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PRESS KIT Sanofi Pasteur – Dedicated to vaccines CONTACT: Global Communications Alain Bernal T. +33-4-37-37-50-38 [email protected] www.sanofipasteur.com October 2016 TABLE OF CONTENTS AN INTRODUCTION TO VACCINES ................................................................................. 3 REALIZING OUR GOAL FOR A WORLD PROTECTED AGAINST VACCINE PREVENTABLE DISEASES ............................................................................................... 6 DENGUE FEVER & THE FIRST DENGUE VACCINE: A GAME-CHANGER IN GLOBAL DENGUE PREVENTION ............................................................................. 8 VACCINATING AGAINST INFLUENZA: AN EVOLVING GLOBAL CHALLENGE .... 10 POLIOMYELITIS: WORKING TOWARDS THE COMPLETE ERADICATION OF THIS DEVASTATING DISEASE ........................................................................................ 12 MENINGOCOCCAL MENINGITIS: TACKLING MAJOR OUTBREAKS .................... 14 YELLOW FEVER: A MAJOR PUBLIC HEALTH CONCERN .................................... 15 EXPLAINING THE COMPLEXITY OF VACCINE MANUFACTURING ............................ 17 PIONEERING VACCINES FOR TOMORROW ................................................................. 19 CREATING STRONG PARTNERSHIPS FOR CONTINUED SUCCESS ......................... 25 SANOFI PASTEUR: COMPANY SNAPSHOT.................................................................. 27 OUR HISTORY AND HERITAGE ..................................................................................... 29 OUR KEY VACCINE MILESTONES ................................................................................. 32 PRESS KIT I 2 AN INTRODUCTION TO VACCINES THE VALUE OF VACCINES “Immunization has been a great public health success story. The lives of millions of children have been saved, millions have the chance of a longer healthier life, a greater chance to learn, to play, to read and write… Vaccination is a benefit to mankind.” Nelson Mandela, Winner of the Nobel Peace Prize, 1993 With the exception of clean, safe drinking water, no human endeavor rivals immunization in combating infectious diseases and reducing mortality rates. Vaccination saves more than 3 million lives each year1 thanks to the vast range of vaccines providing protection from 26 infectious diseases2. Vaccination is one of the most cost-effective healthcare investments available. For instance, a recent analysis demonstrated that 1 euro invested3 in a dose to immunize an adult saves 4 euros. CASE STUDY: The eradication of polio Polio is a highly infectious disease caused by a virus. The majority of polio cases are in children under five and the disease can result in paralysis or disability and, in some cases, death. Although polio cannot be cured, vaccination against the disease is highly effective. Since the creation of the Global Polio Eradication Initiative (GPEI) in 1988, polio cases have decreased by over 99% worldwide. This is thanks to an unprecedented cooperative action involving 200 countries and 20 million volunteers. Today polio is on target to become the second disease (after smallpox) to be eradicated from the face of the earth. (Source : http://www.polioeradication.org/Polioandprevention/Historyofpolio.aspx) VACCINES, VACCINATION AND IMMUNIZATION Infectious diseases are caused by microorganisms, such as viruses, bacteria, parasites or fungi. They are a major cause of death, in particular among children and young adults. It is important to understand the difference between a vaccine, vaccination and immunization: A vaccine provides an individual with protection from an infection by stimulating an immune reaction and thereby boosting the natural defenses of the body. It can be administered through needle injections, by mouth, or by aerosol. 1 http://www.who.int/topics/immunization/en/ http://www.who.int/immunization/diseases/en/ 3 Tariq, L., et al (2015). Modelling the return on investment of preventively vaccinating healthcare workers against pertussis. BMC Infectious Diseases, 15, 75. http://doi.org/10.1186/s12879‐015‐0800‐8 2 PRESS KIT I 3 A vaccine is a biological preparation that improves immunity to a particular disease. A vaccine typically contains an agent that resembles a disease-causing microorganism, and is often made from weakened or killed forms of the microbe, its toxins or one of its surface proteins. 4 The immune response stimulated by a vaccine is vital to ensure that enough antibodies are made and that the body’s natural defenses are able to fight off any infection in the future. A vaccination is the injection of a killed or weakened organism that produces immunity in the body against that organism.5 Immunization is the process whereby a person is made immune or resistant to an infectious disease, typically by the administration of a vaccine. 6 MAIN VACCINE TYPES7 There are three main types of vaccines: Live attenuated vaccines The bacterium or virus is weakened. Its ability to cause disease is reduced, either by growing it in a certain way or by using physical or chemical treatments, but the pathogen is still able to produce an immune response. Examples: Mumps, measles, rubella, polio (oral), yellow fever, tuberculosis. Inactivated vaccines Inactivated vaccines can be produced from either the whole microorganism or parts of it. Whole-germ vaccines are made from the entire pathogenic agent, which is killed using chemicals or heat, without altering its immunogenicity. Sub-unit vaccines only comprise those parts of the infectious agent necessary to obtain an immune response (antigens). Examples: Diphtheria, tetanus, pertussis, Hib, meningococcal infections, typhoid fever, pneumococcal infections, influenza, rabies, polio (injectable), hepatitis A, Japanese encephalitis. Recombinant vaccines Vaccine antigens may also be produced by genetic engineering technology. These products are sometimes referred to as recombinant vaccines. Examples: Hepatitis B, dengue. MANUFACTURING VACCINES Vaccine manufacturing is a long and complex journey, taking up to 36 months to produce, package and deliver to those who need them. This complex journey can introduce a number of production challenges for manufacturers. The complex process to make vaccines includes testing each batch at every step of its journey, and quality control re-testing of batches by different authorities around the world. Approximately 70% of vaccine production time is dedicated to quality control. Any unpredictable event in this quality process may lead to delays in being able to release vaccines and, consequently, shortages in supplying vaccines to the communities who need them. 4 http://www.who.int/topics/vaccines/en http://www.vaccines.gov/basics/ 6 http://www.who.int/topics/immunization/en/ 7 https://www.cdc.gov/vaccines/pubs/pinkbook/downloads/prinvac.pdf 5 PRESS KIT I 4 The production process is under even greater pressure as demand for certain vaccines grows, such as pediatric combination vaccines, and as demand increases from the global public health community to investigate new and emerging threats, such as Zika. THE FUTURE OF VACCINATION Vaccination has delivered enormous benefits in global public health but work remains to be done. It is vital to develop new vaccines and improved versions of existing vaccines, and to increase access to vaccines to enable even more lives to be saved. It is also important to recognize that maintaining high vaccination coverage is an ongoing challenge. History shows that a decrease in immunization coverage sets the stage for the reappearance of disease in previously protected populations. The resurgence of diphtheria in the 1990s in certain Eastern European countries, with more than 125,000 cases and 4,000 deaths reported, illustrates that continued vigilance is crucial to controlling and eradicating infectious diseases in the future. More recently, the U.S. experienced a record number of measles cases during 2014, with 667 cases from 27 states reported to the CDC's National Center for Immunization and Respiratory Diseases (NCIRD). This is the greatest number of cases since measles elimination was documented in the U.S. in 2000.8 At Sanofi Pasteur, we have been developing and producing innovative vaccines for more than a hundred years and are committed to working with stakeholders around the world to achieve our vision of a world in which no one suffers or dies from a vaccine-preventable disease. 8 http://www.cdc.gov/measles/cases‐outbreaks.html PRESS KIT I 5 REALIZING OUR GOAL FOR A WORLD PROTECTED AGAINST VACCINE PREVENTABLE DISEASES At Sanofi Pasteur, we believe in a world in which no one suffers or dies from a vaccine preventable disease, and we have spent more than 100 years discovering, developing and delivering vaccines to make this possible. OUR MANDATE IS TO: Improve human health by developing superior innovative vaccination solutions against infectious diseases Reliably provide high quality vaccines Engage with the public health community to sustainably maximize vaccination impact. We provide more than 1 billion doses of vaccines each year making it possible to immunize more than 500 million people worldwide per year against diseases such as polio, influenza and, most recently, dengue. We have a portfolio of high-quality vaccines that match our areas of expertise and ensure a sustainable future: Cholera Dengue fever Diphtheria Haemophilus influenzae type b (Hib) infections Hepatitis A Hepatitis B Influenza Japanese encephalitis Measles Meningococcal infections Mumps Pertussis (whooping cough) Pneumococcal infections Poliomyelitis Rabies Rubella Tetanus Tuberculosis Typhoid fever Yellow fever We also produce a vaccine against one eradicated disease – smallpox (the vaccine is produced in response to the threat of bioterrorism). PRESS KIT I 6 OUR COMMITMENT TO PUBLIC HEALTH IS WIDESPREAD AND INCLUDES: Launching the first ever vaccine against dengue, following a 20-year commitment to make the vaccine a reality Supplying over 220 million doses of seasonal influenza vaccines in 2015 Being the leading provider of injectable and oral polio vaccines Producing a range of modern pediatric combination vaccines for children all around the world Being the world’s largest provider of vaccines against meningococcal infections Sustaining the largest portfolio of vaccines for travelers and people living in endemic areas Partnering with other world leaders, such as the WHO, UNICEF, Gavi (the Vaccines Alliance) and the Bill & Melinda Gates Foundation, to bring the benefits of vaccines to as many people around the world as possible. PRESS KIT I 7 DENGUE FEVER & THE FIRST DENGUE VACCINE: A GAME-CHANGER IN GLOBAL DENGUE PREVENTION Dengue fever is a mosquito-borne disease caused by four types of dengue viruses (type 1 to 4). Despite vector control efforts, it is the fastest growing mosquito-borne disease in the world today, causing 390 million infections every year and increasing 30-fold in the last 50 years.1 THE 'BREAK-BONE FEVER’: SYMPTOMS Dengue, also known as ‘break-bone’ fever, is a painful disease due to the terrible bone and joint pain it can cause, and until now there has been no specific treatment or prevention to protect against it.2 Symptoms, which appear between three and 14 days after the initial bite by the mosquito, vary from a mild fever to a very high fever accompanied by severe headache, pain behind the eyes, muscle and joint pain, and a rash.3 Severe dengue fever (dengue hemorrhagic fever) is characterized by fever, abdominal pain, persistent vomiting, bleeding and breathing difficulty. This severe form of the disease can be fatal. Dengue affects people from all ages and walks of life, with the greatest number of dengue cases worldwide occurring in the highly mobile and social preadolescent to adult population.4 There is currently no cure for dengue fever but Sanofi Pasteur have recently developed and made available the first dengue vaccine licensed in the world. POSING A THREAT TO HALF THE WORLD’S POPULATION Dengue is found in tropical and sub-tropical climates around the world. According to the World Health Organization (WHO), incidence of dengue has increased 30-fold in the last 50 years; from a handful of countries to 128.5-6 It is estimated that about half the world’s population lives in dengue endemic regions today.5 Many factors have contributed to the re-emergence and dramatic increase in dengue fever including urbanization and increased travel which facilitate the dissemination of dengue viruses and the circulation of the disease. Every year, the world spends USD $9 billion in medical and indirect societal costs on dengue.7 Hospitalized dengue cases consume important resources, leading to significant economic impact at governmental and individual levels.8 The WHO has set a global target to reduce dengue mortality by 50% and morbidity by 25% by the year 2020.9 PRESS KIT I 8 SANOFI PASTEUR’S INNOVATIVE APPROACH TO DEVELOPING THE FIRST DENGUE VACCINE After a 20-year R&D investment, the first dengue vaccine, developed by Sanofi Pasteur, was licensed in Mexico, Brazil and the Philippines, in December 2015. In February 2016, the first vaccinations began in the Philippines, and in April 2016 the WHO Strategic Advisory Group of Experts (SAGE) recommended that the dengue vaccine be introduced in geographic settings (national or subnational) with high dengue endemicity in public immunization programs designed to address endemic country disease burden.10 Our dengue vaccine has the potential to be a game-changer in global dengue prevention. We have reported disease impact modelling results indicating that dengue burden in the endemic countries could potentially be reduced by 50% within five years. 11 The innovative dengue vaccine with proven efficacy against all four types of dengue is the culmination of over two decades of scientific innovation and collaboration, including 25 clinical studies in 15 countries around the world. Over 40,000 volunteers participated in the clinical study program, which concluded in 2014. It demonstrates our long-standing commitment to bring new vaccines to countries facing public health threats like dengue. References 1 World Health Organization. Dengue: guidelines for diagnosis, treatment, prevention and control. New edition. Geneva: WHO, 2009. Available at: http://www.who.int/tdr/publications/documents/dengue-diagnosis.pdf. Last Accessed: 20 May 2016. 2 National Institute of Allergy and Infectious Disease (NIAID). Dengue fever: overview. Available at: http://www.niaid.nih.gov/topics/denguefever/understanding/pages/overview.aspx Last accessed 20 May 2016. 3 World Health Organization, Dengue Fever. Available at http://www.who.int/topics/dengue/en/. Last accessed: 20 May 2016. 4 Egger JR. Age and clinical dengue illness. Emerg Infect Dis. 2007;13:924-5. 5 World Health Organization. Dengue Fact Sheet. Available at: http://www.who.int/mediacentre/factsheets/fs117/en/. Last accessed: 20 May 2016 6 Brady OJ, et al. PLoS Negl Trop Dis. 2012;6:e1760. doi:10.1371/journal.pntd.0001760. 7 Shepard DS, Halasa YA, Undurraga EA, Stanaway J. Global economic cost of dengue illness. Poster presented at: American Society of Tropical Medicine and Hygiene Annual Meeting; Oct. 25-29, 2015, Philadelphia, PA, Poster 781. 8 Suaya JA, et al. Cost of dengue cases in eight countries in the Americas and Asia: a prospective study. Am J Trop Med Hyg. 2009;80:84655. 9 World Health Organization. GLOBAL STRATEGY FOR DENGUE PREVENTION AND CONTROL. Available at: http://apps.who.int/iris/bitstream/10665/75303/1/9789241504034_eng.pdf. Last accessed: 20 May 2016. 10 World Health Organization. http://www.who.int/immunization/research/development/dengue_vaccines/en/. Last accessed 13 July 2016 11 Coudeville L, Baurin N. Potential impact of dengue vaccination: insights from the first large-scale efficacy trials. Poster presented at 64th ASTMH Annual Meeting - October 25-29, 2015, Philadelphia, Pennsylvania, USA. Poster #3234 PRESS KIT I 9 VACCINATING AGAINST INFLUENZA: AN EVOLVING GLOBAL CHALLENGE Influenza (the flu) is an acute viral infection that spreads easily from person to person and circulates year-round worldwide. Influenza can lead to severe medical complications, such as pneumonia, and can aggravate underlying medical conditions, including congestive heart failure and diabetes. The World Health Organization (WHO) estimates that influenza causes up to 500,000 deaths worldwide every year. 1 Vaccination is a vital part of protecting people and communities from the heavy toll that influenza can take. At Sanofi Pasteur, we are the world’s leading supplier of vaccines against influenza and produce approximately 40 percent of influenza vaccines distributed worldwide. In 2015 alone we provided over 220 million doses of influenza vaccine. THE UNIQUE CHALLENGES OF FLU VACCINATION The process for producing vaccines is complex and includes testing each individual batch of vaccine at every step of its journey, as well as additional quality control testing of batches by different authorities around the world at release stage. Producing influenza vaccines is made even more complex as influenza viruses evolve seasonally. Not all influenza is the same and a vaccine that is highly effective one year may offer only minimal protection the next year. Type A and Type B are the influenza viruses most affecting people and are those included in the seasonal influenza vaccine. These viruses evolve to create different strains. Flu – often called ‘seasonal flu’ – is most common in the winter. Because the viruses responsible for seasonal flu evolve and change and because the world experiences two winters each year (one in the Northern Hemisphere and one in the Southern Hemisphere), it is necessary to produce seasonal flu vaccines twice each year to ensure that they are as effective as possible. Unlike seasonal influenza, an influenza pandemic is an unpredictable event that occurs when a flu virus evolves and travels rapidly around the world infecting a great number of people. In a pandemic situation, it may be necessary to rapidly develop and produce a new vaccine. PANDEMIC PREPAREDNESS In the past five years Sanofi Pasteur has built major production facilities in China and Mexico to increase production capacity to meet rising demand for seasonal flu vaccines. All our facilities for producing seasonal influenza vaccines (the newer sites in China and Mexico and our sites in the U.S. and France) are specially designed to be able to switch to the production of a pandemic influenza vaccine should the need arise. We provide vaccines expertise to governments, international organizations and working groups on all aspects of influenza pandemic preparedness, and support dialogue to define vaccination strategies before a pandemic is declared. We were the first company to employ our industrial-scale capabilities PRESS KIT I 10 for the manufacture of a vaccine against a potential A(H5N1) influenza pandemic. Since 2004, millions of doses have been industrially produced, using different A(H5N1) and A(H7N9) avian influenza strains. Industrial and scientific expertise have enabled us to produce A(H5N1) vaccines for several countries, including the U.S., France and Italy for their national pre-pandemic stockpiles, as part of their pandemic preparedness programs. In addition, we are committed to contributing to the WHO pandemic vaccine stockpile in case of a global pandemic. THE FUTURE OF FLU VACCINATION Backed by our experience as a world leader in influenza vaccine research, development and production, we are constantly working to save lives through the development of new and innovative influenza vaccines. We have been investing heavily to support a priority research program for influenza. This program has already yielded significant results showing that the lowest dose known today of a prototype H5N1 influenza vaccine, containing a new adjuvant, induces a strong immune response, thus allowing for the production of a large number of doses in the event of a pandemic. We continue to explore new options for the optimal delivery of influenza vaccines and we are also engaged in a continual program of research to optimize the effectiveness of our vaccines. Given the evolution in seasonal flu epidemiology, we have initiated the switch to Quadrivalent Influenza Vaccine (two A-strains and two B-strains) to ensure a broader protection and to provide vaccine solutions at the forefront of innovation. In December 2014, our Intradermal Quadrivalent Influenza Vaccine for adults was approved by the U.S. FDA. Our ultimate ambition is to develop a broadly-protective influenza vaccine. In November 2015, we presented at the World Vaccine Congress the paradigm shifting potential of broader-spectrum influenza vaccine approaches that stimulate protection against many influenza strains. We are actively exploring the development of a more-broadly protective influenza vaccine that will be designed to prevent the seasonal mismatches that can occur and that are not addressed using the current technology. We have an existing R&D collaboration agreement with the University of Georgia2 on a method that could yield a novel, synthetic vaccine designed to protect against seasonal influenza strains spanning several years, including strains not yet in existence. References 1. World Health Organization Fact sheet N°211 Updated March 2014. Available at: http://www.who.int/mediacentre/factsheets/fs211/en/. Last accessed June 2016 2. Sanofi Pasteur Press Release March 29, 2016. Available at: http://www.sanofipasteur.com/en/media/local-press- releases/ PRESS KIT I 11 POLIOMYELITIS: WORKING TOWARDS THE COMPLETE ERADICATION OF THIS DEVASTATING DISEASE Poliomyelitis (polio) is a highly infectious disease caused by the poliovirus. The majority of polio cases occur in children under five years of age. Initial symptoms are fever, fatigue, headache, vomiting, stiffness in the neck and pain in the limbs. The disease can result in paralysis or disability and, in some cases, death. Although polio cannot be cured, it can be prevented by vaccination. There are three serotypes of wild poliovirus – type 1, type 2, and type 3. Type 2 poliovirus has been eliminated in the wild – the last case was detected in India in 1999. Type 1 and type 3 wild poliovirus continue to circulate in endemic areas and must be eradicated. Today, polio is only routinely transmitted from person to person in three countries – Afghanistan, Pakistan and Nigeria. There were just 74 cases of the paralysing disease in 2015 and as of September 28, 2016, so far there have only been 26. 