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 easily 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 people aged 3six 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 versus 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 international in varying and unpredictable proportions[1]. In recent years, influenza B viruses represented about 23% of the circulating strains about the world. These proportions can easily be as higher as 90% throughout some seasons and are therefore an necessary induce of influenza disease[2]. Provided this current virological situation along with the co-circulation of the 2 B strains, influenza vaccines have to be adapted and to suit along with the latest virological situation to make certain broader degree of protection. Since 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 rather 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 certainly address the unpredictability issue.
“For over 60 years the expertise of Sanofi Pasteur has actually been committed to providing Brand-new immunization solutions for the prevention of influenza to better protect lives and help healthcare providers meet the personal immunization requires of all of types of their patients. This Brand-new quadrivalent influenza vaccine, which entails the two 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 3six months and older and support our public good health ambition to constantly innovate to save lives worldwide“ said David Loew, Executive Vice President Sanofi Pasteur.
The globe good health Organization entails quadrivalent influenza vaccines in its recommendations, stating “Quadrivalent influenza vaccines that could potentially offer wider protection versus influenza B viruses are becoming available and help ought to not be limited to trivalent vaccine.“ [4]
From a public good health perspective, using quadrivalent fairly compared to trivalent influenza vaccines could have actually resulted in a further reduction of up to 1.six 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 producing vaccine solutions that suit along with the influenza epidemiology. VaxigripTetra™ is the newest formulation created by Sanofi Pasteur, offering a quadrivalent influenza vaccine. VaxigripTetra™ entails two A strains and two B strains to Guidance offer broader protection for all of age groups as of 3six months. Sanofi Pasteur intends to steadily switch all of its trivalent influenza vaccines to quadrivalent influenza vaccines worldwide.
About the evolution of influenza vaccines
Influenza viruses mutate regularly and the antigenic and ecological evolution results in the have to adapt the vaccine composition annually to make certain it remains effective[6]. Each winter the strains for the seasonal influenza vaccines are picked from the influenza strains anticipated to circulate in the Northern Hemisphere throughout 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), as soon as the decision was earned to incorporate a second type A influenza strain to Guidance offer protection versus the two A strains that were co-circulating[7]. Due to the fact that then, influenza vaccines have actually been trivalent to Guidance protect versus three strains of influenza virus: a type A(H1N1), a type A(H3N2) and one type B.
However, Due to the fact that the 2001-2002 season, influenza B viruses have actually diverged in to two antigenically distinct lineages (the Victoria and Yamagata lineages). the two B lineages have actually co-circulated along with varying prevalence by season and region, supporting the reason for extended protection along 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 disease are reported worldwide. Depending on virus virulence throughout the influenza season, influenza associated-deaths can easily 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 standard between 1.six 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 globe good health Organization recommends vaccination to Guidance stay clear of influenza for everyone 6 months of age and older.
About Sanofi
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has actually core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal good health and Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Sanofi Pasteur, the vaccines division of Sanofi, provides much more compared to 1 billion doses of vaccine each year, making it feasible to immunize much more compared to 500 million people across the globe. A globe leader in the vaccine industry, Sanofi Pasteur produces a portfolio of higher quality vaccines that fulfills its areas of expertise and meets public-good health demand. The company’s heritage, to produce vaccines that protect life, dates spine much more compared to a century. Sanofi Pasteur is the largest company entirely dedicated to vaccines. Every day, the company invests much more compared to EUR 1 million in research and development. For much more information, please visit: http://ift.tt/134OR0e or http://ift.tt/1yX9lt0
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 about plans, objectives, intentions and expectations along with respect to future financial results, events, operations, services, product development and potential, and statements about future performance. Forward-looking statements are generally identified by the words “expects“, “anticipates“, “believes“, “intends“, “estimates“, “plans“ and similar expressions. Even though Sanofi‘s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking post and statements are subject to various risks and uncertainties, several of which are difficult to predict and generally beyond the regulate of Sanofi, that could induce actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking post and statements. These risks and uncertainties include among others things, the uncertainties inherent in research and development, future clinical data and analysis, including write-up marketing, decisions by regulatory authorities, such as the FDA or the EMA, about whether and as soon as to approve any sort of drug, device or biological application that might be filed for any sort of such product candidates as well as their decisions about labelling and others matters that could affect the availability or commercial potential of such product candidates, the absence of ensure that the product candidates if approved will certainly be commercially successful, the future approval and commercial triumph 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 modifications thereto, the standard number of shares outstanding as well as those discussed or identified in the public filings along with the SEC and the AMF earned by Sanofi, including those listed under “Risk Factors“ and “Cautionary Statement about Forward-Looking Statements“ in Sanofi‘s annual report on Form 20-F for the year ended December 31, 2015. others compared to as needed by applicable law, Sanofi does not undertake any sort of obligation to update or revise any sort of forward-looking post 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)
5. Public good health and economic impact of seasonal influenza vaccination along with quadrivalent influenza vaccines compared to trivalent influenza vaccines in Europe, Human Vaccines & Immunotherapeutics, DOI: 10.1080/21645515.2016.1180490 – http://ift.tt/28O4rs1
6. globe good health Organization. Factsheet (Influenza). Available at: http://ift.tt/15X6oIR 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 illness regulate and Prevention. Seasonal Influenza (Flu). Available at: http://ift.tt/1d7zzzy Accessed June 8, 2016
10. globe good health Organization. Factsheet (Influenza). Available at: http://ift.tt/15X6oIR Accessed June 8, 2016
11. Ryan et al. Vaccine 24 (2006) 6812-6822:
12. Preaud et al. BMC Public good 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
SOURCE Sanofi Pasteur
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