GSK (GlaxoSmithKline PLC) recently commenced follow-up to approval gained from the U.S. Food and Drug Administration for shipping vaccines combating influenza to nationwide health care providers in advance of the 2017-18 flu season.
The U.S. Centers for Disease Control and Prevention routinely recommends flu vaccination for individuals over 6 months old as the top preventive measure against influenza.
GSK’s products, Flulaval Quadrivalent and Fluarix Quadrivalent — targeted to children ages 6 months and up and 3 years and up, respectively — earned the nod from FDA for expanding indicated use in November 2016. Three configurations of the four-strain vaccines will be marketed in different formulations.
“GSK is committed to broad protection against influenza so [the entire] supply is quadrivalent,” the company said.
As many as 40 million doses are predicted for shipping in anticipation of the next flu season. Four-strain or quadrivalent vaccines guard against influenza A and B, which are spread easily from one person to another and which the CDC considers more dangerous for children than a common cold, based on hospitalization and mortality statistics.
Authorization came specifically from the Center for Biologics Evaluation and Research, the arm of the FDA responsible for regulating biological products, based in Silver Spring, Maryland and one of the agency’s six main branches.
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