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Health and Human Services
For Immediate Release
October 28, 2004
HHS Identifies More Influenza Vaccine
Department Takes Steps To Acquire Foreign Vaccine, Redirect Government Doses
Contact: HHS Press Office, (202) 690-6343
HHS Secretary Tommy G. Thompson announced today significant progress toward expanding the nation's supply of vaccines for flu season: the Food and Drug Administration (FDA) has identified about 5 million doses of influenza vaccine from foreign manufacturers; HHS has been able to recoup an additional 300,000 doses of the injectable vaccine originally bought for federal employees and the military; and a major pneumonia vaccine manufacturer plans to triple its production.
Secretary Thompson said these medicines would add to the nation's growing supply of vaccines and medicines to protect Americans during the coming flu season. These new doses would add to the 61 million doses of vaccine already available, including 58 million doses of vaccine from Aventis and 3 million of FluMist nasal spray from MedImmune. Additionally, the nation has a supply of antiviral medicines, potentially enough for more than 40 million people that can be used to prevent or treat the flu.
With the news of additional supply, the Secretary stressed again that millions of influenza vaccine doses are still to be distributed to states this flu season. Specifically, about 17 million of the Aventis vaccine is still to come (about 3 million doses a week are being distributed), as well as 2 million doses of FluMist.
"We're continuing to build our arsenal of vaccines and medicines to confront the coming flu season," Secretary Thompson said. "We are encouraged about the potential for some 5 million doses of vaccine from foreign manufacturers and we're sending our inspectors to those facilities. We're redirecting vaccine originally purchased by the government for federal employees and the military to priority populations throughout the country.
"We're growing stronger each week in our supply of vaccines and medicines, which makes us optimistic about our ability to protect the American public as we go into flu season," he added.
Secretary Thompson said FDA inspectors would be traveling to two foreign manufacturing facilities -- GlaxoSmithKline's facility in Germany and IDBiomedical's facility in Canada -- to inspect their manufacturing plants and products. The inspection teams will confirm the availability of the 5 million doses, assure that the vaccine can be used safely, and then make arrangements to acquire them. The department is still exploring the potential of additional doses of vaccine from other foreign sources as well.
The vaccine from foreign manufacturers would be distributed according to greatest need at the time of acquisition this flu season. These doses would most likely have to be distributed as an investigational new drug (IND), requiring recipients to sign a consent form and follow-up with a health care worker. Additionally, the department has recouped about 300,000 doses of influenza vaccine that had been purchased by the federal government for federal employees and the military this flu season.
This includes 200,000 doses of vaccine purchased originally for the military, which will now use FluMist thus freeing up the injectable vaccine for the priority populations who cannot take FluMist. This shift will not affect the timing or supply of vaccine for members of the military who are eligible to receive the flu vaccine. Additionally, HHS has recouped nearly 100,000 doses from the Federal Occupational Health service. All of these doses will now be redirected to states based on need for their priority populations.
Secretary Thompson also announced that Merck & Co. is tripling its production of pneumococcal vaccine used to prevent one of the major complications of the flu, pneumonia. The company, which typically sells 6 million to 7 million doses of Pneumovax 23, will increase its production to between 17 and 18 million for this flu season. The vaccine is for adults and children ages 2 years and older who are at increased risk for pneumonia.
Pneumovax is not a substitute for the influenza vaccine, but can help shield people against flu complications. A single dose can protect against 23 different types of Streptococcus pneumoniae bacteria that are responsible for causing more than 90 percent of pneumonia cases. Many people who fall into the priority groups for the influenza vaccine should also get the pneumonia vaccine, including seniors. Secretary Thompson said the Centers for Disease Control and Prevention (CDC) is making flu vaccine data available for state health commissioners on a secure Web site to help them track supplies coming to their states. He noted that the data is proprietary information that Aventis asked be protected through the secure Web site. The Web site is the result of efforts by the CDC and Aventis to redirect undistributed vaccine to places of greatest need.
The CDC also has asked states to submit their high-risk needs that are not being met as soon as possible, so that this information can be used to distribute remaining doses to where they are most needed.
Furthermore, the Secretary wants states to be clear that vaccines and medicines will be covered through Medicaid and Medicare for the populations those programs serve. This includes children in Medicaid and seniors in Medicare. In fact, Medicare will reimburse seniors who received their vaccine from a provider who is not enrolled in Medicare, and it will cover the costs of antiviral medicines that can prevent or treat the flu.
Secretary Thompson thanked the American public for its cooperation in making sure the flu vaccine goes to those in priority groups. He reminded the public that the priority groups for influenza vaccination are all children aged 6 months to 23 months; adults aged 65 and older; persons aged 2 to 64 with underlying chronic conditions; all women who will be pregnant during influenza season; residents of nursing homes and long-term care facilities; children aged 6 months-18 years on chronic aspirin therapy.
"On behalf of the President, I want to extend the administration's appreciation to citizens across America, who in accordance with CDC guidelines, are forgoing the flu shot so that someone in a priority category can get one," Secretary Thompson said. "Working together, we can make sure that the vaccine doses go to those who are most vulnerable."
Note: All HHS press releases, fact sheets and other press materials are available at http://www.hhs.gov/news.
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