Attending
Professor Andrew Hall (Chair)
Professor Brent Taylor
Anne McGowan (observer)
Professor David Goldblatt
Dr Paul Jackson
Professor Jonathan Friedland
Dr Richard Roberts
Professor Simon Kroll
Dr Syed Ahmed
Mrs Vivienne Parry
Pauline McDonald (observer)
Ex-Officio
Professor David Hill - NathNac
Dr Claire Cameron -HPS
Observers
Wg CDR Andy Green - MoD
Sq Leader Tania Thomas - MoD
Dr Parameswaram Kishore - Isle of Man
Dr Theresa Tam - Canada
Dr Hester De Melker - Netherlands
Invited to attend
Professor Elizabeth Miller - HPA
Dr Mary Ramsay - HPA
Dr Richard Pebody- HPA
Dr Dan Salmon
Dr Kevin Perrett
Dr Sowsan Ataban
Welsh Assembly Government
Dr Mike Simmons
Mr Neil Robins
Scottish Executive
Dr Elizabeth Stewart
Department of Health
Dr David Salisbury (Medical Secretary)
Dr Dorian Kennedy
Pamela Gardiner (minutes)
Dr Karen Noakes
Dr Arlene Reynolds
Zoltan Bozoky
Heather Lambert
Josie Senior-St.Juste
Tim Hopson
Jo Yarwood
MHRA
Dr Philip Bryan
Sarah Cumber
Parvinder Phul
1. ANNOUNCEMENTS AND WELCOME
The chairman welcomed all those present to the meeting. Pauline McDonald
and Anne McGowan were welcomed and had been invited to attend in advance
of their official appointments letter from the Appointments Commission.
Dr Hester De Melker from the Netherlands and Dr Theresa Tam from Canada
were also welcomed.
The following members had sent their apologies: Professor Alan Emond,
Dr Chris Verity, Dr Anthony Harden and Dr Stephen Inglis.
2. MINUTES OF THE LAST MEETING HELD 18 OCTOBER 2006
Members were informed that the draft minutes of the last meeting had
been placed on the JCVI website and were invited to comment. The following
changes were agreed:
(i) On section 2 Minutes of the last meeting…… amended to'21
June 2006'
(ii) On section 4, last paragraph last sentence deleted and replaced
with 'In future years, as a result of expected additional capital investment
from the Department and contributory funding from a consortium of manufacturers,
NIBSC will provide additional support for production of new virus strains
for vaccine production'.
(iii) Delete Mrs Vivienne Parry from the list of those attending and
insert Professor David Goldblatt and Dr Desmond Walsh as attending.
The final minutes will be placed on the website.
3. MATTERS ARISING
3.0 Connecting for Health
The Committee was informed of the progress being made by Connecting
for Health (CfH) on immunisation issues.
The London PCTs currently using the problematic system CHIA, elected
in January to move to the RiO Community Health system which has become
the CfH strategic solution for London. A number of other PCTs are already
using this system and others will be moving towards it in the near future.
There are some concerns regarding the new system but the DH team is
working with the HPA, the PCTs and CfH to minimise possible risks.
It has agreed an Immunisation Programme Board to oversee appropriate
standards for future IT systems which may impact the national immunisation
programme. David Salisbury will chair this Board, which is to hold its
inaugural meeting in March.
3.1 JCVI Position Statement on BCG immunisation policy
The Committee reviewed the surveillance data on the incidence of tuberculosis
(Focus on Tuberculosis, 2006), and considered whether BCG immunisation
policy needed to be reviewed.
The Committee noted that the incidence of TB had increased by 11% in
case numbers compared to 2004. The rate of TB in the UK-born population
remained relatively stable between 2000 and 2005, whereas the rate of
disease in the non-UK born population increased each year over the same
period. In the UK-born population, the highest rates occurred in Black
African, Indian, Pakistani and Bangladeshi ethnic groups. In the non-UK
born population, those belonging to the Indian, Pakistani and Bangladeshi
ethnic groups accounted for the highest number of cases, while the highest
rates occurred in the Black African ethnic group.
The Committee noted that the data presented showed that there was no
substantial change in the epidemiology of the disease or the population
subgroups who are most affected.
The Committee agreed that the current targeted BCG programme remained
the most appropriate for the risk of TB in the UK. It was agreed that
a priority needed to be focusing the efforts on targeting the highest
risk groups.
The Committee agreed that there should be a JCVI statement on this
topic to ensure transparency of the basis of their advice.
3.2 JCVI subgroup timetable
The chairman updated the Committee with the timetable arrangements
for the subgroups for the coming months, with the HPV subgroup planned
for 28 February, and the flu sub-group planned for 6 March.
Members were asked to inform the secretariat should they wish to
be involved in any of the subgroups.
3.3 Tetanus
The following members declared interest in Sanofi Pasteur or GSK
Professor Simon Kroll non-personal, non-specific
Dr Syed Ahmed non-specific, non-personal
Dr Claire Cameron non-personal, non-specific
Pauline MacDonald non-personal, non-specific
Members were reminded of the brief discussion at the end of the last
meeting about tetanus vaccination. The HPA had prepared a paper on the
issue, and DH had prepared some additional information.
In order to scope the work and progress it efficiently, the Chairman
agreed to hold a meeting with DH and HPA officials to review the available
evidence and agree a suitable way forward.
3.4 HPV
The following member declared interest in Sanofi Pasteur or GSK
Professor Simon Kroll non-personal, non-specific
Dr Syed Ahmed non-specific, non-personal
Dr Claire Cameron non-personal, non-specific
Pauline MacDonald non-personal, non-specific
The Committee was informed that the HPV subgroup was considering new
data on seroprevalence of HPV types by age in UK, mathematical modeling
and cost-effectiveness. However it was noted that further modeling data
was not expected until September. Also the complexities of the issues
had initially been underestimated.
It was agreed that the data being collected over the summer was
essential for the JCVI's consideration on HPV vaccines
Dr Tam reported that Canada was at a similar point in their consideration
on HPV vaccines.
The Committee agreed that it needed to state clearly and openly the
current position on HPV vaccines, and map out its future discussions
on the issue.
3.5 Human H5N1 vaccine and avian influenza in birds
The Chairman explained that the Department of Health sought his advice,
as JCVI Chairman, on the use of existing supplies of H5N1 vaccines held
by DH. His advice was sought in light of the recent avian flu outbreak
in turkeys in Suffolk.
Based on previous discussions in the Committee, the Chairman had advised
the following:
- The H5N1 vaccine had been purchased to vaccinate front line health
workers should a pandemic occur involving this flu strain; and for use
in research. It was noted that this was an unlicensed product with limited
safety data.
- At the time of giving advice, it was hoped that the current poultry
outbreak has been contained and that there is no current evidence of
bird to human transmission in this country. In this situation the risk/benefit
balance did not favour using this vaccine in those in contact with poultry.
- This situation should be reviewed if the infection spreads within
the UK poultry flock but even then it is doubtful if H5N1 vaccination
would be indicated unless there were evidence of person to person transmission
or a high rate of bird-human transmission with severe resulting disease.
The Committee agreed with the response the Chairman had given on their
behalf.
4. EVIDENCE BASE FOR POLICY DECISIONS - SUMMARY PAPER
The Committee considered a paper outlining the current processes involved
in reviewing the evidence that underpins JCVI advice. It considered
ways in which the process could be made more robust and transparent.
The process by which JCVI makes policy decisions is similar to other
national bodies such as the American Advisory Committee on Immunization
Practices (ACIP) & the Canadian National Advisory Committee on Immunization
(NACI).
