News Archives

06/23/2016

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.

Lyon, France – June 23, 2016 – 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 disease2. 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 decade5.

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-circulating7. 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 vaccines8.

 

About influenza and vaccination

Influenza is a serious respiratory illness9. 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 people10 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 deaths11. 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 year12.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: www.sanofipasteur.com or 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.

 

Contacts:

Global Media Relations 

Alain Bernal

Tel. +33 (0)4 37 37 50 38

alain.bernal@sanofipasteur.com

www.sanofipasteur.com

 

Investor Relations

George Grofik

Tel. +33 (0)1 53 77 45 45

ir@sanofi.com

 

 

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.html. Accessed October 11, 2013

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:

06/21/2016

- Costa Rica is 5th country in the world to approve the dengue vaccine, which was recently endorsed by the WHO SAGE recommendations supporting the safety, efficacy and public health value of the dengue vaccine in endemic countries -

- Vaccine needed to address precipitous rise of dengue in Costa Rica, with greater than 500% increase in incidence in 2016 already compared to last year’s numbers -

 

Costa Rica – 21st June, 2016 - Today Sanofi Pasteur, Sanofi’s vaccine division, announced that the National Ministry of Health of Costa Rica has approved Sanofi Pasteur’s tetravalent dengue vaccine, Dengvaxia®to protect individuals 9 to 45 years of age living in endemic areas against all four serotypes of dengue.

This approval in Costa Rica is the fourth registration of the dengue vaccine in Latin America, and the fifth in the world. Sanofi Pasteur’s dengue vaccine has already been approved in Mexico, Brazil, El Salvador and the Philippines.

"Dengue is a disease that is beginning to hit us hard as a result of increased mobility and urbanization in the country. Already in 2016, we have recorded 7,711 cases of dengue at week 22 which is more than a 500% increase in incidence compared to last year,1” said Jorge Martinez, Pediatrician Member of the Pediatrician Society of Costa Rica. “Approval of the dengue vaccine gives us access to critical prevention tool against dengue to curb further spread of this debilitating disease in our country.”

In April 2016, the Strategic Advisory Group of Experts (SAGE) on immunization to the World Health Organization (WHO) recommended endemic countries to consider introduction of Dengvaxia® as part of integrated disease prevention including vector control and community mobilization.2 The WHO has set the objectives of reducing mortality by dengue by 50% and morbidity by 25% by 2020 in the endemic countries.3

“Dengue represents a growing and serious public health issue in many parts of the Americas with significant associated human and economic burden,” according to Cesar Mascareñas, Global Director of Medical Affairs for the Dengue Project, Sanofi Pasteur. “Approval of the dengue vaccine in Costa Rica will give the country’s healthcare providers access to the first clinical preventive tool against dengue, allowing them to better protect their patients against this threat.”

Public vaccinations against dengue began in the Philippines in April, with the goal of initiating the vaccination of 1 million fourth-grade students in highly-endemic regions of the country this year. Introduction of dengue vaccine in private and public immunization clinics in Brazil, Mexico and other countries in Central America are planned also to follow in coming months.

The global burden of dengue

According to the WHO, dengue is currently the fastest-growing mosquito-transmitted disease in the world, causing around 400 million infections every year. Over the last 50 years, dengue has spread; initially present in a handful of countries, it is now endemic in 128, inhabited by around 4 billion people. Also, the incidence of this disease has increased 30 times in this same period.4

Even though dengue affects people of all ages and lifestyles, the greatest number of dengue cases worldwide occurs in individuals 9 years of age and older, who represent a highly mobile and social segment of the community capable of contributing significantly to spread of the disease.5,6

About Sanofi Pasteur’s dengue vaccine

Besides Costa Rica, Sanofi Pasteur’s dengue vaccine has also been registered in Brazil, Mexico, El Salvador and the Philippines to date. Both private and public vaccinations against dengue have been successfully introduced in the Philippines and are being planned in other approval countries. The regulatory review process for the vaccine is continuing in other countries where dengue is a public health priority.

