GSK Ships 2017-18 Seasonal Influenza Vaccines for US Market

GSK has begun shipping quadrivalent 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.

The US 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 people 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.

In November 2016, GSK received approval from the US FDA expanding the indication for FLULAVAL QUADRIVALENT to include use in children aged 6 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. "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 6 months and older."

Three different options of the four-strain vaccines will be available to customers. FLULAVAL QUADRIVALENT comes in a 5mL, multidose vial containing 10 doses (0.5mL each) and a 0.5mL, single-dose, prefilled syringe, while FLUARIX QUADRIVALENT comes in a 0.5mL, 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 one hundred percent of GSK supply is quadrivalent.

Quadrivalent vaccines are designed to help protect against two main types of flu viruses, A and B, which spread between people and can cause mild to severe illness. Most flu activity in the US occurs from October through May, and it usually peaks between December and February. According to the CDC, flu-related hospitalizations have ranged from 140,000 to 710,000 and flu-related deaths from 12,000 to 56,000 annually since 2010.

According to the CDC, the flu is more dangerous than the common cold for children. Severe flu complications are most common in children under the age of 2 years. Each year, millions of children get sick with seasonal influenza and some of those illnesses result in death. The CDC estimates that flu-related hospitalizations among children under the age of 5 have ranged from 7,000 to 26,000 since 2010 and flu-related deaths reported to CDC during regular flu seasons from 37 to 171 since the 2004-2005 flu season.

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/Michigan/45/2015 (H1N1) pdm09-like virus, A/Hong Kong, S.A.R., China/4801/2014 (H3N2)-like virus and B/Brisbane/60/2008-like (B/Victoria lineage) virus, with the addition of B/Phuket/3073/2013-like virus (B/Yamagata lineage) for the quadrivalent vaccine.