HOME >> MEDICINE >> NEWS
Effective government/industry collaboration bolsters flu vaccine supply

When faced with an urgent public health need, the federal government, vaccine manufacturers and university-based researchers can work together quickly and effectively to come up with solutions, as demonstrated in the successful clinical trial of the influenza vaccine Fluarix. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), working closely with the Food and Drug Administration (FDA), sponsored the clinical trial that demonstrated the vaccine's safety and ability to generate an immune response and ultimately led to its expedited approval by FDA in August 2005. Fluarix is the first vaccine to receive FDA approval under the agency's accelerated approval regulations.

Details of the Fluarix clinical study are discussed in the November/December 2005 issue of Human Vaccines, available online December 22.

Clinical testing of the seasonal influenza vaccine Fluarix began in December 2004 as an effort to augment the future U.S. flu vaccine supply, which was experiencing an unexpected, significant shortage. Fluarix, which is manufactured by GlaxoSmithKline Biologicals of Rixensart, Belgium, had been approved in 1998 for use in other countries but had never been tested or licensed for use in the United States.

The vaccine was evaluated in a clinical trial involving nearly 1,000 healthy adults at four sites nationwide. Clinical evaluation of the candidate vaccine was performed under an FDA-reviewed "investigational new drug" application, in which potential study volunteers are fully informed about potential risks and benefits and must provide their informed consent before receiving the investigational product. The clinical trial was rapidly initiated and reached capacity enrollment within five days of its launch in December 2004.

"The Fluarix study is an excellent example of what government and industry can accomplish in a short timeframe when faced with a serious public health nee
'"/>

Contact: Kathy Stover
kstover@niaid.nih.gov
301-402-1663
NIH/National Institute of Allergy and Infectious Diseases
22-Dec-2005


Page: 1 2 3

Related medicine news :

1. Effectiveness of first renin inhibitor drug for treating hypertension is limited
2. Effectiveness of over-the-counter decongestant questioned in new study
3. Effective medical response reduced deaths of critically injured after London bombings
4. Effective HIV control may depend on viral protein targeted by immune cells
5. Effective treatments for panic disorder not reaching patients
6. Effective alcohol dependence treatments defined
7. Effective treatment of a mothers depression reduces risk of psychiatric disorders in her children
8. Effective hospital patient handoffs require better training for physicians
9. Acrux and Oreganon further expand their collaboration
10. Asia-European collaboration addresses water management in Indonesia
11. Penn leads $98 million translational medicine collaboration

Post Your Comments:
(Date:9/4/2015)... ... September 04, 2015 , ... ... taking place in Hollywood, Florida October 9-10, 2015 at the Diplomat Resort & ... 2015 symposium are doctors and researchers at the top of their field and ...
(Date:9/4/2015)... ... September 04, 2015 , ... ... in comparison to settlements under the Stark physician self-referral law. “Stark Law ... 17 webinar from Atlantic Information Services, Inc. (AIS), will detail which deals are ...
(Date:9/3/2015)... ... ... AlignLife of Wauwatosa is excited to hold its annual Coat ... adults who don't have the ability to buy a jacket warm enough for the ... Drive to help those in need." , This is AlignLife's third annual Coat Drive. ...
(Date:9/3/2015)... ... September 03, 2015 , ... William Mattar Law Offices is known ... this does not stop at any certain demographic or segment of the population. ... thirty-, fifteen- and ten-second TV commercials. , The closed captioning will allow people with ...
(Date:9/3/2015)... ... September 03, 2015 , ... Topical BioMedics, Inc., ... destination of his six-month, 10,000 mile journey from Santiago, Chile to Times Square ... calls the “Connecting Las Americas” project—Max crossed six countries in 168 days on ...
Breaking Medicine News(10 mins):Health News:Integrative Healthcare Symposium Focus On: The Microbiome Conference Program Announced 2Health News:Sept. 17 Webinar to Offer Best Practices for Physician Contracts 2Health News:AlignLife is Helping to Keep the Community Warm This Winter 2Health News:Law Firm Focused on “Helping People” Continues to Expand on Vision 2Health News:Topical BioMedics Announces Visit from Max Wohlgemuth Kitslaar, Ending his Six-Month, 10,000 Mile Journey from Chile to New York on a 1976 Moto Guzzi Motorcycle 2Health News:Topical BioMedics Announces Visit from Max Wohlgemuth Kitslaar, Ending his Six-Month, 10,000 Mile Journey from Chile to New York on a 1976 Moto Guzzi Motorcycle 3Health News:Topical BioMedics Announces Visit from Max Wohlgemuth Kitslaar, Ending his Six-Month, 10,000 Mile Journey from Chile to New York on a 1976 Moto Guzzi Motorcycle 4Health News:Topical BioMedics Announces Visit from Max Wohlgemuth Kitslaar, Ending his Six-Month, 10,000 Mile Journey from Chile to New York on a 1976 Moto Guzzi Motorcycle 5Health News:Topical BioMedics Announces Visit from Max Wohlgemuth Kitslaar, Ending his Six-Month, 10,000 Mile Journey from Chile to New York on a 1976 Moto Guzzi Motorcycle 6
(Date:9/4/2015)... 04, 2015 Research ... addition of the "Veterinary Pharmaceutical Submissions in ... conference to their offering. This ... of the constituent parts of the application for ... which a marketing authorisation is sought in the ...
(Date:9/4/2015)... VANCOUVER, British Columbia and MENLO ... DelMar Pharmaceuticals, Inc. (OTCQX: DMPI) ("DelMar" and the ... commercialization of new cancer therapies, today announced its financial ... and provided an overview of recent Company highlights and ... will host a business update conference call and live ...
(Date:9/3/2015)... 3, 2015 Report Details What ... areas are going to grow at the fastest rates? ... 2025, assessing data, trends, opportunities and prospects there. ... graphs. Discover the most lucrative areas in the industry ... you assess forecasted sales at overall world market and ...
Breaking Medicine Technology:Veterinary Pharmaceutical Submissions in the EU: Two day Course - London, UK - December 7-8, 2015 2DelMar Pharmaceuticals Reports Fiscal 2015 Year-End Financial Results and Provides Corporate Update 2DelMar Pharmaceuticals Reports Fiscal 2015 Year-End Financial Results and Provides Corporate Update 3DelMar Pharmaceuticals Reports Fiscal 2015 Year-End Financial Results and Provides Corporate Update 4DelMar Pharmaceuticals Reports Fiscal 2015 Year-End Financial Results and Provides Corporate Update 5DelMar Pharmaceuticals Reports Fiscal 2015 Year-End Financial Results and Provides Corporate Update 6DelMar Pharmaceuticals Reports Fiscal 2015 Year-End Financial Results and Provides Corporate Update 7DelMar Pharmaceuticals Reports Fiscal 2015 Year-End Financial Results and Provides Corporate Update 8Ophthalmic Devices Market Forecast 2015-2025: Future Prospects for Leading Companies in Vision Care, Surgical, Diagnostic & Monitoring Devices 2Ophthalmic Devices Market Forecast 2015-2025: Future Prospects for Leading Companies in Vision Care, Surgical, Diagnostic & Monitoring Devices 3Ophthalmic Devices Market Forecast 2015-2025: Future Prospects for Leading Companies in Vision Care, Surgical, Diagnostic & Monitoring Devices 4
Cached News: