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Joint Committee on Vaccination and Immunisation
Members
Ex-Officio Observers Invited to attend Northern Ireland Department of Health Dr Dorian Kennedy (Admin Secretary) MHRA
The Chairman welcomed all those present to the meeting. Professor Alan Emond, Professor Simon Kroll, Dr Paul Jackson, and Dr Christopher Verity had sent their apologies. 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. The Chairman noted that this was Dr Elizabeth Stewart's last meeting, and she was thanked for her valuable contribution to the work of JCVI.
Members agreed the following changes: i) Page 1 under "Attending" Professor Brent Taylor's name to
appear only once. With these amendments, it was agreed that the final minutes would be placed on the website.
3.1 Revised Declaration of Interest The Committee considered a short paper on the declaration of members' interests. The paper included a review of Members' declaration of interests and, with the JCVI agreement; these changes would be reflected in revised JCVI website text, and the annual and meeting templates. Currently new members had to declare interests for the last three years while existing members for the last 12 months. The Committee agreed that these two should be consistent and agreed that one year for both was preferable. It was agreed that consistency with the rules for other committees should be checked.
Paragraph 8 'Members with non-personal specific interests will be able to answer direct questions from the chair but not take part in the decision making'. Paragraph 15 should reflect that in general JCVI subgroup members should not have a personal specific interest in the topic under discussion. However, in exceptional circumstances where they have particular expertise, they could be invited to attend the meeting but could not take part in any decision making from the subgroup. On the annual declaration of interest form, it was clarified that a (Consultancy), b (Fee paid work) and c (Shareholdings) applied to both specific and non-specific interests. On the JCVI meeting template under footnote c, the text 'has at any time' should be change to 'in the last year' in order to be consistent with JCVI rules. The question of whether support for travel to attend events was also raised. It was suggested that if a JCVI member has their travel for a conference or meeting paid directly by the pharmaceutical company; this should be declared as a personal interest. If however, they were asked to attend an event but their travel was paid by the organisers (and not by the pharmaceutical company) then this would need to be declared as a non-personal interest. The Committee agreed in general with the changes proposed. The Secretariat would send the revised declaration of interest documents to Members by correspondence for final agreement.
The Committee was informed of the processes involved in updating the Green Book on the DH website. They were informed that 'patches' are available that can be printed off and stuck over the relevant section in the Green Book. Updates to changes to the chapters would continue to be communicated through 'Vaccine Update' or a CMO letter as appropriate. The Committee agreed that the updates of the Green Book on the website were an excellent idea and the chair noted that the patches worked very well. Members were reminded that if they wanted to receive Vaccine Update, they should inform the Secretariat and they would be added to the circulation list. 3.3 Update on NICE vaccination inequalities The Committee was updated on progress regarding the NICE project 'Guidance on mechanisms to reduce inequalities in the uptake of immunisation amongst individuals under the age of 19 years (including targeted vaccines)'. Two JCVI representatives (Professor Brent Taylor and Ms Anne McGowan) will be attending the NICE vaccination meeting tomorrow. DH has submitted its comments for the first round of the process. The Chair is to write to NICE about clarifying that the JCVI believes the project should be studying the impact of inequalities on immunisation not inequalities in immunisation.
The following member declared interests in Sanofi Pasteur, and in GSK. Dr Ray Borrow non-personal, non-specific A draft JCVI statement on tetanus immunisation was presented to the Committee for consideration. In the general population, the incidence of tetanus disease is low in the UK. Since 2003, the epidemiology has changed with cases occurring in injecting drug users who are now the most important risk group. The Committee was informed that since 2001 some Accident and Emergency (A&E) departments took up the advice published in the Green Book not to give a booster dose at the time of injury. Instead, some A&E departments are referring patients to their GP if their tetanus vaccinations are incomplete risking failure to make a follow-up appointment with the GP. The committee agreed that the current policy should stand and that people should continue to be offered 5 lifetime doses of tetanus vaccine. The committee asked for the following amendments: A&E departments should take the opportunity to vaccinate if there is doubt that the person is fully immunised (i.e. has completed 5 doses of tetanus vaccination). After being given a booster dose the patient should be referred to their
GP, who should have a record of their vaccination history. The HPA was asked to draft a short document to circulate to members on the proposal to use Human Normal Immunoglobulin (HNIG) in place of Tetanus Immunoglobulin (TIG) for the treatment of tetanus-prone wounds when supplies of TIG were short. 5. Pneumococcal The following members declared interests in Sanofi Pasteur, Wyeth or GSK. Professor Simon Kroll non-personal, non-specific