1 The Global Polio Eradication Initiative (GPEI), an initiative spearheaded by the World Health Organization (WHO), Rotary International, the US Centers for Disease Control and Prevention (CDC) and UNICEF, was created in 1988 and aims at immunizing every child against polio until transmission stops and the world is polio-free. Since the creation of GPEI, cases of the disease have fallen by 99%2, with more than 10 million people escaping paralysis. TWO VACCINES, ONE GOAL: ZERO POLIO There are two types of polio vaccines – Oral Polio Vaccine (OPV) and Injectable, Inactivated Polio Vaccine (IPV). Oral Polio Vaccine: A live-attenuated vaccine (weakened polio virus) that was developed in 1957 by Albert Sabin. The vaccine has been instrumental in the reduction of disease burden by 99% worldwide. Available as a trivalent vaccine, bivalent (types 1 and 3) and two monovalents (type 1 and type 2) to meet various vaccination needs. Injectable, Inactivated Polio Vaccine (IPV): An inactivated vaccine (killed polio virus) that was first developed in 1952 by Jonas Salk. IPV contains all three serotypes of polio and eliminates the risk of vaccine-associated paralytic poliomyelitis (VAPP) that occurs rarely with the use of OPV. OUR COMMITMENT TO FIGHTING POLIOMYELITIS At Sanofi Pasteur we are a leading provider of polio vaccines and have partnered with GPEI for over 25 years. PRESS KIT I 12 In 1982, our enhanced-potency Inactivated Polio Vaccine (IPV) was registered and it is now distributed globally as a stand-alone poliovirus vaccine as well as in combination pediatric vaccines that make it possible to immunize against several diseases in a single shot. Since then we have distributed more than 1 billion doses of IPV and IPV-containing vaccines. Since 2013, WHO has recommended that IPV gradually replace OPV and be included in all countries’ vaccination schedule. 3 In March 2014, UNICEF announced it would purchase significant quantities of IPV from us and make it available in more than 120 countries that routinely used only the Oral Polio Vaccine (OPV). To support rapid and widespread adoption of IPV, we worked with the Bill & Melinda Gates Foundation (BMGF) to develop a joint price support mechanism which includes financial contributions from both BMGF and Sanofi Pasteur. This mechanism enables us to offer IPV at the lowest price possible to 73 of the world’s poorest countries. Gavi, the Vaccine Alliance, will make IPV available for inclusion in routine immunization schedules in these countries. We are also a major provider of OPV and we have provided more than six billion doses of OPV to UNICEF over the past two decades. In April 2013, we announced we will provide 1.7 billion doses of OPV from 2013 to 2017 to support the goal of eradicating the disease. In September 2011, we donated a vaccine strain (type 3 seed strain) used for polio eradication to the WHO. With this donation, the WHO is in full control of all three seed strains and their distribution to vaccine producers worldwide. References 1. World Health Organization Fact sheet N°110 Updated April 2016 – Available at: http://www.who.int/mediacentre/factsheets/fs114/en/. Last accessed June 2016 2. World Health Organization Fact sheet N°110 Updated April 2016 – Available at: http://www.who.int/mediacentre/factsheets/fs114/en/. Last accessed June 2016 3. World Health Organization IPV Introduction, OPV withdrawal and Routine Immunization Strengthening. Available at: http://www.who.int/immunization/diseases/poliomyelitis/endgame_objective2/en/. Last accessed June 2016 PRESS KIT I 13 MENINGOCOCCAL MENINGITIS: TACKLING MAJOR OUTBREAKS Meningococcal meningitis is a bacterial form of meningitis, a serious infection of the thin lining that surrounds the brain and spinal cord.1 It can cause severe brain damage and is fatal in 9-12% of cases despite appropriate treatment. The most common symptoms are a stiff neck, high fever, sensitivity to light, confusion, headaches and vomiting. If the bacteria – called Neisseria meningitides – enters the bloodstream, they can cause another serious condition known as meningococcal sepsis. Meningococcal disease (which includes meningococcal meningitis and meningococcal sepsis) is rare but potentially fatal and most frequently occurs in younger adults. A significant number (around 1 in 5) of those who survive the disease suffer from permanent sequelae which can include brain damage, kidney damage, scarring, amputations and hearing loss. Meningococcal disease is spread from person to person by close contact through saliva, and can be transmitted by coughing or kissing. Although meningococcal infections usually appear in the form of sporadic cases or minor epidemics, unpredictable and devastating epidemics do sometimes occur in certain geographical areas, such as a region of Sub-Saharan Africa which is known as the “African meningitis belt” due to the impact that the infection has had on the region. Fortunately, vaccination is highly effective in preventing the disease. VACCINATING AGAINST MENINGOCOCCAL DISEASE There are several meningococcal serogroups, but serogroups A, B, C, Y, and W135 account for 99% of cases of invasive infection. Vaccines are now available against all five of these serogroups. At Sanofi Pasteur, we have been researching, developing and producing vaccines to prevent meningococcal disease for more than 40 years. Today we are the world’s leading provider of vaccines to fight meningococcal infections. We were the first company to provide a quadrivalent (conjugate) vaccine to protect against four different types of meningococcal meningitis (serogroups A, C, Y and W135) and in September 2013, our vaccine was the first quadrivalent meningococcal vaccine prequalified by the WHO, which makes it eligible to be purchased by United Nations Agencies. Given the unpredictability of the disease, we believe that the quadrivalent vaccine currently offers the most effective way of providing protection against four of the most prevalent strains of the disease for global populations in a single dose of the vaccine. Reference 1. World Health Organization. Factsheet N°141. Updated November 2015. Available at: http://www.who.int/mediacentre/factsheets/fs141/en/. Last accessed June 2016. PRESS KIT I 14 YELLOW FEVER: A MAJOR PUBLIC HEALTH CONCERN Yellow fever is a serious, potentially deadly, viral disease transmitted by infected mosquitos. It is characterized by a high fever and jaundice. While most people who contract yellow fever recover after an initial acute stage in which symptoms include fever, muscle aches, loss of appetite, nausea and vomiting, others (approximately 15%) experience only a brief period of remission before progressing to the more severe stage of the disease. This stage can result in jaundice, damage to multiple organs – including the liver and kidneys, bleeding from the mouth, nose, eyes or stomach, and in up to half of cases, death. There is no cure for yellow fever and treatment can do nothing more than ease the symptoms of the disease; however vaccination is available. In countries at risk for yellow fever, vaccination is recommended in order to prevent and fight epidemics. It is also recommended for travellers visiting endemic regions. A single dose of vaccine can provide life-long protection.1 A RETURNING THREAT In the 20th century, efforts to control yellow fever combined with the development of a highly effective vaccine achieved great results in reducing the burden of the disease around the world. However, the threat of yellow fever has returned given the 2016 outbreaks in Africa. According to a modelling study based on African data sources, it was estimated that the burden of yellow fever during 2013 was 84,000-170,000 severe cases and 29,000-60,000 deaths. 1 The vast majority of cases and deaths occur in 12 west and central African countries in which yellow fever is now once again a major public health concern. A UNITED RESPONSE TO TACKLE YELLOW FEVER According to the WHO, vaccination is the most effective means of prevention against yellow fever. 1 The Yellow Fever Initiative, led by the WHO and UNICEF with the support of Gavi, the Vaccine Alliance, aims to dramatically reduce the risk of yellow fever outbreaks in the 12 African countries in which it is endemic. A key area of focus for the initiative is on creating a stockpile of vaccines that can be used both to manage outbreaks of the disease and to prevent outbreaks from occurring. At Sanofi Pasteur, we are one of the key partners of the Yellow Fever Initiative. Since 2003, we have provided the majority of the 6 million doses of yellow fever vaccine for the Yellow Fever Initiative’s stockpile. PRESS KIT I 15 OUR COMMITMENT TO FIGHTING YELLOW FEVER Our vaccine against yellow fever: Provides high levels of protection against yellow fever in children and adults Requires a single injection, making it practical and easy to use Is prequalified by the WHO for purchase by the United Nations Is registered in more than 100 countries, with more than 415 million doses distributed to residents in, and travellers to, endemic areas In 2014, we inaugurated a new yellow fever vaccine production unit in our industrial site in Val-de Reuil, France. Our 25 million euros investment aims to double our yellow fever vaccine production capacity in the years to come, making it possible to provide a major portion of the doses required to meet global public health needs for the next decade. Reference 1. World Health Organization Fact sheet N°100. Updated May 2016. Available at: http://www.who.int/mediacentre/factsheets/fs100/en/. Last accessed June 2016 PRESS KIT I 16 EXPLAINING THE COMPLEXITY OF VACCINE MANUFACTURING At Sanofi Pasteur, we work every day to realize our vision for a world in which no one suffers or dies from a vaccine preventable disease. This requires high quality, safe and innovative vaccines to combat infectious diseases, a reliable supply, and collaboration with the public health community to ensure vaccines are available for those who need them. Vaccine manufacturing is a long and complex journey, taking up to 36 months to produce, package and deliver to those who need them. WHAT MAKES VACCINE MANUFACTURING SO COMPLEX? The process to make vaccines is lengthy and includes testing each batch at every step of its journey, and quality control re-testing of batches by different authorities around the world. In addition, the production process is under even greater pressure as demand for certain vaccines grows, such as pediatric combination vaccines, and as demand increases from the global public health community to investigate new and emerging threats, such as Zika. As a result, these factors can lead to delays in being able to release our vaccines and, consequently, shortages in supplying vaccines to the communities who need them. Our top priority is to provide vaccines to protect people’s health and we do everything we can to quickly resolve any supply issues that delay us in delivering on this priority. MAKING POSITIVE, LASTING CHANGES Over the last few years, we have implemented a number of organizational changes to improve our infrastructure, update our processes and train our employees around the world, including: Streamlining manufacturing processes: Our production team and development engineers continue to proactively streamline the manufacturing processes to reduce the length of the entire manufacturing cycle and optimize quality control processes so that high quality, safe vaccines are produced as quickly and efficiently as possible. Investing in our people: We are continuously investing in our people, to maximize our teams’ expertise in vaccine production and ensure best ”know how” Scaling up production capacities: We are increasing our production capacities to meet the growing global demands for our vaccines by increasing the volume of vaccine produced, making the best use of our facilities and working around the clock to ensure no time is wasted. Investing in our production facilities: We continue to invest in our production facilities around the world to ensure they are at the state of art, compliant and ready to meet the growing global demand for vaccines. Investments milestones: nearly €3 billion in the last 10 years (2006-2015). PRESS KIT I 17 We have seen great progress but our work is not finished. WORKING TOGETHER FOR A SUSTAINABLE FUTURE We are working closely with policy makers and health regulators to harmonize regulations with the aim of shortening cycle times, reducing complexity and modernizing our production and control methods, and are continuing to establish more transparent and regular dialogue. The vaccine ecosystem needs to be reformed. Too many barriers delay the delivery of our high quality vaccines to those who need them most. It will take true collaboration between industry, policymakers and health regulators to build a sustainable process to produce and supply vaccines for generations to come. PRESS KIT I 18 PIONEERING VACCINES FOR TOMORROW AT THE CUTTING EDGE OF VACCINE DEVELOPMENT “The development and widespread adoption of vaccines has been hailed as the public health triumph of the 20th century, but what does the future hold?” Gary Finnegan, Editor, Vaccines Today At Sanofi Pasteur, we are at the forefront of vaccine research and development, creating immunological solutions to prevent and cure diseases for every stage of life. We continuously harness new scientific knowledge and technologies to design safe and effective vaccines against complex diseases. We know that innovation is key to improving people's health around the world and also to our company's success. That is why we devote more than €1 million to research and development every day. We continually work to remain at the cutting edge of vaccine development. Whether alone or in collaboration with partners, we seek new approaches to combat infectious diseases. THE R&D CHALLENGE There are 70 significant infectious diseases that are potentially preventable by vaccines. 25 of these have already been developed9 but the most challenging targets for the R&D driven industry remain. These include: Antigenic diversity: e.g. HIV (Human Immunodeficiency Virus), HCV (hepatitis C virus), Rhinoviruses Pathogen biology: e.g. Chlamydia, HSV (herpes simplex virus) Limited natural immunity: e.g. HIV, Chlamydia Immunopathogenicity: e.g. SARS (Severe Acute Respiratory Syndrome), RSV (respiratory syncytial virus) DEVELOPING NEW VACCINES The process to develop a new vaccine can take between 14 and 25 years with an overall cost of $300 million to $1 billion. Working alone or in collaboration with third parties, we develop vaccines against diseases for which there are pressing public-health needs. We have 12 new vaccines in development or submitted for approval, focusing on new targets and improved vaccines for every stage of life: New vaccines against endemic diseases, such as hospital-acquired infections (Clostridium difficile), for which no vaccine exists Next-generation vaccines, such as a meningitis quadrivalent conjugate vaccine New combinations vaccines and new administration systems 9 http://www.who.int/immunization/diseases/en/ PRESS KIT I 19 PHASE I Streptococcus pneumonia Meningitis& pneumoniavaccine HerpesSimplexVirus Type2 HSV‐2vaccine PHASE II PHASE III Men Quad TT Vaxigrip® QIV IM 2 generation meningococcal ACYW conjugate vaccine Quadrivalent inactivated influenza vaccine (3‐36 months) Rabies VRVg Purified vero rabies vaccine Tuberculosis Recombinant subunit vaccine Fluzone® QIV HD Quadrivalent inactivated Influenza vaccine – Clostridium dfficile Toxoid vaccine nd Pediatric pentavalent vaccine DTP‐Polio‐Hib Japan REGISTRATION Dengvaxia® Mildtosevere denguefever PR5i DTP‐HepB‐Polio‐ HibPediatric hexavalentvaccine U.S,EU VaxiGrip®QIVIM Quadrivalent inactivated influenza vaccine (3 years +) Here are some of our key R&D collaborations: In March 2014, we signed a cooperation agreement with SK Chemicals Co. of South Korea to codevelop an innovative pneumococcal conjugate vaccine (PCV). In October 2013, we announced collaboration with the Bill & Melinda Gates Foundation to explore and develop new platforms and methods intended to accelerate vaccine R&D in areas of global health. In April 2010, we entered into collaboration with the U.S. Naval Medical Research Center (NMRC) to develop a promising new bacterial vaccine against enterotoxigenic Escherichia coli (ETEC). ETEC causes nearly 400,000 childhood deaths in the developing world each year. PRESS KIT I 20 OUR R&D SITES Six of our sites are dedicated to the research and development of our vaccines: Marcyl’Etoile Toronto Beijing Swiftwater (PA) Cambridge (MA) Orlando (FL) Hyderabad SUCCESS STORY: DENGUE VACCINE Dengue fever is a painful disease caused by four virus serotypes and transmitted through mosquito. Occasionally, dengue can develop into a potentially life-threatening condition called severe dengue, or dengue hemorrhagic fever. There is no specific treatment.10 Dengue causes nearly 400 million infections every year. In the last 50 years dengue has spread 30fold. It is endemic in 128 countries where about 4 billion people live today. Regular dengue epidemics can disrupt local healthcare systems, overloading hospitals and diverting health care resources. Globally, dengue is estimated to cost 9 billion USD annually in direct medical costs and indirect costs.11 The World Health Organization (WHO) called for a vaccine as a critical additional tool to boost ongoing dengue prevention efforts and help endemic countries to achieve the WHO objectives to reduce dengue mortality by 50% and morbidity by 25% by 2020.12 Sanofi Pasteur began vaccine development more than 20 years ago with the goal of bringing the vaccine first to countries where dengue is a major public health priority so that it can have the greatest impact on the disease burden. In December 2015, the vaccine received its first license approvals in Mexico, the Philippines, and Brazil. First vaccinations began in February 2016 in the Philippines. 10 http://www.who.int/mediacentre/factsheets/fs117/en/ Shepard DS, Halasa YA, Undurraga EA, Stanaway J. Global economic cost of dengue illness. Poster presented at: American Society of Tropical Medicine and Hygiene Annual Meeting; Oct. 25‐ 29, 2015, Philadelphia, PA, Poster 781 12 World Health Organization. Global strategy for dengue prevention control 2012‐2020. Geneva: WHO, 2012. Available at: http://apps.who.int/iris/bitstream/10665/75303/1/9789241504034 eng. pdf. 11 PRESS KIT I 21 IN DEVELOPMENT – PHASE III: HOSPITAL-ACQUIRED INFECTIONS Hospital-acquired infections are a major public health concern in many developed countries and cause significant costs to healthcare systems. Clostridium difficile is a potentially life-threatening, spore-forming bacterium that causes intestinal disease. The risk of Clostridium difficile increases with age, antibiotic treatment and time spent in hospitals or nursing homes, where multiple cases can lead to outbreaks. Our candidate vaccine against Clostridium difficile takes a toxoid-based approach, which has been used extensively in our licensed vaccines against tetanus and diphtheria. In August 2013, we initiated our Phase III clinical program called Cdiffense to evaluate the safety, immunogenicity and efficacy of our investigational vaccine for the prevention of symptomatic Clostridium difficile infection. The Cdiffense trial includes up to 15,000 adults at over 200 sites across more than 20 countries. The vaccine was granted fast-track designation by the U.S. FDA in 2010. IN DEVELOPMENT – PHASE II: TUBERCULOSIS More than 2 billion people, equal to one-third of the world’s population, are infected with the tubercle bacilli, the microbes that cause tuberculosis (TB). People infected with Mycobacterium tuberculosis have a lifetime risk of 10% of contracting TB. In 2014, 9.6 million people fell ill with tuberculosis, resulting in 1.5 million deaths13. The only TB vaccine (BCG – attenuated Bacille Calmette Guérin) used in the world today was developed over 80 years ago. TB vaccination is especially important in areas of the world where TB is highly prevalent and the chances of an infant or young child becoming exposed to an infectious case are high. Although BCG is effective in protecting infants against childhood forms of the disease, a more effective vaccine is needed for protection of adolescents and adults against pulmonary TB. We have signed a collaborative agreement with Denmark’s Statens Serum Institut to develop a new vaccine against TB. Our vaccine candidate is currently in Phase II trials. IN DEVELOPMENT – PHASE I: HERPES SIMPLEX VIRUS (HSV) TYPE 2 Infection with the herpes simplex virus (HSV), commonly known as herpes, can be due to either herpes simplex virus type 1 (HSV-1) or herpes simplex virus type 2 (HSV-2). HSV-2 infection is widespread throughout the world and is almost exclusively sexually transmitted, causing genital herpes. Infection with HSV-2 is lifelong and incurable14. Our HSV Type 2 vaccine candidate is currently in a Phase I trial sponsored by the U.S. NIH (National Institute of Health), involving 60 volunteers to assess the safety of the vaccine. The vaccine candidate has been shown to be safe and immunogenic in the preclinical stage, with the 13 14 http://www.who.int/mediacentre/factsheets/fs104/en/ http://www.who.int/mediacentre/factsheets/fs400/en/ PRESS KIT I 22 results supporting entry into Phase I clinical development. The Phase I study is designed to collect safety and immunogenicity data following three doses of the candidate vaccine administered over a period of six months in participants with and without HSV infection. Each of the study participants will be followed for one year from the time of the first immunization. More information on the study design can be found on www.clinicaltrials.gov IN DEVELOPMENT – PHASE I/II: HUMAN IMMUNODEFICIENCY VIRUS (HIV) The WHO estimates that so far, HIV has cost the lives of more than 34 million people. In 2011, more than 36.9 million people were living with HIV15. Despite the intense international response to the HIV/AIDS pandemic, HIV continues to spread. We have been taking part in the global effort to develop an HIV vaccine for more than 20 years, in partnership with a number of leading governmental agencies and the PR (Pox-Protein-Public Private Partnership) companies. Over the years, we have developed several vaccine candidates that have been the subject of clinical studies. In February 2015, an HIV vaccine clinical trial was announced by the U.S. NIAID (National Institutes of Allergy & Infectious Diseases) division of the NIH. This trial uses our ALVAC-HIV investigational vaccine as the prime in a prime-boost regimen being studied in what is called the HVTN-100 (HIV Vaccine Trials Network) in South Africa. It is a preventive vaccine regimen similar to that used in the six-year, HIV vaccine clinical trial in Thailand (RV-144), which was the first HIV vaccine trial to show any efficacy. IN DEVELOPMENT: ZIKA “Our invaluable collaborations with scientific and public health experts, both globally and in the regions affected by the outbreaks of Zika virus, together with the mobilization of our best experts will expedite efforts to research and develop a vaccine for this disease” Dr John Shiver, Global Head of R&D, Sanofi Pasteur. Until recently, the Zika virus (ZIKV) was considered a rare and seemingly benign virus. However, on 1st February 2016, Zika was declared a ‘public health emergency of international concern’(PHEIC) by the World Health Organization (WHO) due to the virus’ rapid geographic spread and suspected association with potential harm to fetuses. The WHO PHEIC designation of Zika will bolster international collaboration towards a prevention solution for this virus and Sanofi Pasteur will seek to leverage this collaboration to expeditiously identify and develop a viable vaccine candidate against Zika. At a briefing session during the 138th Executive Board of the WHO held on January 28, 2016, the WHO Director General, Dr. Margaret Chan, stated that the organization is deeply concerned about ZIKV for four main reasons: The possible association of infection with birth malformations and neurological syndromes 15 http://www.who.int/mediacentre/factsheets/fs360/en/ PRESS KIT I 23 The potential for further international spread given the wide geographical distribution of the mosquito vector The lack of population immunity in newly affected areas Absence of vaccines, specific treatments, and rapid diagnostic tests. Building on our successful heritage in developing vaccines against similar viruses (Flaviviruses), and on the recent introduction of Sanofi Pasteur vaccine against dengue, in February 2016 we launched a vaccine research and development project targeting the prevention of Zika virus infection and disease. There are still a lot of unknowns about Zika right now but it is clear that Sanofi Pasteur’s extensive experience in Flavivirus vaccine development could potentially accelerate vaccine development for Zika. PRESS KIT I 24 CREATING STRONG PARTNERSHIPS FOR CONTINUED SUCCESS PARTNERSHIPS ARE ESSENTIAL Between 2 to 3 million lives are saved around the world every year thanks to vaccines but an estimated 18.7 million infants worldwide are still missing out on basic vaccines.16 Partnerships and cooperation between members of the immunization community are essential if vaccines are to be supplied to those who need them most. At Sanofi Pasteur, we want everyone to have access to our vaccines – no matter where they live. To help achieve this, we work in partnership with the immunization community, including policy makers, donors and non-governmental organizations (NGOs). PARTNERING TO INCREASE ACCESS TO OUR VACCINES The cost of vaccine administration, weak health systems, and in some cases conflict, mean that many people living in the world’s poorest countries do not have access to vaccines. We have ongoing partnerships with a number of international organizations, including the World Health Organization (WHO), Gavi (the Vaccine Alliance), the United Nations Children’s Fund (UNICEF) and the Red Cross, through which we supply vaccines where they are needed most. For these organizations, we have developed specially adapted packaging and established tiered pricing policies in order to widen access to our vaccines in developing countries. OUR KEY PARTNERS: GAVI ALLIANCE We support Gavi, the Vaccine Alliance, which is a public-private partnership focused on increasing children's access to vaccines in poor countries. Gavi was founded in 2000 by the Bill & Melinda Gates Foundation, the World Bank, the WHO, UNICEF and us. Committed to saving children’s lives and protecting people’s health through the widespread use of vaccines, Gavi’s key objective is to make a critical contribution to global immunization goals by supporting immunization programs and health systems, and accelerating the introduction of new vaccines. Between 2000 and 2011, Gavi’s programs helped to immunize 326 million children, saving 5.5 million lives. We and the partners of Gavi have contributed to a major initiative to fight against the high epidemiological risk of yellow fever, and we have provided six million doses of yellow fever vaccine each year since 2003 for the stockpile. We support Gavi's strategic objective on Health System Strengthening by supporting and financing a professional training program for public health officers in West Africa (called the EPIVAC program): The objective of the EPIVAC Program is to train doctors involved in the implementation 16 http://www.who.int/mediacentre/factsheets/fs378/en/ PRESS KIT I 25 of immunization programs in 11 Central and West African countries. Implemented by the Preventive Medicine Agency (AMP), the program was developed in conjunction with the national governments of 11 Gavi eligible countries and participating universities (Cocody-Abidjan in Côte d’Ivoire and Paris-Dauphine in France), in collaboration with the WHO, UNICEF and others working in Africa. Since 2002, EPIVAC has trained and certified more than 550 doctors. Each EPIVAC graduate serves between 30,000--‐200,000 people, which means EPIVAC trained officers have positively impacted an estimated 6 million lives; This EPIVAC program won the 2014 Gates Vaccines Innovation Award in recognition of the interest of the initiative that helps building countries capabilities and has proven being impactful on vaccination coverage. EPIVAC-trained officers positively impacted an estimated six million lives in 2012. OUR KEY PARTNERS: GPEI The Global Polio Eradication Initiative (GPEI), spearheaded by national governments, the WHO, Rotary International, the United States’ Centers for Disease Control and Prevention (CDC) and UNICEF, is the largest public health initiative the world has ever known. Since 1988, some two billion children around the world have been immunized against polio thanks to the unprecedented cooperation of more than 200 countries and 20 million volunteers, backed by an international investment of US$3 billion.17 We are a key partner of GPEI and are fully committed to supporting the initiative. We are the largest corporate donor to GPEI. Since 1988, we have provided over 6 billion doses of oral polio vaccine (OPV) to UNICEF and we provide today the vast majority of inactivated polio vaccines (IPV) needed in the frame of WHO’s Polio End Game strategy. 17 http://www.who.int/mediacentre/factsheets/fs114/en/ PRESS KIT I 26 SANOFI PASTEUR: COMPANY SNAPSHOT HEADQUARTERS: Lyon, France WHAT WE DO We improve human health by developing superior innovative vaccination solutions against infectious diseases. We reliably provide high quality vaccines We engage with the public health community to maximize sustainably vaccination impact. 15 R&D AND INDUSTRIAL SITES WORLDWIDE France (Marcy l’Etoile, largest industrial site dedicated to vaccines worldwide, Neuville-surSaône and Val de Reuil) United States (Swiftwater, PA; Cambridge and Canton, MA; Rockville, MD; Orlando, FL) Canada (Toronto) Argentina (Pilar) China (Shenzhen) Thailand (Chachoengsao) India (Hyderabad) Mexico (Ocoyoacac) OUR PEOPLE President and Chief Executive Officer: David Loew We have approximately 15,000 employees worldwide who are committed to working towards our vision of a world in which no one suffers or dies from a vaccine preventable disease. PRESS KIT I 27 CONTINUALLY INVESTING TO BETTER PUBLIC HEALTH We produce more than 1 billion doses of vaccines each year which helps to protect over 500 million people worldwide from diseases. Our vaccines are available in more than 150 countries. Our portfolio of high-quality vaccines that match our areas of expertise and ensure a sustainable future, includes the first-ever vaccine for dengue fever. We have invested over €1.5 billion over the last five years. We are committed to the future, with 12 vaccines in development or submitted for approval (entirely new vaccines or improved versions of existing vaccines). OUR INVESTMENT MILESTONES 2014: We inaugurated a new yellow fever vaccine production unit in our industrial site in Valde Reuil (France). Our €25 million investment will double our yellow fever vaccine production capacity, making it possible to provide a major portion of the doses required to meet the global public health needs for the next decade. 2009: We started the construction of a new vaccine manufacturing center in Neuville-sur-Saône (France) – investing €300 million to produce our vaccine against dengue fever. The site was opened in 2014 and has started the production of the first approved vaccine for dengue. 2009: The construction of new vaccine production facilities began in China and Mexico to produce seasonal influenza vaccines for the Chinese and Mexican markets. The Mexican production facility has been operational since the end of 2012 and the Chinese facility was certified at the end of 2013. 2009: We were granted licensure from the U.S. FDA (Food and Drug Administration) for a new influenza vaccine production facility in Swiftwater, Pennsylvania (U.S.A) representing an investment of U.S. $150 million. 2009: €300 million invested in Val de Reuil (France) for a new formulation and filling building mainly dedicated to influenza vaccines OTHER KEY INVESTMENTS WE HAVE MADE OVER THE LAST 5 YEARS INCLUDE To help polio-free countries implement international health standards and respond to the WHO’s strategy to eradicate polio, we have invested heavily to increase the production capacity for the inactivated polio vaccine (IPV). We increased the production capacity for the quadrivalent conjugate vaccine against four different types of meningococcal meningitis (serogroups A, C, Y and W-135). We opened a production facility for pediatric vaccines (Haemophilus influenzae type b (Hib)). PRESS KIT I 28 OUR HISTORY AND HERITAGE FOUR PATHS, ONE DESTINY At Sanofi Pasteur, our origins date back more than a century and are closely linked with the achievements of four pioneers: Louis Pasteur, the Mérieux family, John FitzGerald and Richard Slee. Although each followed a unique path, they shared one goal – protecting people from infectious diseases. LOUIS PASTEUR: A SCIENTIFIC VISIONARY Louis Pasteur made a series of discoveries throughout his career that revolutionized modern medicine and laid the groundwork for the practice of microbiology. His contributions stem from his “germ theory of disease” – proving that infectious diseases are caused by microorganisms. Further to this theory, Pasteur found that injecting a weakened form of a microorganism could protect the body from the diseases it causes. This discovery led to the development of a number of vaccines, including the rabies vaccine, first administered to a human in 1885. Pasteur dedicated the final years of his life to the establishment of Institut Pasteur, a non-profit organization that continues to work on protecting people from infectious diseases. We have maintained a privileged relationship with the Institut. THE MÉRIEUX FAMILY: THREE GENERATIONS OF INNOVATORS Profoundly influenced by the teaching of Louis Pasteur, Marcel Mérieux established the Institut Biologique Mérieux. Three generations of the Mérieux family – Marcel, his son Charles and his grandson Alain – dedicated their lives to protecting people from infectious diseases. The most important contribution of the Institut Mérieux was the development of industrial-scale vaccine production, allowing large numbers of people to be vaccinated in a relatively short period of time. In 1974, techniques developed by the Institut stopped an epidemic of meningococcal meningitis in Brazil, where 90 million people were immunized in nine months. PRESS KIT I 29 JOHN FITZGERALD: CANADA’S PUBLIC HEALTH PIONEER John FitzGerald had a vision of producing life-saving, public-health products at prices within everyone’s reach. Founded by FitzGerald in 1914, Connaught Laboratories grew rapidly, producing vaccines and sera against diphtheria, smallpox, tetanus and meningitis. The Laboratories also made an important contribution to the battle against polio. After he developed the first injectable polio vaccine, Dr Jonas Salk used techniques developed by Connaught scientists to produce the polio vaccine on a large scale, bringing an end to the epidemics in North America in the 1950s. These labs are now our headquarters in Canada. RICHARD SLEE: A VACCINE TRAILBLAZER In 1897, Richard Slee founded the Pocono Biological Laboratories in Swiftwater, Pennsylvania, to house the production of a new breed of smallpox vaccine. More than 100 years later, his legacy remains intact – smallpox has been officially eradicated globally since 1980, and his laboratory has grown to become our headquarters in the U.S. OUR HISTORY 1885 Louis Pasteur develops the rabies vaccine. 1897 Profoundly influenced by the teachings of Louis Pasteur, Marcel Mérieux establishes Institut Biologique Mérieux. Across the Atlantic, Richard Slee opens the Pocono Biological Laboratories, which today houses our U.S. headquarters. 1914 In Toronto, John Fitzgerald establishes a laboratory for the production of a diphtheria antitoxin. Formerly known as Connaught Laboratories, this is now our headquarters in Canada. 1937 Charles Mérieux succeeds his father, Marcel. He develops a foot and mouth vaccine, which saves six million cattle during a severe epidemic in 1952. Industrial virology is born and applied to human medicine. 1967 Alain Mérieux succeeds his father, Charles, and Institut Mérieux becomes a worldwide player in the field of applied immunology. 1968 Rhône-Poulenc acquires a majority stake in Institut Mérieux. 1973 Institut Pasteur production site is created in Val de Reuil, France. The site will be acquired by Institut Mérieux in 1985. 1985 Institut Mérieux acquires Institut Pasteur production. 1989 Institut Mérieux acquires Connaught Laboratories and becomes the world leader in vaccines. 1990 Institut Mérieux becomes Pasteur Mérieux Sérums & Vaccins. 1994 Pasteur Mérieux Sérums & Vaccins becomes a wholly owned subsidiary of the Rhône-Poulenc Group. 1994 Pasteur Mérieux MSD is founded. Known today as Sanofi Pasteur MSD, it is a joint venture with Merck & Co. covering 19 countries in Europe. 1996 Pasteur Mérieux Sérums & Vaccins and Connaught Laboratories adopt the name Pasteur Mérieux Connaught. 1999 Rhône-Poulenc and Hoechst merge their life sciences activity – pharmaceuticals, animal health and crop science – to form a single company, Aventis. Pasteur Mérieux Connaught changes its name to Aventis Pasteur. 2004 Sanofi-synthelabo acquired Aventis, becoming sanofi-aventis Group. Aventis Pasteur becomes Sanofi Pasteur. 2008 Sanofi Pasteur acquired Acambis plc, a biotech company. 2009 Sanofi Pasteur acquired Shantha Biotechechnics, a vaccine manufacturer based in India. 2010 Sanofi Pasteur acquired VaxDesign, a U.S. biotechnology company. 2011 Sanofi Pasteur acquired Topaz Pharmaceuticals, a pharmaceutical company PRESS KIT I 31 OUR KEY VACCINE MILESTONES Dates of first license for Sanofi Pasteur’s major products; after 1966, dates correspond to when marketing authorization was first obtained 1922 First tetanus vaccine 1953 Yellow fever vaccine 1955 First Salk (inactivated) polio vaccine (injectable) 1962 First Sabin (attenuated) polio vaccine (oral) 1968 Measles vaccine 1968 Influenza vaccine 1970 Rubella vaccine (human diploid origin) 1974 First group A Meningococcal vaccine 1975 First groups A+C Meningococcal vaccine 1975 Vaccine against diphtheria, tetanus, pertussis and polio (injectable) 1977 First rabies vaccine (human diploid origin) 1981 First plasmatic hepatitis B vaccine 1986 MMR (Measles-Mumps-Rubella) vaccine 1987 Hepatitis B vaccine (based on genetic engineering) 1987 First Haemophilus influenzae type b conjugate vaccine 1988 First typhoid vaccine (polysaccharides) 1993 First pentavalent diphtheria, tetanus, pertussis (whole cell), poliomyelitis and Haemophilus influenzae type b vaccine (awarded the Galien Prize in 1994) 1996 Hepatitis A vaccine 2004 First quadrivalent conjugate vaccine against meningococcal disease 2007 H5N1 pandemic influenza vaccine (to anticipate a potential pandemic) 2008 Smallpox vaccine (to anticipate a potential bioterrorism attack) 2009 A(H1N1) monovalent influenza vaccine to respond to worldwide pandemic 2013 First quadrivalent seasonal influenza vaccine 2015 First vaccine against dengue SPGLB.SAPAS.16.06.0101 PRESS KIT I 32