Sanofi Pasteur’s dengue vaccine is the culmination of over two decades of scientific innovation and collaboration, as well as 25 clinical studies in over 15 countries around the world. More than 40,000 volunteers participated in the dengue vaccine clinical study program (phase I, II and III), of whom 29,000 volunteers received the vaccine.7,8

Pooled efficacy and integrated safety analyses from the 25-month Phase III efficacy studies and the ongoing long-term studies, respectively, were published in The New England Journal of Medicine on July 27th, 2015, documenting the vaccine’s consistent efficacy and longer-term safety profile in a study population 9-16 years of age. In the pooled efficacy analysis in this age group, Sanofi Pasteur’s dengue vaccine was shown to reduce dengue caused by all four serotypes in two-thirds of the participants. Furthermore, this pooled analysis showed that Dengvaxia® prevented up to 93% of severe dengue cases and 8 out of 10 hospitalizations.9

Sanofi Pasteur’s dengue vaccine is the first and only vaccine licensed for the prevention of dengue in the world. The first vaccine doses have already been produced and shipped to countries in Asia and Latin America; the full-scale production capacity of the dedicated vaccine facility in France is 100 million vaccine doses annually.

Additional information about Sanofi Pasteur’s dengue vaccine is available on the web in Spanish at http://es.dengue.info/ or at www.dengue.info (in English).

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 provides 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: www.sanofipasteur.com or 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.

Contacts:

Global Media Relations

Alain Bernal

Tel. +33 (0)4 37 37 50 38

alain.bernal@sanofipasteur.com

www.sanofipasteur.com

 

Regional Media Relations

Marcela Jaramillo

Tel. +57 316466115

marcela.jaramillo@sanofipasteur.com

www.sanofipasteur.com

 

______________________________________________________________

1 Boletín epidemiológico No16-2016 Zika, Chikungunya y Dengue, 15 Jun. 2016

https://www.ministeriodesalud.go.cr/index.php/vigilancia-de-la-salud/analisis-de-situacion-de-salud/3055-boletinepidemiologico-no-16-2016-zika-chikungunya-y-dengue/file

http://www.who.int/immunization/sage/meetings/2016/april/en/. Last accessed 23 May 2016

3 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. Last accessed 23 May 2016

4 World Health Organization. Dengue and severe dengue. Factsheet No 117 http://www.who.int/mediacentre/factsheets/fs117/en/

5 Egger JR. Age and clinical dengue illness. Emerg Infect Dis. 2007;13:924-5

6 San Martin JL, Brathwaite O, Zambrano B, et al. The epidemiology of dengue in the americas over the last three

decades: a worrisome reality. Am J Trop Med Hyg 2010;82:128-35

7 Capeding MR, et al. Lancet 2014;384:1358-65

8 Villar L, et al. N Engl J Med 2015;372:113-23

9 Hadinegoro SR, et al. N Engl J Med 2015; 373:1195-206

05/27/2016

Quebec Science story strikes Green Gold

Award winning writer outlines the pharmaceutic potential of plants

 

Montreal May 27, 2016 — Canada’s development of a vaccine to fight Ebola in 2014 represented a major contribution in global health research, but no less remarkable have been the implications of putting this innovation into clinical practice. Government health care authorities turned to a Quebec firm, Medicago, which is among the leaders in turning plants into living pharmaceutical factories. In this case the firm employed a version of tobacco that was altered to express the vaccine’s essential proteins in its leaves, which could be quickly processed for rapid manufacture and distribution of the medicine.

 

This approach to drug production promises to overcome a key obstacle facing health care providers, which is the significant delay between the identification of a viral threat and the ability to turn out sufficient volumes of a targeted vaccine in time to prevent a population-wide outbreak. Quebéc Science science writer Marine Corniou described how this and many other challenges in drug development are being tackled with the help of “moleculture”, literally cultivating active compounds within plants. In this way, the output of vaccine compound can be accelerated for much quicker distribution.

 

Her feature story on this subject, “L’or Vert des Pharmas”, is now being honoured with this year’s Sanofi Pasteur Medal of Excellence in Health Research Journalism.

 

Award judges were struck by Corniou’s engaging account of this innovative technology, which is new even to informed observers of science and medicine. CHR President Patricia Guyda is also among those who were surprised by the significant medical potential associated with the humblest of plants. “It can be easy for some people to focus on the many unknowns associated with processes around working with bacteria or GMOs, but we can’t let those concerns overshadow the promise that also comes with them,” she insists. “Marine has given us a valuable overview of just how significant that promise can be in the field of human health.”