1. to continue with the pneumococcal polysaccharide immunisation programme for older people. This programme was providing protection against invasive pneumococcal disease at a level estimated prior to the introduction of the programme although of shorter duration than had been predicted. This advice should be reviewed when firm data on the impact of herd immunity from the pneumococcal conjugate immunisation programme is available. 2. that the use of pneumococcal polysaccharide vaccine (PPV) in specific risk groups should be extensively reviewed taking into account the effects of herd immunity and the future availability of conjugate vaccines with increasing valency. The benefits of immunisation with PCV in certain risk groups would also be reviewed. 3. there is a theoretical risk that the administration of PPV after PCV, and the administration of PCV after PPV may attenuate the immune response to these vaccines but there was little clinical information to guide any change in practice at present. The HPA are currently conducting a review of the evidence on PPV and PCV combinations and repeated boosting with PPV and this would be considered by the subgroup at a later date. 4. there is not enough evidence to recommend the extended use of PPV in the event of a pandemic but more data will be reviewed on the benefits of vaccinating young healthy adults. It was noted that three members of the subgroup had personal specific interests and were permitted exceptionally to participate in the discussions due to their expertise in the subject. However, they did not take part in formulating the advice. The committee agreed the advice from the subgroup, and noted that the subgroup would meet in early 2009. Data on the impact of the pneumococcal conjugate programme, particularly the impact of disease in older people (herd immunity), would be available then from the 2008-2009 winter season. An extensive review of the literature regarding PPV and PCV in risk groups will also be completed in time for the next subgroup. The Committee discussed the term 'renal failure' in relation to the Green Book guidance on vaccinating 'at risk' groups. The Committee agreed with the subgroup that renal failure should be judged on an individual basis and was a matter of clinical judgement. It was noted that previously a specialist group has provided advice about renal failure as a risk group for flu vaccination. The Secretariat will seek advice from this group and circulate the findings to the JCVI Committee. Final minutes of the subgroup meeting would be published once agreed by members. 6. Varicella/Herpes Zoster subgroup The following member declared interests in Sanofi Pasteur or GSK. Dr Ray Borrow non-personal, non-specific
The minutes once agreed by subgroup members would be posted on the DH JCVI website. 7. Pandemic Flu The following members declared interests in Sanofi Pasteur, GSK, Baxter, Novartis, or Merck. Professor Jon Friedland non-personal, non-specific The DH Secretariat provided an update on some of the WHO's current pandemic influenza vaccine considerations. Three meetings had been held recently to consider pre-pandemic vaccines. The first held late last year examined the safety and immunogenicity of candidate H5N1 vaccines. They concluded at this meeting that such products were safe and effective, based on immunogenicity data gathered from clinical trials of this product and also on the similarity of these vaccines to pre-existing flu vaccines. A further two meetings have discussed WHO's stockpiling requirements. The WHO Director-General asked the Strategic Advisory Group of Experts (SAGE) to make recommendation for the use of a WHO stockpile of H5N1 pre-pandemic vaccine. The recommendations made were for the WHO to maintain two stockpiles. The first of 50 million doses would be used as a rapid response upon H5N1 human-human transmission in any country. The second stockpile (100 million doses) would be maintained for low and middle income countries and would be distributed on an equal basis to cover 2% of that population. Individual countries would decide how best to use this vaccine, for example to protect essential workers, vulnerable risk groups etc. The need to consider shelf-life extensions to these products had been considered. The Chair informed members of the establishment of a new pandemic influenza committee, headed by Professor Sir Gordon Duff, to replace the previous Scientific Advisory Group (SAG). The Chair of JCVI will sit on this group and represent this committee to ensure close working between the two. 8. Group B streptococcus The Chair reported that a letter had been received from Dr Anne Mackie, Director of the UK National Screening Committee, around the development of a vaccine to prevent Group B streptococcus (GBS) in the newborn. The letter suggested that there were 'legal and regulatory' obstacles to the progress in developing a vaccine indicated for pregnant women. The Committee agreed that there were certain ethical issues for consideration for a clinical trial to evaluate the use of medicines, including vaccines, in pregnant women. There may also be legal issues regarding liability when conducting clinical trials. In terms of regulatory issues, the MHRA reported that the European Medicines Agency (EMEA) has a flexible approach to overcoming the barriers to developing products for pregnant women such as the use of correlates of protection. The MHRA advised that any company wishing to pursue a GBS vaccine could seek advice from the Committee for Medicinal Products for Human Use (CHMP) at EMEA. The Committee agreed that it would be useful to have an update on the progress of GBS vaccine development. Both Novartis and Wyeth are understood to be conducting trials on GBS conjugate vaccines, and a paper would be presented to the Committee at a future meeting. The Chair would write back to Dr Anne Mackie regarding this discussion. 