FDA approves FluLaval

The U.S. Food and Drug Administration (FDA) today 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 have projected making a total of about 115 million doses of influenza vaccine for the 2006–2007 season, but these projections could change as manufacturing continues.

"FDA's Center for Biologics Evaluation and Research (CBER) has taken proactive steps, through additional scientific work and guidance development, to enable manufacturers to improve the science of developing vaccines," said Andrew C. von Eschenbach, M.D., Acting Commissioner, Food and Drugs. "That work is paying off in heightened interest among product developers in entering this vital market."

Influenza, a contagious respiratory disease, is commonly called "the flu."

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 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.

"The challenges of vaccine supply in past flu seasons, the broadening CDC recommendations for annual vaccination, and the threat of a future avian influenza pandemic, all emphasize the value of adding more manufacturers and production capacity. We all benefit from more high quality flu vaccine manufacturers and increased supply," said Jesse L. Goodman, M.D., M.P.H., director, CBER, FDA. "The successful use of accelerated approval illustrates both the value of tools that FDA has put into place to meet critical public health needs, and the benefits of intensive scientific interactions between FDA and manufacturers and advice from FDA during product development and evaluation."

Safety information was collected from two clinical studies involving about 1,000 adults who received FluLaval. Other data from use of the vaccine in Canada, where FluLaval has been available since 2001, were also evaluated as part of FDA's safety assessment. After vaccination, the rate and nature of side effects were similar to those seen with other licensed seasonal influenza vaccines. The most commonly reported side effects included pain, redness and swelling at the injection site and headache, fatigue, and cough.

The vaccine contains inactivated or "killed" virus and cannot cause flu. It is administered as a single injection in the upper arm. The vaccine is packaged in a multi-dose vial with thimerosal, a mercury derivative, as a preservative. The company has plans to develop a thimerosal-reduced or thimerosal-free formulation for studies in the pediatric population.

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.

Seasonal influenza is a serious threat to public health. It can cause mild to severe illness, and at times can lead to death. Although no vaccine is 100 percent effective against preventing disease, vaccination is the best protection against seasonal influenza and can prevent many illnesses and deaths. 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.

FluLaval is manufactured by ID Biomedical Corporation of Quebec, Canada, a subsidiary of GlaxoSmithKline Biologics and will be distributed by GlaxoSmithKline, Research Triangle Park, N.C.

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