Attending
Professor Andrew Hall (Chair)
Professor Brent Taylor
Professor Paul Griffiths
Professor Alan Emond
Ms Anne McGowan
Professor David Goldblatt
Dr Paul Jackson
Professor Jonathan Friedland
Dr Richard Roberts
Professor Simon Kroll
Dr Syed Ahmed
Dr Ray Borrow
Mrs Vivienne Parry
Professor Brent Taylor
Mrs Pauline MacDonald
Dr Anthony Harnden
Ex-Officio
Professor David Hill - NathNac
Dr Steven
Inglis - NIBSC
Dr Jim McMenamin - HPS
Observers
Wg CDR Andy Green - MoD
Sq Leader Tania Thomas - MoD
Dr Parameswaram Kishore - Isle of Man
Invited to attend
Professor Elizabeth Miller - HPA
Dr Richard Pebody - HPA
Dr John Edmunds - HPA
Stephen Smith - Connecting for Health
Welsh Assembly Government
Mr Neil Robins
Scottish Executive
Dr Elizabeth Stewart
Department of Health
Professor David Salisbury (Medical Secretary)
Dr Dorian Kennedy
Dr Kevin Perrett
Dr Karen Noakes
Daniel Eghan (minutes)
Zoltan Bozoky
Pamela Gardiner
Jo Yarwood
Heather Lambert
Josie Senior-St.Juste
Kevin Scott
Peter Grove
Bela Vatsa
MHRA
Dr Mair Powell
Dr Philip Bryan
1. ANNOUNCEMENTS AND WELCOME
The Chairman welcomed all those present to the meeting. Pauline MacDonald,
Anne McGowan and Dr Ray Borrow were welcomed as new members now that
they had been officially appointed by the NHS Appointments Commission.
Dr Kevin Perrett and Bela Vatsa were introduced to the Committee as
the new members of the DH Immunisation Team.
The following members had sent their apologies: Dr Chris Verity and
Dr Claire Cameron (who was represented by Dr Jim McMenamin). Dr Lorraine
Doherty also sent her 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.
2. MINUTES OF THE LAST MEETING HELD 14 FEBRUARY 2007
Members agreed the following change:
The declarations of interest for members on agenda items 8, 10 and
11 should be consistent.
With this amendment it was agreed that the final minutes would be placed
on the website.
3. MATTERS ARISING
3.1 BCG statement
The Committee was pleased that the BCG statement had been placed on
the website. The Committee also noted that the statement needed to be
modified to clarify that travellers under 16 years of age who were:
- previously unvaccinated and tuberculin-negative; and
- going to live or work with local people for more than 3 months in
a country where the annual incidence of TB is 40/100,000 or greater
were recommended to receive BCG vaccine.
The Committee agreed that the modified statement would be placed
on the website.
The Chairman informed JCVI that NEPNEI has expressed concern at the
incidence in Drug Resistant TB (XDRTB). It was noted that the issue
would be discussed at a future JCVI meeting.
3.2 Tetanus
The Committee was informed that the issues around tetanus policy had
been discussed at a meeting of the JCVI chairman, DH officials and the
HPA. It was agreed that a document will be prepared for the October
meeting of JCVI.
3.3 Hepatitis B
The Committee was reminded of the further work on a targeted hepatitis
B vaccination approach in which immunisation is offered to all infants
with one or more parents born in a country with a high or intermediate
enemicity for hepatitis B, and in areas with higher Hepatitis B incidence.
This work was dependent on the availability of data from the Office
of National Statistics (ONS) on the likely number of children who fall
into this category, and this data had been requested.
It was noted that in some areas, where a significant proportion of
infants are recommended the vaccine, that implementation of the vaccination
programme may be easier to deliver by targeting all children in that
area.
A targeted vaccination approach was recently introduced in the Netherlands,
and Sweden are currently in the process of introducing a programme.
3.4 Hib catch up vaccination
Members were reminded that they had recommended at their last meeting
that the cohort of children who had not previously been offered a booster
dose of Hib vaccine, as part of the 2003 Hib catch-up campaign or at
12 months of age following its introduction in September 2006, should
be offered a booster.
