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PRESS KIT
Sanofi Pasteur – Dedicated to vaccines
CONTACT:
Global Media Relations
Alain Bernal
T. +33-4-37-37-50-38
[email protected]
www.sanofipasteur.com
December 2015
TABLE OF CONTENTS
SANOFI PASTEUR – DEDICATED TO VACCINES .......................................................... 3
GLOBAL COMMITMENT TO IMPROVE PUBLIC HEALTH ............................................... 6
BROADEST RANGE OF VACCINES .......................................................................... 6
WORLD’S LEADING INFLUENZA VACCINE MANUFACTURER (PANDEMIC AND
SEASONAL) .............................................................................................................. 12
VACCINES FOR TOMORROW ................................................................................ 14
PARTNERING WITH THE IMMUNIZATION COMMUNITY ...................................... 17
VACCINATION BASICS ................................................................................................... 20
HISTORY AND HERITAGE............................................................................................... 23
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SANOFI PASTEUR – DEDICATED TO VACCINES
Sanofi Pasteur is the vaccines division of Sanofi, a leading global pharmaceutical company
that discovers, develops and distributes therapeutic solutions focused on patients’ needs.
Sanofi Pasteur is the largest company entirely dedicated to vaccines. The company
produces more than 1 billion doses of vaccine each year, making it possible to immunize
more than 500 million people across the globe.
A world leader in the vaccine industry, Sanofi Pasteur offers a broad range of vaccines,
protecting against 20 infectious diseases.
Sanofi Pasteur’s vision is a world in which no one suffers or dies from a vaccinepreventable disease.
Sanofi Pasteur’s mission is to protect and improve human health worldwide by:

Providing superior, innovative vaccines for the prevention and treatment of disease

Playing an active role in the immunization community to maximize vaccination
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SANOFI PASTEUR: A GLOBAL COMPANY

Headquarters: Lyon, France

Revenue: 3,974 million euros in 2014

Market share: responsible for the provision of approximately 20% of the world’s vaccine
market in value, Sanofi Pasteur is amongst the top 3 companies of the industry

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),
Ocoyoacac (Mexico)
SANOFI PASTEUR: OUR PEOPLE

Olivier Charmeil: President and Chief Executive Officer

Almost 14,000 employees worldwide
SANOFI PASTEUR: CONTINUALLY INVESTING IN RESEARCH AND PRODUCTION
CAPACITY

A large product range available, against 20 infectious diseases

R&D: more than 500 million euros invested in 2014

11 vaccines in development or submitted (entirely new vaccines or improved versions of
existing vaccines)

Investment milestones: more than 3 billion euros in the last 10 years (2005-2014)
 2014: Sanofi Pasteur inaugurated a new yellow fever vaccine production unit in its industrial
site in Val-de Reuil, France. The company’s 25 million euros investment will double yellow
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fever vaccine production capacity by 2016, making it possible to provide a major portion of
the doses required to meet global public health needs for the next decade.
 2009: Sanofi Pasteur started the construction of a new vaccine manufacturing center in
Neuville-sur-Saône, France investing 300 million euros to produce Sanofi Pasteur’s vaccine
against dengue fever. The site is now operational.
 2009: Construction of new vaccine production facilities began in China and Mexico to
produce seasonal influenza vaccine for the Chinese and Mexican markets. The Mexican
production facility has been operational from the end of 2012 and the Chinese facility was
certified at the end of 2013.
 2009: Sanofi Pasteur was granted licensure from U.S. FDA (Food and Drug Administration)
for a new influenza vaccine production facility in the U.S. representing a U.S. 150million
investment.
 Other key investments over the last 5 years include:

Increased production capacity for inactivated polio vaccine (IPV) to help polio-free
countries implement international health standards to respond to the World Health
Organization’s (WHO) strategy to eradicate polio

Increased production capacity for quadrivalent conjugate vaccine against four different
types of meningococcal meningitis (serogroups A, C, Y and W-135)

A new building for visual inspection of vials and syringes

New production facility for pediatric vaccines (Haemophilus influenzae type b (Hib)).

New R&D unit in the world’s largest campus dedicated to the research, development
and production of vaccines
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GLOBAL COMMITMENT TO IMPROVE PUBLIC HEALTH
A BROAD RANGE OF VACCINES
Today, according to the WHO, vaccines are available to protect against more than 26
infectious diseases.
Sanofi Pasteur is committed to the health of the world in the area of infectious diseases
with a broad range of vaccines, protecting against 20 infectious diseases:

World’s first dengue vaccine paving the way for active immunization against dengue in
endemic countries

World’s leader of seasonal influenza vaccines: over 220 million doses in 2014

Leading provider of both injectable and oral poliomyelitis vaccines

Range of modern pediatric combination vaccines for children throughout the world

World’s largest provider of vaccines against meningococcal infections

Largest portfolio of vaccines for travelers and people living in endemic areas
DENGUE FEVER
 Dengue fever is a mosquito-borne disease
It is estimated that 390 million people are
caused by four types of dengue viruses
infected annually, of which 96 million
(type 1 to 4). The disease is a threat to
manifest clinically (with any severity of the
almost half of the world’s population —
disease)6. Currently, there is no specific
more than 100 tropical and subtropical
treatment available against dengue fever.
countries.
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FIRST DENGUE VACCINE
Sanofi Pasteur has been investing in the research and development of a dengue vaccine for
over 20 years.
The company conducted a worldwide clinical study program in which nearly 40,000
volunteers participated. It is the first vaccine candidate to successfully complete phase III
clinical studies.
In 2014, world’s first phase III dengue vaccine efficacy study including 10,275 participants in
Asia demonstrated protection against dengue and dengue hemorrhagic fever. The results
were published in The Lancet in July 2014.
A second phase III study in more than 20,869 participants conducted in Latin America has
met its primary endpoint. The results, announced in September 2014, showed efficacy
against each of the four dengue serotypes. The results were published in The New England
Journal of Medicine in November 2014.
In July 2015, The New England Journal of Medicine published new analyses confirming that
Sanofi Pasteur’s vaccine candidate safely protects pre-adolescents to adults against dengue
in endemic countries.
In December 2015, Sanofi Pasteur’s dengue vaccine was approved in Mexico, making it the
first vaccine to be licensed in the world for active immunization against dengue disease in
preadolescents, adolescents and adults (9 to 45 years of age) living in endemic areas. This
is a historic milestone paving the way to significantly impact dengue burden in endemic
countries. More information on www.dengue.info
INFLUENZA: MEETING ESCALATING
GLOBAL DEMAND
INTRADERMAL INFLUENZA VACCINE
Current influenza vaccines are generally
The WHO estimates that influenza causes up
administered intramuscularly (IM). The
to 500,000 deaths worldwide every year1; and
intradermal (ID) route represents an
demand for influenza vaccines is increasing.
alternative route of injection: the vaccine is
Sanofi Pasteur is the world’s largest provider
administered into the dermis, or the top layer
of influenza vaccines. It provided over 220
of the skin. In 2010, the first intradermal
million doses of influenza vaccine in 2014. In
microinjection influenza vaccine produced in
May 2009, Sanofi Pasteur announced the
France was launched in the European Union
licensure from U.S. FDA of a new influenza
and in Australia, Argentina and New Zealand.
vaccine production in the U.S.
In 2011, Sanofi Pasteur’s new intradermal
influenza virus vaccine produced in the U.S.
was launched in the U.S. market. In
December 2014, Sanofi Pasteur’s intradermal
Quadrivalent Influenza Vaccine for adults was
approved by FDA in the U.S.
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QUADRIVALENT INFLUENZA VACCINE
TO ENSURE BROADER PROTECTION
than one billion doses of IPV and IPVcontaining vaccines.
Currently, the annual influenza vaccination
targets the three influenza virus strains
In March 2014, UNICEF announced it would
anticipated to circulate during the influenza
purchase significant quantities of IPV from
season. Given the evolution in seasonal flu
Sanofi Pasteur and make it available based
epidemiology, Sanofi Pasteur has initiated the
on country needs and vaccination plans in
switch to Quadrivalent Influenza Vaccine (two
more than120 countries that routinely use
A-strains and two B-strains) to ensure a
only OPV. To support rapid and widespread
broader protection and to provide ever-better
adoption of IPV, Sanofi Pasteur and the Bill &
vaccine solutions. In June 2013, the new
Melinda Gates Foundation have developed a
Sanofi Pasteur four-strain influenza vaccine
joint price support mechanism, including a
was licensed by U.S. FDA for a broad age
financial contribution from both organizations.
range of children and adults in the U.S. In
This mechanism allows Sanofi Pasteur to
December 2014, the intradermal version of
offer IPV at the lowest price possible to 73 of
Sanofi Pasteur’s influenza quadrivalent
the world’s poorest countries. Gavi, the
vaccine for adults was approved by FDA in
Vaccine Alliance, a global immunization
the U.S. The new quadrivalent vaccine will
partnership, will make IPV available for
progressively become the new standard of
inclusion in routine immunization schedules in
prevention.
these countries. Sanofi Pasteur is also a
major provider of OPV. The company has
POLIOMYELITIS: WORKING TOWARDS
ERADICATION
provided more than five billion doses of OPV
Sanofi Pasteur, as a leader in providing both
2013, the company announced it would
Oral Polio Vaccine (OPV) and Inactivated
provide 1.7 billion doses of OPV from 2013 to
Polio Vaccine (IPV), has been a partner of
2017 for polio eradication.
the Global Polio Eradication Initiative (GPEI)
for over 25 years. Since the creation of GPEI
in 1988, cases of the disease have fallen by
99%2, with more than 10 million people
escaping paralysis.
In 1982, Sanofi Pasteur registered the first
to UNICEF over last two decades. In April
PUBLIC HEALTH COMMITMENT
In September 2011, Sanofi Pasteur donated a
vaccine strain used for polio eradication to the
WHO. With this donation from Sanofi Pasteur,
the WHO is in full control of the storage of the
vaccine strain and its distribution to vaccine
producers worldwide.
enhanced-potency Inactivated Polio Vaccine
(IPV), which is now distributed globally as a
stand-alone poliovirus vaccine as well as in
combination pediatric vaccines to immunize
PEDIATRIC COMBINATION VACCINES:
PROTECTING AGAINST CHILDHOOD
DISEASES
against many diseases in a single shot. Since
Sanofi Pasteur is committed to providing the
then, Sanofi Pasteur has distributed more
same standard-of-care combination vaccines
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throughout the world, offering protection
against diphtheria, tetanus, pertussis and
against major childhood diseases such as
poliomyelitis in children aged 4 to 6 years.
diphtheria, tetanus, pertussis (whooping
cough), polio, hepatitis B, and Haemophilus
influenzae type b (Hib). In April 2013, the
MENINGOCOCCAL MENINGITIS:
TACKLING MAJOR OUTBREAKS
European Medicines Agency (EMA) approved
Sanofi Pasteur is the world’s leading provider
the only fully liquid 6-in-1 pediatric vaccine in
of vaccines to fight meningococcal infections.
Europe. The vaccine which protects infants
Sanofi Pasteur was the first company to
against diphtheria, tetanus, pertussis
provide a quadrivalent conjugate vaccine
(whooping cough), hepatitis B, polio and
protecting against four different types of
invasive infections caused by Haemophilus
meningococcal meningitis (serogroups A, C,
influenzae type b (Hib), is intended for use in
Y and W-135). The vaccine is licensed in the
Latin America, Africa, Eastern Europe, Middle
U.S. and Canada for people aged 2 to55
East and Asia. In May 2011, the first 5-in-1
years. In September 2013, it was the first
combination vaccine (diphtheria, tetanus,
quadrivalent meningococcal vaccine
acellular pertussis, inactivated poliomyelitis
prequalified by the WHO, which makes it
vaccine, and Haemophilus influenzae type b
eligible to purchase by United Nations
conjugate vaccine) from Sanofi Pasteur was
Agencies. In April 2011, the U.S. FDA
launched in China. This vaccine is also
granted licensure to expand the indication for
available to infants in Mexico, Turkey and
the vaccine to infants aged 9 to23 months. In
South Africa through the countries’ national
June 2010, the vaccine was registered by the
immunization programs since 2007.
Health Council for Arab countries in the Gulf.
BOOSTERS: PROVIDING LONGERLASTING PROTECTION
VACCINES FOR TRAVELERS AND
PEOPLE IN ENDEMIC AREAS: OFFERING
A BROAD VACCINE PORTFOLIO
A booster vaccine is a repeat shot that is
used, at intervals, to maintain immunity.
Sanofi Pasteur provides the broadest range
Sanofi Pasteur’s latest booster vaccine is a
of vaccines for travelers, military personnel,
combination against tetanus, diphtheria,
and populations living in tropical areas where
pertussis (whooping cough), and polio. This
infectious diseases are endemic. The
booster vaccine allows parents and relatives
portfolio includes vaccines against cholera,
to protect not yet fully immunized newborns
diphtheria, hepatitis A and B, Japanese
from pertussis by stopping the transmission
encephalitis, meningococcal diseases, rabies,
cycle of the disease. A quadrivalent booster
tetanus, typhoid, yellow fever, and a range of
vaccine including diphtheria, tetanus,
antivenoms sera. In June 2011, the WHO
acelullar pertussis and IPV has been
granted prequalification to Sanofi Pasteur’s
developed for the U.S. market. In March
polysaccharide typhoid vaccine indicated for
2015, the FDA approved use of this
active immunization of persons two years of
quadrivalent vaccine for active immunization
age and older against typhoid fever. It is the
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first WHO prequalified typhoid vaccine. Over
fever outbreaks in Africa. Reemergence of
the past 20 years, nearly 20 million people in
yellow fever results in an estimated 200,000
100 countries have been treated against
cases and 30,000 deaths every year 3.
rabies with Sanofi Pasteur vaccines and
immunoglobulins.
of yellow fever vaccine for Africa for 60 years
VACCINES FOR THE MOST
VULNERABLE
since the vaccine was discovered by Institut
India’s first oral cholera vaccine
Pasteur. In the past 20 years, over 200
introduced by Shantha Biotechnics (part
million doses of yellow fever vaccines were
of Sanofi Pasteur since 2009), was
procured. In September 2014, the company
prequalified by the WHO, in 2011. The
inaugurated a new yellow fever vaccine
vaccine is procured to United Nations
production unit in its industrial site in Val-de
Agencies. The pentavalent vaccine
Reuil, France. The company’s €25 million
against diphtheria, pertussis, tetanus,
investment will double yellow fever vaccine
Haemophilus influenza type b and
production capacity by 2016, providing the
hepatitis B has received prequalification
means to better respond to the growing
by the WHO on May 5, 2014. Sanofi Pasteur has been the primary supplier
global demand and the ability to deal with
recurring epidemics in Africa and in South
America. Sanofi Pasteur has provided 6
million doses of vaccine for the stockpile
funded by the Vaccine Alliance (Gavi) for
routine immunization and to control yellow
PRODUCTION CAPACITY
Sanofi Pasteur has the industrial-scale manufacturing ability to produce vaccines in large
quantities, with the highest quality standards, to help fulfill public health needs. To meet
the growing demand for vaccines, Sanofi Pasteur is continuously investing to increase
production capacity. More than 3 billion euros have been invested between 2005 and
2014.
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SANOFI PASTEUR VACCINE PORTFOLIO
 Cholera
 Mumps
 Diphtheria
 Pertussis
 Dengue
 Pneumococcal infections
 Haemophilus influenzae type b (Hib)
 Poliomyelitis
infections
 Hepatitis A
 Hepatitis B
 Influenza
 Japanese encephalitis
 Measles
 Rabies
 Rubella
 Tetanus
 Tuberculosis
 Typhoid fever
 Yellow fever
 Meningococcal infections
And against one eradicated disease:
 Smallpox (vaccine produced in response to the threat of bioterrorism)
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GLOBAL COMMITMENT TO IMPROVE PUBLIC HEALTH
WORLD’S LEADING INFLUENZA VACCINE MANUFACTURER (PANDEMIC AND
SEASONAL)
Backed by its experience as a world leader in influenza vaccine research, development and
production, Sanofi Pasteur is constantly working to save lives through the development of
new and innovative influenza vaccines.
A WORLD LEADER
Sanofi Pasteur is the world’s leading
manufacturer of vaccines against seasonal
influenza, a disease responsible for up to
half-a-million deaths worldwide each year,
according to WHO estimates. Sanofi Pasteur
has four influenza vaccine production
facilities. Two established sites in the U.S.
and in France where the company has made
large investments to increase production
capacity and two new vaccine production
This greater production capacity for seasonal
influenza vaccines brings both immediate and
long-term public health benefits. It enables
the expansion of current influenza
immunization programs and enhances Sanofi
Pasteur’s ability to respond effectively to a
potential influenza pandemic. As part of a
large industrial network, Sanofi Pasteur also
benefits from Sanofi’s industrial assets to
respond to the increasing worldwide demand
for the influenza vaccine.
centers in China and Mexico to meet local
needs. The Mexican production facility has
been operational since the end of 2012 and
the one located in Shenzhen (Southern
China) was certified at the end of 2013.
LEADING PROVIDER OF SEASONAL INFLUENZA VACCINES
Sanofi Pasteur produces approximately 40 percent of influenza vaccines distributed
worldwide. The company mainly operates influenza vaccine production facilities in its two
established sites, one based in Swiftwater, Pennsylvania, U.S., and the other in Val de
Reuil, France. All Sanofi Pasteur influenza vaccine facilities have been designed and built
to be able to switch from seasonal influenza vaccine production to pandemic influenza
vaccine production.
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INDUSTRIAL-SCALE CAPACITY
Sanofi Pasteur was the first company to
employ its industrial-scale capabilities for the
A(H5N1) influenza virus.
PANDEMIC PREPAREDNESS
manufacture of a vaccine against an A(H5N1)
Sanofi Pasteur has been bringing its
influenza pandemic. Since 2004, millions of
worldwide vaccine expertise to governments,
doses have been industrially produced, using
international organizations, and working
different A(H5N1) and A(H7N9) strains.
groups on all aspects of influenza pandemic
Industrial and scientific expertise have
preparedness and supporting dialogue
enabled Sanofi Pasteur to produce A(H5N1)
between all partners to define vaccination
vaccines for several countries, including the
strategies before a pandemic was declared.
U.S., France, and Italy for their national
prepandemic stockpiles, as part of their
In 2007, Sanofi Pasteur was the first to
pandemic preparedness programs. In the
receive a license for a vaccine against avian
A(H1N1) pandemic situation, the company
influenza in humans from the U.S. FDA.
has produced over 250 million doses of
A(H1N1) monovalent vaccine in 2009-2010.
Sanofi Pasteur has committed to contribute to
WHO pandemic vaccine stockpile in case of a
CONTINUAL NEW RESEARCH
Sanofi Pasteur has been investing heavily to
support a priority research program for
pandemic.
A(H1N1) PANDEMIC RESPONSE
influenza. This program has yielded
Sanofi Pasteur’s response to the emergence
unprecedented results showing that the
of a new A(H1N1) 2009 influenza strain was
lowest dose known today of a prototype
to maintain maximum flexibility in its influenza
H5N1 influenza vaccine, containing a new
vaccine production. The company
adjuvant, induces a strong immune response,
manufactured a new A(H1N1) vaccine while
thus allowing for the production of a large
maintaining its seasonal influenza vaccine
number of doses in the event of a pandemic.
production for the 2009/2010 Northern
Hemisphere influenza season and for the
Results from this program have been applied
2010 Southern Hemisphere influenza season
to the development of Sanofi Pasteur’s
as recommended by the WHO. Production of
adjuvanted pandemic vaccine against A
both Northern and Southern hemisphere
(H1N1) 2009.
seasonal influenza vaccines was considered
as a priority by the WHO and the authorities
Sanofi Pasteur has also been testing the
when the A(H1N1) 2009 pandemic strain
ability of its vaccines to generate immune
emerged.
responses against other types (or strains) of
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GLOBAL COMMITMENT TO IMPROVE PUBLIC HEALTH
VACCINES FOR TOMORROW
The process to develop a new vaccine can take between 14 to 254 years with an overall cost
of US$300 million to US$1 billion5.
Sanofi Pasteur R&D team is fully committed to the research and development of new
vaccines:

