GlaxoSmithKline Gets FDA Approval To Ship Quadrivalent Influenza Vaccine

(RTTNews) - GlaxoSmithKline plc (GSK, GSK.L) said Monday that it has received U.S. Food and Drug Administration approval to start shipping 2013-2014 Fluarix Quadrivalent to CDC distribution centers and U.S. healthcare 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 influenza vaccine approved by the FDA 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.

Before vaccine manufacturers can begin shipping influenza vaccines each season, the FDA first must certify that the supplies to be provided to healthcare providers meet the agency's quality and safety standards.

With today's FDA lot release, GSK's Fluarix Quadrivalent influenza vaccine soon will be supplied to U.S. healthcare providers who placed orders for the new vaccine after it was approved late last year. The U.S. Centers for Disease Control and Prevention placed the largest order for Fluarix Quadrivalent - for more than four million doses - and will allocate those doses to U.S. state and local healthcare providers.

For this influenza season, GSK will supplement the supply of Fluarix Quadrivalent with its trivalent seasonal influenza vaccines. In the U.S., GSK estimates it will provide up to 10 million doses of quadrivalent influenza vaccines, and 22 to 24 million doses of influenza vaccines overall.