Health Issues
New Flu Vaccine Afluria Approved by FDA
By Laura Vess

Oct 1, 2007

A new flu vaccine from has been given approval by the FDA just in time for the upcoming flu season. Afluria, an influenza virus vaccine, has been approved for immunization of adults in the U.S. The approval makes Australian manufacturer CSL Biotherapies the sixth company licensed to distribute flu vaccine in America. CSL is expecting to market 2 million doses of its vaccine this season.  

The Afluria market application was granted priority review status by the FDA in April, 2007, according to a press release from CSL. CSL-branded influenza vaccines are approved and marketed in 16 countries worldwide. The company also provides bulk antigen for influenza vaccine sold in 24 countries. Today marks the first entry for the company into the U.S. vaccine market.  

“CSL Biotherapies is proud to bring our 40-year heritage in influenza vaccines to the U.S. market, where boosting the supply of available flu vaccine and increasing vaccination rates is a priority public health goal,” said Paul Perreault, Executive Vice President of CSL Biotherapies Worldwide Commercial Operations, in a press release.  

Afluria will be available for adults over 18 and protects against influenza type A and type B flu viruses. Afluria will be made available in both single-dose, thimerosal-free, pre-filled syringes and in multi-dose vials in order to provide choice and convenience to caregivers who administer it.  

Last year, CSL, parent company to CSL Biotherapies, announced a $60 million (U.S.D.) investment in plant and equipment to double the manufacturing capacity of the company’s Melbourne facility to 40 million doses per season, making it one of the largest vaccine manufacturing plants in the world. Recently, CSL also announced its intention to expand its fill and finish activities with installation of a new facility in Illinois.  

"Routine immunization is the most effective way to prevent influenza and decrease influenza-related complications which can include serious illness and death," Jesse L. Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research, told Pharmaceutical News. "The licensure of this additional manufacturer contributes to having an adequate supply of seasonal influenza vaccine for Americans, one of FDA's highest priorities."  

The Centers for Disease Control and Prevention estimates that the six licensed flu vaccine manufacturers will supply a record 132 million doses of influenza vaccine to the U.S. for the 2007-2008 influenza season. An estimated 87 million doses were produced in 2005/06. Flu season in American generally lasts from October until May with more than 200,000 people hospitalized with influenza each year. According to the CDC, about 36,000 people die from complications of the flu.  

“Health authorities continue to emphasize the importance of flu vaccination as a front-line defense against a common and serious public health threat that still claims lives every year in the U.S.,” said Kathryn M. Edwards, MD, of Vanderbilt School of Medicine in Nashville, Tennessee, and principal investigator in the National Institutes of Health-funded clinical trial that assessed the CSL influenza vaccine in the U.S, in a press statement.  

Afluria should not be administered to individuals with hypersensitivity to eggs or chicken protein or other components of Afluria, and in anyone who has had a life-threatening reaction to previous influenza vaccination, according to a statement from the manufacturer. Those with HIV or other immunocompromised may have a diminished immune response to the vaccine.  

CSL Biotherapies intends to deliver all shipments to the U.S. before the end of October, 2007.