- ANNOUNCEMENTS AND WELCOME
The Chairmen welcomed everyone to the meeting.
The Chairman welcomed Dr Bickler to the meeting. Dr Bickler had replaced
Dr O’Mahony as Head of the Communicable Disease Branch at the Department
of Health.
Members were reminded to declare any interests
- MINUTES OF THE MEETING HELD ON 7 FEBRUARY
The following were agreed, and the minutes would be amended accordingly:
- Dr Verity confirmed that he had sent his apologies to this meeting.
- Paragraph 6 – The non-personal/non-specific interest of the Chairman
was in Aventis Pasteur
- Paragraph 9.2 – The final sentence should read "An OPV to IPV
switch needs lead-in time for manufacturers".
- MATTERS ARISING
Membership
Professor Emond had recently been appointed to the Committee. He
is currently Professor of Child Health at the University of Bristol.
Interviews would be held in July for a member to represent Welsh
interests on the Committee. It was anticipated that an appointment
would be made in time for the next meeting. The Secretariat would
be considering other vacancies on the Committee.
Members of the Committee were advised that Appraisal Reports would
be needed for those people who would complete their first term of
appointment next year. The Secretariat would contact those members
concerned. Any member who did not wish to be appointed for a second
term was asked to let the Secretariat know.
3.2 Annual Report
It had been agreed previously that the Committee would produce an
Annual Report. The Secretariat had already started work on this and
it was hoped to have an initial draft for consideration at the next
meeting.
3.3 Hib Sub-Group
It had previously been agreed that the Hib sub-Group would need
to reconvene to examine the evidence regarding the potential benefit
of adding a fourth dose of Hib vaccine to the routine childhood immunisation
schedule. The Sub-Group would meet after an initial assessment of
the impact of the current catch-up campaign could be made, and other
data from the UK and abroad was available.
3.4 Cabinet Office Group on Imported Infection
The Cabinet Office Group was continuing to meet, but there was no
report or conclusions as yet.
- COVERAGE
The Committee received an update on childhood immunisation rates
in England, Scotland, Wales and Northern Ireland. Overall uptake was
generally stable, but with a slow decline in MMR in some areas.
It was noted however that the mobility of the population in large
cities presents difficulties in securing accurate vaccine uptake data.
Current data systems are not good for exchanging data when people
move, which can result in them being recorded as living in their previous
and present location. As part of a recent DH initiative, some areas
had demonstrated that the accuracy of data collection could be improved
through cleaning up the data systems.
During the discussion it was noted that a recent study published
by the ESRC had shown that [to be provided]. Other work by the Department
of Health has shown that vaccine uptake falls each time there is significant
publicity in the media about MMR. This may reflect parents delaying
having their child immunised rather than simply not having the vaccine
at all.
The recent outbreak of measles in South London has shown that declining
vaccine uptake did not only affect the children who had not received
MMR. Some of the children who contracted measles in the South London
outbreak were too young to be immunised, demonstrating that unimmunised
children put other children at increased risk of infection.
The Committee was advised that a meeting would shortly be arranged
for Immunisation co-ordinators in the 20 health authorities, which
had the lowest uptake levels, recorded for MMR.
- THIOMERSAL
5.1 Statement from the Committee on Safety of Medicines on Thiomersal
in vaccines.
The Committee was informed that the Committee on Safety of Medicines
(CSM) had recently considered further evidence that supports the safety
of thiomersal (which contains ethylmercury) in vaccines. A statement
by the CSM had been published and is available at medicines.mhra.gov.uk/whatsnew/thiomersalstatement_210203.pdf)
There had been two independently conducted UK epidemiological studies
that investigated the safety of thiomersal-containing vaccines for
infants. These studies showed no evidence of adverse developmental
effects from levels of thiomersal at the amounts used in existing
UK vaccines. A further study had shown that ethylymercury is rapidly
excreted from the body following administration of thiomersal-containing
vaccines, and provides good evidence that it does not accumulate in
the body.
5.2 Thiomersal in Childhood Vaccines, Neurodevelopment Disorders
and Heart Diseases in the United States.
Geier MR and Geier DA. Journal of American Physicians Surgeons
2003;8:6-11.
The paper was accompanied by an independent expert critique. This
highlighted that it was difficult to work out from the paper what
methods had been employed, what data was used and what the results
really meant.
The study relied on analysis of a US system through which parents
and health care workers can report adverse events, which they believe
to be linked to a vaccine. These adverse events are suspected rather
than confirmed events. Overall the paper was considered to be very
poor. The JCVI concluded that it agrees with the CSM Statement on
the issue, which supported unequivocally the safety of current UK
vaccines containing mercurial preservatives.
The Committee also considered a different publication by Geier and
Geier (International Pediatrics 2003; 18(2): 108 – 113) which used
similar methods to look at MMR and autism. This paper shared many
of the weaknesses of the paper above.
A major problem was that the paper compared children who had received
MMR vaccine against a ‘control group’ who had received DTP vaccines.
But these vaccines are usually given to children at different ages:
DTP is usually given in the first four to six months of life, whereas
MMR is usually given at over 12 months of age. The Committee thought
it obvious that more suspected neurological disorders would be reported
after MMR than the control group simply because children are older
when they receive MMR and it is extremely difficult if not impossible
to reliably diagnose a range of neurological disorders in the first
six months of life. The Committee also noted that a diagnosis of mental
retardation or autism cannot be diagnosed within one month – which
was one of the criteria of the study.
The paper was considered to be seriously flawed. It did not alter
the Committee’s opinion regarding the safety of the MMR vaccine.
- PNEUMOCOCCAL
6.1 Pneumococcal conjugate vaccine infant clinical trials
The Committee was updated on progress of the ongoing pneumococcal
vaccine clinical trials to examine the immunogenicity of a 9-valent
pneumococcal conjugate vaccine in infants. This vaccine protects against
the 9 strains of pneumococci that are responsible for the majority
of pneumococcal infections in children in the UK.
The trials include examining the number of doses required to provide
an appropriate level of protection. The committee will be kept informed
of the results of the studies as they become available.
6.2 Pneumococcal conjugate vaccine in adults
A study looking at the effectiveness of the 7-valent conjugate pneumococcal
vaccine in elderly people is due to start. The Committee would be
updated on its progress.
6.3 Pneumococcal conjugate vaccine – cost effectiveness
An economic evaluation had been performed by the HPA to provide information
to the Committee about the cost effectiveness of pneumococcal vaccination
in young children.
The Committee considered that more information and underlying evidence
was needed issues to gain a better understanding of the potential impact
of offering children pneumococcal vaccine. The Committee accepted that
the model had tried to compensate for many of the uncertainties in the
data. However, the Committee also recognised that the outcome of the
model was considerably influenced by the assumptions within it, and
the imprecision of the epidemiology of pneumococcal disease. This is
particularly the case for the burden of pneumonia caused by pneumococci
that are vaccine preventable.
The Committee concluded that the presently available evidence suggested
that the cost-benefit of a pneumococcal conjugate programme was probably
unjustifiable. However that conclusion could change if:
i. the price of the vaccine was considerably cheaper;
ii. adequate protection could be achieved from few doses;
iii. the burden of disease from which protection could be obtained was
shown to be significantly higher than estimated;
iv. the "herd immunity" effect, suggested by early data from
the US, were confirmed; and
v. there was a significant protection against antibiotic resistant strains,
as well as reducing antibiotic use.
Furthermore the Committee also noted that serotype replacement (in
which the strains pneumococci that this vaccine protects against are
replaced by other strains against which the vaccine does not protect)
would undermine the benefits of this vaccine if this replacement was
shown to occur.
- DIPHTHERIA VACCINE SUPPLIES
Low dose diphtheria (d) vaccine for adults had been provided over
a number of years to protect adults against this disease. The Committee
was informed that the Department was having increasing difficulty
in getting supplies of single low dose diphtheria vaccine. The Committee
agreed that the combined tetanus and low dose diphtheria (Td) vaccine
should be offered as a replacement to single low dose diphtheria vaccine
for adults whenever low dose diphtheria was required. Further consideration
needed to be given to laboratory workers who need repeat doses and
may have reactions to repeat exposure to tetanus toxoid.
- MMR
The following interests were declared:
Professor Langman – Non personal/Non- Specific in Aventis Pasteur
[MSD]
Professor Cohen – Personal Non-Specific in Aventis Pasteur
Non-personal and non-specific interests did not debar from taking
a full part but the Chairman ruled that a personal interest precluded
any part in the decision-making but did not preclude participation
in prior discussion.
