GlaxoSmithKline’s Fluarix Quadrivalent receives FDA approval
The first intramuscular vaccine to cover against four influenza strains has just received US Food and Drug Administration (FDA) approval, according to a GlaxoSmithKline (GSK) press release Dec. 17.
The vaccine, Fluarix Quadrivalent was approved for the immunization of children (three years and older) and adults to help prevent disease caused by four seasonal influenza (flu) viruses.
The current approved flu vaccine protect against three strains of influenza, two A strains and a B strain that are predicted to be predominant in a given year.
However, according to the release, since the year 2000, two B virus strains (Victoria and Yamagata) have co-circulated to varying degrees each season. Various degrees of mismatch have occurred between the B strain included in trivalent vaccines and the B strain that actually circulated, causing an increased risk of influenza-related morbidity across all age groups – children, adults and the elderly.
With the approval of Fluarix Quadrivalent, a second B strain can be covered.
The current 2012-2013 influenza (flu) vaccine includes protection against the following three strains:
- A/California/7/2009 (H1N1)-like virus
- A/Victoria/361/2011 (H3N2)-like virus
- B/Wisconsin/1/2010-like virus.
Trivalent influenza vaccines have helped protect millions of people against flu, but in six of the last 11 flu seasons, the predominant circulating influenza B strain was not the strain that public health authorities selected,” said Dr. Leonard Friedland, V.P. and Head, GSK North America Vaccines Clinical Development and Medical Affairs. “Fluarix Quadrivalent will help protect individuals against both B strains and from a public-health standpoint, can help decrease the burden of disease.”
GSK will make Fluarix Quadrivalent available in time for the 2013-14 flu season and and also plans to fulfill orders for its trivalent vaccines.
The U.S. Centers for Disease Control and Prevention (CDC) recommends that children six months of age and older and adults receive a flu shot annually.
Each year experts from the FDA, the World Health Organization, the Centers for Disease Control and Prevention (CDC), and other public health experts study influenza virus samples and global disease patterns to identify virus strains likely to cause the most illness during the upcoming flu season.
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[…] Last December, Fluarix Quadrivalent was approved for the immunization of children (three years and older) and adults to help prevent disease caused by four seasonal influenza (flu) viruses. […]