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GSK begins shipping 2015-16 US flu vaccines

17 July 2015  •  Author: Victoria White

GSK has begun shipping Flaurix® Quadrivalent (influenza vaccine) doses to US healthcare providers, following licensing and lot-release approval from the US Food and Drug Administration’s (FDA) Centre for Biologics Evaluation and Research.

flu-vaccine

“To help our customers meet the flu immunization needs of their patients, GSK has shifted our flu vaccine supply to four-strain (quadrivalent) flu vaccine,” said Patrick Desbiens, Senior Vice President, US Vaccines. “This decision gives patients the opportunity for broader protection since it covers a fourth flu virus strain compared to trivalent vaccines that only cover three strains. With flu a priority focus of our portfolio, we have made a significant investment in customer service upgrades, designed to accelerate delivery timelines to customers.”

GSK also has received 2015-16 US license approval for its other quadrivalent flu vaccine Flulaval® Quadrivalent (Influenza Vaccine). Pending additional FDA lot releases, GSK expects to begin shipping Flulaval® Quadrivalent in August. This means that two different presentations of the four-strain vaccines will be available to customers. Fluarix® Quadrivalent comes in a 0.5-mL, single-dose, prefilled syringe while Flulaval® Quadrivalent comes in a 5-mL, multidose vial containing 10 doses (0.5mL each).

GSK to supply around 38 million doses across both vaccines for the US market

GSK expects to supply an estimated 32-38 million doses across both vaccines for the US market for the 2015-16 season. The company shipped approximately 27 million doses for the 2014-15 season -19 million quadrivalent and eight million trivalent. This year’s anticipated volume of quadrivalent doses is nearly double the amount shipped last year. GSK made the decision to switch to 100% quadrivalent following customer demand from the 2014-15 flu season and early pre-booking for the 2015-16 season.

Quadrivalent vaccines are designed to help protect against two different types of “A” flu strains and two types of “B” flu strains. Influenza A and Influenza B are the viruses that spread between people and can cause mild to severe illness, leading to seasonal flu. Most flu activity in the US occurs from October-May, and it usually peaks in the US between December-February.

For this year’s flu season, the World Health Organization (WHO) and FDA’s Vaccines and Related Blood Products Advisory Committee recommended that quadrivalent vaccines include an A/California/7/2009 (H1N1)pdm09-like virus, an A/Switzerland/9715293/2013 (H3N2)-like virus, a B/Phuket/3073/2013-like (B/Yamagata lineage) virus, and a B/Brisbane/60/2008-like (B/Victoria lineage) virus (2). This represents a change in the influenza A (H3) and influenza B (Yamagata lineage) components compared with the composition of the 2014-15 influenza vaccines.

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