The FDA ( Food and Drug Administration ) approved Fluarix, an influenza vaccine for adults that contains inactivated virus.
Fluarix is approved to immunize adults 18 years of age and older against influenza virus types A and B contained in the vaccine.
The approval of Fluarix breaks new ground in that it is the first vaccine approved using FDAs accelerated approval process.
Accelerated approval allows products that treat serious or life-threatening illnesses to be approved based on successfully achieving an endpoint that is reasonably likely to predict ultimate clinical benefit, usually one that can be studied more rapidly than showing protection against disease.
In this case, the manufacturer demonstrated that after vaccination with Fluarix adults made levels of protective antibodies in the blood that FDA believes are likely to be effective in preventing influenza.
GlaxoSmithKline, the manufacturer of Fluarix, will do further clinical studies as part of the accelerated approval process to verify the clinical benefit of the vaccine.
FDA based the accelerated approval of Fluarix on thorough evaluation of safety and effectiveness data from four clinical studies involving approximately 1,200 adults.
Other data from post-marketing reports in other countries where Fluarix is already approved were also reviewed as part of FDAs safety assessment.
In the United States it is estimated that more than 200,000 people are hospitalized from flu complications, and about 36,000 people die from flu each year.
Although no vaccine is 100% effective against preventing disease, vaccination is the best protection against influenza and can prevent many illnesses and deaths.
Source: FDA, 2005