage rates increase, for which there is presently little evidence, some of those with little immunity will be boosted, others may develop invasive disease. In cases that have occurred in immunised children, Hib infection is more likely in those children who received two doses or more of DTaP/Hib as part of their primary immunisation programme, compared to those children who received doses of DTwP/Hib. The use of DTaP, at a time when DTwP was not available, appears to have exacerbated the already occurring rise in Hib infections. Though the UK programme had been highly successful, further enhancement of immunity appears necessary.

In light of the increase in the incidence of Hib disease, the Committee recommended that all children between 6 months and 4 years would benefit from a further dose of Hib vaccine. In addition to improving protection of this cohort, it was recognised that this type of programme would be expected to reduce incidence of Hib disease in all age groups, and to interrupt the transmission of the disease – thereby reducing incidence of Hib for a number of years.

8. Respiratory Syncytial Virus – Indications for Palivizumab

There were no interests declared by members of the Committee.

NICE had asked JCVI to consider use of the monoclonal antibody, Palivizumab, in protecting at-risk groups against Respiratory Syncytial Virus (RSV). JCVI requested an expert consultation on the evidence supporting the use of Palivizumab.

The at-risk groups were considered as follows:

1. Babies under 2 years of age with severe chronic lung disease, on home oxygen during the RSV season (around 500 babies each year)
   
2. Babies under 2 years with chronic lung disease not on home oxygen (around 1000 babies a year, about a quarter of whom are likely to have been on oxygen in the last 6 months)
   
3. Babies with rare conditions such as severe multiple congenital abnormalities or severe immuno-deficiency; this would include severe congenital cardiac disease
   
4. Babies born at less than 32 weeks gestation.
   

It was agreed that these groups represented a small proportion of the burden of RSV illness and that a vaccine was required to make an overall impact.

In the meantime, palivizumab should be offered to babies in Group 1. They had a twofold risk of readmission. Palivizumab was likely to reduce admissions by 39% and be cost neutral.

For babies in Group 2, treatment was likely to reduce admissions but not necessarily the number ventilated or deaths. A decision should await further evidence. It was noted that further data may arise out of a 5 year follow-up study by Greenough1 following the retrospective study of RSV hospitalisations in infants with chronic lung disease.

Group 3 consisted of children with a variety of disorders, often multiple, including severe congenital heart disease and severe immuno-deficiency. It was not possible to give a complete list. The small numbers meant that evidence was unlikely to be obtained. Treatment with palivizumab should be recommended on a case by case basis. A recommendation may depend on the likelihood of a child being admitted to hospital during the RSV season. This was likely to increase their risk of acquiring infection.

Treating Group 4 babies was likely to be very expensive and could not be recommended at this time.

9. Pneumococcal vaccine

9.1 Update on age policy

At its last meeting the Committee had recommended that pneumococcal vaccine be offered to all those aged 65s and over. The Committee was informed that the pneumococcal vaccine was now being offered routinely to those over 65s years in Northern Ireland and was under consideration in England and Scotland.

9.2 Pneumococcal surveillance

It was agreed that heightened surveillance of pneumococcal disease was essential to underpin any new immunisation initiatives. JCVI requested that PHLS should devise and cost an enhanced surveillance strategy.

9.3 Poster from ICAAC conference, September 2002 Effectiveness of Pneumococcal Polysaccharide vaccine in older adults.

This was provided for information.

9.4 Cochlear implants and the risk of pneumococcal meningitis

Information had been received from the US Food and Drug Administration and the UK Medicines Devices Agency that cochlear implant recipients may be at an increased risk from pneumococcal meningitis. In light of this the Department of Health revised its recommendations to add existing and prospective cochlear implant patients to the at-risk groups who should receive pneumococcal vaccine. Within these provisions, children under the age of two falling within the at risk groups should be offered Prevenar, whereas all those over the age of two should be offered the 23-valent pneumococcal polysaccharide vaccine.

10. MMR

The following interests were declared:

The Chair said that those with non-personal/non-specific interests could take full part. All those with personal interests could take part in the discussion but not participate in the decision-making.

Members agreed that there was no new information that changed the previous recommendation of JCVI.

10.1 Availability of single vaccines

The Committee was updated on the importation of single mumps vaccine from the Czech Republic that was claimed to contain the Jeryl Lynn strain.

It was noted that there were concerns about the safety and efficacy of this vaccine and the Committee on Safety of Medicines was to investigate this. It was also noted that the vaccine had unusual storage requirements (between –20^o and –10^o C).

The Committee was concerned about the use of this unlicensed product that had been grown in primary dog kidney cells and for which there appeared to be limited data on safety and efficacy.

10.2 Recent scientific research

The Committee was provided with recent research published on the safety of MMR, in particular the link with inflammatory bowel disease and autism. The following papers had undergone review by experts:

1. "Neuro-immunopathogenesis in Autism" V Singh. New Foundation of Biology 2001, 447-458.

