Sanofi Pasteur’s Typhim Vi®, granted prequalification by the WHO

Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE: SNY), announced today that the World Health Organization (WHO) has granted prequalification to its Typhim Vi® polysaccharide typhoid vaccine. Typhim Vi® is the first WHO prequalified typhoid vaccine.

WHO prequalification is a key step that allows for the procurement of vaccines by UNICEF and other United Nations (UN) agencies like the Pan American Health Organization (PAHO) Revolving Fund. It is also a prerequisite for GAVI Alliance New and Underused Vaccines Support for vaccine distribution, ensuring and improving developing countries’ access to vaccines that meet unified standards of quality, safety and efficacy.

“In line with our ambition to provide the best vaccines at affordable prices to developing countries, Sanofi Pasteur is truly pleased and proud to bring to the immunization community the first WHOprequalified typhoid vaccine, Typhim Vi®, to help combat a serious disease that affects the lives of millions of individuals each year particularly in the most impoverished countries,” said Olivier Charmeil, President and CEO of Sanofi Pasteur.

As a dedicated, longstanding contributor to public health, Sanofi Pasteur collaborates with global heath authorities and international organizations, including GAVI, UNICEF and WHO, committed to controlling and preventing enteric and other infectious diseases. Through these collaborations, Sanofi Pasteur aims at sharing its strong R&D, industrial and logistical expertise, know-how and experience in vaccines, and at providing the developing countries with full support to introduce typhoid vaccination in their national immunization programs to prevent childhood typhoid fever in endemic regions.

Sanofi Pasteur is also a member of the Coalition against Typhoid (CaT), a global forum of typhoid immunization experts hosted by the Sabin Vaccine Institute, whose goal is to identify the barriers to the adoption of typhoid vaccine and the key activities needed for these barriers to be broken down. “WHO prequalification of a typhoid vaccine is a crucial step towards universal access and the use of these vaccines where they are needed most,” confirmed Ciro De Quadros, MD MPH, Executive Vice President at the Sabin Vaccine Institute.

In addition, Sanofi Pasteur is a key partner in the Vi-based Vaccines for Asia (VIVA) initiative of the International Vaccine Institute (IVI), a Seoul, Korea-based international organization, on pilot typhoid vaccine introduction programs to provide resources and technical support to assist authorities in defining optimal disease control strategies in the countries and regions where typhoid fever is an important public health issue affecting, in particular, the children in the poorest populations.

Typhim Vi® polysaccharide typhoid vaccine is licensed in over 100 countries and is indicated for active immunization of persons two years of age and older against typhoid fever. First licensed in 1988 in France, Typhim Vi® vaccine, manufactured at Sanofi Pasteur’s facility in Marcy L’Etoile, France, has established a longstanding safety and seroprotection track record.

About Typhoid Fever

Typhoid fever is a bacterial disease, caused by Salmonella enterica serovar Typhi (Salmonella Typhi). It is transmitted through the ingestion of food or drink contaminated by the faeces or urine of infected people. Symptoms usually develop 1–3 weeks after exposure, and may be mild or severe. They include fever, malaise, headache, constipation or diarrhoea, rose-coloured spots on the chest, and enlarged spleen and liver. Healthy carrier state (persisting for month or years) may follow acute illness. Typhoid fever can be treated with antibiotics. However, resistance to common antimicrobials is widespread. Healthy carriers should be excluded from handling food. http://www.who.int/topics/typhoid_fever/en/

Typhoid fever is a major cause of morbidity with an estimated global incidence of approximately 21 million cases each year. According to one conservative estimate, there were approximately 216,000 deaths from typhoid worldwide in the year 2000. http://www.ivi.int/program/tr_domi_typhoid.html

About WHO Prequalification Process

WHO prequalification is a regulatory step aimed at ensuring that diagnostics, medicines and vaccines for high-burden diseases meet global standards of quality, safety and efficacy, in order to optimize use of health resources and improve health outcomes.

The prequalification process consists of a transparent, scientifically sound assessment, which includes dossier review, consistency testing or performance evaluation and site visits to manufacturers. This information, in conjunction with other procurement criteria, is used by UN and other procurement agencies to make purchasing decisions regarding diagnostics, medicines and/or vaccines. http://www.who.int/topics/prequalification/en/

About Typhim Vi® Vaccine
http://www.who.int/immunization_standards/vaccine_quality/pq_238_typhoid_20dose_sanofi_paste ur/en/index.html

About GAVI Alliance New and Underused Vaccine Support http://www.gavialliance.org/support/index.php

About the International Vaccine Institute (IVI)
http://www.ivi.org/

About the Coalition Against Typhoid
http://www.sabin.org/advocacy-education/coalition-against-typhoid

About Vi-based Vaccines for Asia (VIVA) initiative
http://viva.ivi.int/TyphoidInformationCenter/Forresearchers.html