Tonka
Well-known member
http://www.newsinamerica.com/noticia.php?idnoticia=6833
March 15, 2010
HUMENZA ? *, vaccine against influenza A (H1N1) from Sanofi Pasteur, recommended by the European Medicines Agency
Sanofi Pasteur, the vaccines division of sanofi-aventis (EURONEXT: SAN and NYSE: SNY), announced that its adjuvanted monovalent vaccine against influenza A (H1N1), Humenza ?, recently received a positive opinion from the Committee for Medicinal for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA).
The CHMP recommends the marketing authorization granted in the European Union countries for the use of the vaccine Humenza ?, for the active immunization in persons over 6 months against influenza infections caused by the pandemic virus A ( H1N1) 2009.
The favorable opinion issued today for Humenza ? is the result of the application for European marketing authorization under the centralized procedure, and results from the evaluation of the results of clinical trials conducted by Sanofi Pasteur with its candidate vaccine against influenza A (H1N1) containing the adjuvant AF03. In these trials involved people who had good health, children and adolescents (aged between 6 months to 17 years), adults and seniors, to assess the tolerability of Humenza ? and its ability to induce an immune response sero -protective immunity against the pandemic strain A (H1N1) currently circulating.
The tolerability profile of Humenza ? proved to be satisfactory in all age groups from the different trials, and similar to other pandemic influenza vaccines containing adjuvants, which have been already approved. In all age groups - children and adolescents aged 6 months to 17 years, adults and seniors - one dose of monovalent Humenza ? against influenza A (H1N1) 2009 induced a strong antibody response, which was evaluated elapsed 21 days of his administration, and meets the three criteria required by immunological European Medicines Agency to be regarded as sero-protective.
Sanofi Pasteur, a world leader in research, development and manufacturing of influenza vaccines, has committed to a triple role in the area of public health, which is to manufacture and supply of seasonal flu vaccine for the southern hemisphere, making in 2010 the seasonal flu vaccine for the Northern Hemisphere, and working with health authorities around the world to protect human health against the actual pandemic, preparing to counter health threats that may arise in the future. Sanofi Pasteur has been mobilized on all fronts.
* Humenza ? is a registered trademark of Sanofi Pasteur's vaccine against pandemic influenza in Europe and other countries.
About Humenza ?
Humenza ?, the monovalent vaccine inactivated influenza A (H1N1) 2009, adjuvanted, Sanofi Pasteur is made in the French center of Val de Reuil, following the same manufacturing process that the trivalent vaccine against seasonal influenza at Sanofi Pasteur approved in Europe.
Humenza ? is formulated with 3.8 micrograms of hemagglutinin (HA) of influenza virus strain closely related A/California/07/2009 (H1N1) and contains AF03, the proprietary adjuvant from Sanofi Pasteur, created to stimulate the immune system and increase the response to the vaccine.
Humenza ? will not be distributed in the U.S., where another vaccine manufacturer Sanofi Pasteur flu pandemic already approved by the U.S. FDA.
Sanofi Pasteur and manufacture of influenza vaccine
Sanofi Pasteur manufactures the flu vaccine at two centers: one located in the USA (Swiftwater, Pennsylvania) and the other in France (Val-de-Reuil, Eure). All Sanofi Pasteur factories have been designed and constructed according to standards that enable Sanofi Pasteur to easily switch from production of seasonal flu vaccine to the vaccine against pandemic influenza. Sanofi Pasteur produces approximately 40% of the influenza vaccine distributed worldwide. His American factory produces over 45% of vaccines are being distributed in the United States for the 2009-2010 season. For more information on the program of preparedness against the threat of pandemic influenza Sanofi Pasteur, consult the website http://pandemic.influenza.com
About sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of every person. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and New York (NYSE: SNY). For more information, go to: www.sanofi-aventis.com.