11 vaccines are in development or submitted for market authorization, including:
 New vaccines against endemic diseases, and against hospital-acquired infections
(C. difficile), for which no vaccines exist yet
 Next-generation vaccines such as a meningitis quadrivalent conjugate vaccine
 New combinations vaccines and new administration systems
HOSPITAL-ACQUIRED INFECTIONS
Hospital-acquired infections are a major
concern for public health in many
industrialized countries and cause significant
annual costs to healthcare systems.
include up to 15,000 adults at 200 sites
across ~20 countries. A Phase II study of the
vaccine against Clostridium difficile was done
in the U.S. The U.S. FDA granted fast-track
designation to Sanofi Pasteur's
investigational Clostridium difficile vaccine.
CLOSTRIDIUM DIFFICILE
Sanofi Pasteur’s candidate vaccine against
Clostridium difficile takes a toxoid-based
approach, which has been used extensively
in Sanofi Pasteur’s licensed vaccines against
tetanus, diphtheria and pertussis (whooping
cough). In August 2013, the company
SANOFI PASTEUR’S OPEN INNOVATION
initiated its Phase III clinical program called
APPROACH
Cdiffense to evaluate the safety,
immunogenicity and efficacy of its
Sixty percent of Sanofi Pasteur’s current
investigational vaccine for the prevention of
pipeline is the result of external
primary symptomatic Clostridium difficile
partnerships.
infection (CDI). The Cdiffense Phase III
clinical program has started recruiting
volunteers for an international trial that will
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HUMAN IMMUNODEFICIENCY VIRUS (HIV)
Vaccines & Diagnostics and Sanofi Pasteur,
with the collaboration of the National
Sanofi Pasteur is taking part in the global
Department of Health in South Africa)
effort to develop an HIV vaccine. Over the
committed to building on the success of the
last 20 years since Sanofi Pasteur's HIV
RV144 HIV vaccine trial and evaluating
vaccine development program was
potentially improved pox-protein vaccines to
established, the company has been
determine if they might provide a significant
collaborating with a number of leading
public-health benefit. The P5 is working on
governmental agencies and pharmaceutical
follow-up clinical studies using improved
companies. These partnerships have led to
vaccine regimens in southern Africa and
major advances in research, clinical study
Thailand.
design, and implementation. 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 (National Institutes of
Health). This includes Sanofi Pasteur’s
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 6-year, HIV vaccine clinical trial in
Thailand (RV-144), which was the first HIV
vaccine trial to show any efficacy, in
September 2009. The new study in South
Africa is enrolling participants and is expected
to take approximately two years to complete.
HERPES SIMPLEX VIRUS (HSV)
Sanofi Pasteur’s HSV vaccine candidate is
currently in Phase I in a trial sponsored by the
U.S. NIH, 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
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 6
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
HVTN 100 is the result of the Pox-Protein
www.clinicaltrials.gov
Public-Private Partnership (P5), a diverse
group of organizations (the NIH, the Bill &
Melinda Gates Foundation, HVTN, the U.S.
Military HIV Research Program, Novartis
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AT THE CUTTING EDGE OF VACCINE DEVELOPMENT
Sanofi Pasteur continually works to remain at
In October 2013, Sanofi Pasteur announced
the forefront of vaccine research and
a partnership with the Bill & Melinda Gates
development. Whether alone or in
Foundation to explore and develop new
collaboration with partners, Sanofi Pasteur is
platforms and methods intended to accelerate
seeking new approaches to combat infectious
vaccine R&D in areas of global health. In
diseases. Several vaccines are under
June 2011, a U.S. 101 million vaccine
development stemming from agreements
research and development facility was
signed between Sanofi Pasteur and
opened at the Connaught’s Campus in north
biotechnology industry partners.
Toronto. This facility establishes the
Connaught Campus as the North American
Research into disease epidemiology and
Centre of Excellence in analytical and
basic immunology is also supported,
bioprocessing R&D for Sanofi Pasteur
underpinning the scientific rationale for
globally. In 2014 and 2010, Sanofi Pasteur
vaccine development and improving
signed agreements with Valneva (ex-Vivalis)
knowledge of when and where vaccines are
for the discovery of human monoclonal
required most. In March 2014, Sanofi Pasteur
antibodies against infectious diseases. In
signed a cooperation agreement with SK
April 2010, Sanofi Pasteur entered into a
Chemicals Co. of South Korea to co-develop
partnership with the U.S. Naval Medical
an innovative pneumococcal conjugate
Research Center (NMRC) to develop a
vaccine (PCV).
promising new bacterial vaccine against
enterotoxigenic Escherichia coli (ETEC).
ETEC causes nearly 400,000 childhood
deaths in the developing world each year.
VaxDesign is a U.S. biotechnology company that develops, manufactures and markets in
vitro models of the human immune system. VaxDesign is the developer of the Modular Invitro Construct (MIMIC®) technology that melds immunology with engineering to find
solutions to complex biological problems. MIMIC®is useful in assessing the potential of
