Quadrivalent Flu Vaccine Gains Regulatory Approval
Vaccine offers active immunization against two A strains and two B strains (August 16)
The FDA has approved FluLaval Quadrivalent (GlaxoSmithKline) influenza virus vaccine for the active immunization of persons 3 years of age and older to help prevent disease caused by seasonal influenza virus subtypes A and B contained in the vaccine. This is the second GSK intramuscular quadrivalent flu vaccine to gain regulatory approval. The company’s Fluarix Quadrivalent was the first intramuscular flu vaccine approved by the FDA (in December 2012).
Scientists classify the influenza strains that cause seasonal flu as A or B strains. Flu vaccines have been used in the U.S. for more than 50 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. However, two distinct B virus strains (Victoria and Yamagata) co-circulate to varying degrees each flu season. According to GSK, FluLaval Quadrivalent helps protect against the two A strains and B strains, decreasing influenza-related morbidity across all age groups — children, adults, and the elderly.
Seasonal influenza may cause 3 to 5 million cases of severe illness and up to 500,000 deaths per year worldwide. Vaccination against the flu is considered one of the most effective ways of preventing mortality, complications, and hospitalizations. The Centers for Disease Control and Prevention (CDC) recommends that children (6 months of age and older) and adults receive an influenza vaccine annually.
GSK anticipates making a limited amount of FluLaval Quadrivalent vaccine available this flu season. The vaccine will be available in multi-dose vials.
Source: GSK; August 16, 2013.