The Hib booster will be offered as part of the pre-school immunisation
programme by temporarily changing the pre-school booster vaccine to
one that contains an additional Hib component. Accordingly, the current
pre-school booster will be temporarily changed from DTaP/IPV (Infanrix
IPV™) or dTaP/IPV (Repevax™) to DTaP/IPV/Hib (given as Infanrix-IPV+Hib™,
or alternatively Pediacel™). Older children who have already received
their pre-school booster will be offered Hib-MenC (Menitorix™).
Also, during the course of this campaign, the age at which the pre-school
immunisation is offered will be reduced - in areas where this is not
already the case - to between 3 years 4 months and 3 years 6 months
of age, in line with recommended best practice.
This will require that Infanrix-IPV+Hib™ and Pediacel™ are
used off label beyond the upper age limit of '36 months' and 'the fourth
birthday' respectively. In the case of Menitorix™, although there
is no upper age limit specified in the SPC, there is no experience of
its routine use in older age groups. The Committee noted that Pediacel™
is already currently used off-label in older children, in cases of uncertain
or incomplete immunisation. A similar vaccine to Pediacel™ is also
frequently used in older children in Canada. Some members asked to review
the available safety and efficacy data of these vaccines in older age
groups in order to come to a decision as there was a theoretical risk
that these vaccines could be more reactogenic in older age groups. Members
also noted that booster doses of aP containing vaccines, if they follow
primary immunisation with an aP vaccine, had been associated with an
increased risk of limb swelling. This is more common in countries where
a fifth dose of aP containing vaccine is recommended and is related
to an increased number of aP doses rather than older age of vaccination.
The Committee agreed that a small representative group meet
next week in a teleconference with the scientific data to support this
proposal.
4. JCVI processes
This paper providing draft text that could be placed on the JCVI website,
explaining the Committee's functions and decision making process was
tabled on the day.
The Committee agreed that members should give comments by e-mail.
5. Pandemic Flu update
Delivery plan for the pandemic flu vaccine
The following members declared interest in Sanofi Pasteur or GSK.
Professor Simon Kroll non-personal, non-specific
Professor Jon Friedland non-personal, non-specific
Dr Syed Ahmed non-specific, non-personal
Dr Ray Borrow non-personal, non-specific
Dr Stephen Inglis non-personal, non-specific
Pauline MacDonald non-personal, non-specific
Dr John Edmunds from the HPA also declared a personal, non-specific
interest.
A brief summary was given of what is covered by the draft national
plan for delivering vaccination in the event of a pandemic. A national
delivery plan is required to support the policy decisions on vaccination
outlined in the national framework for responding to an influenza pandemic.
The plan being developed covers the delivery of a specific pandemic
vaccine to the entire population and also the delivery of the current
limited stockpile of A/H5N1 pre-pandemic vaccine to health care workers.
The plan offers a model for immunising the whole population using a
specific pandemic vaccine over several months based on existing primary
care delivery systems. The plan concludes that the balance of arguments
favors a primary care based model.
Several points were raised by committee members. Vaccine supply security
was noted as a potential problem and it was suggested security arrangements
would be easier if a mass vaccination centre model was used. It was
also noted that prioritisation of specific pandemic vaccine would be
needed, particularly in light of the fact that producing sufficient
vaccine for the entire population would take several months. Questions
were raised about the criteria for prioritisation and the committee
asked that planning be strengthened in regard to this issue.
It was confirmed that sleeping contracts are now in place for specific
pandemic vaccine supply. It was noted that vaccine availability will
occur within a European and wider international context.
Members of the committee raised several questions about the practicalities
of delivering population-wide immunisation in the event of a pandemic,
and it was agreed that members would be invited to send in comments
on the full delivery plan.
Estimating the effect of vaccination against pandemic influenza
An age-structured transmission dynamic model was presented that estimated
the number of clinical cases and deaths prevented if vaccination was
offered before and after the first wave of influenza activity. The model
predicts that if a pandemic flu vaccine prevents infection as well as
providing individual protection then the most benefit is achieved if
children are vaccinated as a priority. This is because children are
known to be efficient spreaders of influenza virus due to high levels
of viral secretion and social mixing behavior. If a pandemic flu vaccine
only protects against disease, then more benefit is gained by vaccinating
those most at risk from influenza such as the clinical risk groups and
the elderly.
Predicting the effectiveness of a pre-second wave immunisation programme
is difficult because the size of the second wave of influenza is dependent
on the number of people still susceptible in the population. This type
of information, including the case fatality ratio, would be collected
during the first wave. It is likely that the second wave of influenza
activity would only be bigger than the first wave if seasonality comes
into the equation. If the first wave starts in the UK summer, then a
second wave occurring in the winter period could be bigger.
The Committee noted the importance of obtaining information on the
immunogenicity of any pandemic flu vaccine on these groups so that the
vaccine wasn't prioritised in a group for whom the vaccine wasn't immunogenic.
6. HPV subgroup
The following members declared interest in Sanofi Pasteur or GSK.
Professor Simon Kroll non-personal, non-specific
Professor Jon Friedland non-personal, non-specific
Dr Syed Ahmed non-specific, non-personal
Dr Ray Borrow non-personal, non-specific
Dr Stephen Inglis non-personal, non-specific
Pauline McDonald non-personal, non-specific
Dr John Edmunds (HPA) also declared a personal, non-specific interest
Additional papers were circulated prior to the meeting that summarised
the scientific evidence reviewed by the HPV subgroup.
The Chairman read out the executive summary of the HPV subgroup;
- The subgroup's view was that there is sufficient evidence on the
protective effect of HPV vaccines on cervical cancer in the UK to
suggest vaccination of girls at 11-12 years of age (in the first year
of secondary school) as part of a school-based programme in conjunction
with a sexual education programme (through Personal & Social Education-PSE).
The vaccine has been shown to have a good safety record, and be highly
effective in protecting against the precursors of cervical cancer. The
vaccine has been followed for 5 years in clinical trials so far, and
the level of antibodies remained at a high level and appears not to
decline. This suggests that the duration of immunity is expected to
be long-lasting.
The Committee discussed whether the programme would be more practical
for schools if the age was from 12-13 years old because the girls would
be established within the school and their records transferred to their
new school and up to date. A cross-sectional panel of serum samples
from women aged 10-29 years in England suggests that HPV seroprevalence
is low up to age 14 and then increases rapidly. Taking into account
that it can take from 6 months to up to a year to seroconvert and that
girls will start to become infected just before seroprevalence is seen
to rise, 12 to 13 years was considered to be an appropriate age to vaccinate.
- The subgroup considered that a catch-up campaign to include all
girls up to the age of 15/16 years would be beneficial.
The main Committee noted this advice and the need for a cost-effectiveness
analysis to consider this issue further.
- The subgroup strongly recommended the implementation of procedures
to record individual vaccination and other disease surveillance measures
to facilitate subsequent assessment of the impact of the vaccination
programme.
The Committee agreed with the need for careful recording of vaccination
data in order to assist the effective implementation of an HPV vaccination
programme, and to assessing the impact of the programme. A detailed
surveillance plan will be provided at the next meeting.
- The sub-group agreed that the effectiveness and cost-effectiveness
model developed by the HPA needed to be peer reviewed by biologists,
mathematical modellers and economists to ensure that the model was
robust.
- The main Committee agreed that peer-review of the HPA cost benefit
analysis would add rigour to the JCVI decision-making process.
- The subgroup noted that with any introduction of routine HPV vaccination
the national cervical screening programme should continue unchanged
until further investigation assesses the impact of immunisation on
its cost-effectiveness. This may also help to identify HPV related
cervical lesions that are not covered in the current HPV vaccines
and to evaluate the impact of the vaccination programme. It was suggested
that as the vaccinated individuals reach screening age, the frequency
of screening might need to be amended.
- Based on the data provided, the subgroup committee felt that further
analysis of the benefits of warts prevention was necessary to make
an informed decision on the choice of vaccine (bivalent vs. quadrivalent).
This was not essential to forming a recommendation on vaccination
in general, as the main objectives relate to the prevention of cervical
cancer. The sub-group favoured the use of the most cost-effective
vaccine against all endpoints, including genital warts.
The Committee agreed with the remaining conclusions of the subgroup
and would await the final peer-reviewed analysis before making detailed
recommendations. It was noted that this would be the first published
analysis that hadn't been funded or carried out by manufacturers of
the vaccine.
The Chairman pointed out that there were two recent vaccine safety
concerns reported by the media. Firstly, there were 3 reported cases
of death in women in the US who were vaccinated with HPV vaccine. However
the cause of death in all three cases was due to pre-existing medical
conditions (heart conditions and thrombosis) and were not related to
HPV vaccine. Secondly, the media reported 30 girls in Australia who
had recently been immunised with HPV vaccine and had fainted following
the injection but this was not directly related to the vaccine (because
fainting is know to have occurred in similar situations), nor was it
an unexpected observation in this age group.
Advice on the choice of HPV vaccine would be based on the cost effectiveness
of each vaccine taking into account that one does not protect against
genital warts caused by HPV types 6 and 11. The additional benefits
of vaccinating against genital warts would be examined as part of the
peer reviewed economic analysis.
With high vaccine coverage in girls, the vaccination of boys adds little
additional benefit to either the prevention of cervical cancer or genital
warts due to the expected benefits of herd immunity. There was not yet
any data on the efficacy of this vaccine against cancers also affecting
males such as anal, head and neck cancers. When more data becomes available,
high risk groups such as gay men would be considered.
A further point was raised about what advice should be offered to girls
and women requesting vaccination, who fall outside of these specified
age groups including the catch up. The JCVI agreed that their remit
was only to advise on the national programme and this was not for them
to address but noted this was an issue for DH.
The Committee agreed the following advice;
- HPV vaccines should be introduced routinely for girls aged around
12-13 years, subject to independent peer review of the cost benefit
analysis.
- An additional cost-effectiveness analysis to determine the benefits
of a catch-up for older girls was required before a recommendation
could be made by the main Committee. This would be available for the
meeting in October.
- Any new data on HPV vaccines would be kept under review by JCVI
7. Horizon Scanning
A summary paper highlighting new vaccine developments that were relevant
to the UK was presented. The vaccines in development were Meningococcal
group B, Pseudomonas aeruginosa, Staphylococcus aureus, Clostridium
difficile, Cytomegalovirus and Epstein-Barr virus. It was noted that
this review did not include progress on the development of vaccines
to protect against HIV, Malaria, TB and Hepatitis C which all were of
major global interest.
Meningococcal group B
The Health Protection Agency reported on clinical trials that were
being conducted by the National Vaccine Evaluation Consortium on candidate
Meningococcal group B vaccines. Recombinant vaccines that protect against
a broad range of strains are also being developed by Novartis. Phase
1 trials are showing promising results and interim immunogenicity results
are expected at the end of 2007. A carriage study in adolescents to
assess potential herd immunity from the candidate vaccines is planned.
A Lactamica vaccine being developed by the HPA was also being tested
in a phase 1 trial.
Pseudomonas aeruginosa
A vaccine against Pseudomonas aeruginosa for people with cystic fibrosis
is currently being developed by Berna Biotech. The vaccine is in phase
III trials in Europe and is believed to prevent the progressive destruction
of the lungs caused by colonisation.
Staphylococcus aureus and Clostridium difficile
Vaccines to protect against healthcare associated infections are a
high priority.
Trials on the S. aureus vaccine developed by Nabi were terminated in
2005 due to disappointing results. Prospects for a S.aureus vaccine
include a chloroform inactivated whole S.aureus vaccine being developed
by Vaccine Research International, who are currently taking a vaccine
into a phase 2 trial.
In February 2006, Acambis plc announced results from a Phase 1 trial
of its vaccine against C. difficile. A second phase 1 trial is currently
underway in healthy elderly adults with phase 2 trials also scheduled
to commence.