Sanofi Pasteur’s vaccine candidates, providing a key filter in the preclinical stage before
Phase I clinical trials. In October 2011, Sanofi Pasteur’s VaxDesign Corp. entered a 4-year
collaboration in the field of prophylactic and therapeutic vaccines for infectious diseases.
The agreement signed by Sanofi Pasteur S.A., Curevac (German global leader in mRNA
based vaccination technologies) and In-Cell-Art (French Biotech company specialized in
nano-carriers technologies) concerns a project co-funded by the U.S. Defense Advanced
Research Projects Agency (DARPA). Sanofi Pasteur acquired VaxDesign in 2010.
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GLOBAL COMMITMENT TO IMPROVE PUBLIC HEALTH
PARTNERING WITH THE IMMUNIZATION COMMUNITY
Sanofi Pasteur works in partnership within the immunization community, including policy
makers, donors, and non-governmental organizations (NGOs), to ensure that the largest
number of people benefit from vaccination.
Immunization Community: Partnerships and co-operation between members of the immunization
community are essential if vaccines are to be supplied to those who need them most. Sanofi
Pasteur works with many of the institutions represented in this diagram.
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INTERNATIONAL ORGANIZATIONS
Sanofi Pasteur supports Gavi, the Vaccine
Alliance, which is a public-private partnership
focused on increasing children's access to
vaccines in poor countries. Partners include
national governments, UNICEF (United
Nations Children’s Fund), WHO, The World
SUPPORTING IMMUNIZATION
INFRASTRUCTURE
The cost of vaccine administration, weak
healthcare infrastructure and in some cases
conflict mean that many people living in the
world’s poorest countries do not have access
to vaccines.
Bank, the Bill & Melinda Gates Foundation,
the vaccine industry, public health institutions,
and non-governmental organizations (NGOs).
Sanofi Pasteur has developed specially
adapted packaging and established tiered
pricing policies in order to widen access to
Sanofi Pasteur has ongoing partnerships with
a number of international organizations,
including UNICEF, to supply vaccines where
vaccines in developing countries. This
strategy helps provide access to vaccines in
countries supported by Gavi.
they are needed most. Each year, the
company provides nearly 400 million doses of
vaccine to UNICEF and other international
organizations. Since 2003, Sanofi Pasteur
has provided 6 million doses of yellow fever
vaccine each year for the stockpile funded by
Gavi to control outbreaks in Africa.
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TRAINING AND KNOWLEDGE SHARING
PROGRAMS
From 2002 to 2014, EPIVAC has trained and
certified nearly 525 doctors.
The EPIVAC Program is one of Sanofi
Pasteur’s contributions to the Vaccine
Alliance (Gavi). It is implemented by the
Preventive Medicine Agency (AMP) and aims
at strengthening the performance of the
national immunization programs in
Francophone sub-Saharan Africa. The
program was developed in conjunction with
the national governments of eleven Gavi
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.
eligible countries (Benin, Burkina Faso,
Cameroon, Central African Republic, Côte
d’Ivoire, Guinea, Mali, Mauritania, Niger,
EPIVAC-trained officers positively impacted
Senegal, and Togo) and participating
an estimated 6 million lives in 2012. In 2014,
universities (Cocody-Abidjan in Côte d’Ivoire
the EPIVAC program was restructured,
and Paris-Dauphine in France), in
leading to new university partnerships and
collaboration with the WHO, UNICEF and
diplomas adapted to reflect the changing
others working in Africa.
immunization context under the name of
EPIVAC PLUS.
In the areas of research and knowledge sharing, Sanofi
Pasteur maintains privileged partnerships with Fondation
Mérieux (a non-profit organization founded in 1967 by Dr
Charles Mérieux). The Foundation contributes to medicine
and the improvement of public health by organizing scientific
events and training courses, publishing reports, and funding
research. Since its inception, Sanofi Pasteur has supported
many of the Foundation’s events, such as the International
Vaccinology Program.
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VACCINATION BASICS
THE VALUE OF VACCINES
However, it remains important to develop
improved vaccines and increase access to
Apart from clean, safe drinking water, no
human action rivals immunization in
preventing infectious diseases and reducing
these vaccines, enabling even more lives to
be saved. It is also important to recognize
that vaccination is an ongoing challenge.
mortality rates7. Vaccination saves lives:
History shows that a decrease in
more than 3 million lives every year8 thanks
immunization coverage sets the stage for the
to the vast range of vaccines providing
protection from over 26 infectious diseases.
reappearance of disease in previously
protected populations. The resurgence of
diphtheria in the 1990s in certain Eastern
Vaccination also saves money, being one of
the most cost-effective healthcare
investments available. For instance, in the
U.S., a cost-benefit analysis indicates that
every dollar invested in a vaccine dose saves
up to US $27 in health-care expenses9.
European countries, with more than 125,000
cases and 4,000 deaths reported10, illustrates
that continued vigilance is crucial to
controlling and eradicating some infectious
diseases in the future. More recently, the U.S.
experienced a record number of measles
cases during 2014, with 668 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 2000.11
REDUCING THE BURDEN OF DISEASE
Since the Global Polio Eradication Initiative (GPEI) was
launched in 1988, reported cases of polio have fallen by 99%
with more than 10 million people escaping paralysis12.
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WHAT IS IMMUNIZATION?
Infectious diseases are a major cause of
death, in particular among children and young
adults. Infectious diseases are caused by
microorganisms such as viruses, bacteria,
parasites or fungi. They are present
everywhere and may survive in many types of
environments (soil, water, food) or hosts
(humans, animals).
Vaccines are produced from whole bacteria
or viruses, from their components
(polysaccharides, proteins), or the
substances they secrete (toxins), in which
their capacity to provoke a disease has been
eliminated while keeping intact their ability to
induce a specific immune response. The
immune response stimulated by a vaccine is
vital to ensure that enough antibodies are
made and that the body’s natural defenses
Vaccination can protect against these
are able to fight off any infection in the future.
diseases. It provides an individual with
protection from an infection by stimulating an
immune reaction and thereby boosting the
natural defenses of the body.
MAIN VACCINE TYPES
LIVE ATTENUATED VACCINES
The bacteria or virus is weakened. Its ability to cause disease is removed, 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 the whole microorganism or only 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
Recombinant vaccines are produced by genetic engineering. Other animal cells or yeasts
can be used as ‘antigen-factories’ producing large amounts of vaccine antigen, which are
then used to produce an immune response.
Example: Hepatitis B.
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THE VACCINE DEVELOPMENT CYCLE
Vaccine research is long, complex and costly. Because a vaccine is a biological product made
from living microorganisms, its development cycle is quite different from that of a pharmaceutical
product:
Exploratory stage: to understand the disease, its epidemiological data and the right proteins
(antigens) to use in preventing or treating the disease
Pre-clinical stage: to assess antigen safety and select the best candidate vaccine
Clinical development: a dozen (Phase I) to thousand people (Phase III) are involved in clinical
trials and the first batches are produced (clinical batches and industrial batches for compliance)
Regulatory approval: all the data collected through the preceding stages are submitted to the
relevant health authorities for approval
Manufacturing process: takes 6–22 months to produce a single batch of vaccine
Quality control: approximately 70% of production time is dedicated to quality control and
pharmacovigilance procedures in the clinical development and production phases
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HISTORY AND HERITAGE
FOUR PATHS, ONE DESTINY
The origin of Sanofi Pasteur dates back more
than a century and is closely linked with the
achievements of 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
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,
son Charles and grandson Alain—dedicated
their lives to protecting people from infectious
diseases. The most important contribution of
the Institut Mérieux was the development of
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
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 Institute
stopped an epidemic of meningococcal
meningitis in Brazil, where 90 million people
were immunized in nine months.
“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 that 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.
Sanofi Pasteur has maintained a privileged
relationship with the Institute.
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JOHN FITZGERALD: CANADA’S PUBLIC
HEALTH PIONEER
RICHARD SLEE:
A VACCINE TRAILBLAZER
John FitzGerald had a
In 1897, Richard Slee
vision of producing life-
founded the Pocono
saving, public-health
Biological Laboratories in
products at prices
Swiftwater, Pennsylvania,
within everyone’s
to house the production of
reach. Founded by FitzGerald in 1914,
a new breed of smallpox vaccine. More than
Connaught Laboratories grew rapidly,
100 years later, his legacy remains intact—
producing vaccines and serums against
smallpox has been officially eradicated
diphtheria, smallpox, tetanus and meningitis.
globally since 1980, and his laboratory has
The Laboratories also made an important
grown to become the location of Sanofi
contribution to the battle against polio. After
Pasteur in the U.S.
he developed the first injectable polio
vaccine, Dr. Jonas Salk used techniques
developed by Connaught scientists to
produce polio vaccine on a large scale,
bringing an end to the epidemics in North
America in the 1950s.
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SANOFI PASTEUR’S HISTORY
1885
Louis Pasteur creates 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 the U.S. headquarters of Sanofi Pasteur.
1914
In Toronto, John Fitzgerald establishes a laboratory for the production of a diphtheria antitoxin.
Formerly known as Connaught Laboratories, this is now the headquarters of Sanofi Pasteur 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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References

