Memorandum by GlaxoSmithKline
GlaxoSmithKline (GSK) is committed to supporting
the NHS in improving the health of the nation. An essential element
of this commitment is our research and development of innovative
treatments that provide patients with life improving medicines
for diseases such as asthma, diabetes, cancer and HIV/AIDS. As
the UK's leading supplier of vaccines, GSK also plays an important
role in disease prevention (see Appendix for information about
GSK believes that significant improvements in
public health can be achieved through sustainable partnerships
with government, the NHS and most importantly the general public
that requires a commitment to health promotion, improvements in
socio-economic inequalities, availability of effective treatments
and disease prevention.
GSK believes that the NHS should
give greater prominence to life saving vaccinations that are currently
available but not being used as effectively as they could be to
prevent the progression of potentially fatal diseases. The UK
Government currently spends £68.9 billion on healthcare and
only an estimated 0.03 per cent of that total is spent on the
Vaccination is one of the safest
and most effective healthcare interventions available today. Developing
new vaccines is a fundamental part of GSK's commitment to public
Vaccination is also one of the most
cost effective measures a society can take to prevent the spread
of disease, which the treatment of can often be an expensive burden
on an already stretched healthcare system.
Yvette Cooper, Parliamentary Under-Secretary
of State for Health stated in an adjournment debate earlier this
year, "We should not underestimate the impact on public health
of immunisation programmes such as the NHS programme. Immense
improvements have been made not through treatment but through
vaccinationa fact that is of worldwide significance. It
is because of the immunisation programme that the incidence of
childhood disease in this country has fallen to its lowest ever
levels, greatly reducing morbidity and mortality from such diseases."
One vaccine that we believe is currently
under-utilised in the UK is for the prevention of hepatitis B.
The following case study on the disease outlines some of the evidence
for a more universal approach to the prevention of hepatitis B.
GSK commends the Government for its
ability to implement extremely successful mass vaccination programmes
in the UK. In 1992, the Hib vaccine was introduced into mass vaccination
and in 1994 the measles and rubella campaign vaccinated five to
16 year old children in the UK. The measles mass vaccination programme
successfully averted an imminent measles epidemic. More recently
in 1999 the meningitis C vaccination campaign was launched due
to a number of outbreaks in teenagers. Children up to 18 years
of age were vaccinated resulting in a decrease in the number of
There are several vaccines that are
currently licensed in the UK but are under-utilised by the Government;
hepatitis A and B, strep pnemococcal and varicella. The following
case study on hepatitis B outlines some of the evidence for a
more universal approach to the prevention of the disease.
100 times more infectious than HIV.
One in 10 infected people will develop
chronic carriage of HBV.
Patients chronically infected with
hepatitis B are at high risk of death from cirrhosis of the liver
and liver cancer.
About two thirds of hepatitis B infections
are asymptomatic and therefore may not be diagnosed.
In England and Wales, the proportion
of reported cases of acute hepatitis B infection in 2001 with
no identified risk was 53 per cent.
The number of acute cases of hepatitis
B reported to the PHLS and SCIEH (Scottish Centre for Infection
and Environmental Health) do not account for underreporting.
It is currently thought that there
is about 20 per cent of underreporting of acute hepatitis B cases
The US Centers for Disease Control
(CDC) study estimated that only 8.7 per cent of hepatitis B infections
are actually reported.
Our concern is that underreporting
is potentially indicative of a lack of government recognition
of the importance of hepatitis B. This lack of surveillance may
also apply to other infectious diseases.
Cost-effectiveness of universal hepatitis B:
In the UK, studies show universal
mass vaccination for hepatitis B to be more cost effective in
the longer term than selective vaccination even in a low prevalence
A recent review of the evidence:
"epidemiological data and economic evaluation show that universal
hepatitis B vaccination is cost effective in countries with low
endemicity and that it will control hepatitis B, reinforcing the
necessity for action."
In 1992, the World Health Assembly
endorsed a recommendation of the Global Advisory Group of the
Expanded Programme on Immunization which was held in Turkey in
October 1991. The recommendation asked all Member States with
an hepatitis B carrier rate of 8 per cent or greater to expedite
the integration of hepatitis B vaccine immunization into their
routine infant immunization programmes by 1995 and all other countries
to introduce such immunization by 1997.
The UK is one of the few countries
in Europe that has still not followed the WHO recommendation.
Although it is a significant start,
current Department of Health policy targets a defined set of "at-risk"
groups such as intravenous drug users, gay and bisexual men, but
these groups are very hard to reach. 63
Vaccination uptake in many of the
high risk population groups that are recommended for hepatitis
B immunisation is poor and transmission of hepatitis B remains
a problem. 65
In many instances, the present immunisation
strategy for the prevention of hepatitis B functions poorly and
there are clear inequalities. 65
Many people at extremely low risk
of hepatitis B are being vaccinated, while those at highest risk
are often unlikely to be offered the vaccine. 65
We do not believe the current policy
goes far enough because the "at risk" behaviours for
hepatitis B includes piercing, tattooing, engaging in high risk
activities while travelling to endemic areas and having multiple
The most frequent mode of transmission
of hepatitis B is through sexual activity, either heterosexual
or homosexual, between an infected and a susceptible person.
There is no way of knowing now which
children and adolescents will be susceptible to hepatitis B due
to their future lifestyle choices as the vast majority of new
hepatitis B infections acquired in the UK occur in adults.
Vaccination against hepatitis B will
protect the public now and ensure a healthier future.
GSK strongly endorses the continued
role of the Joint Committee on Vaccination and Immunisation (JCVI)
as the main decision making body for vaccination and immunisation.
However, whilst supportive of the
JCVI's recent moves to reform, GSK believes that to restore public
confidence and avoid criticisms of political bias following sustained
negative media coverage of the vaccine decision making process,
exemplified by MMR policy and the Government's handling of the
small pox vaccine tendering process, further changes still need
to be made to the JCVI.
GSK believes that to achieve the
best public health strategies for the UK population, and to ensure
informed decision making there needs to be greater scope for consultation
and the inclusion of all relevant stakeholders in the JCVI decision
GSK would suggest that the JCVI include
representatives from the following key stakeholder groups:
Vaccination and immunisation experts.
Patient groups (we understand there
are proposals already in place).
Suppliers (industry involvement in
a neutral capacity).
GSK also recommends that all interested
parties should have an opportunity to address the JCVI in relation
to a proposed policy change. This would allow the views of all
stakeholders to be heard and considered, resulting in decisions
based on informed debate. The US Advisory Committee on Immunisation
Practices (ACIP) takes a similar approach and could be a model
To avoid accusations of political
bias we would also recommend that the role of the Secretariat
is not undertaken by the membership of JCVI but by a neutral body.
In addition, the agendum would be
available in advance and the minutes of the meeting published.
Decisions that are taken by JCVI would be announced to the public
and open for appeal.
The current and future public health
of our nation is dependent on the decisions that are made on the
best interventions to protect against infectious diseases. We
believe that it is crucial that these decisions are taken with
full stakeholder involvement to ensure that patients receive faster
and more equitable access to vaccinations.
It has been well documented, in recent
times, that communication of scientific information to the public
can be alarmist and undermine public confidence. However, patients
need to understand the risk and benefits of any medicines.
It is all of our responsibility,
especially scientists, to communicate effectively through the
media to the general public. It is also the media's responsibility
to distil very complicated information in a responsible way.
For example the debate on MMR is
misleading about the benefits of single vaccinations over combination
vaccinations. The facts about combined vaccines:
Combined vaccines go through rigorous
testing to ensure their safety and efficacy. Combined vaccines
are as safe as each component of separate vaccines and after licensing
are continuously monitored for any adverse events.
Both parents and healthcare professionals
hesitate to give a child more than two injections per visit. Fewer
injections in the form of a combined vaccine means less discomfort
for the child and allow protection against more diseases.
Scientific evidence proves that multiple
vaccines do not overwhelm or weaken the immune system of a child.
In fact, vaccines protect children against the diseases that do
weaken the immune system.
Combined vaccines result in fewer
visits to the GP with a less likelihood that a child will be exposed
to the risk of infection unnecessarily between vaccinations.
We believe that JCVI has a clear
responsibility to educate and support the public. The media is
an obvious tool to use and if JCVI were more independent from
government they would be in a stronger position to do this.
GSK believes that only through partnership
with all stakeholders can we ensure that there are adequate plans
in place to identify areas for research and to share best practice
on new vaccines so that we can control the emerging threats to
GSK supports "Getting Ahead
of the Curve" which is crucial to combating infectious
disease in the UK. However, GSK believes that vaccination policy
making must be improved to ensure that current vaccines which
are now available such as Hepatitis B are better utilised and
that future vaccines when they become available are used as quickly
GlaxoSmithKline is one of the largest
vaccine manufacturers in the world.
In 2000, the company delivered over
1.1 billion vaccine doses to people in 177 countries.
Every second 35 doses of GSK vaccines
are distributed worldwide.
GSK Biologicals is located in Rixensart,
Belgium, and is the centre of all GSK's activities in the field
of vaccine research, development and production.
The headquarters of the company in
Rixensart, Belgium, employs over 3,000 people of which over 900
are research scientists devoted to discovering new vaccines and
developing more cost-effective and convenient combination products
to prevent infections which cause serious medical problems worldwide.
In order to ensure its leadership
in vaccinology, GSK continues to invest important funds in research
and development, in facilities and in leading edge technology
GSK owns an influenza vaccine production
plant located in Germany and has initiated ambitious projects
in China, India, Russia, Egypt and Brazil.
Over the last 10 years, GSK has lead
innovation and launched 15 new vaccines which were a world first
innovation, including Havrix the first vaccine against hepatitis
A, and many new combinations.
GSK has a rich pipeline of 18 vaccines
including vaccines to protect against Malaria, Rotavirus, HIV,
HPV, Herpes and Meningitis B.
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