Apr 5, 2007 (CIDRAP News) – CSL Biotherapies, the US branch of an Australian vaccine producer, announced this week it has applied for Food and Drug Administration (FDA) approval to market a seasonal influenza vaccine in the United States.
The company, with US headquarters in King of Prussia, Pa., has requested an expedited review from the FDA, with the intention of having the vaccine ready for distribution for the 2007-08 flu season, company spokeswoman Sheila Burke told CIDRAP News by e-mail. The number of doses to be made available is yet to be determined and will depend on the FDA approval and antigen yields from various virus strains.
"By extending our influenza vaccine franchise into more geographies, including the U.S., our goal is to help address a large and growing critical public health need," said Paul Perreault, executive vice president of CSL Biotherapies worldwide commercial operations, in a press release.
The flu vaccine, which is intended for people 18 years and older, is a purified, inactivated, trivalent vaccine made in embryonated eggs. It will be available in both single-dose, thimerosal-free, prefilled syringes and in multi-dose vials.
A clinical trial sponsored by the National Institutes of Health (NIH) and involving 1,359 adults at nine sites began last June to test the vaccine's safety and immunogenicity. Results of the phase 3 study have not yet been published, Burke said.
There have been 26 clinical trials of the vaccine in various countries, according to a June 2006 CSL press release. The company already supplies the vaccine in 16 other countries, including the United Kingdom.
The vaccine will be manufactured in Melbourne, Australia, at the facilities of CSL Limited, the parent company. It will then be finished in Marburg, Germany and distributed out of Kankakee, Ill., Burke reported.
CSL Limited plans to invest $60 million to double the capacity of the Melbourne facility to about 40 million doses per season, according to a company statement released in February. After the expansion project, the company plans to supply up to 20 million doses per season to the US market, the statement said.
With FDA approval, CSL Biotherapies would become the fifth provider of seasonal flu vaccines in the United States, joining Sanofi Pasteur, GlaxoSmithKline, Novartis, and MedImmune. The four companies distributed more than 100 million doses of vaccine for the 2006-07 season, according to the Centers for Disease Control and Prevention.
April 3 CSL news release
CSL Biotherapies Submits BLA to Introduce Flu Vaccine to U.S. Market
Feb 7 CSL news release
CSL to Seek Approval for US Flu Vaccine
June 5, 2006, CSL news release
Flu Vaccine Trial Begins