Select Committee on Science and Technology Written Evidence

Memorandum by PowderJect Pharmaceuticals Plc


  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 disease targets.

  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 Control.

  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.

Locations:United Kingdom Oxford (Corporate, R&D)
Speke, Liverpool (Manufacturing)
SwedenSolna, Stockholm (Manufacturing, Sales)
United StatesMadison, 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
DNA vaccines
Oral rCTB technology
Therapeutic focus:Vaccines and immunotherapeutics
Major partnerships:GlaxoSmithKline, Aventis, Bavarian Nordic

Clinical:Arilvaxg (yellow fever—US—Phase III), Dukoralg (traveller's diarrhoea & cholera—EU—filed 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.


(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 groups—public 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 trends.

    —  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 others simultaneously5.

  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 as influenza.

    —  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.


  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 be included.

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 agents

  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.


  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 years.

    (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 & D investment.

    (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 together.

    (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.


  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 near-to-medium term:

Pandemic Flu

  In the 20th century major worldwide influenza epidemics—pandemics—occurred 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.

H. pylori

  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:

Herpes simplex

  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.

Human Papillomavirus

  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 morbidity.

  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.


  PowderJect believes that the key policy interventions which would have the greatest impact on preventing diseases outbreaks include:

    —  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 infectious diseases.

Annex 1


  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 PaediatricsEhanced Paediatrics Proprietary PaediatricsAdult/Travel
OPVIPVPneumococcal and Meningococcal conjugates Hepatitis A
BCGDTaPVaricella Yellow fever
TTHepatitis B Typhoid
DTPHib Influenza
2000 Revenue:
$680 million
MMR2000 Revenue:
$2 billion
2000 Revenue:
$1.7 Million
2000 Revenue:
$1.7 billion

  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:

    —  Economics—An increased acceptance of the pharmaco-economic value of vaccines as a method of disease prevention. Put simply, prevention is cheaper than cure.

    —  Technology Push—The 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 products—The 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 product development.

    —  Societal Pressures—At 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.

    —  Industry—The vaccines sector has already seen significant consolidation, and it is likely that this trend will continue.

    —  The Developing World—The 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.

Annex 2


  Vaccine development and production is a complex process. Typically, there are four principal stages in the development of a vaccine:

  1.   Research—Identification 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 Development—Optimization and testing of prototype vaccine in animal models to determine safety and potential efficacy. Time-scales are around one to three years.

  3.   Clinical Development—This involves the testing in humans in three stages—Phase 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 Registration—Approval of a product by the relevant regulatory authorities—FDA 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 pneumoccocal conjugates).

  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 low.


  1.  WHO definition of surveillance can be found at

  2.  Public Health Laboratory Service Corporate Plan 2001-06 (2001).


  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 than one country: Systems approach to evaluating the approach. BMJ 323:861-863 (2002).

  6.  CDC, An Ounce of Prevention . . . What are the returns? Atlanta: CDC, ed.2, rev; available at (October 1999).

  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.

  12.  World Health Organisation. Influenza pandemic plan. 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 (2002).

  16.  Datamonitor. Strategic Vaccine Market Review Report (2002).

  17.  Datamonitror. Strategic Vaccine Market Review Report (2002).

  18.  Datamonitor. Strategic Vaccine Market Review Report (2002).

  19.  The PHLS web site,—az/hiv—and—sti/epidemiology/sti—data.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 (2001).

October 2002

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