FDA approves FluLaval Quadrivalent influenza vaccine for persons three years and older
Pharmaceutical, biologics and vaccine company, GlaxoSmithKline (GSK), announced Friday that the Food and Drug Administration (FDA) has approved FluLaval Quadrivalent influenza vaccine for the active immunization of persons three years of age and older to help prevent disease caused by seasonal influenza (flu) virus subtypes A and B contained in the vaccine.
Image/GSK
This is the second GSK intramuscular quadrivalent influenza vaccine approved by the FDA.
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.
“Since the late 1980s, public-health authorities have known that four primary influenza strains circulate each year causing the majority of influenza illness, but the influenza vaccines used for the past thirty years only covered against three strains”, said Dr. Leonard Friedland, V.P., Director, Scientific Affairs and Public Health, GSK Vaccines North America.
“With this limitation, global influenza experts have had to make a difficult determination around the strains each season to cover, and in six of the past 11 influenza seasons (2001-2012), one of the predominant strains was not included in the season’s influenza vaccines. Trivalent vaccines do reduce influenza risk even in years when a vaccine strain-mismatch occurs, though quadrivalent influenza vaccines are the important next step in broadening strain coverage,”Friedland adds.
Scientists classify the influenza strains that cause seasonal influenza as A or B strains. Influenza vaccines have been used in the U.S. for more than fifty years, most recently in the trivalent (three-strain) form to help protect against the two A virus strains most common in humans and the B strain expected to be predominant in a given year.
Earlier this year, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) met to select the influenza viruses for the composition of the influenza vaccine for the 2013-2014 U.S. influenza season.
The committee recommended that the trivalent formulation influenza vaccines for the U.S. 2013-2014 influenza season contain the following:
- an A/California/7/2009 (H1N1)-like virus;
- an (H3N2) virus antigenically like the cell-propagated prototype virus A/Victoria/361/2011;
- a B/Massachusetts/2/2012-like virus.
The committee also recommended that quadrivalent influenza vaccines contain the above three strains and the following additional B strain:
- a B/Brisbane/60/2008-like virus
Seasonal influenza may cause three to five million cases of severe illness and up to 500,000 deaths per year worldwide. Vaccination against influenza is considered one of the most effective ways of preventing mortality, complications and hospitalizations.
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