The key stages of the current process are:
a) identification of relevant information from a range of sources
b) systematic review of the evidence taking into consideration its quality
and validity
c) review of cost-effectiveness work and qualitative research
d) expert review of published and unpublished information or ongoing
research
e) commissioning of work
f) provision of summary papers routinely to JCVI outlining the evidence
base for recommendations
g) agreement and publication of recommendations on the JCVI website
with accompanying background papers outlining the evidence base
The paper proposed a number of ways in which the current process could
be made more systematic;
a) the use of inclusion and exclusion criteria for selecting papers
b) documentation of the search strategy used, and inclusion and exclusion
criteria used
c) grading of the level of evidence on which a recommendation is based
d) grading of recommendations based on the strength of supporting evidence
e) the use of evidence tables in the appraisal process
f) formalising the process of putting JCVI statements and supporting
background papers on the JCVI website
JCVI welcomed the principles outlined in the paper, including the suggestion
of the grading of research papers and the use of inclusion/exclusion
criteria. It also agreed that it would be helpful to explain more clearly
on the JCVI website how the Committee reached its decisions.
The Committee was concerned that following an inflexible, formal and
resource intensive procedure could result in very significant delays
to the JCVI decision-making process. It felt that any procedures agreed
needed to be proportionate to the level of change to policy or importance.
For example, major decisions on national policy needed to be supported
by a very robust evidence base, whereas decisions on small modifications
to a risk group could be made using a less detailed analysis.
The Committee welcomed the intent of the paper in providing a format
in which the rigor of the Committee's analysis could be demonstrated.
The Committee also requested that the Secretariat explore how a clear
explanation of the Committee's functions could be made publicly available.
5. COVERAGE
5.1 Quarterly COVER report for England
The quarterly vaccination coverage statistics for the United Kingdom
for the period July to September 2006 were presented to the Committee
in paper JCVI(07)4 and JCVI(07)6.
The Committee noted that uptake of the primary vaccinations ranged
from 93.8% in England to 97.7% in Scotland (by aged 24 months). MMR
uptake at the same age ranged from 85% (England) to 92% (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.
5.2 COVER/HPA liaison group
It was noted that representatives of DH, HPA, the Information Centre
and the Child Health Informatics Consortium met regularly to discuss
issues on the collection and presentation of vaccine uptake data. An
area of interest was data collection in teenagers, which was organised
differently to collection of data of young children. DH agreed to keep
the Committee updated on progress.
6. SEASONAL INFLUENZA VACCINATION
6.1 Seasonal Flu review
The Committee was updated on the seasonal flu review. The SoS had requested
the review following reported shortages of seasonal flu vaccine in 2005.
The Report was close to completion and the Committee would be alerted
to its publication.
6.2 Update for 2006 flu season
The Committee were updated on seasonal flu for the 2006 flu season.
15.2 million doses of vaccine had been made available for distribution
for this flu season, which was 1 million doses more than the previous
year. Despite the delay to distribution of vaccine, about 14.7 million
doses of flu vaccine had been distributed up to the end of January 2007.
Provisional data from the Health Protection Agency showed that vaccine
uptake for those 65 years and over by the end of January 2007 was about
74% compared to 75% in the previous year. It was suggested that due
to the increasing population of those aged 65 years and over, the number
of people vaccinated may be about the same or slightly higher than last
year.
Scotland noted that their provisional data suggested a slight drop
in vaccine uptake, and Wales and Northern Ireland had no data yet available.
Final uptake figures would be made available at the next meeting.
It was noted that seasonal flu reports this winter remained relatively
low, and were following last year's pattern. Just over 30 GP consultations
for flu- like illness per 100,000 of the population had been recorded
in February, indicating that flu was circulating, and advice from DH
had been issued to GPs on the National Institute of Clinical Excellence
(NICE) recommendation on the use of antivirals.
6.3 Risk groups for 2007/08
A cost-benefit analysis of the vaccination of pregnant woman was brought
to the Committee's attention. It was noted that the available evidence
was insufficient to demonstrate cost-effectiveness. It was noted that
the HPA had been commissioned by DH to collect further information on
the impact of influenza on pregnant women, and that the JCVI flu sub-group
would be asked to re-examine the evidence.
Canada reported that they were in a similar position in that they were
expecting to have more information by the end of the year.