8.1 Mumps outbreak in Sheffield
Between 1 January 2003 and 28 April 2003 there had been 175 suspected
and confirmed cases of mumps in Sheffield. Over 100 cases were amongst
students at the University of Sheffield, with some cases also reported
at Sheffield Hallam University. The rate of complications and hospitalisation
rate was about 10%, with 3 cases of meningitis, 2 of pancreatitis, one
of oophoritis and pancreatitis, and one of orchitis. All cases were
between 18 and 25 years (born 1977 to 1985). In light of the large numbers
or cases and the high rate of complications, it was decided to offer
MMR to students in this age group as anyone born before 1984 would not
have been offered MMR previously.
Over a period of two days, about 6000 students were vaccinated with
MMR. The lessons learnt from dealing with this outbreak included the
fact that e-mail and text messaging proved effective ways of spreading
the message; and that many students were often unsure whether they had
received MMR or MR as a child.
The Committee noted that the 1996 Edition of "Immunisation Against
Infectious Diseases" (the Green Book) stated that students who
have not received MR or MMR vaccine should be offered MMR at or before
entry to college or university, and noted that the Department of Health
had updated the advice in 2001 when advising Immunisation Co-ordinators
that students who had either received no or one dose of MMR should be
offered another dose of the vaccine. This outbreak of mumps demonstrates
the importance of this advice.
The Committee supported the action taken locally together with the
HPA in dealing with this outbreak.
8.2 Shortage of Single Rubella Vaccine
Women of childbearing age who are not protected against rubella are
currently offered a dose of rubella vaccine. However the Department
is having increasing difficulty in sourcing this vaccine as manufacturers
preferentially switch to MMR production. In light of this, the Committee
was asked to advise on the appropriate action to take, in case supplies
of rubella vaccine become exhausted. DH is currently inviting tenders
to supply rubella vaccine but in the event of a lack of response, an
alternative will be needed to protect women against rubella.
The Committee concluded that:
- rubella infection in pregnant women, particularly at the beginning
of pregnancy, can have extremely serious consequences on the unborn
child;
- the policy of offering MMR vaccine to children, and rubella vaccine
to women of childbearing age, has proved very effective in preventing
the transmission of rubella and reducing the incidence of Congenital
Rubella Syndrome (CRS) in the UK;
- this policy has also reduced the number of terminations of pregnancies
associated with rubella infection;
- the policy in the UK is consistent with the WHO recommendation for
the elimination of rubella and CRS;
- women of childbearing age who are unprotected against rubella need
to be offered a rubella containing vaccine; and
- MMR is an appropriate alternative to single rubella to protect such
individuals.
- Update of BCG Immunisation Policy
The BCG Panel had recently met to review the current policy on BCG
immunisation. The Panel is considering the options, taking into account
the latest evidence. The Panel will continue this consideration.
- Hib
The Hib catch-up campaign had started on 12 May. This followed the
recommendation from JCVI that children under the age of four should
be offered an additional dose of Hib vaccine to combat the recent
increase in Hib disease. In order to ensure effective distribution
of vaccine supplies, the Hib vaccine had been allocated to surgeries
based on their population data. Information resources such as leaflets,
and Factsheets had also been distributed, and a website created (www.immunisation.nhs.uk/hib).
The Committee was also told that raising the profile of the campaign
had been carried out through "sign posting" style advertising
(i.e. informing parents of the issue and directing them where to find
further sources of information) in national, regional and newspapers
and parenting magazines.
- SARS
The Committee was provided with a brief update on SARS. One confirmed
case of SARS has been reported in the UK. Samples taken from the three
remaining probable cases and those categorised as "suspected"
were still being analysed. It is possible that this testing will confirm
further cases. However these samples are all from people who have
recovered. No new cases of SARS have been reported in the UK since
29 April.
Key to the success in controlling SARS has been the high level of
international co-operation and exchange of information. While a reliable
test to detect SARS had been developed, it may be some time before
an effective vaccine to protect against this infection is available.
The WHO was organising a Conference on SARS in July this year.
- SMALLPOX
The Committee was updated on the Government’s continuing policy
to vaccinate a cohort of key health workers. The programme is underway
and the regional response teams are being built up. All symptoms of
possible adverse reactions are recorded, and serious events are reported
to the MHRA.
- POLIO
The draft minutes of the Meeting of the Working Party for the Laboratory
Containment of Poliovirus were provided for information. Progress
is being made for the future laboratory containment of wild poliovirus,
starting with the identification of laboratories that may hold wild
poliovirus or have potentially infected poliovirus materials. The
work is progressing satisfactorily.
