The Fluarix vaccine being purchased by HHS has been approved by the European equivalents of the FDA, but is considered an investigational new drug in the U.S.

The purchase is part of the Department's ongoing effort to find and distribute more influenza vaccine doses to protect the American public for this winter's flu season. The doses of Fluarix vaccine add 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. (The nasal spray is not recommended for use among the population most in need of vaccination, however.)

Informed Consent Required

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.

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 investigational new drug, or IND, because it is not currently licensed by FDA. GlaxoSmithKline (GSK) has agreed to make up to 4 million doses available under the IND, a status that permits its "investigational" use.

Patients who are offered the Fluarix vaccine are given an informed consent form that provides important information, and they are required to sign an acknowledgement that they are aware of 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.

U.S. Inspected German Facility

FDA has reviewed extensive manufacturing and clinical information and conducted an inspection of the GSK manufacturing facility in Germany over the past month, and determined that this vaccine is suitable for use as 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 that the product is safe for use during the current flu season.

HHS encourages those in high-priority groups to continue to check with their local health officials about availability of vaccine. Individuals who are having difficulty finding vaccine or who want additional information on influenza can call the CDC's hotline at 1-800-CDC-INFO.

Flu Vaccine Distribution Guidelines

The high-priority groups include the following:

• All children aged 6-23 months;
  
• Adults aged 65 years and older;
  
• People aged 2-64 years with 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;
  
• Healthcare workers with direct patient care; and

• Out-of-home caregivers and household contacts of children aged less than 6 months.

Finally, everyone can take practical steps to help prevent the spread of flu:

• Avoid close contact with people who are sick;
  
• Keep your distance from others if you are sick;
  
• When possible, stay home from work and school, and avoid running errands when you are sick;
  
• Don't send your children to child care or school if they are sick;
  
• Cover your mouth and nose when coughing or sneezing; and
  
• Clean your hands often.

For more information about the flu, visit the CDC Web site.