Cytomegalovirus
In 1999, the Institute of Medicine ranked a vaccine to prevent cytomegalovirus
(CMV) disease at the highest priority on the basis of the economic costs
that would be avoided and the years of life and disability that would
be saved by a successful vaccine. CMV is a cause of mononucleosis (glandular
fever) in healthy individuals and is a well known cause of serious morbidity
and sometimes fatal infections in immunocompromised individuals. Congenital
CMV infection can lead to deafness and other neurological problems.
A clinical trial is being conducted on a candidate vaccine at the Royal
Free by Professor Griffiths. Results are expected later in the year
and these would be reported back at a future meeting
Epstein-Barr virus
The Epstein-Barr virus is thought to be responsible for a number of
disease in addition to mononucleosis and Burkitt's lymphoma. It has
been proposed as a possible cause of Hodgkin's disease and nasopharyngeal
carcinoma. Separate lines of research are being carried out to develop
vaccines to prevent glandular fever and the possible cancers caused
by EBV.
8. Rotavirus
A subgroup consisting of JCVI members, laboratory scientists, clinicians
and epidemiologists were asked via correspondence to review published
papers on rotavirus disease burden, vaccine efficacy and safety and
cost effectiveness. They were asked to comment on the suitability of
these vaccines for the routine immunisation programme, including where
the two vaccines were interchangeable and whether they could be safely
given with the other vaccines already in the programme.
The subgroup considered that:
The conclusions of the subgroup would be written up in detail and reported
at the next meeting, together with additional safety data from post-marketing
surveillance.
9. COVERAGE
9.1 & 9.2 Quarterly COVER report for England
The quarterly vaccination coverage statistics for the United Kingdom
for the period October to December 2006 were presented to the Committee
in paper JCVI(07)40 and JCVI(07)41.
The Committee noted that uptake of the primary vaccinations ranged
from 93.7% in England to 98% in Scotland (by aged 24 months). MMR uptake
at the same age ranged from 85% (England) to 92.8% (Scotland), with
all countries seeing an encouraging increase in MMR uptake over the
last couple of years. It is hoped that the increase in MMR uptake will
continue in future months.
The overall uptake was encouraging but the Committee expressed its
concern at the continuing lower vaccination uptake in London.
9.3 Informatics update
The DH Immunisation Informatics team presented on the background and
process leading up to the deployment of the Health Protection Informatics
Website and the projects delivered and being developed by the team.
These included projects for pandemic preparedness, the influenza surveillance
programme, pneumococcal vaccine uptake, seasonal influenza vaccine uptake,
and an Immunisation leaflet service as well as developments on the web
site itself to enable geographic mapping, role profiling and new web
links which have now been incorporated.
Enhancements to the COVER collections to be deployed later this year
and the development of a new vaccine supply project to be piloted this
year and deployed next year were also outlined.
In addition, the team were participating in a new National Child Health
Board that had been set up by the Connecting for Health team to co-ordinate
IT standards in child health systems. In conjunction with this an Immunisation
subgroup is being set up by the Immunisation team to be chaired by Professor
David Salisbury.
9.4 Connecting for Health
A paper was presented by Connecting for Health.
In summary the Information and IT support for child health services
is currently provided mainly through a range of standalone IT systems
(including Child Health systems and GP systems) in health and social
care agencies. These typically cover specific functional needs rather
than providing a holistic view. The NPfIT Child Health Programme is
exploring potential opportunities to ensure that professionals (and
parents and carers) can access an integrated child health record and
that system development and deployment plans are aligned with the emerging
pattern of service delivery by NHS and other agencies.
The overall aims of the NPfIT Child Health Programme are to ensure that
NPfIT work programmes take account of and reflect the requirements of
child health and related maternity services which includes consistency
across the country in core content, and to establish and provide a definitive
source of advice and guidance for NPfIT programmes and suppliers on
these requirements.
The principal specific objectives of the NPfIT Child Health programme
are to:
1. Define a standard child health record for use by NHS and other agencies
and parents and carers to support both the provision of preventive and
therapeutic care to the individual and the planning and delivery of
services to children across all settings, and a 'reference specification'
for child health information systems (CHIS) used by child health organisations
(usually PCTs).
2. Ensure that requirements and delivery are aligned with a coherent
and widely accepted clinical and business model for child health and
related maternity services.
3. Develop a business case for investment to deliver a child health
record, along with a strategy for delivery of the child health record
and for CHIS compliance with the reference specification, including
procurement and commercial strategy, technical architecture (including
interfacing/ integration), existing systems and planned developments,
and business process redesign.
4. Plan, commission and manage delivery (by NHS CFH and others) of the
solutions and services.
5. Provide direction and guidance to NHS CFH and other organisations,
including NPfIT suppliers, regarding current and planned IT support
for child health services, to ensure convergence, compatibility and
consistency.
The Committee was informed and supported the programme of work,
it was also reminded that consultations are still taking place looking
at data quality and matching issues.
10. SEASONAL INFLUENZA VACCINATION
The following members declared interest in Sanofi Pasteur or GSK.
Professor Simon Kroll non-personal, non-specific
Professor Jon Friedland non-personal, non-specific
Dr Syed Ahmed non-specific, non-personal
Dr Ray Borrow non-personal, non-specific
Dr Stephen Inglis non-personal, non-specific
Pauline MacDonald non-personal, non-specific
Dr John Edmunds also declared a personal, non-specific interest
10.1 Flu review progress report
The Committee was updated on the seasonal flu review, which was published
on 8 March 2007 alongside a Written Ministerial Statement.
A main conclusion of the Review is the achievements already reached
by the programme, its management and the high uptake in England. Year
on year increases in vaccine uptake led the NHS to achieve the WHO target
of 75% coverage of older people in 2005/06, ahead of 2010 target. Uptake
was slightly lower in 2006/07 due to delays in vaccine supply.
The Review contains 14 recommendations for the DH and NHS to consider
including the current vaccine supply system and the scope of improving
the national programme. DH is continuing to work on the recommendations
appropriate, and will keep JCVI updated on developments. .
10.2 Immunisation of Poultry workers
An oral update provided about programme which was introduced in December
2006 following expert advice that a theoretical risk existed for circulating
human flu virus to genetically re-assort with avian flu virus, thereby
producing a new flu virus. 90% of PCTs ran schemes.
The DH estimated a maximum possible of 75,000 poultry workers although
recognised that it would be highly unlikely that the NHS would be able
to reach all of these through the programme. Data was collected centrally
through the DH Health Protection Informatics website and is currently
being validated.
The Committee were also informed of the latest Defra assessment of
risk of avian influenza for the UK, based on the migration of birds
confirming the current risk of avian influenza is low, but not nil.
The Department is likely to run the programme again this winter.
10.3 Flu uptake CMO letter
The Committee was pleased that the CMO letter announcing the seasonal
flu programme had been sent out in March this year, earlier than ever
before. It also noted that vaccination uptake in 2006/07 was 74% in
those aged 65 years and over.
10.4 Roles and responsibilities of Flu coordinators
DH gave a summary paper on the roles and responsibilities of Flu Coordinators.
The Seasonal Flu Review had highlighted the importance of the Flu coordinators,
and suggested that their roles needed to be clarified.
At this years Flu Coordinators Conference, a helpful discussion was
held on what resources were needed by PCT Flu co-ordinators. In light
of these discussions, DH will work with a group of co-ordinators to
develop a 'toolkit' providing information on the various issues upon
which PCT co-ordinators want advice and guidance.
10.5 Flu subgroup minutes
The Committee was informed that the minutes of the JCVI flu sub-group
had not yet been signed off, and that they would be completed as soon
as possible.
11. Health Professionals Survey
DH explained that the survey is conducted in six annual waves of research
that
have been conducted among health professionals from 1999 to 2005.
The Committee agreed that this was a useful paper and would be helpful
data for training purposes for health professionals.
12. Articles for information
The following articles for information were bought to the Committee's
attention.
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are here: 