6.4 Immunisation of poultry workers
The Committee welcomed the Department of Health's decision to implement
flu vaccination of poultry workers. The Committee was updated on progress
but it was too early to provide feedback on uptake. It was noted that
access to the information in the GB Poultry Register, which is held
by Defra, had been very important in assisting PCTs to implement the
programme.
The Committee asked to be updated on the programme at the next meeting.
The Chairman also explained that the Scottish Executive had sought advice
on the vaccination of pregnant poultry workers. The Committee agreed
with the Chairman's advice that:
"There is no evidence of harm from vaccinating pregnant women
at any stage of pregnancy. Nor is breastfeeding a contraindication.
Women who have a medical condition such as severe asthma, that increases
their risk of complications from influenza, should be vaccinated regardless
of the stage of pregnancy. Poultry workers and health care workers should
defer vaccination in the first trimester to avoid wrongly associating
spontaneous abortion or the later identification of birth defects with
flu vaccination.
Where possible, pregnant women should receive a thiomersal-free influenza
vaccine. If a thiomersal-free influenza vaccine is unavailable then
a thiomersal-containing vaccine should be given. The benefits of vaccination
outweigh the risks, if any, of exposure to thiomersal-containing vaccines".
7. PANDEMIC FLU UPDATE
7.1 Vaccine prioritisation
Dr Salisbury explained that the issue of prioritization of pandemic
flu vaccines had been discussed at the Pandemic flu Ethics committee.
They concluded that prioritisation of vaccines was ethically justifiable
and noted that a number of strategies could meet this aim.
In addition to the information presented to the Committee on risk groups,
the Committee requested that this information was combined with mathematical
modeling in order to present a comprehensive package.
The Committee's view was that, while it was able to provide advice
on health aspects of pandemic flu vaccines, other factors such as prioritization
of essential workers was outside of their remit. The Committee was very
firmly of the opinion that a public debate on vaccine prioritization
was needed to inform decision-making.
7.2 Evidence base for pandemic vaccines
A paper was presented summarizing the published scientific data currently
available on pre-pandemic and pandemic vaccines. The Committee was encouraged
by the quality and direction of the published research.
7.3 Pandemic preparedness update
The Committee was updated on the range of activities being taken forward
by DH on pandemic flu preparedness, which currently included a focus
in enhancing NHS preparedness. The revised contingency plan is due to
be published shortly, and this and other information on pandemic flu
preparedness was available on the DH website.
8. MEASLES, MUMPS AND RUBELLA
The following member declared interest in Merck, 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 Claire Cameron non-personal, non-specific
8.1 Review of UK seroepidemiology
The Committee was provided a paper by the HPA summarising the results
of a survey of measles, mumps and rubella susceptibility in the general
population in England in 2004. This paper assessed the progress towards
national and international control targets.
The findings, based on a reasonable but not large sample size suggested
that:
Measles susceptibility is:
It concluded that:
- uptake of MMR (doses 1 and 2) needs to be improved to reduce the
build-up of measles susceptible school-aged children if we are to
reach the WHO targets;
- the issue of high rubella susceptibility in females born between
1996-99 (who are now too old to receive MMR as a pre-school booster)
should be considered;
- strategies to prevent the future potential of mumps outbreaks in
young adults should be considered.
The Committee noted that the susceptibility of some young children
was a consequence of the fall in uptake of MMR vaccine.
The Committee will be presented with options for consideration on how
to address the above issues at its next meeting. The consideration would
include feedback on the 'Capital Catch-up' Campaign.
8.2 Vaccine Effectiveness estimates, 2004-2005 Mumps Outbreak, England
The Committee was invited to note a paper reporting the vaccine effectiveness
of the mumps component of the MMR vaccine given to teenagers. Vaccine
effectiveness was 88% for 1 dose and 95% for 2 doses. The effectiveness
of 1 dose declined from 96% in 2 year olds to 66% in 11-12 year olds.
8.3 Response from Dr Wakefield to De Souza paper
The Committee was reminded of an email that Dr Wakefield had sent to
Dr Salisbury on the above paper, and that had been shared with the Committee.
Members had previously asked whether the note changed their view on
the MMR vaccine, and they had confirmed it did not.