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3.World Health Organization Fact sheet N°100 Updated March 2014 – Available at:
http://www.who.int/mediacentre/factsheets/fs100/en/. Accessed November 20, 2015.
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4.Tomich N, ed. The Global Vaccine Shortage: The Threat to Children and What to Do About It. New Canaan, Conn: The
Albert B. Sabin Vaccine Institute; 2003:26. Available at: http://www.sabin.org/files/attachment/entiredoc.pdf. Accessed
December 2, 2011
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7.Plotkin SA, Orenstein WA. Vaccines. 4th ed. Philadelphia, Pa: W.B. Saunders; 2004:1
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8.World Health Organization. 2004 immunization data. Available at:
http://www.euro.who.int/data/assets/pdf_file/0017/84302/Seven_Key_Reasons.pdf. Accessed April 17, 2014.
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9.Path. The Cornerstone of Public Health. Publication date: April 2015 – Available at:
http://www.path.org/publications/detail.php?i=1937. Accessed November 20, 2015.
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10.World Health Organization. Expanded program on immunization (EPI). Update: diphtheria epidemic in the newly
independent states of the former USSR, January 1995-March 1996. WER [serial online].1996;71(33):245-252. Available at:
http://www.who.int/docstore/wer/pdf/1996/wer7133.pdf.Accessed November 20, 2015.
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11.Centers for Disease Control and Prevention. Measles Cases Outbreaks. http://www.cdc.gov/measles/casesoutbreaks.html. Accessed November 20, 2015
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http://www.who.int/mediacentre/factsheets/fs114/en/. Accessed November 20, 2015.
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