British OK Production at Flu Vaccine Plant

British OK Production at Flu Vaccine Plant

British OK Production at Flu Vaccine Plant

Chiron Can Resume Production, but U.S. Officials Cautious

March 2, 2005 - British health regulators Wednesday lifted their months-long license suspension of the company whose safety problems left the U.S. without half of its expected supply of flu vaccine for the 2004-2005 flu season.

U.S. officials said they were encouraged by the decision but stressed that they remain unsure whether the company would be allowed to sell vaccine doses to this country next year.

According to a news release from Chiron Corp., the company anticipates that the FDA will conduct a full inspection to allow resolution of the warning letter issued in 2004.

The Medicines and Healthcare Products Regulatory Agency (MRHA) -- the U.K.'s equivalent of the FDA -- announced that Chiron had corrected manufacturing lapses that caused it to lose its license in October 2004 and would be allowed to resume making flu vaccine.

"The MHRA inspectors have concluded that satisfactory progress has been made in the manufacturing areas which had previously caused concern," the agency says. Chiron "is now free to recommence full manufacturing of the vaccine."

Chiron was one of only two U.S. suppliers of the flu vaccine last fall when British regulators suspended its operating license because of potential contamination in the filling process for vaccine vials.

The move denied the U.S. some 48 million vaccine doses and sent American officials scrambling overseas to find additional doses to meet demand. It also touched off criticism of FDA officials for not foreseeing the problems, given a years-long track record of safety problems at that company's Liverpool, England plant.

The shortage forced federal health officials to restrict the vaccine to high-risk groups, including those over 65, children between 6 and 23 months of age, and those with chronic diseases.

FDA officials reacted positively to the British announcement but said that further inspections will be needed before Chiron is cleared to ship vaccine to the U.S.

The flu vaccine is remade each year with new viral strains, with production usually beginning in late spring or summer.

"FDA considers MHRA's action today an extremely important milestone in Chiron's efforts to supply influenza vaccine for the U.S. market for the coming flu season, but work remains," Jesse Goodman, MD, director of the FDA's Center for Biologics Evaluation and Research, says in a statement.