Professor Miller presented a critique of the note from Dr Wakefield.
The Committee welcomed the analysis by Professor Miller, which they
thought was a first class analysis of the evidence.
9. RECENT RESEARCH ON VACCINE SAFETY
9.1 Risk of serious neurological disease after immunisation of young
children in Britain and Ireland
This paper looked at the risk of serious neurological disease following
immunisation with DTP/Hib (diphtheria, tetanus, whole-cell pertussis/Haemophilus
influenzae type b), menC and MMR vaccines. This paper showed that there
was no evidence of a raised incidence of serious neurological disease
after DTP/Hib and MenC vaccines, or 15-35 days after MMR vaccine. It
did however, identify an increased risk of fever and convulsions 6-11
days following MMR.
9.2 Post- licensure safety of the meningococcal group C conjugate
vaccine
A possible increased risk of convulsions and purpura following MenC
vaccine has previously been suggested through passive surveillance (Yellow
Card reporting). This paper investigated this issue further using record-linkage
and the self-controlled case-series method. The results of this study
showed that there was no evidence of an increased incidence of convulsions
2 weeks following MenC vaccine. It also showed that there was no evidence
of an increase in purpura in the 4 weeks following MenC.
9.3 Risk of convulsions and aseptic meningitis following measles
mumps- rubella vaccination in the UK
This paper reports on the enhanced post-licensure surveillance of aseptic
meningitis and convulsion in the 15- to 35-day period after Priorix,
using hospital- and laboratory-based methods. This surveillance programme
began following the introduction of a new MMR vaccine in the UK in May
1998. This followed the withdrawal of the Urabe-containing MMR vaccine
which was shown to be associated with an increased risk of aseptic meningitis
15-35 days after vaccination. This study confirmed that the risk of
aseptic meningitis following Priorix vaccine, if it exists at all, is
significantly lower than with Urabe-containing mumps vaccines. This
study also demonstrates the power of post-licensure surveillance methods
using record-linkage.
10. HIB VACCINATION
The following members declared interest in Sanofi Pasteur or GSK
Professor Simon Kroll non-personal, non specific
Dr Syed Ahmed non-specific, non-personal
Dr Claire Cameron non-personal, non-specific
Pauline MacDonald non-personal, non-specific
The Committee considered the incidence of Hib disease in children aged
3 to 4 years and over. More Hib disease was occurring in these age groups
than was expected. Following the Hib catch-up campaign in 2003, the
number of cases in the age groups targeted had fallen but a strong herd
immunity effect had not been observed in older children.
The Committee considered the cost- effectiveness of adding a booster
dose of Hib vaccine to the pre-school booster. It was estimated that
50 cases of Hib disease and 2 deaths could be prevented, but the cost
of the programme was very high - above the threshold of about £30,000
per QALY.
Despite the cost effectiveness being unfavourable, the Committee recommended
that Hib booster dose should be given at pre-school booster to improve
Hib protection in children too old to routinely receive the Hib/MenC
booster. One member of the Committee disagreed with the recommendation.
DH would consider this advice.
11. HEPATITIS B
The following members declared interest in Sanofi Pasteur or GSK
Professor Simon Kroll non-personal, non specific
Dr Syed Ahmed specific, non-personal
Dr Claire Cameron non-personal, non-specific
Pauline MacDonald non-personal, non-specific
11.1 Minutes of the Hep B implementation sub group meeting January
The committee were provided a copy of the draft minutes of the above
meeting for information.
12. GREEN BOOK
No major updates of the web version of the Green book were so far required.
The JCVI BCG subgroup had advised that the travel recommendation should
be changed from those under 35 years of age going to live or work in
a country with a high incidence of TB to those under 16 years of age
going to live in a country with a high incidence of TB. This change
would be made when the Yellow Book is published later in the year so
that the two publications are consistent.
13. YELLOW BOOK
Professor David Hill presented to the Committee an update of the Yellow
Book. He explained that this would be web-based and by country of destination.
He explained that the aims and objectives are to:
You
are here: 