Issuu on Google+

5954 IFPMA Vaccine Overview (8pp) ENG:Layout 1

8/5/2008

12:45

Page 1

The Value of Vaccines: Two Centuries of Unparalleled Medical Progress

May 2008


5954 IFPMA Vaccine Overview (8pp) ENG:Layout 1

8/5/2008

12:45

Page 2

The value of vaccines Since the discovery of modern vaccination over 200 years ago, vaccines have proved to be ‘one of the most successful and cost-effective public health interventions’1. Indeed, with the exception of clean, safe drinking water, no treatment rivals immunization in reducing mortality rates2. Vaccine use has resulted in the global eradication of smallpox and regional elimination of polio and measles, and vaccines save the lives of over 2 million children each year3. In the period from 2000 to 2006, targeted immunization campaigns helped reduce the number of deaths caused by measles by 68%, from 757,000 to 242,000, with a corresponding 91% reduction in Africa4. With sustained effort and sufficient financial resources WHO believes that vaccines can save an additional 10 million lives over the next decade5.

COURTESY SANOFI PASTEUR

Vaccines save over 2 million children every year – WHO

100 90 80 70 60 50 40 30 20 10

Immunization coverage (%)

5,000,000 4,500,000 4,000,000 3,500,000 3,000,000 2,500,000 2,000,000 1,500,000 1,000,000 500,000 0

0 1980 1981 1982 1983 1984 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006

Number of cases

MEASLES GLOBAL ANNUAL REPORTED INCIDENCE AND MEASLES-CONTAINING VACCINE COVERAGE, 1980-2006

Number of cases

Official coverage

WHO/UNICEF estimated coverage

Dramatic reduction in global cases of measles with corresponding increase in vaccine coverage.8

Vaccines not only save lives, their costeffectiveness is also well documented. A study in Kenya estimated that a oneweek measles vaccination campaign for nearly 13 million children would prevent 3,850,000 infections and 125,000 deaths and save $12 million in health costs over a ten-year period. Similarly, a cost-benefit analysis in the US found that every dollar invested in vaccines saved between $2 and $27 in health costs6.

2

COVER PHOTO COURTESY MERCK & CO., INC.

Protecting people around the world Vaccine coverage has improved dramatically since the introduction of the WHO Expanded Programme on Immunization (EPI) began in 1974. Beyond basic immunization against six key diseases (diphtheria, measles, pertussis, polio, tetanus and tuberculosis), developing countries are increasingly introducing vaccines against hepatitis B, Haemophilus influenzae b (Hib) and yellow fever6. With the launch of the GAVI Alliance (formally the Global Alliance for Vaccines and Immunization) in 2000, vaccine uptake has continued to improve, and by 2007 WHO estimates that an additional 36.8 million children received basic immunization against diphtheria, tetanus and pertussis, and a further 176 million were protected with new and underused vaccines7. As a result of this progress vaccination rates against the six key diseases have increased from around 20% in 1980 to approximately 80% in 2006, and the burden of vaccine-preventable diseases has dropped dramatically8. Vaccines used in routine immunization are highly effective at preventing disease. However, in addition to directly protecting those who are vaccinated, widespread immunization throughout the population can block the spread of infection even to those who are not vaccinated, by providing what is termed ‘herd immunity’. Although, like many medicines, vaccines are not 100% effective, they have a good safety record and most side-effects are minor and serious complications rare6.

Global vaccine coverage against six key childhood diseases has increased from 20% to 80% – WHO


5954 IFPMA Vaccine Overview (8pp) ENG:Layout 1

Harnessing the power of the immune system Unlike traditional pharmaceuticals, vaccines are prophylactic medicines designed to prevent rather than treat disease. Vaccines achieve this by stimulating an immune response, which includes the production of antibodies and creation of immune memory, that can protect against disease-causing micro-organisms such as viruses or bacteria. Vaccines are produced from whole bacteria or viruses, or specific parts of the organisms (polysaccharides or proteins), or compounds that they produce (toxoids). All of these vaccines are specifically processed to prevent them causing disease while stimulating the appropriate immune response to provide protection.

8/5/2008

12:45

Page 3

COURTESY CRUCELL

VACCINE TYPES AND VACCINE-PREVENTABLE DISEASES VACCINE TYPES

LICENSED VACCINES

Live attenuated vaccines

consist of weakened viruses or bacteria that the immune system cannot differentiate from a real infection and consequently mounts a strong response similar to that induced by the natural disease.

BCG, cholera (oral), influenza (intranasal), measles, mumps, polio (oral), rotavirus (oral), rubella, smallpox, typhoid (oral), varicella, yellow fever.

