New Four-Strain Influenza Vaccine, VaxigripTetra™, regulatory dossier approved in Europe

Stockholm, Sweden – June 27, 2016 – Sanofi Pasteur MSD, the European joint venture between Sanofi Pasteur (Sanofi group) & Merck Vaccines (known as MSD outside US & Canada), announced today that its quadrivalent influenza vaccine VaxigripTetra™ obtained the approval (End of Procedure) from the German Reference Member State Paul Ehrlich Institute, as a conclusion of a European Decentralized Procedure. National 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 children from 36 months of age and adults. VaxigripTetra™ is the newest addition to the Vaxigrip^® family of influenza vaccines. 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.” [1]

Sanofi Pasteur MSD is committed to delivering vaccination solutions that support influenza immunization policies and fit with the evolution of the influenza virological situation.“We are delighted by the approval of this new four-strain influenza vaccine which demonstrates our capacity to constantly innovate,said Dr Stephen Lockhart, Vice President Development at Sanofi Pasteur MSD.This approval is a key step towards making VaxigripTetra® available to people from 36 months and olderin Europe”he added.

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[2]. Given this current virological situation with co-circulation of the two B strains, influenza vaccines need to be adapted to ensure broader protection.

It has been estimated that, by using quadrivalent rather than trivalent influenza vaccines in the EU over a decade[3], an additional 1.6 million influenza cases could have been avoided, including 37,300 influenza-related hospitalizations and 14,800 influenza-related deaths.

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About the evolution of influenza vaccines

Influenza viruses mutate often and the antigenic evolution results in the need to adapt the vaccine composition annually to ensure it remains effective[4].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[5]. Since then, influenza vaccines have contained 3 strains of influenza virus: a type A(H1N1), a type A(H3N2) and one type B.

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[6].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[7]. In Europe in 2015 92% 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 help to address this unpredictability.

About influenza and vaccination

Influenza is a serious respiratory illness[8]. 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[9] 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[10]. Currently seasonal influenza vaccination is recommended in most countries for those at risk of influenza, however vaccination rates remain sub-optimal and as a result programmes prevent 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[11].The World Health Organization recommends vaccination to help prevent influenza for everyone six months of age and older urging the need for satisfactory vaccination rates in the higher risk-groups, including seniors and persons with underlying chronic medical conditions.

About Sanofi Pasteur MSD http://www.spmsd.com

Sanofi Pasteur MSD is a European joint venture formed between Sanofi Pasteur (the vaccine division of Sanofi) and Merck (known as MSD outside the United States and Canada). Combining innovation and expertise, Sanofi Pasteur MSD is the only European pharmaceutical company dedicated exclusively to the distribution of vaccines. Sanofi Pasteur MSD makes use of the combined expertise resulting from Sanofi Pasteur and Merck’s research to focus on the development of new vaccines in Europe in order to produce the most effective, most acceptable and better tolerated vaccines.

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References

[1]http://www.who.int/wer/2012/wer8747.pdf?ua=1&ua=1

[2]Hannoun, Expert rev. Vaccines 12(9), 1085-1094 (2013)

[3]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

[4]World Health Organization. Factsheet (Influenza). Available at: http://www.who.int/mediacentre/factsheets/fs211/en/index.html. Accessed June 8, 2016

[5]Hannoun, Expert rev. Vaccines 12(9), 1085-1094 (2013)

[6] Caini S et al, IORV 9 (supl 1), 3-12 (2015)

[7] Hannoun, Expert rev. Vaccines 12(9), 1085-1094 (2013)

[8]Centers for Disease Control and Prevention. Seasonal Influenza (Flu). Available at: http://www.cdc.gov/flu/about/disease/index.html. Accessed October 11, 2013

[9]World Health Organization. Factsheet (Influenza). Available at: http://www.who.int/mediacentre/factsheets/fs211/en/index.html. Accessed June 8, 2016

[10] Ryan et al. Vaccine 24 (2006) 6812–6822 :

[11] Preaud et al. BMC Public Health 2014, 14:813: