HHS purchases 1.2 million doses of GSK's Fluarix flu vaccine

Dec 8 2004

HHS Secretary Tommy G. Thompson has announced that the Food and Drug Administration authorized the use of GlaxoSmithKline influenza vaccine, Fluarix, in the United States under an Investigational New Drug application. Additionally, HHS has reached an agreement with the company to purchase 1.2 million doses of the vaccine for distribution to areas most in need.

This purchase is part of the Department's ongoing effort to identify and make available additional influenza vaccine doses to protect the American public for this winter's flu season. The doses of Fluarix vaccine are in addition to the existing supply of 61 million doses of licensed influenza vaccine, which includes about 58 million doses of Aventis injectable vaccine and 3 million doses of FluMist nasal spray.

"Our public health community has done an outstanding job of making sure the vaccine gets to those who need it most," Secretary Thompson said. "With this latest purchase, we will be able to protect more high-risk Americans this flu season in communities across the country."

Beginning this week, the Fluarix vaccine will be sent to the United States for distribution by the Centers for Disease Control and Prevention (CDC), based on the agency's determination of communities most in need. Fluarix has not been licensed for use in the United States and will be administered under an Investigational New Drug application (IND). The Fluarix vaccine being purchased by HHS has been approved by the European equivalents of the Food and Drug Administration (FDA), but is considered an IND because it is not currently licensed by FDA. The IND allows the investigational use of Fluarix, and HHS is immediately purchasing 1.2 million doses that are available this month. GlaxoSmithKline (GSK) has agreed to make up to 4 million doses available under the IND.

Under an IND, patients who are offered the Fluarix vaccine must sign an informed consent form that provides important information and acknowledges that they are aware of the potential adverse effects associated with the investigational vaccine. Sponsors of INDs are required to monitor the use of the investigational product, maintain adequate records, control the supply of product, provide periodic reports to FDA regarding safety and other issues and make sure informed consent is obtained from individuals before receiving the vaccine. CDC will assist GSK with these activities.

FDA has, over the past month, reviewed extensive manufacturing and clinical information and conducted an inspection of the GSK manufacturing facility in Germany to determine that this vaccine is suitable for use under an IND. FDA reviewed GSK's proposed clinical study plan and informed consent document, as well as the clinical protocol and manufacturing data. The IND mechanism can be used in this situation because there is not enough time or information to allow U.S. licensure. These steps along with the conditions and controls required under the IND are designed to assure the product is safe for use during the current flu season.

Additionally, the federal government has purchased and stockpiled antiviral medicines to treat more than 7 million people. Supplies of antiviral medicines also exist in the private sector and manufacturers indicate that they have the ability to significantly ramp up production. All told, between existing stockpiles, private sector supplies and production capabilities, the FDA estimates there could be enough medicine to treat tens of millions of people through the heart of flu season.

When President Bush and Secretary Thompson took office in early 2001, HHS spent just $39.3 million on flu surveillance, research, education and vaccine procurement activities. However, President Bush and Secretary Thompson aggressively moved HHS forward on flu-preparation activities, including producing the nation's first pandemic flu response plan, and an increase in spending to $283.1 million in fiscal year 2005.