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:3/28/2017)... ... March 28, 2017 , ... With expansion and efficiency in mind, Patten Seed ... The seed processing plant opened in Marshallville in 2006, and a bagging and shipping ... opportunity for transition of Patten Seed operations to the Middle Georgia location from their ...
(Date:3/28/2017)... ... ... Thank you to all who attended Capio Partners Winter 2017 Healthcare Leadership Symposium ... providers and offered an opportunity to collaborate and network with healthcare colleagues across the ... attendees gathered for a lively discussion on trends and issues that healthcare leaders will ...
(Date:3/28/2017)... California (PRWEB) , ... March 28, 2017 , ... Bacteria and fungi are probably not ... microorganisms are bad. In fact, including the right microorganisms in your diet can actually improve ... favorite foods. , This is the topic of a new peer-reviewed paper ...
(Date:3/27/2017)... ... March 27, 2017 , ... ... custom smile makeovers without requiring a referral. Trimble Dental offers a ... treatment, cosmetic dentistry and dental implants. Whether patients have discolored, crooked or missing ...
(Date:3/27/2017)... Philadelphia PA and London UK (PRWEB) , ... ... ... have the speed, agility and ability to gain site attention and engagement over ... DrugDev educational webinar will discuss how partnering with the ...
Breaking Medicine News(10 mins):
(Date:3/27/2017)... , March 27, 2017  A new ... (AADE) found that Medicare,s Competitive Bidding Program (CBP) significantly ... testing supplies. The lack of choice forces beneficiaries to ... have dire health consequences. AADE,s survey ... by AADE and others pointing out the inherent problems ...
(Date:3/27/2017)... , March 27, 2017 BioLineRx ... and immunology, announced today that AGI-134, an immunotherapy for the ... of Agalimmune Ltd., will be featured at the upcoming ... Washington, DC to be held on ... ...
(Date:3/27/2017)... , March 27, 2017  BERG, a ... data-driven, biological research approach, today announced that ... the discovery of new data using a ... brown fat metabolism. Joslin Diabetes Center led ... Biology┬« platform for analysis of samples.  The ...
Breaking Medicine Technology: