LYON, France, June 23, 2016 /PRNewswire/ --
New VaxigripTetra™
vaccine:
- A 4-strain influenza vaccine for people
36 months of age and older,
- Helps protect children, adults and
seniors against both influenza B
strains (B/Victoria
and B/Yamagata),
- Newest addition to the Vaxigrip®
family of influenza vaccines.
Sanofi Pasteur, the vaccines division of Sanofi, announced today
that its quadrivalent influenza vaccine VaxigripTetra™ obtained a
positive end of procedure from the German Reference Member State
Paul Ehrlich Institute, as a conclusion of the European
Decentralized Procedure. Marketing Authorizations can now be issued
in the Reference Member State (Germany) and each of the Concerned Member
States involved in this procedure. VaxigripTetra™ is a four-strain
influenza vaccine, containing two A strains (A/H1N1 and A/H3N2) and
two B strains (B/Victoria and
B/Yamagata), for use in individuals aged 36 months or older.
VaxigripTetra™ is the newest addition to the Vaxigrip®
family of influenza vaccines.
Currently, the majority of seasonal influenza vaccines are
trivalent meaning that they protect against three strains: two A
strains and a single B strain (B/Victoria or B/Yamagata). However, two distinct
influenza B strains (B/Victoria
and B/Yamagata) now co-circulate worldwide in varying and
unpredictable proportions[1]. In recent years, influenza
B viruses represented around 23% of the circulating strains around
the world. These proportions can be as high as 90% during some
seasons and are therefore an important cause of influenza
disease[2]. Given this current virological situation
with the co-circulation of the two B strains, influenza vaccines
need to be adapted and to fit with the current virological
situation to ensure broader level of protection. Because trivalent
influenza vaccines only contain one B strain, this co-circulation
makes the selection of the right strains to be included in the
seasonal vaccine very difficult to predict. As an example in
Europe in 2015 92%[3]
of the documented B influenza cases were caused by the
B/Victoria strain not included in
the vaccine. Adding the second B strain to VaxigripTetra™ will
address the unpredictability issue.
"For over 60 years the expertise of
Sanofi Pasteur has been committed to providing new immunization
solutions for the prevention of influenza to better protect
lives and help healthcare providers meet the specific
immunization needs of all types of their
patients. This new quadrivalent influenza vaccine, which
includes both co-circulating B strains, completes our long line of
Vaxigrip® family vaccines dedicated to
fighting influenza infections and its
complications. Once launched in
Europe VaxigripTetra™
will offer broader protection for
people from 36 months and older and support
our public health ambition to constantly innovate to save lives
worldwide" said David
Loew, Executive Vice President Sanofi Pasteur.
The World Health Organization includes quadrivalent influenza
vaccines in its recommendations, stating "Quadrivalent
influenza vaccines that could potentially provide wider protection
against influenza B viruses are becoming available and
recommendations should not be limited to trivalent
vaccine." [4]
From a public health perspective, using quadrivalent rather than
trivalent influenza vaccines could have resulted in a further
reduction of up to 1.6 million influenza cases, 37,300
influenza-related hospitalizations and 14,800 influenza-related
deaths in the EU over a decade[5].
Sanofi Pasteur supports influenza immunization policies and is
committed to developing vaccine solutions that fit with the
influenza epidemiology. VaxigripTetra™ is the newest formulation
designed by Sanofi Pasteur, offering a quadrivalent influenza
vaccine. VaxigripTetra™ includes two A strains and two B strains to
help provide broader protection for all age groups as of 36 months.
Sanofi Pasteur intends to progressively switch all its trivalent
influenza vaccines to quadrivalent influenza vaccines
worldwide.
About the evolution of influenza
vaccines
Influenza viruses mutate often and the antigenic and ecological
evolution results in the need to adapt the vaccine composition
annually to ensure it remains effective[6]. Each winter
the strains for the seasonal influenza vaccines are selected from
the influenza strains anticipated to circulate in the Northern
Hemisphere during the approaching influenza season by WHO. Until
1978, seasonal influenza vaccines contained only two strains (one
strain of type A influenza and one strain of type B influenza),
when the decision was made to incorporate a second type A influenza
strain to help provide protection against both A strains that were
co-circulating[7]. Since then, influenza vaccines have
been trivalent to help protect against three strains of influenza
virus: a type A(H1N1), a type A(H3N2) and one type B.
However, since the 2001-2002 season, influenza B viruses have
diverged into two antigenically distinct lineages (the Victoria and Yamagata lineages). Both B
lineages have co-circulated with varying prevalence by season and
region, supporting the need for extended protection with
quadrivalent influenza vaccines[8].
About influenza and vaccination
Influenza is a serious respiratory illness[9]. Each
year, 3 million to 5 million cases of severe illness are reported
worldwide. Depending on virus virulence during the influenza
season, influenza associated-deaths can range from 250,000 to
500,000 people[10] worldwide.