9. Q fever The Chair reported that a letter had been received from the Health and Safety Executive (HSE) for advice on the use of Q Fever vaccination for high risk occupational groups such as abattoir workers, vets and farmers. In Australia such workers are routinely offered Q fever vaccination. Q-vax vaccine is licensed in Australia but is not licensed elsewhere. The vaccine is reported as being highly effective with protection lasting 5 years. Because the whole-cell vaccine is highly immunogenic and there is a possibility of severe reactions to the vaccine in previously exposed individuals, pre-immunisation screening is required to exclude individuals previously exposed to Q fever bacterium Coxiella burnetii and individuals who have previously received the vaccine. Two papers recently reviewed by the Advisory Committee on Dangerous Pathogens (ACDP) were included for information. Although vaccine protection against disease was known to last for up to 5 years, it was not known whether the vaccine would reduce severity of disease beyond that time. The Committee was asked to consider whether the vaccine could be used in the event of an outbreak of Q fever among workers or whether it would need to be given routinely. Based on the experiences of outbreaks in Scotland, the view of those who had evaluated the outbreak was that there would be no window of opportunity to vaccinate workers in an outbreak. There is a long lag period between exposure to, and diagnosis of, Q Fever so many people would already have been exposed before the outbreak was identified. It was noted that there were also operational issues in delivering the vaccination programme. For example, GP practices do not routinely administer intradermal injections. The Committee asked the Secretariat to obtain more information on how the Q fever vaccination program is delivered in Australia, and to find out whether alternative acellular Q Fever vaccines are available. Observers for Northern Ireland also agreed to pull together data on recent Q Fever outbreaks that had occurred in Northern Ireland. The Chair would write back to HSE to convey the Committee's views. 10. Coverage 10.1 & 10.2 Quarterly COVER report for England and UK The Health Protection Agency (HPA) reported on vaccine coverage in England between July - September 2007. Eight PCTs, all within London SHA, were unable to provide any vaccine uptake data. Vaccine coverage in England at 12 and 24 months was similar to the previous quarter, with 90% of children receiving three doses of Diphtheria, Tetanus, Pertussis, inactivated polio and Hib combined vaccine (DTaP/IPV/Hib) by 12 months of age, and 84% of children receiving their first dose of Measles, Mumps and Rubella (MMR) vaccine by 24 months. Coverage of neonatal hepatitis B vaccine was 70% for England and was highest in London (76%). Data on coverage of the Pneumococcal Conjugate Vaccine (PCV) was reported for the first time. The number of children receiving two doses of PCV vaccine by 12 months of age was 88%. This was similar to the uptake when MenC vaccine was first introduced. For the catch-up for children aged 13-24 months, 65% of children were reported as having received one dose of PCV as part of the catch-up campaign. This figure may be an underestimate. Northern Ireland reported stable and mainly high vaccine uptake but noted that there had been a problem with the main Child Health System in Northern Ireland and this meant that some areas had been unable to either schedule vaccinations or monitor vaccine uptake. Scotland and Wales also reported high vaccine uptake rates at 12 and 24 months. The DH Secretariat reported that a series of meeting had been held between the Department and the London SHA. This followed continued concern from JCVI about low vaccination uptake reported, and data collection problems in London, and following a report from the Greater London Authority (GLA) on low vaccine uptake rates in London. The Committee was informed that London SHA had confirmed that the NHS Operating Plan for London would include an additional priority on immunisation. It would come into effect from April 2008. Also the London Joint Strategic Board for Young People and Children had also recognised immunisation as a key issue. DH also reported that it was planning to hold a joint immunisation conference with London SHA in April. Measles outbreaks in London The North-West London Health Protection Unit presented data on the measles
outbreak of 2007. Cases have also been reported in hospital settings. It was suggested that some Acute Trusts did not have robust MMR vaccination policies for health care workers. It was noted that low vaccination uptake in some members of the Orthodox Jewish Community was linked to issues around access to primary health care services rather than perceived safety concerns around the vaccine. It was also noted that some PCTs no longer routinely send out appointments for immunisations, and therefore the onus is on the parent to remember when a child's appointment is due and to arrange an appointment at the surgery accordingly. The Committee expressed its concern about the ongoing measles epidemic in London, and noted that other parts of the country may be vulnerable to similar outbreaks. The Committee advised that more needs to be done locally, including the roll out of IT systems that are able to issue immunisation appointments and are able to provide data on who has been vaccinated, and who needs to receive further invitations. The following members declared interests in Sanofi Pasteur, GSK, Baxter, Novartis, or Merck. Professor Jon Friedland non-personal, non-specific
The advice to use antivirals remained in place as virological surveillance had shown a slight increase in the circulation of influenza B strains. Influenza B tends to circulate in February and affect young people/communities so another peak of influenza activity might be expected in the next couple of weeks. There have been no problems with vaccine supply this year. In England, provisional vaccine coverage is 74% for people aged 65 years
