Memorandum by PowderJect Pharmaceuticals
PowderJect is the UK's only commercial vaccine
manufacturer, the world's largest independent vaccines company,
and fourth largest biotechnology company in Europe by revenues.
The UK has a strong tradition in infectious
diseases and public health, with centres such as the PHLS, NIBSC,
NHS and universities making a strong contribution to the ongoing
surveillance and improvement of healthcare research and delivery.
PowderJect welcomes the new government initiative, Getting
Ahead of the Curve.
Surveillance of communicable diseases needs
to provide the necessary information for the development and evaluation
of public health strategies, the identification of threats, and
the control of the spread of diseases throughout populations.
In the UK, and Europe generally, there is a
dearth of surveillance information across a broad range of infectious
The lack of a broad database is in stark contrast
to the availability of data covering a major number of infectious
diseases in the United States through the Centers for Disease
Another major challenge is the generation of
Europe-wide standards in surveillance and monitoring which can
give consistent and accurate information across all Member States.
PowderJect welcomes the Government's strategy
document, Getting Ahead of the Curve, but believes a number
of gaps still need to be addressed. The key factor in determining
whether or not the implementation of the report is a success will
depend upon the levels of investment made by the Government in
fighting infectious diseases.
Vaccination has proven to be the most effective
strategy to prevent communicable diseases, thereby diminishing
the risk of epidemic outbreaks and eventually leading to the elimination
or eradication of disease.
A number of key diseases will pose significant
threats to the UK in the near to medium term including pandemic
flu, HIV, TB, H. pylori, Group B Meningitis, and Chlamydia.
Other initiatives, such as the development of
a national biologicals manufacturing institute for teaching and
public-private partnerships in vaccines manufacturing for the
developing world, should also be explored.
PowderJect is the world's largest independent
vaccines company and is the UK's only vaccine manufacturer. The
Company is headquartered in Oxford, UK with its major manufacturing
facilities located at Speke, Liverpool. PowderJect achieved sales
of £113 million for 2001-02 and invested £33 million
in its R & D pipeline. An investment of £70 million has
been made in the manufacturing facilities at Speke in the last
five years. PowderJect's leading product is its influenza vaccine,
Fluviring, which is the second best selling flu vaccine in the
world. In April 2002, PowderJect was awarded a £32 million
one-year agreement to supply the UK Government with smallpox vaccine.
TABLE 1: CORPORATE SUMMARY
||Oxford (Corporate, R&D)|
Speke, Liverpool (Manufacturing)
|Sweden||Solna, Stockholm (Manufacturing, Sales)
|United States||Madison, Wisconsin (R&D)
|No. employees:||1,000 (750 based in UK, 600 at Speke)
|Product portfolio:||Vaccines for influenza, yellow fever, traveller's diarrhoea (ETEC), cholera, tuberculosis, smallpox, polio, tetanus|
|R & D platforms:||Needle-free powder injection technology|
|Oral rCTB technology
|Therapeutic focus:||Vaccines and immunotherapeutics
|Major partnerships:||GlaxoSmithKline, Aventis, Bavarian Nordic
TABLE 2: R & D PIPELINE
|Clinical:||Arilvaxg (yellow feverUSPhase III), Dukoralg (traveller's diarrhoea & choleraEUfiled March 2003), hepatitis B DNA prophylactic and therapeutic (Phase I with GlaxoSmithKline), PJ Fluviring (Phase I)
|Lead:||PJ Influenza DNA vaccine, PJ HSV DNA vaccine, PJ HIV DNA
|Preclinical:||prophylactic and therapeutic (with GSK).
PJ = PowderJect powder injection vaccine
PowderJect's expertise is in the research, development, manufacture
and sale of vaccines for both national and international markets.
Although the remit of the inquiry covers issues relating to human
infectious diseases in the United Kingdom, including surveillance,
prevention and treatment of infectious diseases, the principle
focus of this response will be in disease prevention through vaccination
since this represents PowderJect's core competency.
PowderJect would like to thank the Science and Technology
Sub-Committee for the opportunity to submit written evidence on
a critical aspect of national health.
1. WHAT ARE
(a) Infectious Disease Surveillance
The World Health Organisation ("WHO") defines surveillance
as the "ongoing systematic collection, collation, analysis,
and interpretation of data; and the dissemination of information
to those who need to know in order that action may be taken"1.
Surveillance of communicable diseases needs to provide the necessary
information for the development and evaluation of public health
strategies, the identification of threats, and the control of
the spread of disease throughout populations. This data is an
essential basis for determining future actions by a variety of
different groupspublic health and medical professionals,
industry and the general population. Surveillance data quantifies
medical needs, monitors disease trends, allows initiation of appropriate
public health measures, such as vaccination, and the assessment
of their impact.
For many years, in Europe and the UK, communicable diseases
have been perceived as a receding health threat, thanks to immunisation,
effective treatment, and overall improved living conditions. It
is only in the last decade that it has become apparent that treatment
options might disappear due to the emergence and spread of anti-microbial
resistance. Furthermore, increased population mobility, travel,
and trade have facilitated an unprecedented spread of communicable
diseases, whether they be new infections such as HIV/AIDS, or
hitherto controlled ones, such as tuberculosis. There has also
been the emergence of new categories of at-risk groups within
the population, such as immuno-compromised individuals, and the
expansion of pre-existing groups such as the elderly. Finally,
the potential threat of bio-terrorism has added another dimension
to the issue of communicable diseases.
Epidemiological data is critical for virtually all strategies
of communicable disease control:
For public health authorities and the general
public, epidemiological data forms the basis for rational strategy
development and informed decision-making in healthcare.
Communicable disease epidemiology and knowledge
about disease-burden allows performance measures for vaccination
programmes and other approaches to disease control to be developed.
It facilitates the adaptation of strategies to evolving disease
For vaccines already in use, epidemiological data
is critical for post-marketing surveillance and assessment of
vaccine effectiveness and safety.
For diseases where a vaccine is not yet available,
quantitative data on disease-burden, including mortality and morbidity
and long-term sequelae, form the basic rationale for embarking
on a vaccine project; they also enable better definition of target
populations and potential vaccination targets. Finally, they form
the basis for health economic assessments.
This latter point is especially important to industry. In
the UK, and Europe generally, there is a dearth of up-to-date
surveillance information across a broad range of infectious disease
targets. For groups wishing to find up-to-date and accurate information
for a range of diseases, eg for Group B meningitis, Helicobacter
pylori, rotavirus, Respiratory Syncytial Virus, and others,
there is no easily accessible, regularly updated data source.
While there is data on diseases covered under current surveillance
programmes, eg HIV, HSV, TB, etc., such data is also not always
up to date. The PHLS Corporate Plan2 outlines proposals for upgrading
the dissemination of surveillance information and it is hoped
that these issues will be addressed in this.
The lack of a broad database is in stark contrast to the
availability of data covering a major number of infectious diseases
in the United States through the Centers for Disease Control3.
The CDC combines technical excellence and independence from health
care providers, payers, and commercial interests, thereby providing
irrefutable data and objective advice. No equivalent exists in
the UK. The CDC represents an ambitious and comprehensive effort
to monitor health, to investigate health problems, and to issue
recommendations for prevention and treatment.
Another major challenge is the generation of Europe-wide
standards in surveillance and monitoring which can give consistent
and accurate information across all Member States. There are considerable
differences across Member States in the organisational and operational
aspects of surveillance. For example, countries use different
case definitions of disease. The Community has established a network
of epidemiological surveillance and control of infectious diseases
in Europe (2119/98/EC) 4. This network should fulfil two main
functions: (i) the epidemiological surveillance of communicable
diseases; and (ii) the co-ordination of early warning and response
to outbreaks. One of the results of the Network is the timely
realisation that a problem in one Member State is also affecting
Consequently, there remain within the UK and Europe a number
of challenges to improve the control of vaccine preventable diseases:
The lack of consistent knowledge about infectious
diseases incidence and prevalence that delays thoughtful recommendations
by public health authorities.
Poor awareness of the importance of vaccination,
both among the general public and, increasingly, among health
care professionals, which leads to low levels of immunisation.
Poor awareness greatly diminishes uptake of novel
opportunities, unnecessarily exposing individuals to disease.
Lack of information on vaccine safety and efficacy
prevents swift countering of allegations made by special interest
groups, fuelled by unbalanced reporting of scientific research
in the media.
In conclusion, there is a serious lack of surveillance data
in the UK covering infectious diseases, and a lack of harmonisation
in the surveillance and reporting of infectious diseases in Europe.
(b) Infectious Disease Prevention
The challenges facing the prevention of human infectious
diseases are varied. The list of issues below is not exhaustive,
but does reflect the broad range of challenges facing the prevention
of infectious diseases in the UK:
The emergence of new diseases, such as HIV/AIDS,
vCJD, Legionnaires Disease.
The re-emergence of old diseases such as Tuberculosis.
The threat of transboundary movements of non-endemic
diseases such as malaria.
The threat of pandemic outbreaks of diseases such
Public perception and attitudes to vaccination
leading to lower immunisation rates and the increasing likelihood
of re-emergence of vaccine preventable diseases.
Lack of R & D investment in new vaccine targets
combined with long and complex development programmes.
The low cost of vaccines in general and an unwillingness
on the part of payers to pay higher prices for new, high technology
vaccines. This is a key issue for industry where higher prices
are required for new vaccines to recoup the R & D investment
made. If payers such as the Government are unwilling to pay higher
prices for new vaccines, then there is little commercial incentive
to develop them.
Over the last decade the interface between scientific
advice and Government policy in areas such BSE, vCJD and more
recently MMR has led to a scepticism within the general public
about the validity of the scientific process.
2. WILL THESE
The Government's recent strategy document, Getting Ahead
of the Curve, proposes a number of actions to combat the modern
threat of infectious diseases. PowderJect welcomes this initiative
and supports a number of the proposals, such as the creation of
a new health protection agency, a national expert panel, the rationalisation
of microbiology laboratories and introduction of standards, and
a review of the law. PowderJect believes there remain gaps that
need to be addressed.
A new National Infection Control and Health Protection Agency
We believe that the creation of a new Agency for infection
control and health, is a positive step and the responsibilities
assigned to the Agency should lead to improved surveillance and
monitoring within the UK. However, PowderJect also urges a strong
vision of European collaboration in disease surveillance and communication.
Organisations such as the European Scientific Working Group on
Influenza (ESWI) have a disease specific focus involving epidemiology.
A strengthened and expanded system of infectious disease surveillance
The strengthening of infectious disease surveillance is to
be welcomed. It is essential that this is accompanied by frequent
and accessible reporting of the prevalence and incidence of a
broad range of infectious diseases.
New action plans to address infectious disease priorities
This is to be welcomed but the list of disease priorities
should be reviewed regularly to see if additional targets should
A programme of new vaccine development
The uptake of existing vaccines to larger numbers of people
is an essential component of any public health vaccination strategy.
In particular, the recommendations covering expanded use of an
influenza vaccine will be an important component in capacity building
against the possible threat of pandemic flu.
Further development of plans to combat the threat to public
health of deliberate release of biological, chemical or radiological
A key component in this area should be the long-term planning
for anti-viral and vaccine research against biological weapons.
The time scales required in the R & D process and in the manufacturing
of such materials is extremely long, and if industry is to play
its part in this programme, there needs to be a proactive and
long-term strategy for tackling high risk threats. It is not evident
that this approach is being adopted in the UK.
A research and innovation programme
There remains a dearth of fundamental research in the UK
against a broad range of infectious diseases. This is reflected
in the extremely low levels of investment in this field. If the
UK is to have an effective and integrated strategy for tackling
infectious diseases, then funding into basic research must be
increased. There should also be additional incentives in the development
process, such as government grants to assist in the large scale
clinical testing of new vaccine candidates. Greater incentivisation
is needed in the industrial development of certain disease targets,
such as rotavirus and chlamydia. While industrial R & D is
focused on high priority areas such as HIV, hepatitis C and improved
hepatitis B vaccines, there is limited interest in targets such
as rotavirus, herpes simplex, chlamydia and also for improving
existing vaccines, eg TB. This deficit needs to be critically
evaluated and appropriate incentives put in place so that greater
investment is made in high-health impact targets.
Improved public information and involvement on infectious diseases
This remains a key area for improvement. The issues surrounding
MMR vaccination have highlighted the public distrust of scientific
evidence. A clear and well-thought out programme focused on vaccination,
the long term benefits of public health policy and the scientific
issues around vaccine safety, and the continuing threat of infectious
diseases is urgently needed.
In summary, the initiatives described in Getting Ahead
of the Curve are to be welcomed. However, the key factor in
whether or not the implementation of the report is a success will
depend upon the levels of investment made by the Government in
fighting infectious diseases. Good surveillance, research and
healthcare services are essential and it is not clear from the
report whether the levels of investment will be sufficient to
carry this through.
3. SHOULD THE
Vaccination has proven to be the most effective strategy
to prevent communicable diseases, thereby diminishing the risk
of epidemic outbreaks and eventually leading to the elimination
or eradication of disease6. Indeed, the individual and societal
benefits to immunisation cannot be overstated. In every instance,
the availability of vaccines correlates with dramatic decreases
in morbidity, mortality and treatment costs.
The effectiveness of vaccines can also be measured in terms
of benefits to healthcare costs. Vaccines are cost effective because
their cost is lower than the cumulative costs of treatment, hospitalisation
and working days lost7. For example, the measles, mumps and rubella
vaccine saves $16.34 in direct medical cost for every $1 dollar
spent, whereas the diphtheria, tetanus and pertussis vaccine (DTP)
saves $6.21 for every $1 spent.
While the achievements to date for vaccination have been
considerable, current research is also focusing on the possibility
of development of novel vaccines for currently unmet disease targets
such as HIV, HSV, hepatitis C and many others. There is also the
potential to develop vaccines for post-infection therapy in certain
diseases such as genital herpes and cervical cancer (caused by
HPV). Such approaches would open up the possibility of using vaccines
to treat cancer and chronic immunotherapeutic disease targets.
Vaccine research has the potential to broaden its scope beyond
infectious diseases. For example, a greater understanding of the
immune system and adjuvant technology may facilitate the development
of vaccines against allergic rhinitis and asthma.
Despite the successes of vaccination, the future of vaccination
as a preventative strategy remains problematic. There are a number
of reasons for this:
(a) Vaccine sales account for only two per cent of the
global pharmaceutical market8 and are therefore generally unattractive
to the pharmaceutical industry. Returns on investment in vaccines
are often regarded as poorer than in traditional pharmaceuticals.
(b) Traditional vaccines such as BCG, polio, tetanus,
diphtheria and measles are produced at low cost and do not return
margins that are competitive with traditional pharmaceutical products.
However, continuously improving regulatory standards mean that
some of these traditional processes are no longer adequate by
today's regulatory standards. Yet, there is no incentive to reinvest
in improved products and processes due to the low price of these
vaccines. One likely outcome will be a shortage of some of these
products, and this has already happened in the United States.
(c) The costs and time-scales for developing vaccines
are higher than for traditional pharmaceutical products. Many
of the challenges facing the development of new vaccines are extremely
complex and require a substantial period of research before development
can begin. For many companies, the time-scales for development
are too long, especially if R & D programmes take up to 15
(d) The high R & D costs and complex manufacturing
processes for many new vaccines require a high final sales price
to recoup the R & D investment. Many Governments are unwilling
to reimburse these higher prices. This consequently reinforces
the view that vaccines are not an attractive area for R &
(e) Many smaller R & D companies are investing in
new vaccine development, but the risks are increasing. For example,
the complex immunology associated with many diseases and the difficulty
in developing effective vaccination strategies is increasing R
& D expenditure and time-scales. Yet such companies cannot
develop a new product through to market, and the selection of
future partners is limited. There are only four truly global vaccine
manufacturers, and the risks associated with partnering strategies
for these SMEs are extremely high.
(f) These difficulties are compounded when vaccines are
developed for complex targets such as HIV, HPV and Pneumococcus.
Such targets may require multiple component vaccines, which in
turn need more complex development programmes geared to the individual
testing of the vaccine components followed by testing of the components
(g) The continued exposure of vaccine companies to legal
liability. This is not only a problem in clinical testing where
the incidence of legal actions is increasing, but also in product
liability. A viable clinical population is essential for vaccine
development and concerns around liability may put companies off
from undertaking complex clinical programmes involving vaccines.
At the same time, the general public needs to be satisfied that
current liability schemes, such as the Vaccine Damages Payment
Scheme, provide a balanced compensation scheme.
(h) The increasing complexity of developing new biological
manufacturing processes for vaccines is also a significant hurdle.
The manufacturing of vaccines requires expertise in personnel
and heavy investment in state-of-the-art facilities to satisfy
increasingly stringent regulatory requirements. New vaccines are
likely to be no exception and the investment required for such
facilities is likely to be significant.
While the above issues individually are unlikely to cause
major problems, when taken collectively, they represent a potentially
significant disincentive to long-term vaccine R & D. The Government
has recognised pressures on vaccines companies in relation to
the diseases of poverty9, but it remains to be seen whether such
initiatives are sufficient to incentivise R & D.
4. WHICH INFECTIOUS
While it is always difficult to gauge the impact of emerging
or new diseases in the future, PowderJect believes that number
of key diseases will pose significant threats to the UK in the
In the 20th century major worldwide influenza epidemicspandemicsoccurred
in 1918-19, 1957-58, and 1968-69. It is estimated that by the
end of winter 1918-19, two billion people in the world had become
infected with influenza, and between 20 million and 40 million
people died from influenza10. The total number of deaths in Europe
during the 1918-19 pandemic was an estimated to be around 2.3
million11. The WHO has strongly recommended that all countries
establish multidisciplinary national pandemic planning committees,
responsible for developing strategies appropriate for their countries
in advance of the next influenza pandemic12. The United Kingdom
published its first pandemic plan in 1993. One strategy to counter
the threat of a pandemic outbreak is to increase inter-pandemic
uptake, thereby guaranteeing supplies in a pandemic.
HIV remains a significant problem in the UK with a reported
43,000 HIV-infected living adults in the UK in 200013. The lack
of any effective prophylactic vaccine remains a major R &
D challenge, and it is difficult to give any accurate estimates
as to the likely availability of one. Nearly half of the 3400
new HIV infections in 2000 resulted from heterosexual sex, compared
to 21 per cent a decade earlier.
Although the incidence of tuberculosis is lower than for
other infectious diseases in the UK, trends in the disease have
shown an increase in incidence (6,379 cases in 2000, up from 5,938
in 199914). This is the result of a complex set of issues, such
as immigrant populations, but reinforces the need for continued
surveillance, treatment and vaccination programmes.
Infection with Helicobacter pylori can lead to the
formation of gastric and duodenal ulcers. Ulcers generally heal
following effective treatment against H. pylori. A potentially
more serious consequence of H. pylori infection is the
six-fold increase in the risk of contracting gastric cancer. Prevalence
of H. pylori in the UK is estimated at 22.1 million in
200015. No vaccine is available for the prevention or treatment
of H. pylori infection.
Group B Meningitis
Group B is the most dominant strain of Meningitis in Europe
with the exception of Spain.
Over 3.5 million cases of rotavirus are reported each year
in the United States. There are no equivalent figures for the
UK or Europe.
Although Sexually Transmitted Diseases are not of primary
concern in this Inquiry, the increasing rate of transmission and
high incidence increasingly make them major threats. These include:
The estimated prevalence of HSV in the UK in 2000 is 17.8
million16. There are two main infective forms of HSV, namely HSV-1,
most commonly associated with cold sores, and HSV-2 the primary
cause of genital herpes. 40 per cent of HSV-1 and 80 per cent
of HSV-2 patients experience recurrent flare-ups, resulting in
high treatment costs, in terms of drug therapy and counselling
for the psychological impact of the disease. No preventative vaccine
is currently available for HSV.
HPV is responsible for genital warts and cervical cancer.
40 million cases of HPV were reported in the US in 2000 and 48,000
died from HPV-related cancers17. There are no vaccines available
either for pre-infection prophylaxis or post-infection treatment.
Sexually transmitted chlamydia is increasing significantly
in Europe with a total of 5.5 million cases in Europe18. In the
UK chlamydia is now the most common STD19. It is likely that this
figure is a significant under-estimate due to the high incidence
of asymptomatics (50 per cent in men and 75 per cent in women).
In women the disease can progress to cause pelvic inflammatory
disease. No prophylactic vaccine is currently available.
There are two other diseases that also should be mentioned:
Although this disease is not endemic to the UK, there are
over 1,500 cases per annum from people travelling abroad. Malaria
remains a key target for the development of an effective vaccine
in the Developing World.
Although biodefense is outside of the remit of the Inquiry,
it should be noted that any deliberate release of smallpox in
the UK could have a profound effect in terms of mortality and
Finally, the emergence of new diseases should not be underestimated,
including potential new pathogens in the blood supply, the emergence
of a new STD and a major international epizootic.
6. WHAT POLICY
PowderJect believes that the key policy interventions which
would have the greatest impact on preventing diseases outbreaks
Better and more up-to-date surveillance across
a range of diseases.
Broader R & D incentives across a range of
diseases for the development of new vaccines and anti-viral agents
where there is currently insufficient R & D.
Greater core research funding in Universities
into new vaccine technologies, delivery systems, adjuvants, immunology
and antigen discovery.
Greater public awareness of the benefits for vaccines,
aimed at alleviating concerns over vaccine safety.
Long-term planning in response capabilities in
relation to biological weapons, and other major threats from infectious
diseases. The long timescales and costs associated with R &
D make it essential that there is a long-term strategy for tackling
The vaccines industry has gone through a significant shift
in the last decade. Global revenues have grown from $2.9 billion
in 1992 to $6 billion at a 10 per cent annual rate20. The vaccine
market can be split into a number of product segments (Table 1).
|Basic Paediatrics||Ehanced Paediatrics
|OPV||IPV||Pneumococcal and Meningococcal conjugates
The industry today is split into three main categories:
The large multinational companies which include
vaccines as part of their overall pharmaceuticals portfolio, eg
Aventis Pasteur, GlaxoSmithKline, Merck and Wyeth.
A small group of dedicated vaccine companies operating
internationally which includes PowderJect (UK), CSL (Australia)
and Berna (Switzerland).
Regional and local players principally based in
the developing world focused on low cost production, eg Serum
Institute of India, Biofarma.
The value of today's market has been fuelled by growth from
the introduction of the hepatitis B vaccine in the early 1980s
and the ongoing introduction of combination and proprietary vaccines
during the 1990s. Future growth will be driven by the introduction
of vaccines against new diseases and, in the longer term, through
the introduction of post-infection therapeutic vaccines.
A number of factors are expected to change the dynamics of
the vaccines industry. These include:
EconomicsAn increased acceptance
of the pharmaco-economic value of vaccines as a method of disease
prevention. Put simply, prevention is cheaper than cure.
Technology PushThe revolution in
the biological sciences based on genomics, DNA platforms, new
delivery systems, improved adjuvants and the potential for therapeutic
vaccines as a means of post-infection treatment offer significant
opportunities for expanding the diseases targeted by vaccines
and in improving selected current vaccines.
Market-driven productsThe emergence
of new disease applications in the industrialised countries, ongoing
pressures arising from global mobility, eg global travel and trade,
and the demand for simpler more effective vaccination will impact
Societal PressuresAt the same time,
there are a number of other factors such as safety concerns, increasing
regulatory requirements and healthcare economic pressures all
of which will impact the vaccines industry.
IndustryThe vaccines sector has
already seen significant consolidation, and it is likely that
this trend will continue.
The Developing WorldThe continuing
need for the supply of cheap vaccines for expanded immunisation
strategies and the development of vaccines against the diseases
of poverty, ie HIV, TB and malaria.
Vaccine development and production is a complex process.
Typically, there are four principal stages in the development
of a vaccine:
1. ResearchIdentification of candidate
strategies for target disease prevention, assessment of the most
effective route for prevention and construction of a candidate
vaccine. The time-scale is typically three years, but can be longer
for more complex diseases such as HIV, malaria and dengue.
2. Pre-clinical DevelopmentOptimization
and testing of prototype vaccine in animal models to determine
safety and potential efficacy. Time-scales are around one to three
3. Clinical DevelopmentThis involves the
testing in humans in three stagesPhase I (safety), Phase
II (efficacy), Phase III (large-scale registration trials). Timings
can vary significantly depending on the target, but typically
can range from five to seven years. During this period pilot-scale
and commercial manufacturing processes are also developed.
4. Product RegistrationApproval of a product
by the relevant regulatory authoritiesFDA in the United
States, and EMEA in Europe. Again, timings can vary, between one
and three years.
From research through to product launch of a pharmaceutical
or vaccine product can take between 12 and 15 years and cost in
excess of $350 million21. It should also be recognised that the
development of a biological product is generally more complex
and time-consuming than a traditional chemical-based pharmaceutical
product. In addition, the manufacture of biologicals is often
much more difficult than chemicals due to the inherent complexities
of handling living organisms and ensuring continued reproducibility
of finished product within narrowly defined specifications. These
combined factors make new vaccine development and large-scale
manufacturing particularly challenging in today's regulatory environment.
Over the last decade R & D investment in vaccines has
increased significantly. There are over 380 vaccines in various
stages of development, including 113 in pre-clinical development
and 276 in clinical development22. The pipeline contains increasingly
complex vaccines, including:
Genetically engineered recombinants (eg HSV, HIV,
HPV, diabetes, fertility)
Conjugates (eg Group B streptococcus)
Combinations (eg DTaP/Hib/HB, nine- and 11-valent
However, a substantial proportion of the R & D investment
is targeted at "big-ticket" diseases such as HIV and
improved hepatitis B vaccines. Investment in new vaccines such
as chlamydia and improved "old" targets such as TB remain
1. WHO definition of surveillance can be found at www.who.int/emc/surveill/index.htmlsurveillance.
2. Public Health Laboratory Service Corporate Plan 2001-06
4. Decision 2119/98/EC of the European parliament and
of the Council of 24 September 1998 setting up a network for the
epidemiological surveillance and control of communicable diseases
in the Community, OJ L268 of 03/10/98.
5. Machehose L, Brand L, Camaroni I, Fulop N, Noel G,
et. al. Communicable diseases outbreaks involving more
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BMJ 323:861-863 (2002).
6. CDC, An Ounce of Prevention . . . What are the returns?
Atlanta: CDC, ed.2, rev; available at www.cdc.gov/epo/prevent.htm.
7. Stratton KR, Durch JS, Lawrence RS, Eds. Vaccines
for the 21st Century. A Tool for Decision Making. National
Academy Press, Washington, DC, pp. V-460 (2000).
8. Rappuoli R, Miller HI, Falkow S. The intangible value
of vaccination. Science, 297:937 (2002).
9. Tackling the Diseases of Poverty. A Report
by the UK Government Performance and Innovation Unit (2001).
10. Leese J, Tamblyn SE. Pandemic planning. In: Textbook
of Influenza, Blackwell Science, London 1998.
11. Patterson KD, Pyle GF. The geography and mortality
of the 1918 influenza pandemic. Bull Hist Med 1991:65:4-21.
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The role of WHO and guidelines for national and regional planning.
Geneva: WHO, 1999 (WHO/CDS/CSR/EDC/99.1).
13. UNAIDS Fact Sheet 2002.
14. Department of Health. TB
15. Datamonitor. Strategic Vaccine Market Review Report
16. Datamonitor. Strategic Vaccine Market Review Report
17. Datamonitror. Strategic Vaccine Market Review
18. Datamonitor. Strategic Vaccine Market Review Report
19. The PHLS web site, http://www.phls.org.uk/topicsaz/hivandsti/epidemiology/stidata.htm.
20. Mercer Management Consulting. Lessons Learned:
New Procurement Strategies for Vaccines (2002).
21. ABPI. Pharmaceutical Fact Sheet (2000).
22. Datamonitor. Strategic Perspective 2001: Vaccines