In Europe, in the absence of
vaccination, the annual burden related to influenza was estimated
at 22 million cases, 3.5 million flu-associated hospitalizations
and 171,000 flu-associated deaths[11]. Currently
seasonal influenza vaccination prevents on average between 1.6
million and 2.1 million cases of influenza, 45,300 to 65,600
hospitalizations, and 25,200 to 37,200 deaths every
year[12]. The World Health Organization recommends
vaccination to help prevent influenza for everyone six months of
age and older.
About Sanofi
Sanofi, a global healthcare leader, discovers, develops and
distributes therapeutic solutions focused on patients' needs.
Sanofi has core strengths in diabetes solutions, human vaccines,
innovative drugs, consumer healthcare, emerging markets, animal
health and Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Sanofi Pasteur, the vaccines division of Sanofi, provides 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 produces a portfolio
of high quality vaccines that matches its areas of expertise and
meets public-health demand. The company's heritage, to create
vaccines that protect life, dates back more than a century. Sanofi
Pasteur is the largest company entirely dedicated to vaccines.
Every day, the company invests more than EUR
1 million in research and development. For more information,
please visit: http://www.sanofipasteur.com or
http://www.sanofipasteur.us
Forward Looking Statements
This press release contains forward-looking statements as
defined in the Private Securities Litigation Reform Act of 1995, as
amended. Forward-looking statements are statements that are not
historical facts. These statements include projections and
estimates and their underlying assumptions, statements regarding
plans, objectives, intentions and expectations with respect to
future financial results, events, operations, services, product
development and potential, and statements regarding future
performance. Forward-looking statements are generally identified by
the words "expects",
"anticipates",
"believes",
"intends",
"estimates",
"plans" and similar expressions. Although
Sanofi's management believes that the expectations
reflected in such forward-looking statements are reasonable,
investors are cautioned that forward-looking information and
statements are subject to various risks and uncertainties, many of
which are difficult to predict and generally beyond the control of
Sanofi, that could cause actual results and developments to differ
materially from those expressed in, or implied or projected by, the
forward-looking information and statements. These risks and
uncertainties include among other things, the uncertainties
inherent in research and development, future clinical data and
analysis, including post marketing, decisions by regulatory
authorities, such as the FDA or the EMA, regarding whether and when
to approve any drug, device or biological application that may be
filed for any such product candidates as well as their decisions
regarding labelling and other matters that could affect the
availability or commercial potential of such product candidates,
the absence of guarantee that the product candidates if approved
will be commercially successful, the future approval and commercial
success of therapeutic alternatives, the Group's
ability to benefit from external growth opportunities, trends in
exchange rates and prevailing interest rates, the impact of cost
containment initiatives and subsequent changes thereto, the average
number of shares outstanding as well as those discussed or
identified in the public filings with the SEC and the AMF made by
Sanofi, including those listed under "Risk
Factors" and "Cautionary Statement
Regarding Forward-Looking Statements" in
Sanofi's annual report on Form 20-F for the year
ended December 31, 2015. Other than
as required by applicable law, Sanofi does not undertake any
obligation to update or revise any forward-looking information or
statements.
References
1. Hannoun, Expert rev. Vaccines 12(9), 1085-1094 (2013)
2. Caini S et al, IORV 9 (supl 1), 3-12 (2015)
3.
http://ecdc.europa.eu/en/publications/Publications/ERLI-Net%20report%20April%202016.pdf
4. http://www.who.int/wer/2012/wer8747.pdf?ua=1&ua=1
5. Public health and economic impact of seasonal influenza
vaccination with quadrivalent influenza vaccines compared to
trivalent influenza vaccines in Europe, Human Vaccines &
Immunotherapeutics, DOI: 10.1080/21645515.2016.1180490 -
http://www.tandfonline.com/doi/pdf/10.1080/21645515.2016.1180490
6. World Health Organization. Factsheet (Influenza). Available
at: http://www.who.int/mediacentre/factsheets/fs211/en/index.html
Accessed June 8, 2016
7. Hannoun, Expert rev. Vaccines 12(9), 1085-1094 (2013)
8. Hannoun, Expert rev. Vaccines 12(9), 1085-1094 (2013)
9. Centers for Disease Control and Prevention. Seasonal
Influenza (Flu). Available at:
http://www.cdc.gov/flu/about/disease/index.htm Accessed
June 8, 2016
10. World Health Organization. Factsheet (Influenza). Available
at: http://www.who.int/mediacentre/factsheets/fs211/en/index.html
Accessed June 8, 2016
11. Ryan et al. Vaccine 24 (2006) 6812-6822:
12. Preaud et al. BMC Public Health 2014, 14:813:
Contacts:
Global Media Relations
Alain Bernal
Tel. +33(0)4-37-37-50-38
alain.bernal@sanofipasteur.com
Investor Relations
George Grofik
Tel. +33(0)1-53-77-45-45
ir@sanofi.com
http://www.sanofipasteur.com