FDA Approves Fifth U.S. Flu Vaccine
FluLaval, already used in Canada, expected to help beef up U.S. anti-flu arsenal
THURSDAY, Oct. 5 (HealthDay News) -- The U.S. Food and Drug Administration has granted accelerated approval to another influenza vaccine for use during the 2006-2007 flu season. The vaccine, FluLaval, will be distributed by GlaxoSmithKline and is the fifth flu vaccine to be approved for use in the United States.
The vaccine is approved as a single, upper-arm injection in patients aged 18 or older. The vaccine, which consists of inactivated virus, contains the mercury derivative thimerosal.
The vaccine won accelerated approval after the manufacturer's early research showed it boosted likely flu-protective blood antibody levels, according to an FDA statement. The agency also reviewed information on the vaccine in Canada, which allowed its use in 2001.
"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," Jesse L. Goodman, M.D., director of the FDA's Center for Biologics Evaluation and Research, said in a statement.
Those allergic to eggs or chickens should not take FluLaval, the FDA cautions. The manufacturer plans to study a reduced-thimerosal vaccine in children.