Agency: German Flu Vaccine Safe for U.S.

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The government said Tuesday that flu vaccine manufactured in Germany was safe enough to be used in the United States and that as many as 4 million doses would be available to alleviate the U.S. shortage.

Health and Human Services Secretary Tommy Thompson said the government was immediately buying 1.2 million doses of the vaccine, called Fluarix, which will be available this month, and said British manufacturer GlaxoSmithKline had agreed to make about 3 million more doses available later.

"It will allow us to get more vaccine into the hands of those who need it most," Thompson said.

Health officials also were hoping to license and buy extra vaccine from a Canadian manufacturer, but that company, ID Biomedical, said it would sell its extra 1.2 million doses in Canada. The company made its decision at the request of the Canadian government.

The German-made vaccine, Fluarix, has not been licensed for use in the United States, so it will be available as an investigational new drug, meaning that it can be used but patients will have to sign a consent form acknowledging there could be risks.

Before allowing the vaccine into the United States, the Food and Drug Administration inspected the German facility where the vaccine was made. The agency also tested whether the drug was effective against the dominant flu strain expected in the United States and made sure the vaccines have been stored properly since they were made.

On Monday, the director of the Centers for Disease Control and Prevention cautioned health care officials to remain alert even though the flu season has begun slowly, with no widespread outbreak reported.

"A slow start doesn't necessarily reflect a slow season," Dr. Julie Gerberding, director of the CDC, said at an American Medical Association conference in Atlanta. "The most common month of peak activity is February."

The FDA has been working since October to arrange for additional flu shots that were not made for U.S. consumption.

About 61 million doses have been available this season, including a nasal vaccine only for healthy people ages 5-49. The CDC has said 98 million people, including 9 million children, need the vaccine.

Separately, Illinois, New Mexico and New York City have located another 650,000 doses from drug wholesalers, but have not yet gotten FDA approval to purchase the vaccine for residents.

Health officials had planned to have more than 100 million doses of the vaccine this season, the biggest supply ever. But flu shot maker Chiron Corp. announced Oct. 5 that it could not ship its 48 million doses after British health officials suspended its license because of contamination at a Liverpool plant.

The resulting shortage was a major concern to physicians at the AMA meeting who complained that the flu vaccine was at times available on a first-come basis instead of reaching high-risk patients as a top priority.

However, Gerberding said, "volunteerism works" as most Americans followed CDC guidelines for reserving the vaccine for those in greatest need.

"The people who should step aside stepped aside," she said, adding that she does not endorse penalizing healthy patients who are taking the vaccine.

Each year, the flu kills about 36,000 people in the United States and sends another 200,000 to the hospital.