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GSK announced today it has begun shipping quadrivalent 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. It is the first company to ship quadrivalent vaccine for the 2016-17 flu season.
The 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 Americans over the age of six 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.
“Our goal is to be a reliable partner in the annual flu immunization campaign by developing and manufacturing high quality quadrivalent influenza vaccines for the U.S. population,” said Patrick Desbiens, senior vice president of U.S .Vaccines. “This year we introduced new functionality to our eCommerce platform to allow those who stock and administer our vaccines to further accelerate delivery of their flu vaccines when they order directly from us. We believe this enhancement supports healthcare providers by helping to ensure that their patients have access to the vaccines they need.”
Two different options of the four-strain vaccines will be available to customers. FLULAVAL® QUADRIVALENT comes in a 5-mL, multidose vial containing 10 doses (0.5mL each), 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 U.S. market in the 2016-17 season. One hundred percent of GSK supply is quadrivalent doses.
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 U.S. occurs from October to May, and typically peaks in the U.S. between December-February. According to the CDC, each year approximately 5 percent to 20 percent of people in the U.S. 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 including the A/California/7/2009 (H1N1)pdm09-like virus, A/Hong Kong/4801/2014 (H3N2)-like virus, and B/Brisbane/60/2008-like virus (B/Victoria lineage), with the addition of B/Phuket/3073/2013-like virus (B/Yamagata lineage), for the quadrivalent vaccine.