GSK announces that it has begun shipping FLUARIX® QUADRIVALENT (Influenza Vaccine) doses to U.S. healthcare providers, following licensing and lot-release approval from the Food and Drug Administration (FDA)'s Center for Biologics Evaluation and Research.
“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,” says Patrick Desbiens, senior vice president of U.S. 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 expects to supply an estimated 32 million to 38 million doses across both vaccines for the U.S. 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 percent 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 U.S. between December and February. According to the Centers for Disease Control and Prevention (CDC), each year approximately 5 percent to 20 percent 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 6 months to get a flu vaccination each year as the first and most important step in protecting against this disease. GSK’s flu vaccines are indicated for use in persons 3 years and older.