HHS Orders H1N1 Vaccines and Vaccine Antigen - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

HHS Orders H1N1 Vaccines and Vaccine Antigen


ePT--the Electronic Newsletter of Pharmaceutical Technology

The United States Department of Health and Human Services (HHS) this week placed an initial order with Sanofi Pasteur (Lyon, France) for a vaccine to fight influenza A (H1N1) infection. Valued at $190 million, the order is pursuant to an existing contract between the agency and the company and provides for the production of the bulk vaccine. However, Sanofi Pasteur still awaits the seed virus from the US Centers for Disease Control. Once the seed virus is obtained, the company says it will have a better timeline of when the vaccine might be available. Typically, it takes approximately six months to develop and manufacture an influenza vaccine. Also to be determined are the dosage requirements and the final formulation, filling, and distribution of the vaccine. Sanofi Pasteur says it “is prepared to commence commercial-scale production in June following certification of the working seed by the US Food and Drug Administration.”

The vaccine order follows an initial order by HHS of GSK’s influenza A (H1N1) antigen as the company’s proprietary AS03 adjuvant system, which the company already used in Phase II trials of an adjuvanted influenza A H5N1 (avian flu) vaccine. According to a May 15 release, GSK is also waiting on a seed virus from the World Health Organization. The company says it has also received orders from the governments of France, Finland, Belgium, and the United Kingdom for an influenza A (H1N1) adjuvanted vaccine.

See PharmTech's previous coverage:

WHO, GSK Provide Update on Pandemic Flu Production

Swine Flu Update

Q&A: How to Make a Swine Flu Vaccine

Continued Steps toward H1N1 Vaccine

Vaccines Progress Along the Critical Path

 

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
26%
Attracting a skilled workforce
29%
Obtaining/maintaining adequate financing
14%
Regulatory compliance
31%
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Obama Administration Halts Attack on Medicare Drug Plans
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here