Chiron's license to manufacture influenza vaccine, which was suspended in October as a result of contamination at the company's Liverpool, England, facility, has been reinstated, and vaccine manufacturing for the coming season will proceed.
The British Medicines and Healthcare Products Regulatory Agency (MHRA), working closely with the U.S. Food and Drug Administration, has been monitoring Chiron's progress in correcting the manufacturing problems that reduced the doses of vaccine slated for the U.S. market for the 2004-2005 flu season by nearly 50 million.
The MHRA made the decision to lift the suspension, but the FDA will conduct a comprehensive inspection of the facility once manufacturing resumes and the corrective action can be evaluated to ensure production of a safe and effective vaccine, according to a statement by Jesse Goodman, M.D., director of the FDA's Center for Biologics Evaluation and Research.
The vaccine shortages that resulted from Chiron's license suspension brought the FDA under fire from government officials, who said the crisis was in part a result of the agency's lax oversight of the facility after previous findings of bacterial contamination and poor sanitary procedures.
Sharon Worcester