The U.S. Food and Drug
Administration today approved Afluria, an additional seasonal
influenza vaccine for the immunization of people ages 18 and older.
Afluria is intended to protect adults from influenza type A and
type B flu viruses. Influenza is a contagious respiratory illness
that can cause annual epidemics.
The approval of Afluria, manufactured by CSL Limited of
Parkville, Australia, brings the number of seasonal influenza
manufacturers licensed for the U.S. market to six.
Based on current manufacturing trends, the Centers for Disease
Control and Prevention estimates that the six manufacturers will
supply a record 132 million doses of influenza vaccine for the
2007-2008 influenza season.
"Routine immunization is the most effective way to prevent
influenza and decrease influenza-related complications which can
include serious illness and death," said Jesse L. Goodman, M.D.,
M.P.H., director of FDA's Center for Biologics Evaluation and
Research. "The licensure of this additional manufacturer contributes
to having an adequate supply of seasonal influenza vaccine for
Americans, one of FDA's highest priorities."
Flu season in the United States can begin as early as October and
can last as late as May, according to the CDC. Every year in the
United States, more than 200,000 people are hospitalized with
influenza and about 36,000 people die from its complications. While
it is best to be immunized as soon as the vaccine is available,
usually in September, getting a flu shot any time during influenza
season is also appropriate because the influenza season often peaks
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Afluria was approved using FDA's accelerated approval pathway for
serious or life-threatening diseases, which reduces the time for
needed medical products to become available to the public. In this
case, the manufacturer demonstrated that the vaccine induced levels
of antibodies in the blood likely to be effective in preventing
seasonal influenza. As part of the accelerated approval process, the
manufacturer will conduct further studies to verify that the vaccine
decreases seasonal influenza disease after vaccination.
The most commonly reported adverse events were tenderness, pain,
redness and swelling at the injection site, and headache, fatigue
and muscle aches.
Afluria contains inactivated influenza viruses grown in chicken
eggs. People who are allergic to eggs or any other component of the
vaccine should not receive Afluria.
The vaccine is administered as a single injection in the upper
arm, and is available in both a single-dose, preservative-free,
pre-filled syringe and a multi-dose vial with thimerosal, a mercury
derivative, as a preservative.
from U.S. Food and Drug Administration