Health
Flu vaccine maker gets FDA warning letter
NEWS IN BRIEF — Posted July 24, 2006
The Food and Drug Administration issued a warning letter to Sanofi Pasteur, one of the manufacturers of influenza vaccine, because of sterility problems reported by the company to the government agency. Regulators do not believe, however, that this development will affect flu shot supplies in the fall.
"The deficiencies noted ... are not expected to significantly affect the availability of [influenza vaccine] for the 2006-2007 flu season, but we continue to review the progress made by the company," read an FDA statement issued earlier this month.
Sanofi contacted the FDA in March because of problems with its monovalent concentrates, one of the vaccine's key ingredients. The company's plant in Swiftwater, Pa., was inspected in April, and the agency found that procedures designed to prevent contamination were not always followed.
According to a statement issued by the company, Sanofi has addressed most of the agency's concerns and is working to resolve the remaining ones. The contaminated substance has been destroyed, and Sanofi is still on track to produce at least 50 million flu shots.
Note: This item originally appeared at http://www.ama-assn.org/amednews/2006/07/24/hlbf0724.htm.