 

CHR launched the Sanofi Pasteur Medal of Excellence in Health Research Journalism in 1995, and administers the selection process. Sponsored by Sanofi Pasteur Ltd., Canada's premier vaccine company, the inaugural medal recipient was Globe & Mail science reporter Stephen Strauss for his longstanding contribution to promoting public awareness of science. Other recent awardees include Ivan Semeniuk of the Globe & Mail, Mark Witten for his work in Homemakers magazine and Hannah Hoag for an article in the Montreal Gazette.

 

“As a company that is built on nearly a century of science, Sanofi Pasteur is pleased to be associated with this prestigious award that recognizes excellence in science journalism,” says Maggie Wang Maric, Head of Toronto Hub Communications, Sanofi Pasteur.

           

As part of the award, Corniou will receive a plaque and a $2,500 bursary on June 4, 2016, during the Canadian Science Writers’ Association annual general meeting at the University of Guelph.

 

Canadians for Health Research (CHR) is a nonprofit organization committed to promoting the stability and quality of Canadian health research.  It fosters communication between health researchers, the government and the Canadian public, and publishes a quarterly magazine entitled Future Health.  For more information, or to become a member, please visit the CHR website at http://www.chrcrm.org.

 

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 match its areas of expertise and meet 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: www.sanofipasteur.com or www.sanofipasteur.us

 

For more information, please contact:

 

Tim Lougheed                                               Maggie Wang Meric               

CHR Chair                                                     Head of Toronto Hub Communications

(613) 979-7227                                             Sanofi Pasteur Limited

stormchild@sympatico.ca                           Toronto, Ontario

                                                                        (416) 667-2955                                  

                                                                        Maggie.WangMaric@sanofipasteur.com

05/03/2016


 

Canada’s Top Student Scientist Recognized at Sanofi Biogenius Canada National Final 
Iveta Demirova, 16, student at New Westminster Secondary School in British Columbia, Recognized for Novel HIV-1 Treatment

 

Ottawa, Ontario – May 3, 2016 – Iveta Demirova from New Westminster Secondary School in New Westminster, British Columbia, has been awarded top honours at the national final of the prestigious Sanofi Biogenius Canada (SBC) competition in Ottawa.  The 16-year-old, grade 11 student, was chosen by the judges for her research project exploring the development of a novel HIV-1 therapy.
 

The results of Iveta’s research project, completed with the support of mentor Dr. Ralph Pantophlet of Simon Fraser University, could offer numerous advantages to those living with HIV, which remains one of the world’s leading infectious diseases. Although current treatment options have managed to successfully target and suppress the virus among patients, many individuals become resistant to treatment, and it is among this population that Iveta’s project could play a significant role. 
 

“I was very pleased with the results of my research and I am hoping that my findings will have an impact within the field of HIV research, and, more importantly, in the lives of patients living with this disease,” she said. “I am truly honoured to have won the Sanofi Biogenius Canada competition, and thrilled to have the opportunity to represent the country at the 2016 International BioGENEius Challenge in San Francisco in June.”
 

One of the country’s most prestigious student competitions, Sanofi Biogenius Canada pairs exceptional young scientists at the high school level with academic mentors to pursue real-world research projects. These enriching partnerships have resulted in many promising breakthroughs across various scientific fields.
 

Hosted at the National Research Council of Canada (NRC), the competition’s national final featured the winners of all nine Sanofi Biogenius Canada regional competitions across the country. The nine finalists presented their research projects to a judging panel of esteemed members of the scientific community, including Dr. Robert Tsushima, Associate Dean, Research and Partnerships, Faculty of Science, York University; Dr. Thomas Merritt, Canada Research Chair in Genomics and Bioinformatics, Laurentian University; Dr. Lakshmi Krishnan, Program Leader, NRC and Michael McCluskie, Senior Research Officer, NRC.
 

“What distinguishes Sanofi Biogenius Canada from other science competitions is the real-life experience that participants gain by working in close collaboration with a mentor. There is nothing more inspiring than having the opportunity to pursue groundbreaking research projects with experts and leaders in their respective fields. Not only is the depth of Iveta’s research project commendable, but it is a concrete example of the benefits of programs like SBC, which help transform passion into tangible results,” said Mark Lievonen, Canada Country Chair, Sanofi and General Manager, Sanofi Pasteur.
 

Iveta receives a cash prize of $5,000, a portion of which will go to New Westminster Secondary School, and she will now progress to the 2016 International BioGENEius Challenge in San Francisco in June, where she will submit her work to a panel of pre-eminent international scientists.    

Runners-up in this year’s national SBC competition were awarded cash prizes ranging in value from $1,000 to $4,000.
 

Second prize went to Melody Song, a student from Evan Hardy Collegiate in Saskatoon, Saskatchewan. Melody earned high praise for her research project which focused on preventing disease in Faba Bean crops, and was completed with the support of mentors Dr. Kirstin E. Bett and Dr. Hamid Khasaei of the University of Saskatchewan.
 

Third prize was awarded to Denis Drewnik, a grade 12 student from Sisler High School in Winnipeg, Manitoba, for a project that examined how to protect the canola crop from the devastating Blackleg disease, which can reduce yield by up to 20% and have a devastating economic impact. Denis’ project was supported by mentor Dr. Mark Belmonte of the University of Manitoba.
 

Dina Shehata from Holy Heart of Mary High School in St. John’s, Newfoundland earned the competition’s Commercialization prize. The Commercialization prize recognizes the project with the most commercial potential and viability. Dina’s research focused on developing a low cost gel model for ultrasound training.

 

About the Sanofi Biogenius Challenge (SBC)

Sanofi Biogenius Canada is a national science research competition open to high school students, which since 1992, has helped almost 5,000 young Canadians pursue real-world scientific research projects that have been the launch pads to future studies and careers. Coordinated by Partners In Research, the initiative is sponsored by Sanofi Canada, the National Research Council Canada/Conseil national de recherches Canada (NRC-CNRC), Centre for Drug Research and Development (CDRD) and DelMar Pharmaceuticals.
 

For more information, visit biogenius.ca, or follow SBC on Facebook (facebook.com/SanofiBiogenius) or Twitter (@biogeniusca) using the hashtag #SBC2016.

 

 

Media Contacts:
Maxime-Elisabeth Illick
NATIONAL Public Relations
meillick@national.ca
Tel.: 514- 843-2322
Cell: 514-475-9131

Mel Kern
Partners In Research
mkern@pirweb.org
Tel.: 519-433-7866 ext. 29

02/24/2016

Canada’s National Advisory Committee on Immunization recognizes superior efficacy of high dose vaccine for adults 65 years of age and older compared to standard dose trivalent influenza vaccine

 

Toronto, Canada – February 24, 2016 – Sanofi Pasteur announces Health Canada’s approval of FLUZONE® High-Dose vaccine, the first and only influenza vaccine developed for adults 65 years of age and older with evidence demonstrating that it is significantly more effective in preventing lab-confirmed influenza illness versus a standard dose trivalent influenza vaccine (TIV).1-3

 

In its immunization advisory statement for the upcoming 2016/2017 influenza season, Canada’s National Advisory Committee on Immunization (NACI) has stated: ‘Considering the burden of disease associated with influenza A(H3N2) and the evidence of superior efficacy of high dose TIV compared to standard dose TIV, it appears that high dose TIV would provide the greatest benefit to the ≥65 years age group.’4

 

As the immune system declines with age, older adults do not respond to standard dose influenza vaccines as well as younger adults.1,4,5FLUZONE® High-Dose vaccine was developed to address the need for an enhanced immune response in those 65 years of age and older.1 Importantly, FLUZONE® High-Dose was recognized by Health Canada and NACI to have demonstrated higher efficacy against lab-confirmed influenza illness compared to a standard dose vaccine in adults 65 years of age and older.1-3

 

“Reducing the rates of influenza and its complications in the senior adult population is a key public health priority,” said Dr. Janet McElhaney, Geriatrician, Medical Lead for Seniors Care, Health Sciences North Volunteer Association Chair in Healthy Aging and Scientific Director for the Advanced Medical Research Institute of Canada. “There is now strong data which demonstrates that this high dose vaccine provides those 65 years of age and older with enhanced protection against influenza. This is the first randomized trial that has shown not only an increase in efficacy, but has also translated into clinically important outcomes.”

