Navigation Links
FDA Licenses First US Vaccine Against Avian Flu

Sanofi pasteur, the vaccines division of the sanofi-aventis Group has received the license from the US FDA for its H5N1 vaccine, the first avian influenza vaccine for humans in// the US. Sanofi pasteur, in collaboration with the National Institutes of Health, submitted a biologics license application to the FDA for this H5N1 vaccine. The licensure serves as a first key step in achieving the government's goal of stockpiling vaccine intended to protect those who are at increased risk of exposure to the H5N1 influenza virus contained in the vaccine during the early stages of a pandemic.

"The licensure of the nation's first vaccine is a significant milestone in pandemic preparedness," said David Williams, President, Chairman and Chief Executive Officer of sanofi pasteur. "As the leading manufacturer of influenza vaccine in the world and a longstanding, responsible member of the immunization community, we will play a key role in helping safeguard human health if an influenza pandemic strikes. We look forward to continuing to work with the US government and others, to prepare for this crisis."

The licensure of this vaccine was based on a clinical trial conducted by the National Institute of Allergy and Infectious Diseases. This trial evaluated the safety and ability to generate an immune response of this vaccine when administered in two 90-ug/ml doses in healthy adults 18 through 64 years. The study, which was completed in 2005, showed that the vaccine elicited an immune response against the H5N1 virus and was associated with mild side effects.

As the world leader in research, development and manufacturing of influenza vaccines, sanofi pasteur is actively involved in pandemic preparedness. Sanofi pasteur is committed to continuing its robust research and development program by exploring strategies for protecting more people, including the evaluation of new adjuvants; the use of cell culture production processes; and assessing the ability of vaccine formulations to generate immune responses against other strains of the H5N1 virus. Additionally, sanofi pasteur has invested in a major expansion of its influenza vaccine production capacity in both the US and France.

Source-BioSpectrum/V
'"/>




Related medicine news :

1. US Government Licenses New Hypertension Drug
2. Panacea Biotec In-Licenses FMD Vaccine
3. Thailand Goes Ahead With Licenses for Generic Drugs
4. Swedish Biotech Licenses HIV Drug to China for Development
5. More Foreign Trained Doctors Receive Licenses
6. First Vaccine Designed for Africa Cleared for Testing in Humans
7. Ajanta Launches Worlds First Once-A-Day Nimesulide Oral Formulation
8. First human clone is near
9. First Artificial Heart patient has Major setback
10. First head-to-head trials of once weekly Fosamax and Actonel therapies
11. WHO Declares Vietnam First Country to Control SARS
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:2/5/2016)... ... ... The American public tends to feel uncomfortable about drinking recycled waste water ... well water. The recent experience with lead contaminated water in Flint, Michigan, according to ... increasing public acceptance of recycled waste water as drinking water. , The Flint ...
(Date:2/5/2016)... ... ... Boar’s Head Brand®, one of the nation’s leading providers of premium delicatessen foods, ... out of your party preparation – follow these easy, yet delicious recipes with the ... , “The key to hosting a successful game-day party is creating a flavorful menu ...
(Date:2/5/2016)... (PRWEB) , ... February 05, 2016 , ... Dr. Justin ... announce their 2nd Annual No Cost Dental Day to individuals in need. The event ... purpose of this No Cost Dental Day is to provide dental care to community ...
(Date:2/5/2016)... ... ... Colorize is a web theme package created exclusively for Final ... dynamic moving camera. Colorize is perfect for personal and web related videos and its ... to 5 focus points per scene, stage floor scene presets that are great for ...
(Date:2/5/2016)... ... February 05, 2016 , ... California Mobile Kitchens ... debut of their latest mobile kitchen model, featuring customizable stainless steel interiors and ... commercial kitchens for use anywhere in the U.S. Many of their units can ...
Breaking Medicine News(10 mins):
(Date:2/5/2016)... -- Site Profile: --> ... Speech Recognition People, announced their latest primary healthcare case study where ... turnaround times and to save the practice money. Site ... Challenge: --> ,- Wirral CCG ,- VoicePower ... doctors ,- Wirral CCG ,- VoicePower client since 2013 ...
(Date:2/4/2016)... 2016  Edwards Lifesciences Corporation (NYSE: EW ), ... disease and critical care monitoring, announced today that it ... with Morgan Stanley & Co. LLC to repurchase $325 ... of the Company,s previously authorized program to repurchase up ... --> --> Under ...
(Date:2/4/2016)... , Feb. 4, 2016  SciClone Pharmaceuticals, Inc. ... it has entered into a settlement agreement with ... fully resolving the SEC,s investigation into possible violations ... the terms of the settlement agreement, SciClone has ... including disgorgement, pre-judgment interest and a penalty.  This ...
Breaking Medicine Technology: