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:4/18/2014)... (April 21, 2014) -- A group of scientists ... and the Sanders-Brown Center on Aging has found ... and neuropsychological function in Parkinson,s disease (PD). ... , the study, which assessed cognitive function in ... the dopamine replacement therapy commonly used to treat ...
(Date:4/18/2014)... memories? How did it make you feel? According to ... experience, such as how sad you were or how ... when you can,t stop thinking about it. , ... context of the memories, rather than how you felt, ... the negative effects of these memories, a new study ...
(Date:4/18/2014)... scientists could lead to potential new treatments for breaking ... , Fibrosis, or scarring, is a hallmark of ... lungs can lead to serious organ damage and, in ... options centers on findings made by Swati Bhattacharyya, PhD, ... that a specific protein plays in promoting fibrosis. ...
(Date:4/17/2014)... One of the most popular vaccine brands for children ... may be overlooking some cost factors when choosing vaccines, ... expensive option, according to a new study by University ... administer can be driven by numerous factors," says Sheldon ... professor of computer science and of mathematics at the ...
(Date:4/17/2014)... In a review published in the April issue of ... The Feinstein Institute for Medical Research, says it,s time ... approach to treating sepsis, which kills millions ... Sepsis occurs when molecules released into the bloodstream to ... body. Inflammation is necessary for maintaining good health ...
Breaking Medicine News(10 mins):Health News:Treating depression in PD patients: New research 2Health News:New study suggests a better way to deal with bad memories 2Health News:New study suggests a better way to deal with bad memories 3Health News:New clues on tissue scarring in scleroderma 2Health News:Study recalculates costs of combination vaccines 2Health News:Feinstein Institute researcher publishes new perspective on sepsis 2
(Date:1/15/2014)...  Celsion Corporation (the "Company") (NASDAQ: CLSN ) ... investors to purchase an aggregate of approximately $15 million ... direct offering, led by a dedicated health care fund. ... with these investors pursuant to which the Company agreed ...
(Date:1/15/2014)... 2014  Humberto C. Antunes,  Galderma  worldwide CEO, will receive ... Journal of Drugs in Dermatology (JDD) at the ... event is January 17-20, 2014, at the Omni Orlando Resort at ... The ODAC is a distinguished event that delivers ...
(Date:1/15/2014)... PALM BEACH GARDENS, Fla. , Jan. 15, 2014  In an ... C. difficile and TB in ambulances and other transport vehicles, an ... being used by rescue personnel for the first time. ... coming in contact with these deadly pathogens, West Palm ...
Breaking Medicine Technology:Celsion Corporation Announces $15 Million At-The-Market Registered Direct Offering 2Celsion Corporation Announces $15 Million At-The-Market Registered Direct Offering 3Galderma's global leader honored with a "Lifetime in Dermatology Achievement Award" by Journal of Drugs in Dermatology 2Galderma's global leader honored with a "Lifetime in Dermatology Achievement Award" by Journal of Drugs in Dermatology 3Galderma's global leader honored with a "Lifetime in Dermatology Achievement Award" by Journal of Drugs in Dermatology 4Superbugs No Longer Ride In Rescue Vehicles 2
Cached News: