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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
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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:
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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
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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.
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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.
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A vaccination is the injection of a killed or weakened organism that produces immunity in the
body against that organism.5
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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
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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
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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:
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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:
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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).
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OUR COMMITMENT TO PUBLIC HEALTH IS WIDESPREAD AND INCLUDES:
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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.
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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
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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
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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
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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/
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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.
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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
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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.
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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.
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OUR COMMITMENT TO FIGHTING YELLOW FEVER
Our vaccine against yellow fever:
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Provides high levels of protection against yellow fever in children and adults
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Requires a single injection, making it practical and easy to use
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Is prequalified by the WHO for purchase by the United Nations
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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
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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).
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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.
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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
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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.
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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
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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
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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
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


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.
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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
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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
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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.
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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).
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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.
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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
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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
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