HHS buys and authorizes use of 1.2 million doses of Europe-approved Fluarix flu vaccine
HHS buys and authorizes use of 1.2 million doses of Europe-approved Fluarix flu vaccine
WASHINGTON, D.C., December 7, 2004 -- HHS Secretary Tommy G. Thompson announced that the FDA had authorized the use of GlaxoSmithKline's 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."
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.
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. The high-priority groups include:
- 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
- Health-care workers with direct patient care
- Out-of-home caregivers and household contacts of children aged <6 months.
Finally, everyone can take practical steps to help prevent spread of flu, including:
- Avoid close contact with people who are sick
- Keep your distance from others if you are sick
- When possible, stay home from work, school, and errands when you are sick, and don't send your children to child care or school if they are sick
- Cover your mouth and nose when coughing or sneezing
- Clean your hands often.
For more information about the flu, visit the CDC Web site: www.cdc.gov/flu
Source: FDA
Pharma Industry News Archive
2007: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2006: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2005: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2004: Jan | Feb | Mar | Apr | May | Jul | Aug | Sep | Oct | Nov | Dec
2003: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2002: Jan | Apr | May | Jun | Aug | Sep | Oct | Nov | Dec
