GSK Ships Flu Vaccine for US

GlaxoSmithKline (GSK) has begun shipping Fluarix Quadrivalent (influenza vaccine) doses to US healthcare providers following licensing and lot-release approval from the US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research.

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. Flulaval Quadrivalent comes in a 0.5-mL, single-dose, prefilled syringe, and Flulaval Quadrivalent comes in a 5-mL, multidose vial containing 10 doses (0.5 mL each).

GSK expects to supply an estimated 32 million to 38 million doses for 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 United States between December-February. According to the US Centers for Disease Control and Prevention (CDC), each year approximately 5-20% of people in the US get the flu and more than 200,000 people are hospitalized for flu-related complications.

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.

The CDC has a routine recommendation for Americans over the age of six months to get a flu vaccination each year. GSK's flu vaccines are indicated for use in persons three years and older. The CDC does not make preferential recommendations about which flu vaccine an individual should receive.

Fluarix Quadrivalent is manufactured in GSK’s facility in Dresden, Germany. Flulaval Quadrivalent is manufactured in GSK’s facility in Ste-Foy, Quebec, Canada.

Source: GlaxoSmithKline

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