System bracing for future flu shot shake-up

Chiron Corp. is working hard to return to the U.S. market, but many are not so sure it can do it.

By Victoria Stagg Elliott, AMNews staff. Jan. 17, 2005.

While public health officials, physicians and other health care professionals are struggling with one of the most difficult flu vaccine supply situations in years, plans are also in the works for the possibility that next season might not get much better.

"On Oct. 5, we recognized that our strategic outlook had to take into consideration the possibility that there could be no Chiron vaccine next year," said Centers for Disease Control and Prevention Director Julie Gerberding, MD, MPH.

That was the day the Medicines and Healthcare Products Regulatory Agency, the Food and Drug Administration's British equivalent, suspended Chiron Corp.'s license to manufacture influenza vaccine because of contamination problems. Instantly, the 46 million to 48 million doses promised to the United States were put on hold, nearly halving the total expected supply.

Chiron submitted to the FDA in November 2004 a remediation plan and has made clear its intent to be back in the flu vaccine business for the 2005 season.

"We are committed to taking all necessary actions to ensure an adequate vaccine supply for the 2005-06 influenza season," said Howard Pien, Chiron's president and CEO, in a statement on the firm's Web site.

Still, although nobody doubts that Chiron's efforts are sincere, many experts are less than sure that the company can resolve its difficulties as soon as this spring, when the vaccine production cycle begins again.

"Most of us are pessimistic," said William Schaffner, MD, who serves as chair of the Dept. of Preventive Medicine at Vanderbilt University Medical Center in Nashville, Tenn.