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:8/21/2017)... ... ... The Industrial Designers Society of America (IDSA) hosted the ... Aug. 19, 2017 in Atlanta, GA—revealing which 25 designs won Gold and which 52 ... See all the winners at http://www.idsa.org/awards/idea/gallery . , “I hope you’re as excited ...
(Date:8/20/2017)... ... August 20, 2017 , ... State Farm Neighborhood Assist® has named The ... a $25,000 grant. If the initiative wins, Gals Lead – Dream Queen Foundation’s signature ... Tri-County area of St. Mary’s, Calvert and Charles Counties. The program could potentially impact ...
(Date:8/19/2017)... ... 18, 2017 , ... Western University of Health Sciences will host a special ... new Center for Innovation on Wednesday, September 6, 2017. , The symposium will be ... by a technology exhibition from 1 to 3 p.m. showcasing virtual reality education technology, ...
(Date:8/19/2017)... New York, New York (PRWEB) , ... August ... ... Fruit Street Health has announced that it is the first organization with pending ... the CDC’s National Diabetes Prevention Program (“DPP”) via group telehealth classes and live ...
(Date:8/19/2017)... ... , ... Yesterday, the President of the United States retracted his condemnation of ... not two sides to hatred, bigotry, discrimination, and a white supremacy nationalist agenda. ... against all forms of such hatred and discrimination in this country and globally. ...
Breaking Medicine News(10 mins):
(Date:8/17/2017)... -- MJAC2017 , the premier cannabis event devoted to ... its leading lineup. MJAC2017 is proud ... specializing in the development of pharmaceutical and consumer products, will ... The Green Organic Dutchman are gold sponsors for the event, ... ...
(Date:8/15/2017)... , Aug. 15, 2017   Mostyn Law and Gulf ... Houston, Texas . The Mostyn Law family ... 2 years. That is why Mostyn Law is partnering ... to show its appreciation. Blood supplies are running ... 5% short of hospital needs in August. That is why the ...
(Date:8/15/2017)... AccuGenomics, Inc., a diagnostic company based in ... the company has provided an AccuKit to the HIV ... Chapel Hill and to Qura Therapeutics for evaluation in ... HIV reservoir and viral expression in human CD4+ T ... Center is a joint initiative between the University of ...
Breaking Medicine Technology: