News in brief - Aug. 8, 2005

Chiron scraps 12 million doses of influenza vaccine - Abortion drug gets FDA warning

Chiron scraps 12 million doses of influenza vaccine

Chiron Corp., the company that triggered last years flu vaccine crisis because of contamination problems, will not be providing the expected 12 million doses of vaccine to patients in Europe because of problems at its plant in Germany, according to a series of statements issued by the company last month. The company will attempt to address any shortfall by reallocating supplies produced by its plant in Italy.

Whether Chiron will be able to supply the United States is still uncertain. The company expects to provide 18 million to 26 million doses for the upcoming influenza season, contingent on the results of the Food and Drug Administration's Good Manufacturing Practices inspection, which is ongoing and expected to continue for the next few weeks. The company also needs to arrange additional approvals from Britain's Medicines and Healthcare Products Regulatory Agency.

Meanwhile, Sanofi Pasteur is expanding its ability to produce flu vaccine and broke ground on a new plant in July. This facility will replace its old one in Swiftwater, Pa., in 2009 and is expected to double the company's ability to produce vaccine. Sanofi is expected to produce around 50 million doses for the coming season.

Abortion drug gets FDA warning

The Food and Drug Administration is warning physicians to be alert to the possibility that patients undergoing medical abortion using mifepristone may develop sepsis, particularly if the drug is not used in accordance with the labeling.

"We believe it is important to share with health care providers and patients the latest serious reports of infection associated with this drug that we have received," said Steven Galson, MD, MPH, acting director of the agency's Center for Drug Evaluation and Research.

From September 2003 until June 2005, the agency recorded four deaths due to sepsis following a medical abortion. The agency is particularly concerned because symptoms in these cases were unusual for sepsis and linked to a bacterium, Clostridium sordelli, that rarely causes illness.

Sepsis is a known risk of any type of abortion. The agency has not conclusively linked these cases to the use of the drug.