U.S. Says No More Flu Vaccine

Supplies from Chiron factory in England can't be salvaged, health officials say

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HealthDay Reporter

FRIDAY, Oct. 15, 2004 (HealthDayNews) -- U.S. health officials shut the door Friday on the possibility of any flu vaccine from Chiron's troubled British plant ever reaching the United States this year.

"None of the influenza vaccine manufactured by Chiron is safe for use based on the FDA's evaluation and inspection of the manufacturing plant in Liverpool, England, which concluded this afternoon," said Dr. Lester Crawford, acting commissioner of the U.S. Food and Drug Administration at a hastily gathered late-day news conference.

Half the U.S. flu vaccine supply this year was to have been manufactured at Chiron's Liverpool plant. On Oct. 5, however, British authorities unexpectedly suspended the company's license due to bacterial contamination of the vaccine. That left the United States with only about 55 million doses of flu vaccine, all from Aventis Pasteur, the only other company that manufactures vaccine for the American market.

On Oct. 6, FDA inspectors arrived in Britain to conduct their own inspection of the plant and review records. What they found were violations of "good manufacturing practices," meaning that appropriate steps to ensure the vaccine was not contaminated had not been taken.

"We tried to assure ourselves that this was isolated to those two lots, [but] we were unable to do so based on records and also based on testing," Crawford said. "We were unable to determine that they [Chiron] had assured safety, and we believe that all of the lots produced here by that plant are suspect at this point."

"Our intention here is to test and retest and reevaluate the lots to see if some of it can be used, but we are not optimistic about that and do not believe that any of it can be used," Crawford added. "But we feel obligated to do every possible thing we can to be diligent about this unfortunate situation."

Crawford said the FDA inspectors found contamination in lots other than those that were originally identified. The organism causing all the trouble is the bacterium Serratia marcescens.

Although a final determination had not been reached, Crawford said experts suspect the contamination probably resulted from the filling of vaccine vials in an unsterile way. "We're not sure that was the case, [but] that is most likely the point where violations occurred," he said.

Meanwhile, the U.S. Centers for Disease Control and Prevention continues to work with Aventis and with local health authorities to equitably distribute the remaining 22 million doses from Aventis.

Two million of those doses were shipped this week and have gone to Veterans Administration facilities, long-term care facilities, acute care hospitals, state public health vaccine programs, vaccine-for-children programs and private providers that care for young children, Dr. Julie Gerberding, head of the CDC, said at the news conference.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, again implored people dispensing the vaccine "in the strongest terms possible" not to give inoculations to people who do not fall into one of the high-risk categories.

"Every time a clinic somewhere freely gives out vaccine to people who don't need it, an equal number of people in a risk category will likely not get the vaccine," he said.

Gerberding also pointed out that the flu season is not yet here, even though there have been isolated outbreaks across the country. She said more Aventis vaccine is on its way.

"We have very limited [flu] activity right now so there is still time to get the vaccine without having to land in very, very long lines," she said. "We're not in a situation where it's an emergency for people to run out and get vaccinated."

She also acknowledged that some health officials are prioritizing the list even further to try to get the vaccine to the most fragile and most vulnerable first.

And she urged all smokers to quit because that would reduce the chance of developing additional complications from influenza.

The federal government's final verdict on the Chiron vaccine was delivered at the end of a week in which the shortage clearly was hitting home, resulting in a frenzied atmosphere reminiscent of a run on banks.

"Now it's a panic," said Pat Russo, 65, after he had been turned away Thursday from a flu shot clinic in New York City. "People that didn't go before will go."

A handful of states were threatening doctors and nurses with fines or even jail if they give flu shots to healthy, low-risk people. Health-care violators in Michigan face a misdemeanor punishable by up to six months in jail and a $200 fine if convicted, the Associated Press reported. At least four other states -- Massachusetts, New Mexico, Oregon and Wisconsin -- and Washington, D.C., have issued similar orders within the last two days with varying penalties.

In Washington, D.C., violators could be fined up to $1,000; in Wisconsin, penalties include up to 30 days in jail and a $500 fine; in Massachusetts, the penalty is a $200 fine per infraction and six months in jail.

"It's not rationing," Massachusetts Public Health Commissioner Christine Ferguson told the AP. "It's being rational about how to reduce the number of deaths that could result from a serious flu season."

Meanwhile, in California, a 79-year-old woman who had stood in line for five hours Wednesday outside a local supermarket for a flu shot collapsed and died a day later, the AP reported Friday.

Marie Franklin, an award-winning artist, left the line in Lafayette, Calif., seeking shade from the heat, but collapsed as she walked and struck her head.

More information

The CDC has more on the flu and the vaccine shortage.

SOURCES: Oct. 15, 2004, news conference with Lester Crawford, DVM, Ph.D., acting commissioner, Food and Drug Administration; Julie Gerberding, M.D., director, Centers for Disease Control and Prevention; and Anthony Fauci, M.D., director, National Institute for Allergy and Infectious Diseases

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