Sanofi Pasteur, the vaccines division of sanofi-aventis Group, sold more than 1,600 million doses of vaccine in 2008, offering protection to more than 500 million people worldwide. Sanofi Pasteur is a world leader and has the broadest range of vaccines protecting against 20 infectious diseases. Sanofi Pasteur's experience in the area of vaccines goes back more than a century. It is currently the largest company entirely dedicated to the vaccine and invests more than a million euros in research and development. For more information please visit: www.sanofipasteur.com <http://www.sanofipasteur.com
March 15, 2010
HUMENZA ? *, vaccine against influenza A (H1N1) from Sanofi Pasteur, recommended by the European Medicines Agency
Sanofi Pasteur, the vaccines division of sanofi-aventis (EURONEXT: SAN and NYSE: SNY), announced that its adjuvanted monovalent vaccine against influenza A (H1N1), Humenza ?, recently received a positive opinion from the Committee for Medicinal for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA).
The CHMP recommends the marketing authorization granted in the European Union countries for the use of the vaccine Humenza ?, for the active immunization in persons over 6 months against influenza infections caused by the pandemic virus A ( H1N1) 2009.
The favorable opinion issued today for Humenza ? is the result of the application for European marketing authorization under the centralized procedure, and results from the evaluation of the results of clinical trials conducted by Sanofi Pasteur with its candidate vaccine against influenza A (H1N1) containing the adjuvant AF03. In these trials involved people who had good health, children and adolescents (aged between 6 months to 17 years), adults and seniors, to assess the tolerability of Humenza ? and its ability to induce an immune response sero -protective immunity against the pandemic strain A (H1N1) currently circulating.
The tolerability profile of Humenza ? proved to be satisfactory in all age groups from the different trials, and similar to other pandemic influenza vaccines containing adjuvants, which have been already approved. In all age groups - children and adolescents aged 6 months to 17 years, adults and seniors - one dose of monovalent Humenza ? against influenza A (H1N1) 2009 induced a strong antibody response, which was evaluated elapsed 21 days of his administration, and meets the three criteria required by immunological European Medicines Agency to be regarded as sero-protective.
Sanofi Pasteur, a world leader in research, development and manufacturing of influenza vaccines, has committed to a triple role in the area of public health, which is to manufacture and supply of seasonal flu vaccine for the southern hemisphere, making in 2010 the seasonal flu vaccine for the Northern Hemisphere, and working with health authorities around the world to protect human health against the actual pandemic, preparing to counter health threats that may arise in the future. Sanofi Pasteur has been mobilized on all fronts.
* Humenza ? is a registered trademark of Sanofi Pasteur's vaccine against pandemic influenza in Europe and other countries.
About Humenza ?
Humenza ?, the monovalent vaccine inactivated influenza A (H1N1) 2009, adjuvanted, Sanofi Pasteur is made in the French center of Val de Reuil, following the same manufacturing process that the trivalent vaccine against seasonal influenza at Sanofi Pasteur approved in Europe.
Humenza ? is formulated with 3.8 micrograms of hemagglutinin (HA) of influenza virus strain closely related A/California/07/2009 (H1N1) and contains AF03, the proprietary adjuvant from Sanofi Pasteur, created to stimulate the immune system and increase the response to the vaccine.
Humenza ? will not be distributed in the U.S., where another vaccine manufacturer Sanofi Pasteur flu pandemic already approved by the U.S. FDA.
Sanofi Pasteur and manufacture of influenza vaccine
Sanofi Pasteur manufactures the flu vaccine at two centers: one located in the USA (Swiftwater, Pennsylvania) and the other in France (Val-de-Reuil, Eure). All Sanofi Pasteur factories have been designed and constructed according to standards that enable Sanofi Pasteur to easily switch from production of seasonal flu vaccine to the vaccine against pandemic influenza. Sanofi Pasteur produces approximately 40% of the influenza vaccine distributed worldwide. His American factory produces over 45% of vaccines are being distributed in the United States for the 2009-2010 season. For more information on the program of preparedness against the threat of pandemic influenza Sanofi Pasteur, consult the website http://pandemic.influenza.com
About sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of every person. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and New York (NYSE: SNY). For more information, go to: www.sanofi-aventis.com.
Sanofi Pasteur, the vaccines division of sanofi-aventis Group, sold more than 1,600 million doses of vaccine in 2008, offering protection to more than 500 million people worldwide. Sanofi Pasteur is a world leader and has the broadest range of vaccines protecting against 20 infectious diseases. Sanofi Pasteur's experience in the area of vaccines goes back more than a century. It is currently the largest company entirely dedicated to the vaccine and invests more than a million euros in research and development. For more information please visit: www.sanofipasteur.com <http://www.sanofipasteur.com