cphi-onlineJuly 18, 2017
Tag: GSK , influenza vaccines
Company expects to supply up to 40 million doses across both vaccines for the US market in the 2017-18 season.
GSK has begun shipping quadrivalent vaccine doses to US healthcare providers, following licensing and lot-release approval from the FDA Center for Biologics Evaluation and Research.
The US Centers for Disease Control and Prevention (CDC) recommends flu vaccination as the single best measure for flu prevention. The CDC has a routine recommendation for people over the age of 6 months to get a flu vaccination each year as the first and most important step in protecting against this disease.
In November 2016, GSK received approval from the FDA expanding the indication for FLULAVAL QUADRIVALENT to include use in children aged 6 months and older. FLUARIX QUADRIVALENT is indicated for use in persons aged 3 years and older.
"Since 2013, GSK has lead the industry by offering the broad protection of a quadrivalent (four-strain) flu vaccine to the US market," said Patrick Desbiens, Senior Vice President, US Vaccines. "The expanded indication for FLULAVAL QUADRIVALENT in the US builds upon GSK's commitment to being a reliable partner to our customers and the patients they protect against the flu by enabling providers to use the same dose to vaccinate all recommended patients aged 6 months and older."
Three different options of the four-strain vaccines will be available to customers. FLULAVAL QUADRIVALENT comes in a 5 mL, multidose vial containing 10 doses (0.5 mL each) and a 0.5 mL, single-dose, prefilled syringe, while FLUARIX QUADRIVALENT comes in a 0.5 mL, single-dose, prefilled syringe.
GSK expects to supply up to 40 million doses across both vaccines for the US market in the 2017-18 season. GSK is committed to broad protection against influenza so one hundred percent of GSK supply is quadrivalent.
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