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CHICAGO Gov. Rod Blagojevich (D-Illinois) today announced that his administration has negotiated a tentative agreement -- subject to approval from the U.S. Food and Drug Administration (FDA) -- to immediately ship at least 30,000 doses of flu vaccine from Europe for Illinois residents at critical risk. Another 32,000 to 57,000 will be available to the State for purchase by mid-week. The flu vaccine was made available to Illinois through wholesalers in the United Kingdom that the state has been in contact with through the governor's I-Save Rx program, which offers Illinois and Wisconsin residents access to affordable, safe prescription drugs from pharmacies in the United Kingdom and Canada.
"The flu season is nearly here, and based on the supply offered to us by the federal government, thousands of senior citizens and others in Illinois would be forced to brave the winter without a flu shot. It's dangerous to expect them to do that," Blagojevich said. "We can provide the same exact flu shots, made by the same manufacturer, so that people who face the most serious risk will be taken care of. I am calling on the FDA to work with us immediately to allow us to purchase the flu shots we need. The sooner they give their approval, the sooner we can get flu vaccines to the senior citizens who need them the most."
The United States flu vaccine supply was recently decimated after British health officials found that some doses produced by Chiron Corp., a manufacturer that was expected to produce nearly half of the 100 million doses needed for U.S. residents, were infected by bacteria and its entire supply was condemned. As a result, the United States has only the 55 million doses of vaccine manufactured by its other supplier the French drugmaker Aventis Pasteur to meet its entire demand.
While the FDA announced last week that it has asked Aventis Pasteur to manufacture an additional 2.6 million doses of vaccines to address shortages across the United States, the new shots are not expected to be ready until January. Flu season in Illinois lasts from November to April, peaking in January and February. State health officials encourage the elderly and young children to get vaccinated early in the winter to allow the vaccine at least two weeks to become effective before peak season.
When news of the flu vaccine shortage was made public, Illinois officials turned to suppliers outside the U.S. that they have developed relationships with while establishing Illinois new I-SaveRx prescription drug importation program.
The opportunity to purchase flu vaccine from Europe came about because of our prescription drug program, I-Save Rx. Last week, our inspectors happened to be in the United Kingdom to inspect more pharmacies for our program, and they began discussions with some of the wholesalers who are part of program to see whether they could obtain flu vaccines for the people of Illinois. After a week of scouring Europe for as much flu vaccine as they could find, we were able to identify at least 30,000 doses that can be shipped within hours of approval by the FDA, the governor explained.
By immediately obtaining existing Aventis vaccine from European countries not facing shortages, Blagojevich would provide Illinois most vulnerable residents -- senior citizens in nursing homes -- with flu shots within days, long before peak flu season. President Bush and HHS Secretary Tommy Thompson have both said recently that the federal government is looking into buying the Aventis vaccine, and similar vaccines from Canada. Blagojevich today asked the FDA to act quickly if it needs to inspect Aventis manufacturing facility in Lyon, France -- which makes the Aventis flu vaccine that is distributed in Canada and Europe. The Illinois Department of Public Healths evaluation of the manufacturer's product descriptions and examination of dosage, strains of flu, processing and formulation, advisories and contraindications all show that the Aventis vaccine produced for Canada and Europe contains the identical properties as the Aventis vaccine produced for the United States.
To further reduce the nations flu vaccine shortage, the governor also called on the FDA to expedite U.S. inspections and approval of a flu vaccine made by GlaxoSmithKline (GSK) that is widely used in Europe for the same purpose as the Aventis and Chiron products. An initial evaluation by the Illinois Department of Health found the GSK vaccine is the same as the one being used now in the U.S. If approved soon by the FDA for distribution in the U.S., it could be used as soon as November to help meet the need in Illinois and other states across the country.
"We should leave no stone unturned. The FDA needs to immediately inspect those companies. They should send their inspectors to the GlaxoSmithKline facility in Germany so we can see whether their supply can be used here in Illinois, and across the United States," Blagojevich said.
In 2002, there were nearly 3,000 influenza and pneumonia-related deaths in Illinois. Of those, 2,610 were people over the age of 65, and 10 were children under the age of five. Last year, the Centers for Disease Control and Prevention (CDC) reported that roughly 36,000 people nationwide died from flu-related illnesses.
The Illinois Department of Public Health has developed a plan for distributing the initial 30,000 additional flu shots to nursing home residents throughout the state. Because nursing home patients are usually elderly or disabled, and live in communal settings where illnesses can spread quickly, they are often highly vulnerable to the flu. Illinois has approximately 100,000 residents living in nursing homes. The Department had received previous assurances from the federal government that 35,000 doses of flu vaccine would be available for nursing homes. With the 32,000 to 57,000 more doses later in the week, Illinois would be able to vaccinate nursing home patients and the most at-risk children who are being treated in hospitals. Once those populations are served, the Governor said the priority would be getting vaccine to seniors not living in nursing homes and children under the age of four.
Blagojevich asked the CDC to allow Illinois to use federal funds to purchase the vaccinations. If the CDC refuses his request, Blagojevich has pledged to cover the cost through existing state funds.
The governor also said that the state is in discussions with its European suppliers for the I-SaveRx program to find additional stocks of the Aventis flu vaccine. He offered to provide any doses not needed for critical cases in Illinois to the Centers for Disease Control (CDC) to distribute immediately to senior citizens, young children and the chronically ill in other states. The governor requested that the CDC first provide the excess vaccinations to Wisconsin, which is participating in I-Save Rx.
In addition to securing more vaccine, the governor and the Department of Public Health are also taking steps to prepare in the event that the state faces another difficult flu season. On Wednesday, public health and local experts will meet in Chicago to discuss how to best coordinate efforts this upcoming flu season. In particular, the state will be working with hospitals to develop contingency plans and strategies to help ensure that everyone receives proper care.
U.S. Representative Rahm Emanuel (D-Chicago) stood with the Governor today in support of his efforts to obtain flu vaccine from Europe for at-risk Illinois residents. This is a serious crisis that demands real leadership and quick action at both the state and federal levels. I am pleased that Gov. Blagojevich is taking these steps on behalf of the people of Illinois, while at the same time a bi[artisan coalition of members of Congress works for speedy action on my legislation, the Flu Protection Act, said Emanuel.
Emanuel is chief sponsor of the bill, HR 3758, which would improve the vaccine production system and lessen the chance of future shortages. He and other bill sponsors have asked House Speaker Dennis Hastert for a vote on the legislation during a Congressional session to be held in November.
Todays announcement also underscores the value and effectiveness of the Governors I-SaveRx program, said Emanuel. Its not merely about saving money its about saving lives.
Source: Illinois Department of Public Health