2. Abnormal measles-mumps-rubella antibodies and CNS auto-immunity in children with autism. V Singh et al. Biomedical Science 2002; 9; 359-364

3. Small intestinal enteropathy with epithelial IgG and complement deposition in children with regressive autism. Torrente et al. Molecular Psychiatry 2002; 7(4);375-382

4. Development of an "allelic discrimination" type assay to differentiate between the strain origin of measles virus detected in intestinal tissue of children with ileocolonic lymphonodular hyperplasia and concomitant development disorder. O Sheils et al. Abstract presented at the Pathological Society of Great Britain and Ireland in July 2002.

5. Review article: the concept of entero-colonic encephalopathy, autism and opioid receptor ligand. A Wakefield et al. Alimentary Pharmacology and Theraputics 2002; 16: 663-674.

The following papers had not undergone external review but were provided and summarised:

6. Relation of childhood gastrointestinal disorders to autism; nested case-control study using data from the UK General Practice Research Database. C Black et al. British Medical Journal; 21 August 2002; 325:419-421.

7. Paper by Paul Shattock; Autism Research Unit, University of Sunderland.

8. Testimony to Us Congress by A Krigsman. June 2002.

9. Measles. A Donald and V Muthu. Clinical Evidence 2002; 7: 331-340.

10. Banbury Center Cold Spring Harbor Meeting on microbiology, immunology and toxicology of autism and other neurodevelopment disorders. February 11 – 14 2001.]

This paper had also been considered at the recent Committee on Safety of Medicines Vaccine Working Group. Their view was that this new evidence did not alter the CSM view: there was no evidence to support a causal link between MMR vaccine and autism and bowel disease.

JCVI found the papers helpful and expressed its strong support for the conclusion reached by the CSM.

The Committee also considered a summary of the comments from the experts on the quality and significance of the research. Members found this most helpful. It was agreed that this and subsequent summaries should be made publicly available on www.mmrthefacts.nhs.uk.

Members were told that the twenty districts in England with the lowest MMR uptake had agreed plans to increase uptake levels. Districts were working to their own action plan which met local needs, and considered issues such as quality of information systems, staff training and seminars for parent groups.

Professor Langman asked Professor Hall to chair this item as he had acted as an assessor for CSM for one manufacturers’ Product Licence application.

No interests were declared.

11.1 Information about medical and health care workers about BCG Vaccine.         JCVI(02) 61a

Evans had withdrawn all stocks of BCG vaccine because there was concern about its efficacy. Negotiations had been taking place with Statens Serum Institute (SSI) to supply vaccine, with the aim being that the new vaccine would be licensed and available at the beginning of December.

It was noted that new information had been prepared for healthcare workers and the public to explain the differences between the new vaccine and that used previously. Additional training may be required for healthcare workers involved in neo-natal programmes to explain the differences between the new and old vaccine.

It was agreed that the JCVI BCG Panel needed to be reconvened to consider the issue of BCG immunisation strategies for the United Kingdom. The Panel would report back to the next meeting of JCVI.

PHLS would be able to prepare some extra work to help inform the Committee’s decision.

12. Rubella vaccine supplies

Single rubella vaccine is offered to women of childbearing age who are not already protected against the disease. The Committee was informed that the Department of Health had sufficient supplies of single rubella vaccine to last until September 2003.

It was noted that the Committee may have to consider the advice it would need to provide for women to child-bearing age who are not protected against rubella if supplies of single rubella were no longer available.

A meeting of the Influenza Panel had met on 24 May to review the 2001/02 programme and seek advice on future policy and vaccines.

The minutes of this meeting were included for information.

14. Poliomyelitis elimination       JCVI(02) 64

The European region of the World Health Organisation (WHO) was certified polio-free on 21 June 2002.

CDR News Quarterly issue No 28 July 2002 was provided for information.

15. Memorandum – Immunisation against infectious diseases

The 1996 edition was now available on line at www.doh.gov.uk/greenbook.

Some chapters for the new edition had been received. However it was pointed out that outstanding draft chapters must be received by December if the new edition is going to be ready on line by April next year, and in hard copy by May. Delays in receiving these chapters would further delay the timetable for publication.

A sub-group had been established to look at this and would meet on 28 November. Professor Langman will chair the group, and it will also include other members of JCVI, and the Advisory Group on Hepatitis (AGH) and other independent experts.

17. Yellow Card Data – Adverse Reactions        JCVI(02) 65

This paper provided information on Yellow Card data received in 2002 for routine childhood vaccines. The data did not appear to provide any signals of possible emerging risks.

18. For information         JCVI (02) 66

The following papers were provided for information:

CMO letter August 2002 – Update on immunisation issues.

W135 transmission and the Hajj. Smith et al. British Medical Journal; 325; 17 August 2002; 365-366

On the 2002 measles vaccination furore in the UK. Editorial; Vaccine; 20 (2002) 2845-2847.

9. Dates for 2003 meetings:

Friday 7 February 2003
Friday 6 June 2003
Friday 3 October 2003

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copyright: © | published: 6 March, 2003