Sanofi's U.S. flu-shot unit fails FDA sterility test

The contamination affected about 5% of this year's batches of a flu-shot component produced between February and April at Sanofi's Swiftwater, Pennsylvania site, the U.S. Food and Drug Administration said today in a warning letter on its Web site. Sanofi failed to correct the “objectionable conditions'' after more than two months of talks, FDA officials said. The manufacturing disruption is “not expected to significantly affect'' the availability of flu shots for the 2006-2007 flu season, the FDA said. The U.S. has had shortages or delays in vaccine supply three of the past five periods, the federal Centers for Disease Control and Prevention said in February. “The problems were reported very early in the season, allowing for enough time for early intervention,'' said Mary Malarkey, director of the FDA office of compliance and biologic quality, on a conference call with reporters. The contamination probably was caused by a faulty filtration system and no contamination has occurred since the problem was corrected in April, said David Johnson, Sanofi's director for scientific and medical affairs. None of the unsterile vaccine had been sold. Sanofi discovered the problem in 11 of the 250 to 300 vaccine batches it plans to produce this year during a routine sterility test and notified the FDA on March 30, Johnson said. About two weeks later, the FDA inspected the plant. The company plans to make about 50 million shots of the vaccine, called Fluzone, this year, 10 million fewer than last year, providing an estimated 50% of the U.S. supply, Johnson said. Sanofi is making fewer vaccines this year because more manufactures are producing it, said Sanofi spokesman Len Lavenda. American depositary receipts of Sanofi rose 53 cents, or 1.1 percent, to close at $49.23 in New York Stock Exchange composite trading. U.S. markets closed three hours early today and will be shut tomorrow for Independence Day. The Swiftwater plant, which continues to produce vaccine, has a U.S. government contract to manufacture inoculations for avian influenza in case of a widespread outbreak in humans. The FDA and Sanofi said the sterility issue won't affect work the company is doing with the U.S. National Institutes of Health to develop and test a bird flu vaccine. Use of the vaccine helps protect people against seasonal flu and its complications, which hospitalize about 200,000 people annually in the U.S., killing about 36,000 patients, according to the CDC. Last year, the CDC recommended older, sicker people with weak immune systems along with very young children get priority for flu shots, after Chiron Corp. made less vaccine than anticipated and delivered it about a month late. Flu vaccine is time-consuming to make because the correct strains must be identified each year and manufactured using live virus grown in chicken eggs. “Vaccines are biological products and the majority of vaccines of this type are thought to be more complex and more challenging to manufacture'' than drugs, said Johnson. The U.S. government will ask drugmakers in the coming months for proposals on expanding or building new influenza-vaccine plants to help prepare for a potential pandemic, said Health and Human Services Secretary Michael Leavitt last week. The request is aimed at increasing the country's flu vaccine capacity using the chicken-egg technology, while the government and drug developers experiment with newer methods. (Bloomberg)