and over, and 46% for those in clinical risk groups that are aged under
65 years. The Department is also working on how best to communicate the importance of influenza vaccination to HCWs. It was noted that the strength of the evidence used as a rationale for vaccinating HCWs should be emphasised in communications to health professionals. Provisional data from the poultry worker immunisation programme indicate around 20% vaccine uptake so far but data collection was not finishing until the end of March. It was also noted that data from occupational health departments may not have been included in the data return so far. Flu vaccination coverage in Scotland for the 65 and over programme is under 70%, and in the under-65 risk groups it is 45-55% and will not reach the 60% target. No data was reported for poultry workers. No data was reported for Wales. The Committee noted that there will be no changes to the risk groups for the forthcoming season. 12. Horizon Scanning: Cytomegalovirus (CMV) vaccines The Committee was given a presentation on scientific progress for Cytomegalovirus (CMV) vaccines. The Committee was made aware of the importance of CMV as a pathogen in congenital infection, transplant patients, AIDS patients, the elderly and those in intensive care. A viral load threshold needs to be exceeded for manifestation of disease, and steroid use is known to lower this threshold. Infection can be primary, a reinfection or a reactivation, and immunisation may prevent the first two. The US Institute of Medicine Report, 2001, concluded that CMV vaccination would be cost-saving (cost per QALY of -$50,000), and made it a top priority. There are ongoing clinical trials in normal individuals, toddlers, women of childbearing age, adolescents and transplant patients, and initial data are encouraging. The Committee noted this issue and agreed to consider it again when results
from further vaccine trials became available. The following members declared interests in Sanofi Pasteur or GSK. Professor Jon Friedland non-personal, non-specific The Department of Health updated the Committee on how they are dealing
with the implementation of the HPV vaccination programme. The following
were noted: The Committee noted that a CMO letter would address many of the implementation issues for PCTs. Comments on the draft Green Book HPV chapter were requested from the Committee. The Committee also briefly discussed post-implementation research, for which the MRC has received an application for funding. It was also noted that the Australian SPC for Cervarix has been amended to permit a more flexible schedule. 14. Vaccine supply The Committee was given a summary of the supply of vaccine for the routine childhood immunisation programme in the UK. The Department purchases vaccines for the childhood immunisation programme, and distributes them free of charge to the NHS. As a general rule, if there is only one supplier of a vaccine, then the Department may hold about six months worth of stock at its central storage facility. This helps reduce the risk to supply of vaccine should a manufacturing problem occur. When there is more than one supplier of vaccine, about 3 months of vaccine may be held centrally. The Committee was informed that the policy of central purchase and distribution had resulted in a continuous supply of vaccines (with no shortages) for at least the last five years; competitive prices could be achieved through bulk purchase; and vaccine wastage could be minimised. It was noted that a different system was used for the supply of influenza vaccines (the GP is responsible for the purchase of flu vaccine from the supplier), and that this system could cause problems when vaccines were in short supply or delayed. The Committee also noted that a number of vaccine shortages had occurred in other countries over the same timeframe, and that the same shortages had not occurred in the UK due to the central purchase and supply of vaccine. The Committee agreed that the centralised system has been highly effective in maintaining a continuous supply of vaccines for the routine childhood immunisation programme in the UK, and that this system had advantages over more local systems. The Committee also advised that the information on vaccine supply should be made more widely available as it was an important part of the overall vaccination programme. 15. Articles for information The following articles for information were bought to the Committee's attention. " Vaccine Damage Payment Scheme The Committee discussed the paper by the Future II study group on the efficacy of HPV vaccine. The chair noted that it is still unclear, and difficult to work out from the data, whether people who are serologically positive but PCR negative are protected against the virus to which they were previously exposed. The Chair asked for this paper to be considered by the HPV subgroup via correspondence. 16. AOB The chair had received two letters from intensive care neonatologists questioning the use of Palivizumab for RSV in premature infants as was expensive. It was commented that Scotland has or is producing guidelines on neonatal practice so perhaps a review of this issue had already been conducted. The Chair noted that the HTA were conducting an economic review of the issue which should be available shortly. Trusts in Manchester were also planning an audit on the use of Palivizumab. It was agreed that this data should be reviewed by JCVI and the current recommendation re-considered. The Committee also discussed the hexavalent vaccine (Hib, HepB, pertussis, diphtheria, tetanus, and polio) and agreed that Professor Miller would be asked to present a summary of the pros and cons of the choice of childhood combination vaccines at the next meeting.
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