People who are most at risk for flu are seniors, children, and people with suppressed immune systems.
The FDA reports that although no vaccine is 100% effective against preventing disease, vaccination is the best protection against influenza (flu) and can prevent many illnesses and deaths.
New Flu Vaccine for Adults
The FDA has approved Fluarix, a flu 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.
Fluarix is the first flu vaccine approved using FDA"s 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 flu. 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 against flu.
FDA Takings Steps to Avoid Flu Vaccine Shortages This Season
"Previous shortages highlighted the need for additional influenza vaccine manufacturers for the U.S. market," said FDA Commissioner Lester Crawford. "Accelerated approval has allowed us to evaluate and approve Fluarix in record time so that we can make available additional safe and effective flu vaccines.”
"FDA"s approval of Fluarix is a big step toward providing an adequate supply of flu vaccine for the American public," said Mike Leavitt, Secretary of Health and Human Services (HHS), in a press release from the FDA.
"Having more manufacturers of influenza vaccine licensed in the U.S., and having more (flu) vaccine dosages, is critical to public health."
