No Chance of Chiron Vaccine, U.S. Says

None of Chiron Corp.’s (CHIR.O: Quote, Profile, Research) flu vaccine made at a British plant is safe, which means the U.S. flu vaccine supply will be half of what was expected, U.S. health officials said on Friday.

Federal and state health officials worked to make sure that vaccines made by rival Aventis-Pasteur (AVEP.PA: Quote, Profile, Research) got to people who needed it most, such as the elderly and babies, while several states took action against price-gougers. Long lines for shots were seen in some areas across the country. Last week, British regulators suspended Chiron’s license for the vaccine plant, throwing half the expected U.S. influenza vaccine supply into doubt. They and FDA inspectors have determined that Chiron’s entire manufacturing process for the vaccine was unsafe and they have rejected all of the 48 million doses at the facility. “All the lots produced by the plant are suspect at this point, and we cannot allow them to be used in the United States in the interest of public health,” acting U.S. Food and Drug Administration Commissioner Lester Crawford told reporters in a telephone briefing. “The problems that we found in the plant in the U.K., in Liverpool, were what we call good manufacturing practice violations,” he said. Crawford said it appeared there was a problem in filling the vials for the vaccine. Chiron said in a statement it was working to resolve the concerns raised by U.S. and British regulators in order to resume manufacturing Fluvirin for the 2005/2006 flu season. “No doses of Fluvirin were released into any territory for the 2004/2005 flu season,” said the company, based in Emeryville, California. CONTAMINATION REPORTED Chiron had found and reported contamination with a bacteria called Serratia but had hoped to correct the problem in time to save most of the vaccine production.Crawford said whatever went wrong apparently affected everything Chiron made at the plant, which the California-based company acquired when it bought a British company called PowderJect. Crawford said the FDA would certainly have found the problems, because even if Chiron had verbally reported it cleared them up, the FDA would have tested the vaccine before releasing it and would have found the contamination. Crawford said the FDA was looking elsewhere for vaccine but warned it could take time to approve anything for the U.S. market. “We are checking with every known source and every government that we deal with,” he said. The U.S. Centers for Disease Control and Prevention said it was working with Aventis to reroute some of its vaccine. This week, doses were directed to Veterans Administration hospitals, nursing homes, state health agencies, the Vaccines for Children program and to pediatricians. Because only about 55 million doses of vaccine will be available this year, as compared to 100 million expected doses, the CDC asked that only high-risk people get the vaccine. These include people over 65. children aged 6 months to 23 months, the chronically ill, caregivers of these people and pregnant women. MORE VACCINE COMING “This shortage is frightening to people, and they’re rushing out and standing in long lines thinking they need the vaccine right now before it’s all gone. We want them to know that more is coming,” CDC Director Dr. Julie Gerberding said. “More doses of vaccine will be going out over the next six to seven weeks, so there will be more opportunity for those who need the vaccine to get it in time for this year’s influenza season,” she added. After several clinics began offering vaccine to anyone who asked for it, the Washington, D.C., Department of Health issued an emergency rule saying only the priority groups should get the vaccine. Wisconsin Gov. Jim Doyle issued a similar order. Officials in Illinois and Florida threatened legal action against price-gougers overcharging for the vaccine. In an average year, influenza kills 36,000 people in the United States, most of them elderly but also a few previously healthy children. Nonetheless, almost every year, companies that make the vaccine have to throw some away because it goes unused, and most manufacturers have stopped making vaccine for the U.S. market. (Source: Reuters, Oct 2004)