GSK Ships Seasonal Influenza Vaccines for US Market

GlaxoSmithKline (GSK) has begun shipping quadrivalent vaccine doses to US healthcare providers, following licensing and lot-release approval from FDA’s Center for Biologics Evaluation and Research, GSK announced in a July 14, 2017 press release. In November 2016, GSK received approval from FDA expanding the indication for FLULAVAL QUADRIVALENT to include use in children aged six months and older. FLUARIX QUADRIVALENT is indicated for use in persons aged three 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, GSK, in the press release. “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 six 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; 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 100% of GSK supply is quadrivalent.

Source: GSK