FDA Approves Additional Vaccine for Upcoming Flu Season

The U.S. Food and Drug Administration (FDA) has now approved FluLaval, an influenza vaccine to immunize people 18 years of age and older against the disease caused by strains of influenza virus judged likely to cause seasonal flu in the Northern Hemisphere in 2006-2007. With the addition of FluLaval, there are now five FDA-licensed vaccines for the United States for the upcoming influenza season.

According to the Centers for Disease Control and Prevention (CDC), the manufacturers will make about 115 million doses of influenza vaccine for the 2006–2007 season, but these projections could change as manufacturing continues.

FluLaval was approved using FDA's accelerated approval pathway, which allows the agency to approve products for serious or life-threatening diseases based on early evidence of a product's effectiveness, reducing the time it takes for needed medical products to become available to the public. In this case, the manufacturer demonstrated that the vaccine induced levels of antibodies in the blood likely to be effective in preventing seasonal influenza. As part of the accelerated approval process, the manufacturer will conduct further studies to verify that the vaccine will decrease seasonal influenza disease after vaccination.

It is best to be immunized in October or November, but getting the vaccine in the winter months when flu season often peaks is also recommended. People who are allergic to eggs, chicken proteins, or any other components of the vaccine should not receive FluLaval. FluLaval has not been studied in children and pregnant women.

According to CDC, every year in the United States, on average: 5 to 20 percent of the population gets seasonal flu; more than 200,000 people are hospitalized from its complications; and about 36,000 people die.

FluLaval is the second seasonal influenza vaccine approved using the accelerated approval process; GlaxoSmithKline's Fluarix received approval in 2005.