Inactivated vaccines

contain either whole or portions of killed bacteria or viruses and require several doses, generally to ‘prime’ the immune system and then ‘boost’ the immune response to provide protection.

Hepatitis A, influenza, Japanese encephalitis, polio, Q fever, rabies, tick-borne encephalitis.

Toxoid vaccines

contain toxins produced by bacteria that have been inactivated to avoid toxic effects while producing a protective immune response.

Diphtheria, tetanus.

Sub-unit vaccines

consist of specific proteins purified from viruses or bacteria that are capable of generating an immune response.

Anthrax, influenza, pertussis.

Polysaccharide vaccines

contain purified sugar molecules taken from the surface of bacteria that can stimulate the immune system to generate antibodies.

Meningococcal, pneumococcal, typhoid.

Conjugate vaccines

contain polysaccharides joined to immunestimulating molecules to develop a more robust immune response.

Haemophilus influenzae b, meningococcal, pneumococcal, typhoid.

Recombinant vaccines

consist of virus proteins or live weakened viruses or bacteria produced using recombinant genetic engineering.

Hepatitis B, human papillomavirus, rotavirus (oral, reassortant).

3


5954 IFPMA Vaccine Overview (8pp) ENG:Layout 1

8/5/2008

12:46

Page 4

Investing in future vaccines Investment in research and development, largely by the pharmaceutical industry, has resulted in a broad range of vaccines targeting over 25 infectious diseases. During the last 30 years scientists have made further breakthroughs by harnessing the power of biotechnology, genetic decoding and information technology, and the pace of vaccine

development has accelerated. As a consequence, the vaccine industry has recently introduced a number of new vaccines such as those against cervical cancer (human papillomavirus), meningococcal infection, pandemicpotential influenza, pneumococcal diseases, rotavirus diarrhea and varicella zoster.

RECENTLY INTRODUCED VACCINES VACCINE TARGET

DISEASE IMPACT

VACCINES

Cervical cancer caused by human papillomavirus (HPV)

HPV is the major cause of cervical cancer, which is responsible for 240,000 deaths and affects 500,000 women each year, 80% of who are in the developing world.

Two vaccines are available that protect against the 16 and 18 subtypes of the virus, which are responsible for 70% of HPV cervical cancers. One of the vaccines also protects against the 6 and 11 subtypes, which are responsible for genital warts.

Meningococcal disease

Meningococcal infection can lead to meningitis. Several meningococcal subtypes exist, with subtype A prevalent in the African ‘meningitis belt’ causing frequent epidemics. Of those infected, between 10% and 20% die, and of the survivors 20% are likely to suffer a permanent disability, such as hearing loss, mental retardation or paralysis. Subtype B is important in industrialized countries with many of the other cases caused by type C.

Polysaccharide vaccines are used during outbreaks, but are not highly effective in young children and do not result in longlasting immunity. A number of conjugate vaccines against type C are now available with others targeting different subtypes in development. A conjugate vaccine covering subtypes A, C, W and Y, which account for many cases of disease, is available in a number of countries.

Pandemic and pre-pandemic influenza virus

Previous influenza pandemics have resulted in large numbers of deaths. The largest pandemic in the last century in 1918-19 caused between 40 – 50 million deaths. Scientists suggest that a future pandemic may result in millions of fatalities and cause great disruption to society.

Several vaccines have received preliminary approval for use during a pandemic, once the exact virus strain is available for production. Others based on potential pandemic strains (such as H5N1) have been developed for stockpiling or use prior to a pandemic occurring.

Pneumococcal diseases

Pneumococcal disease is responsible for approximately 1.6 million deaths worldwide each year, many of which occur in young children, particularly in the developing world. WHO recommends routine vaccination, particularly where the mortality in children is high.

The first pneumococcal vaccines were based on polysaccharides and given to older children and the elderly as they are not as effective in those under 2 years old. However, a new conjugate vaccine offers protection to this important at-risk age group, and others are in development.

Rotavirus diarrhea

Rotavirus is an important cause of acute diarrhea, and in 2004 was responsible for the deaths of over 500,000 children under the age of five, the majority of whom were in the developing world.

Two vaccines are now available and used in a number of countries. The vaccines have undergone major clinical testing to establish their safety, following rare but serious complications called intussusception with an earlier unrelated rotavirus vaccine.

Chickenpox caused by varicella zoster virus

Varicella zoster virus is responsible for chickenpox, a highly contagious disease prevalent in children. Chickenpox is usually mild, but can be severe in adults and those with compromised immune systems, such as those with HIV.

Vaccines against the disease are available and are used in many industrialized countries.

Shingles caused by varicella zoster virus

After recovering from chickenpox, the varicella zoster virus remains in the body and can cause the painful skin rash commonly called shingles years later. The disease is quite prevalent with an estimated 1 million cases annually in the US, most commonly in those over 50 years old.

A vaccine specifically designed to protect against shingles is available. Testing in thousands of adults showed that the vaccine can reduce the incidence of shingles by approximately half, and neuralgia was reduced by two-thirds.

COURTESY GLAXOSMITHKLINE

Investment in modern technology has resulted in a range of innovative new vaccines

COURTESY MERCK & CO., INC.

4

References 9, 10, 11, 12, 13, 14, 15, 16, 17


5954 IFPMA Vaccine Overview (8pp) ENG:Layout 1

As biological sciences continue to advance rapidly, the pharmaceutical industry is making significant investments to further extend the range of available vaccines. Scientists continue to work on preventing infectious diseases, including those that disproportionately affect the developing world such as HIV/AIDS, malaria and tuberculosis. A number of vaccines are now in development that are designed to treat diseases, such as cancer. Unlike more traditional vaccines, these aim to focus the immune system on attacking established disease, rather than offering protection against infections.

8/5/2008

12:46

Page 5

Therapeutic treatments for diseases such as cancer are now in development COURTESY NOVARTIS VACCINES & DIAGNOSTICS

VACCINES IN DEVELOPMENT Bacterial diseases

Viral diseases

Parasitic diseases

Therapeutic treatments

Clostridium difficile

Cytomegalovirus

Hookworm

Allergic rhinitis (hay fever)

Chlamydia

Dengue fever

Leishmaniasis

Alzheimer’s

Escherichia coli

Ebola

Malaria

Breast cancer

Helicobacter pylori

Epstein-Barr

Schistosomiasis

Cervical cancer

Meningococcus B

Genital herpes

Cocaine addiction

Plague

Hepatitis C

Colorectal cancer

Pseudomonas aeruginosa

Hepatitis E

Lung cancer

Herpes simplex

Melanoma

HIV

Multiple sclerosis

Influenza (universal)

Nicotine addiction

Streptococcus group A&B

Parainfluenza

Pediatric tumors

Tuberculosis

Respiratory syncytial virus

Shigella Staphylococcus

SARS West Nile

Reference18

Developing, producing and supplying vaccines: The role of industry The process of researching, testing, gaining regulatory approval and manufacturing vaccines is costly, complex and lengthy. Unlike traditional pharmaceuticals, vaccines are biological medicines based on living organisms and therefore must meet specific, extensive regulatory requirements throughout their development, production and distribution cycles. As a result, developing a new vaccine takes on average 18.5 years, costs over $500 million19 and can require testing in tens of thousands of subjects. In addition, unlike many traditional pharmaceuticals, the production of

vaccines is highly complicated and can take many months, and sometimes more than a year. Of this time, a significant proportion is spent on quality testing and manufacturing controls to make sure the vaccines are of the highest standard. Consequently, only industry is in the position to take the significant risk and make the major investment required to develop and produce new vaccines. Achieving this sustainable investment requires long-term commitment, predictable future demand and government policies that recognize the value of vaccination.

Developing a new vaccine is complex and risky, takes on average 18.5 years and costs over $500 million

5


5954 IFPMA Vaccine Overview (8pp) ENG:Layout 1

8/5/2008

12:46

Page 6

Immunization policy must reflect the value of vaccination Increasingly public health policies at national and international levels recognize the importance and value of vaccination. However, to ensure continued stability and provide a supportive environment for ongoing investment in innovative new vaccines, long-term partnership and collaboration between policy makers, public health authorities and industry is crucial. Ensuring vaccines for all Since their introduction, vaccines have proved highly effective at reducing death and disease. However, with the success of immunization, complacency and shifting priorities can result. In countries with broad immunization coverage people rarely encounter vaccine-preventable diseases such as diphtheria, and consequently the motivation for vaccination can wane. Following the successful introduction of the WHO’s EPI program of basic immunization, developing countries enjoyed dramatic falls in the incidence of vaccinepreventable diseases20. However, by the 1990s immunization rates were falling in many of these countries. As a result, an innovative public-private partnership was COURTESY PAHO

6

COURTESY GAVI/07/CHRISTINE NESBITT

launched in 2000 to increase access to vaccines and drive up their use. The resulting GAVI Alliance brings together many of the organizations involved in immunization to combine their skills and resources. Since its establishment, the GAVI Alliance has raised over $3.5 billion in funding from governments and private donors to greatly increase immunization levels in over 70 of the world’s poorest countries21. In addition, the GAVI Alliance has initiated programs to address some of the most important factors that impact access to vaccines, in particular improving the local healthcare infrastructure needed to deliver immunization. The Alliance has also established a number of important financing initiatives. The International Finance Facility for Immunization raised $4 billion22 in commitments from donor governments to further improve vaccination with underused and new vaccines, including rotavirus and pneumococcal vaccines. Advance Market Commitments are designed to create market-based incentives to encourage the development of new vaccines for use in developing countries.


