US FDA approves shipment of quadrivalent flu vaccine to health care providers

The US subsidiary of UK pharma giant GlaxoSmithKline (LSE: GSK) says it has received Food and Drug Administration approval to start shipping 2013-2014 Fluarix Quadrivalent (influenza virus vaccine) to Centers for Disease Control (CDC) distribution points and US health care providers. This is the first season that vaccines protecting against more than three strains of influenza will be commercially available.

Fluarix Quadrivalent was the first intramuscular quadrivalent flu vaccine approved by the FDA [on December 14, 2012] for the immunization of children (three years and older) and adults to help prevent disease caused by seasonal influenza virus subtypes A and B contained in the vaccine, the drugmaker noted. Before vaccine manufacturers can begin shipping influenza vaccines each season, the FDA first must certify that the supplies to be provided to health care providers meet the agency's quality and safety standards, GSK stated.

"Trivalent (three-strain) influenza vaccines offer important protection against influenza. 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," said Leonard Friedland, vice president, scientific affairs and public policy, at GSK Vaccines, North America, adding: "Fluarix Quadrivalent addresses this by protecting against both B strains."