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HHS Purchases 1.2 Million Doses of Flu Vaccine
GlaxoSmithKline Vaccine Adds To 61 Million Doses
In United States
Dec. 7, 2004 - HHS Secretary Tommy G. Thompson
announced today 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.
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.
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