FDA Approves New Flu Shot
FDA Approves New Flu Shot
Fluarix Gets Fast-Track Approval to Help Avoid Flu Shot Shortages
Aug. 31, 2005 -- The FDA has approved a new flu vaccine called Fluarix for adults age 18 and older.
The move comes before flu season starts in the U.S. Fluarix is the first vaccine approved under the FDA's accelerated approval process.
The shot got fast-track status to help ensure adequate supplies of flu shots this year. Fluarix is made by a subsidiary of GlaxoSmithKline in Germany.
GlaxoSmithKline, a WebMD sponsor, was not involved in U.S. flu shot production during last year's flu shot shortages.
"Previous shortages highlighted the need for additional influenzavaccine manufacturers for the U.S. market," says FDA Commissioner Lester Crawford in a news release. "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."
Fluarix was shown to be safe and effective in four studies involving about 1,200 adults, and GlaxoSmithKline will do more studies to verify the vaccine's benefits, states the FDA news release.
Fluarix has been used in other countries since 1992, with more than 150 million doses distributed worldwide since then, notes a GlaxoSmithKline news release.
Don't mistake influenza, or flu, for a plain old cold. The flu can be much more serious and even fatal.
Most people recover from the flu after a week or two. However, the CDC estimates that every year, more than 200,000 people in the U.S. are hospitalized from flu complications and about 36,000 people die from the flu.
Complications are more likely for babies, children, the elderly, and people who are chronically ill.
The flu doesn't stay the same from year to year. So vaccine makers have to tweak their formula, making their best guess about which viruses will dominate the upcoming flu season.
Fluarix targets influenza virus types A and B, says the FDA.
Flu season can start as early as October and end as late as May, according to the CDC.
The best time to get vaccinated is October or November, but getting vaccinated in December or even later can still be beneficial, states the CDC's web site.
FDA Approves New Flu Shot
Fluarix Gets Fast-Track Approval to Help Avoid Flu Shot Shortages
Aug. 31, 2005 -- The FDA has approved a new flu vaccine called Fluarix for adults age 18 and older.
The move comes before flu season starts in the U.S. Fluarix is the first vaccine approved under the FDA's accelerated approval process.
The shot got fast-track status to help ensure adequate supplies of flu shots this year. Fluarix is made by a subsidiary of GlaxoSmithKline in Germany.
GlaxoSmithKline, a WebMD sponsor, was not involved in U.S. flu shot production during last year's flu shot shortages.
Speedy Approval
"Previous shortages highlighted the need for additional influenzavaccine manufacturers for the U.S. market," says FDA Commissioner Lester Crawford in a news release. "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."
Fluarix was shown to be safe and effective in four studies involving about 1,200 adults, and GlaxoSmithKline will do more studies to verify the vaccine's benefits, states the FDA news release.
Fluarix has been used in other countries since 1992, with more than 150 million doses distributed worldwide since then, notes a GlaxoSmithKline news release.
Flu Can Be Dangerous
Don't mistake influenza, or flu, for a plain old cold. The flu can be much more serious and even fatal.
Most people recover from the flu after a week or two. However, the CDC estimates that every year, more than 200,000 people in the U.S. are hospitalized from flu complications and about 36,000 people die from the flu.
Complications are more likely for babies, children, the elderly, and people who are chronically ill.
The flu doesn't stay the same from year to year. So vaccine makers have to tweak their formula, making their best guess about which viruses will dominate the upcoming flu season.
Fluarix targets influenza virus types A and B, says the FDA.
Flu Season Is Coming
Flu season can start as early as October and end as late as May, according to the CDC.
The best time to get vaccinated is October or November, but getting vaccinated in December or even later can still be beneficial, states the CDC's web site.