HHS buys 1.2 million doses of flu vaccine
The Food and Drug Administration has authorized the use of GlaxoSmithKline influenza vaccine, Fluarix, in the United States under an investigational new drug application (IND). The U.S. Department of Health and Human Services (HHS) also reached an agreement with the company to buy 1.2 million doses of the vaccine for distribution to areas most in need.
The purchase is part of an ongoing effort to make more influenza vaccine doses available to protect Americans during this 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 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,” says HHS Secretary Tommy G. Thompson. “With this latest purchase, we will be able to protect more high-risk Americans this flu season in communities across the country.”
Beginning in December 2004, the Fluarix vaccine was 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. The Fluarix vaccine has been approved by the European equivalents of the FDA. It has not been licensed by the FDA for use in the United States, which is why it will be administered under an IND. This allows the investigational use of Fluarix.
Under an IND, people 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 the FDA regarding safety and other issues, and make sure informed consent is obtained from individuals before receiving the vaccine. The CDC will assist GlaxoSmithKline with these activities. The company has agreed to make up to 4 million doses available under the IND.
The FDA has reviewed extensive manufacturing and clinical information and has conducted an inspection of the GlaxoSmithKline manufacturing facility in Germany to determine that this vaccine is suitable for use under an IND. The FDA reviewed the company’s proposed clinical study plan and informed consent document, as well as the clinical protocol and manufacturing data.
According to HHS, the IND mechanism can be used in this situation because there is neither the time nor the required 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.
The federal government has also purchased and stockpiled enough 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, 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 Thompson took office in early 2001, HHS was spending just $39.3 million a year on flu surveillance, research, education, and vaccine procurement activities. However, Bush and Thompson aggressively moved HHS forward on flu-preparation activities, including an increase in spending to $283.1 million in fiscal year 2005. HHS also released the nation’s first plan that aims to protect against a flu pandemic–a global event in which a new strain of flu virus circulates and infects a large number of people.
HHS encourages those in high-priority groups to continue to check with their local health officials about availability of flu vaccine. The high-priority groups include all children ages 6 months to 23 months; adults ages 65 years and older; anyone between the ages of 2 years to 64 years who have underlying chronic medical conditions; all women who will be pregnant during influenza season; residents of nursing homes and long-term care facilities; children 6 months to 18 years of age on chronic aspirin therapy; health care workers with direct patient care; and out-of-home caregivers and household contacts who are exposed to children younger than 6 months.
Individuals who are having difficulty finding vaccine or who want more information on influenza can call the CDC’s hotline at (800) CDC-INFO (232-4636) or visit www.cdc.gov/flu.
COPYRIGHT 2005 U.S. Government Printing Office
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