- DISEASE SURVEILLANCE DATA
14.1 Paper for information on disease data in 2002 by CDSC
The paper updated the Committee on the incidence of vaccine preventable
disease in the UK in 2002. It was noted that the incidence of most
vaccine preventable diseases remains constant, except for measles,
Hib and rubella for which increases have been recorded.
It was noted that the number of notifications of pertussis was an
under estimate because it is very unlikely that all cases are reported.
14.2 Meningococcal Disease Update
The Committee received its regular update on the rates of meningitis
C, following the introduction of Meningitis C vaccine in 1999. While
cases rapidly increased to a peak of just under 1000 cases of meningitis
C per year in 1999, rates of meningitis C continue to fall and are
now down to about 70 cases per year. While rates are lowest in the
vaccinated age groups, rates are also falling in those age over 25
years old, which suggests that herd immunity may be occurring. It
was also noted that the efficacy of this vaccine is over 80% in all
age groups.
While the introduction of the Men C vaccine has been a huge success,
there is no vaccine to protect against meningitis B. This now accounts
for the vast majority of meningitis cases in the UK.
- HEPATITIS
15.1 The hepatitis B sub-group
A JCVI subgroup had been set up to review the evidence regarding
hepatitis B, such as incidence and distribution of the disease in
the population; the efficacy of available vaccines; and the potential
impact of such vaccines on public health. While the Committee noted
the work carried out so far by the sub-group, a further meeting had
been scheduled to try to conclude the work of the sub-group.
15.2 EMEA reviews hexavalant vaccines: Hexavac and Infanrix Hexa
The MHRA informed the Committee that the European Agency for the
Evaluation of Medicinal Products (EMEA) through its Scientific Committee
(Committee for Proprietary Medicinal Products (CPMP)) had reviewed
the safety of two vaccines, Hexavac and Infanrix Hexa. This review
followed five reports of unexplained deaths in children in Germany
and Austria occurring within 24 hours of receiving these vaccines.
Neither of these vaccines is used in the UK immunisation programme.
The overall conclusions were that, apart from the temporal association,
there was no evidence to link the vaccines to the events and possible
alternative explanations existed. Nonetheless, on the basis of the
available evidence, a causal relationship could not be established
or excluded. CPMP concluded that there was no change in the benefit/risk
profile of these vaccines and did not recommend any change to their
use. JCVI endorsed this recommendation.
- MENINGITIS AND TRAVELLERS
Advice was sought from the Committee on the appropriate travel vaccine
to protect against meningococcal infection when abroad.
Currently the combined meningococcal polysaccharide A and C vaccine
is the recommended vaccine for travellers. The largest epidemics occur
across a belt in Africa from Senegal to Ethiopia, and have traditionally
been caused by meningococcal A infection. However accurate determination
of the strain of meningitis is challenging in parts of Africa.
Meningitis outbreaks have been clearly documented following the
annual pilgrimages to Mecca (the Hajj). After s large outbreak of
meningococcal A infection in 1977, Saudi authorities required all
pilgrims attending the Hajj to be immunised against at least meningitis
A.
An outbreak of meningitis W135 among pilgrims in 2000 resulting
in cases in many countries, including 45 cases and 8 deaths in the
UK. Since then the Department of Health recommends, and the Saudi
authorities require, that all pilgrims receive the quadravalent meningococcal
ACWY vaccine. Outbreaks of W135 infections have been reported in Burkina
Faso in 2001 and 2002, and cases of W135 infection have been reported
to the WHO from Benin, Ghana, Mali, Niger and Nigeria.
The Committee considered this evidence and recommended that people
in the recognised risk groups intending to visit high risk areas be
offered the ACWY vaccine, which gives protection against meningitis
strains A, C, W and Y.
The Committee was also asked to advise on whether meningococcal
vaccine should still be recommended to people travelling to Bhutan,
Brazil, Mongolia and Nepal.
The risk to travellers (apart from the pilgrimages) was considered
very low, apart from certain travellers to the African meningitis
endemic zones during the dry season (when the risk is greatest), specifically
those on longer trips and/or backpacking or working with the local
population.
There have been no recent outbreaks or documented cases in travellers
to non-African countries. Most European and the American and Canadian
authorities have removed all non-African countries from the list of
countries where vaccination is recommended for visitors. This change
in advice has resulted in no increase in cases among travellers.
In light of this evidence, the Committee recommended that Bhutan,
Brazil, Mongolia and Nepal should be removed from the list of countries
for which meningitis vaccine is recommended.
- National Travel Health Network and Centre
The Committee was updated about the National Travel Health Network
and Centre that has been set up with funding from the Department.
Its primary aims are to develop and promulgate guidance on travel
health matters for health professionals advising the public travelling
abroad; to carry out surveillance of infectious and non-infectious
hazards abroad; to administer the yellow fever vaccination centres,
and to help train health care professionals on travel health issues.
In light of the remit of the National Travel Health Network and
Centre, its Director will be invited to attend JCVI as an ex-officio
member.
- Articles for information
The Committee was updated about the Report of the National Audit
Office "Procurement of Vaccines by the Department of Health"
that was published recently and attracted some media interest.
The Committee was informed that "For the vaccine contracts
that we examined, the Department acted properly in awarding these
contracts by complying with appropriate EU procurement regulations,
encouraging sufficient competition and evaluating tenders fairly.
The procurement arrangements for emergency supplies of smallpox vaccine
were unusual as the Department chose not to adopt standard competitive
procedures for national security reasons, which is allowable under
EU regulations."
The recommendations specific to vaccine purchase included looking
at ways to make information on the vaccine purchase process available
to the public; to develop protocols in relation to procurements addressing
specific threats; and to consider the need for a more proactive approach
to address the threat of supply shortages of some vaccines.
18.1 Extract from Hansard about Tetanus
The Committee was provided with the extract from Hansard from 25
March which recorded the debate in the House of Commons about tetanus
and tetanus vaccinations.
18.2 Autism; Vaccine Link Considered by Mark Benjamin from the
Washington politics and Policy Desk
A Report of a meeting in the US that claims that autism and other
brain problems in American children are linked to vaccines.
18.3 MMR vaccine and idiopathic thrombocytopenic purpura (ITP).
C Black et al
ITP is an autoimmune disease in which platelets are destroyed leading
to spontaneous bruising. This research paper confirms pervious evidence
that the increased risk of ITP within 6 weeks of MMR vaccination,
and that the risk is about 1 in 25000 vaccinations. This is distinctly
lower than the risk of 1 in 3000 in children suffering from rubella,
and 1 in 6000 for children suffering from measles.
MMR and autistic enterocolitis: Consistent Epidemiological Failure
to find an association. E Fombonne and EH Cook.
This paper reviews the epidemiological evidence about MMR and autistic
enterocolitis. The reports that all papers that have studies the association
between trends in autism and either the introduction of the MMR vaccine
or variations in vaccine uptake have failed to demonstrate an association.
18.4 Bacterial Infections, Immune Overload and MMR vaccine. E
Miller et al
This paper examined whether MMR vaccine increased the risk of hospitalisation
with invasive bacterial infection in a three-month period after vaccination.
It was carried out to test whether the MMR vaccine somehow overloads
the immune system, as has been claimed. If the immune system was overloaded,
the body would be less able to fight infections and more cases of
bacterial infections would be seen.
The paper found that children are at no greater risk of being hospitalised
from invasive bacterial infections after receiving MMR than before.
It in fact suggests a protective effect. The paper does not support
the concept of "immunological overload"
18.5 MMR Vaccine. How effective and How Safe. Independent Review
from the Consumers’ Association
This paper reviews the evidence for the effectiveness and safety
of MMR vaccine. The paper concludes that there is no convincing evidence
that MMR vaccine causes, or facilitates the development of, either
inflammatory bowel disease or autism. It also finds no good reason
to adopt a policy of single use antigen vaccine because it has no
sound scientific basis and is likely to result in increased rates
of disease, leading to an increase in morbidity, mortality and risk
to others through reduced overall vaccine uptake.
18.7 Pediatric MMR Vaccine safety. Geier and Geier
A copy of the article by Geier and Geier was provided. This article
had been discussed under Item 5.
- Any other business
19.1 Rabies
The Advisory Committee on Dangerous Pathogens (ACDP) had recently
considered issues relating to rabies. They had a number of questions
relating to rabies vaccination, and sought advice from JCVI. It was
agreed that a sub-group of experts should be established to examine
the issue and report back to the main committee.
19.2 Pertussis
Concern was raised about the lack of vaccines licensed for use in
children over the age of 7 years. This follows evidence that some older
children could infect younger children.
The Committee agreed to continue to monitor the incidence of pertussis
infection, and review its advice on pertussis when appropriate.
- DATE OF NEXT MEETING
The next meeting will be on Friday 3 October.
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