FDA approves sixth flu vaccine for US market

Sep 28, 2007 (CIDRAP News) – The Food and Drug Administration (FDA) today announced the approval of an Australian-made influenza vaccine called Afluria for use in adults, raising the number of US-licensed flu vaccines to six.

The vaccine, made by CSL Limited, based in Parkville, Australia, was approved for protecting people aged 18 and older from type A and B influenza viruses.

Like most flu vaccines, Afluria contains inactivated (killed) flu viruses grown in chicken eggs. People who are allergic to eggs should not receive the vaccine, the FDA said in a news release.

The vaccine is given as a single injection in the upper arm. It will be available in single dose, preservative-free syringes and in multiple-dose vials containing thimerosal, a mercury compound, as a preservative, the FDA said.

CSL expects to supply up to 2 million doses of the vaccine in the United States this season, according to Paul Perreault, executive vice president of commercial operations for the company's US division, CSL Biotherapies, based in King of Prussia, Pa. Plans call for delivering all the doses to the United States by the end of October, the company said in a news release today.

The FDA said the Centers for Disease Control and Prevention (CDC) has estimated that the six vaccine makers will supply a record total of 132 million doses of flu vaccine in the United States this year. The CDC had cited the same figure at a news conference last week, without mentioning the CSL vaccine.

"The licensure of this additional flu vaccine contributes to having an adequate supply of seasonal influenza vaccine for Americans, one of FDA's highest priorities," said Jesse L. Goodman, MD, MPH, director of the FDA's Center for Biologics Evaluation and Research, in the agency news release.

CSL Biotherapies announced its filing for FDA approval of Afluria in April. The application included the results of a phase 3, randomized, placebo-controlled clinical trial that involved 1,357 volunteers at nine US sites, the company news release said. Sponsored by the National Institutes of Health, the study evaluated the safety and immunogenicity of thimerosal-free and thimerosal-containing formulations of the vaccine.

The FDA used its accelerated approval pathway in evaluating the vaccine. "The manufacturer demonstrated that the vaccine induced levels of antibodies in the blood likely to be effective in preventing seasonal influenza," the agency said. "As part of the accelerated approval process, the manufacturer will conduct further studies to verify that the vaccine decreases seasonal influenza disease after vaccination."

CSL-branded flu vaccines are approved and sold in 16 countries, and the company provides bulk antigen for flu vaccines sold in 24 countries, according to the CSL news release. Officials said the company has been making flu vaccines for 40 years.

Perreault told CIDRAP News that the bulk antigen for the vaccine is made in Australia, and this year the product will be finished and packaged in a facility in Germany. But in the future the finishing and packaging will be moved to a CSL plant in Kankakee, Ill., he said.

In August, CSL announced plans to expand the Kankakee plant by adding a line to fill single-dose syringes. The company plans to start operating the line and packaging flu vaccine at the plant in 2010, according to the August announcement.

Last year CSL announced it would spend $60 million to double the capacity of the company's Melbourne, Australia, plant to 40 million doses per year, making it one of the largest flu vaccine production facilities in the world.

Other injectable flu vaccines licensed in the United States, with their manufacturers, are FluLaval, ID Biomedical; Fluarix, GlaxoSmithKline; Fluzone, Sanofi Pasteur; and Fluvirin, Novartis. The other licensed product is FluMist, the nasal-spray vaccine made by MedImmune.

See also:

Sep 28 FDA news release
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01714.html

Sep 28 CSL Biotherapies news release

Oct 5, 2006, CIDRAP News story "FDA approves 5th flu vaccine"

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