Source Pravda.Ru

Some doses of flu vaccine may be contaminated

The U.S. government announced Friday that nearly half of this year's flu vaccine supply will arrive about a month late because some doses may be contaminated. Despite the delay, health officials said there was little to worry about, and that the vaccine will eventually be available to anyone who needs one. The delay is because Chiron, Inc., a leading manufacturer of the vaccine, discovered that a small number of doses already made were not sterile. Rather than ship the rest of the vaccine, the company has decided not to ship any until it gets to the bottom of the problem. Chiron's vaccine is called Fluvirin, informs Health Day News. "Chiron expects to fix the problem," Dr. Julie L. Gerberding, director of the CDC, said during a press conference. "They believe they have identified exactly what the source of the problem was, and they are aggressively pursuing all steps to insure that they have the safest, effective vaccine for us in time to protect people." Gerberding noted that delays in delivering the vaccine are nothing new. "This is not a problem that we haven't experienced before. But it is a problem we are staying on top of," she said. The CDC is still projecting that more doses of flu vaccine will be available this year than ever before. "We are expecting more than 100 million doses this year. Ultimately, all people who need flu vaccine should be able to get their shots and can be protected," Gerberding said. According to Newsday, U.S. health officials said Friday they do not expect a flu-shot shortage in the wake of a leading flu vaccine maker's announcement that it would hold up millions of doses because several batches were contaminated. About 4 million doses appear to be tainted - not enough to have a big impact on this year's supply although there may be a delay in making some shots available, the officials said. "This is not a crisis," said Dr. Julie Gerberding, director of the U.S. Centers for Disease Control and Prevention. "We'll end up having more vaccine doses than we've ever had before." On Thursday, Chiron Corp. said tests revealed that some batches were tainted, and that all 50 million doses would be held up for additional tests. "We are confident that we've identified the root cause," said John Vavricka, Chiron's vice president of commercial operations for North America. He would not identify the contaminant. Chiron still plans to ship 46 million to 48 million doses by early October. Reuters repots that additional tests on new shipments will cause a delay on releasing the product until early October, the company said. Chiron also said it expects to be within the range of earnings per share estimates of $1.80 to $1.90 for 2004, but at the low end of the range assuming the release of the vaccine in October. The news sent Chiron (CHIR: Research, Estimates) shares tumbling 6.8 percent in after-hours trading Thursday, after falling about 1 percent on Nasdaq during the regular session. Chiron, the No. 2 maker of flu vaccines, supplied 38 million doses of vaccine for last year's flu season and said it will have between 46 million and 48 million Fluvirin doses on the U.S. market in October. Last month, the company, whose other products include treatments for multiple sclerosis and cystic fibrosis, said it was on track to deliver 50 million doses of Fluvirin in the United States this season. John Vavricka, vice president of North American commercial operations, said the company is retesting its manufacturing process as a "cautionary principle."

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