FDA approves 5th flu vaccine

Oct 5, 2006 (CIDRAP News) – FluLaval has become the fifth influenza vaccine licensed by the US Food and Drug Administration (FDA) for use during the upcoming flu season, the FDA announced today.

FluLaval, produced by ID Biomedical Corp. of Quebec, a subsidiary of GlaxoSmithKline (GSK), has been marketed in Canada under the brand name Fluviral since 2001. It was granted fast-track review status by the FDA in July 2005.

It is the second seasonal flu vaccine approved using an accelerated approval process, after GSK's Fluarix last year, according to an FDA news release today.

FDA approval of FluLaval—for patients 18 years old or older—is projected to bring the total available number of doses to more than 110 million, according to the Centers for Disease Control and Prevention (CDC). The largest number of doses distributed in any year was 83.1 million, in 2003, according to the CDC. About 81.2 million doses were distributed last year.

The FDA cautions, however, that projections for total doses could change, because vaccine manufacturing is still under way.

"The challenges of vaccine supply in past flu seasons, the broadening CDC recommendations for annual vaccination, and the threat of a future avian flu pandemic all emphasize the value of adding more manufacturers and production capacity," said Jesse L. Goodman, MD, MPH, director of the FDA's Center for Biologics Evaluation and Research, in the FDA release. "We all benefit from more high quality flu vaccine manufacturers and increased supply.

"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," he added.

During the approval process the FDA collected data from two clinical studies involving about 1,000 adults in the United States and 658 patients who received the vaccine in Canada, according to a GSK news release today. The rate and nature of FluLaval's side effects were similar to those seen with other licensed seasonal flu vaccines, according to the FDA.

The agency said ID Biomedical showed that the vaccine induced levels of antibodies likely to prevent seasonal flu. In line with the approval process, the company will conduct further studies to verify that the vaccine reduces the risk of flu, the statement said.

FluLaval contains inactivated viruses (which cannot cause the disease) and is administered as a single injection in the upper arm. It is packaged in a multi-dose vial with thimerosal, a mercury derivative, as a preservative. GSK plans to develop a reduced-thimerosal or thimerosal-free formulation for studies in children, the FDA said.

FluLaval has not been studied in children and pregnant women, the FDA said.

Besides FluLaval and Fluarix, the other FDA-approved seasonal flu vaccines are Fluzone (Sanofi Pasteur), FluMist (MedImmune), and Fluvirin (Novartis).

See also:

Oct 5 FDA news release
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2006/ucm108753.htm

Sep 6 CIDRAP News story: "CDC expects 100 million doses of flu vaccine this season"

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