5954 IFPMA Vaccine Overview (8pp) ENG:Layout 1

8/5/2008

12:46

Page 7

As a key partner in improving public health, industry is committed to increasing global access to vaccines COURTESY GAVI/07/CHRISTINE NESBITT

The vaccine industry is a key GAVI Alliance partner, and is committed to increasing global availability of vaccines, including those that are underused or newly introduced. For many years industry has supplied vaccines for use in the developing world at preferential prices through international agencies such as UNICEF, and this commitment continues. Industry also makes donations of vaccines to improve public health in the poorest countries23. Although newer vaccines based on complex new technologies are inevitably more expensive due to their significant development costs, a strong and enduring partnership between industry, governments, public health authorities, international organizations and specialized alliances, such as the GAVI Alliance, can help ensure that vaccination remains one of the world’s most important and cost-effective public health measures.

References: 1. WHO Weekly Epidemiological Record No. 19, 2006, 81, 189-196. 2. Plotkin SA, Orenstein WA. Vaccines. 4th ed. Philadelphia, Pa: W.D. Saunders; 2004:1. 3. WHO Immunization Homepage (http://www.who.int/topics/immunization/en/ accessed February 2008). 4. WHO News Release 29 November 2007; Measles deaths in Africa plunge by 91%. 5. WHO News Release 9 December 2005; With an additional US $1 billion per year immunization could save ten million more lives in a decade. 6. WHO Fact Sheet 288. Immunization against diseases of public health importance. March 2005. 7. GAVI Alliance Global Results (http://www.gavialliance.org/performance/global_results/index.php accessed February 2008). 8. WHO Vaccine-preventable diseases: monitoring system. 2007 Global Summary. 9. WHO Fact Sheet 289. Development of new vaccines. December 2006. 10. WHO Initiative for Vaccine Research (IVR). Neisseria meningitidis (http://www.who.int/vaccine_research/diseases/soa_bacterial/en/index2.html accessed February 2008). 11. IFPMA IVS ITF presentation at WHO Scientific Consultation on Options for the Use of Human H5N1 Influenza Vaccines and the WHO H5N1 Vaccine Stockpile. 1-3 October 2007. 12. WHO Epidemic and Pandemic Alert and Response (EPR). Pandemic preparedness (http://www.who.int/csr/disease/influenza/pandemic/en/index.html accessed February 2008). 13. WHO Weekly Epidemiological Report 23 March 2007. No. 12, 2007, 82, 93-104. 14. WHO Immunization surveillance, assessment and monitoring . Estimated number of rotavirus deaths for children under 5 years of age: 2004, 527,000. 15. WHO Immunization, Vaccines and Biologicals. Varicella vaccine (http://www.who.int/vaccines/en/varicella.shtml accessed February 2008). 16. CDC. Shingles Disease Questions and Answers (http://www.cdc.gov/vaccines/vpd-vac/shingles/dis-faqs.htm accessed February 2008). 17. CDC. Herpes Zoster Vaccine Q&A (http://www.cdc.gov/vaccines/vpd-vac/shingles/vac-faqs.htm accessed February 2008). 18. IFPMA data. October 2007. 19. Biomedical Industry Advisory Group. The Biomedical Research & Development Guide 2006. 20. GAVI Alliance Fact Sheet. Immunisation (http://www.gavialliance.org/resources/FS_Immunisation_Aug06_en.pdf accessed February 2008). 21. GAVI Alliance Fact Sheet. The GAVI Alliance (http://www.gavialliance.org/resources/FS_GAVI_Overview_Feb07_web_EN.pdf accessed February 2008). 22. GAVI press release 7 November 2006. International Finance Facility for Immunisation Issues Inaugural Bonds. 23. Partnerships to Build Healthier Societies in the Developing World. IFPMA May 2007.

7


5954 IFPMA Vaccine Overview (8pp) ENG:Layout 1

Dr Ryoko Krause Director, Biologicals and Vaccines, IFPMA Ch. Louis Dunant 15, P.O. Box 195 1211 Geneva 20, Switzerland Tel: +41 22 338 3200 Fax: +41 22 338 3299 Web: www.ifpma.org Email: r.krause@ifpma.org Š2008 IFPMA P-0018-1(e)

8/5/2008

12:46

Page 8


Value of Vaccines