 

A large, randomized, controlled study, published in the New England Journal of Medicine, in a study population of approximately 32,000 adults 65 years of age and older, demonstrated that about one quarter (24.2%, 95% CI: 9.7 to 36.5) of all breakthrough influenza illnesses influenza caused by any influenza viral types or subtypes could be prevented if high dose vaccine were used instead of a standard dose TIV.1,2,*

 

“Public health authorities have long recognized a large unmet need among seniors as it relates to influenza and have been asking for the development of more effective influenza vaccines for this age group who are more vulnerable to the consequences of the flu,” said Dr. Dion Neame, Head, Scientific and Medical Affairs, Sanofi Pasteur Limited. “As a company, we invested in a large efficacy trial which has provided robust evidence that addresses a public health priority to help reduce influenza illness among adults 65 years and older. FLUZONE® High-Dose vaccine has been available in the U.S. since 2009 and we look forward to bringing this innovation to Canada this fall.”

 

Impact of Influenza on adults 65 years and older in Canada: Key Facts

 

  • Adults 65 years and older experience heightened susceptibility to influenza-related complications due in large part to a natural and progressive weakening of the immune system with age.1,4,5
  • Adults 65 years of age and older represent 15 per cent of Canadian population but account for 70 per cent of total influenza-related hospitalizations and 90 per cent of total influenza-related deaths6,7
  • While most people can recover from influenza in as few as seven days, it may take longer for adults 65 years of age as they are at risk of developing more severe complications, including pneumonia or worsening underlying medical conditions4

 

All adults 65 years of age and older are advised to receive an influenza vaccine annually according to NACI as this age group is considered to be at particularly high-risk of influenza-related complications or hospitalization.4,5

 

About FLUZONE® High-Dose Vaccine

 

FLUZONE® High-Dose is a trivalent vaccine that contains four times the amount of hemagglutinin (HA) per strain as compared to a standard dose vaccine.1,2FLUZONE® High-Dose is indicated for active immunization against influenza caused by the specific strains of influenza virus contained in the vaccine in adults 65 years of age and older. It is administered as a single 0.5 mL injection by the intramuscular route.1 Higher rates of some injection-site and systemic reactions were observed among recipients of the high-dose vaccine compared to standard-dose vaccine, but most reactions were mild and resolved within three days.1,4

 

For more information about FLUZONE® High-Dose Influenza Vaccine, please visit: www.sanofipasteur.ca/PM/fluzoneHD_e .

 

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 offers a broad range of vaccines protecting against 20 infectious diseases. 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: www.sanofipasteur.ca

 

For more information or to arrange an interview, please contact:

                                                                                                                                                                                                                            

Sanofi Pasteur Limited

Danielle Richardson                                                               

T. 416-667-2700 ext. 6950.

Danielle.Richardson@sanofipasteur.com

References                                                                            

 

  1. Product Monograph: FLUZONE® High-Dose Influenza Virus Vaccine Trivalent Types A and B (Split Virion). Sanofi Pasteur.  Approved September 2015
  2. DiazGranados, C. A. et al. Efficacy of high-dose versus standard-dose influenza vaccine in older adults. The New England journal of medicine 371, 635-645 (2014).
  3. DiazGranados, C. A. et al. Prevention of serious events in adults 65 years of age or older: A comparison between high-dose and standard-dose inactivated influenza vaccines. Vaccine 33, 4988-4993 (2015).
  4. Public Health Agency of Canada (2016). An Advisory Committee Statement (ACS) National Advisory Committee on Immunization (NACI): Canadian Immunization Guide Chapter on Influenza and Interim Statement on Seasonal Influenza Vaccine for 2016-2017.
  5. Public Health Agency of Canada (2016). An Advisory Committee Statement (ACS) National Advisory Committee on Immunization (NACI): A Review of the Literature of High Dose Seasonal Influenza Vaccine for Adults 65 Years and Older.
  6. Centers for Disease Control and Prevention. What You Should Know and Do this Flu Season If You Are 65 Years and Older. http://www.cdc.gov/flu/about/disease/65over.htm.
  7. Statistics Canada. 2011 Census of Canada: Topic-based tabulations. http://www12.statcan.gc.ca/census-recensement/2011/dp-pd/tbt-tt/Rp-. Accessed June 2015.

*The pre-specified statistical superiority criterion for the primary endpoint (lower limit of the 2-sided 95% CI of the vaccine efficacy of FLUZONE® High-Dose relative to FLUZONE® >9.1%; p-value against H0:VE ≤ 9.1% = 0.022 one-sided) was met in a large, randomized, double-blinded, active-controlled clinical trial with approximately 32,000 subjects 65 years of age and older. The primary endpoint was the occurrence of laboratory-confirmed influenza caused by any influenza viral types or subtypes, in association with a protocol-defined influenza-like illness.1,2

 

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