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FOR IMMEDIATE RELEASE: October 10, 2004

SCHUMER: FEDS TO BLAME FOR FLU VACCINE SHORTAGE; ANNOUNCES PLAN TO SOLVE CRISIS AND URGES U.S. TO IMPLEMENT IMMEDIATELY

1.5 million New Yorkers at risk; new emergency plan would import an adequate supply of the flu vaccine from Canada, Europe, and Japan

Schumer: Feds can't keep relying on a small number of Rx companies; lack of a back up plan put thousands of New Yorkers at risk this season

Long term Schumer plan includes a gov’t guarantee to drug companies that vaccines will be purchased; tax breaks for drug companies who produce flu shots and expediting vaccine production in effort to end reliance on a small # of drug companies

US Senator Charles Schumer today charged the Federal government with being woefully unprepared to deal with this week’s news of drastic flu vaccine shortages and called for the immediate importation of emergency supplies from Canada, Europe, and Japan. With just two drug makers producing the flu vaccine for use in the US and no back up system in place, Schumer faulted the federal government for leaving thousands of high risk New Yorkers in the cold this flu season. To ensure the high risk are vaccinated this year, Schumer called for importation of the vaccine from abroad. In addition, Schumer unveiled a long term plan to end the federal government's reliance on a few drug companies to produce enough vaccine, to guarantee supply levels, and to boost research into expediting production of flu vaccine.

"Last year’s flu outbreak should have been a wake up call but instead warnings of repeat shortages fell on deaf ears and now in one fell swoop this week at Chiron, we are once again backed into a corner, unable to protect even our highest risk citizens," Schumer said. "Instead of taking steps to prepare for such an outbreak, the federal government sat on its hands for another year and let two drug companies have sole control over how much vaccine to produce for the nation. We have to put solutions for faster and wider production of the flu vaccine in place for the future and we have to deal with the immediate crisis by finding supplies from abroad."

The expected U.S. supply of flu vaccine was cut in half on Wednesday to 54 million doses, when British government regulators shut down production at supplier Chiron due to concerns about bacterial contamination. Chiron was to supply just under half of the 100 million vaccine doses planned for use in the U.S. this year. The remaining supplier of the flu shot to the U.S. market is Aventis Pasteur, which will send all 52 million vaccines it has produced. MedImmune, which produces the vaccine in a nasal spray that cannot be used by many in the high risk categories, is producing only two million doses of its FluMist vaccine.

There are approximately 1.5 million New Yorkers and 185 million Americans considered most at-risk for the flu who should be given priority for immunization including the elderly, care givers, and children under the age of two. To ensure these high risk individuals get their vaccination, Schumer announced that he is co-sponsoring a measure with Rhode Island Senator Jack Reed and Massachusetts Senator Ted Kennedy that would allow for the immediate importation of flu vaccines that have been approved for use in Europe, Canada and Japan. The measure directs the Food and Drug Administration (FDA) to perform an expedited review of these vaccines for immediate distribution in the US.

Schumer said that the Federal government has a track record of under preparing for a flu outbreak. Last year’s outbreak hit particularly strong and early in the season, causing a critical vaccine shortage by December. The shortage was blamed in part because drug companies, who were seeking to avoid any surplus of vaccinations, only produced 83.9 million doses for the winter 2003-2004 season, 11.1 million fewer doses than they did the year before. When the outbreak hit the US, however, it was too late in the production process for the nation's two flu vaccine makers, who need four months to make the doses.

Schumer said that not only is our reliance on a small number of drug companies to produce the entire supply of vaccines problematic, it is irresponsible and unnecessary. Currently vaccines are made using a lengthy four month process involving chicken eggs, however research suggests that using human or monkey tissue cells to develop the vaccines could reduce turn around time to just nine weeks. This means that in a shortage scenario such as the one currently facing the US, drug companies could have provided some vaccination relief by mid December, still early in the flu season. A few companies have been running experiments on this type of vaccine and one company, Baxter International, has received approval in the Netherlands to produce the vaccine. Baxter, which is set to begin round three of its US trials next fall, is not expected to have a flu shot ready for use in the US until 2007.

Schumer said it was the federal government's job to work with the drug companies to produce enough vaccine more efficiently so that a surprise contamination at one company does not cripple its ability to protect high risk Americans. He urged the Federal government to take several steps to prevent future flu vaccine shortages:

• Faster Turn Around Time: Developing ways to expedite the production of flu vaccine - Baxter International has developed a new vaccine whose production time requires nine weeks and uses tissue cultures instead of chicken eggs. The Baxter vaccine has not yet received FDA approval but has gotten approval in the Netherlands. Schumer called on the federal government to expedite the approval process for Baxter’s vaccine and to provide additional funding for research into even faster ways to produce vaccine and other, low-cost, non-injectable ways of delivering it to people.

• A Government Guaranteed Vaccine Market: Bringing more companies into the flu vaccine market- Schumer today proposed that the federal government guarantee the purchase of an adequate supply of the vaccine. This will entice more companies to enter the market by alleviating the risk of a mild flu season in which they are stuck with surplus unsold vaccines. Drug companies now under produce in an effort to minimize this risk, however, if the government guaranteed their purchase, the US would achieve a greater supply of the vaccines. Schumer is also co-sponsoring a measure with Senators Bayh and Craig that would provide a 20% investment tax credit for companies to construct new or renovate facilities for improved vaccine production.

• Education and awareness campaign - If there is a guaranteed supply of vaccine, the CDC could step up outreach efforts and mount an even more aggressive education campaign to make sure that those most at risk for the flu get vaccinated.

"One of the reasons we have a federal government is to deal with situations like this one, to deal with the unknown and the unexpected," Schumer said. "The CDC and the federal government have got to start learning their lessons and take steps to ensure that we have a reserve on hand to contain that an outbreak, to research ways to expedite production of flu vaccine, and to make sure those at risk get vaccinated."

According to the New York City Department of Health, over 500,000 New Yorkers contract the flu every year. In 2001, influenza and pneumonia caused more than 2,000 deaths in New York City – which is twice the national rate on a per-capita basis. The flu was also the third leading cause of death among persons age 75 years and older in New York City.

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