SATURDAY, OCTOBER 1, 2016

GSK receives FDA approval to ship quadrivalent influenza vaccine

GlaxoSmithKline, a research-based pharmaceutical company, recently announced that it received approval from the U.S. Food and Drug Administration to begin shipping its four-strain influenza vaccine to healthcare providers.

GSK's Fluarix Quadrivalent was the first intramuscular quadrivalent influenza vaccine approved by the FDA for the immunization of adults and children three years and older to prevent disease caused by seasonal influenza virus subtypes A and B contained in the vaccine. The FDA is required to certify that supplies meet the agency's quality and safety standards prior to shipping.

While most current influenza vaccines provide trivalent, or three-strain, influenza protection, this is the first season in which vaccines protecting against more than three strains of influenza will be available commercially.

"Trivalent influenza vaccines offer important protection against influenza," Leonard Friedland, the vice president of scientific affairs and public policy for GSK Vaccines in North America, said. "But since the late 1980s, scientists noted that two B virus lineage strains circulate to varying degrees each year, and it's difficult to predict which one will cause the most illness in a particular influenza season. Fluarix Quadrivalent addresses this by protecting against both B strains."

GSK will now supply its Fluarix Quadrivalent influenza vaccine to U.S. healthcare providers who placed orders for the vaccine after it was approved in December. GSK estimates it will provide up to 10 million doses of quadrivalent influenza vaccines and 22 to 24 million doses of influenza vaccines overall.