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.


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:

(Date:11/25/2015)... ... November 25, 2015 , ... TyloHelo Inc , ... accessories. , Sauna accessories help improve the bather experience in the sauna, and ... styles for the purist looking for simplicity in design to accessories that encourage ...
(Date:11/25/2015)... ... November 25, 2015 , ... According to an article published November ... more widely heralded as a breakthrough for performing hernia repairs. The article explains that ... surgery is that it can greatly reduce the pain that a patient might otherwise ...
(Date:11/25/2015)... ... , ... The McHenry County law firm of Botto Gilbert Lancaster, PC ... J. Botto and Alex C. Wimmer. Attorneys Botto and Wimmer represented the claimant David ... 130884WC. , According to court documents, Adcock testified that on May 10, 2010 he ...
(Date:11/25/2015)... ... 25, 2015 , ... Brillianteen, McGaw YMCA’s student-produced musical show, ... 65th Anniversary Brillianteen Revue, scheduled for March 4-6, 2016. Auditions for this final ... has been a treasured tradition for numerous families in the Evanston community. Over ...
(Date:11/25/2015)... ... November 25, 2015 , ... In honor ... Periwinkle Pioneers, individuals and groups responsible for advancing care for pulmonary hypertension (PH) ... nominated by the public, will receive special recognition throughout 2016 as part of ...
Breaking Medicine News(10 mins):
(Date:11/26/2015)... Research and Markets ( ) ... Future Horizons and Growth Strategies in the Japanese ... Segment Forecasts, Competitive Intelligence, Emerging Opportunities" report ... --> This new 247-page report ... drug monitoring market, including emerging tests, technologies, instrumentation, ...
(Date:11/26/2015)... November 26, 2015 ... addition of the  "2016 Future Horizons ... Cell Surface Testing Market: Supplier Shares, ... their offering.  --> ... the  "2016 Future Horizons and Growth ...
(Date:11/26/2015)... November 26, 2015 ... universitetssjukhus ser potential att använda SyMRI för ... för patienter med multipel skleros (MS) ... med SyntheticMR AB för att kunna använda ... sjukhuset. Med SyMRI kan man generera flera ...
Breaking Medicine Technology: