500,000 Flu-Shot Doses Recalled
Some Vaccine for Low-Income Children Was Found Frozen

By David Brown
Washington Post Staff Writer
Saturday, October 21, 2006; A02

The pharmaceutical company Novartis is recalling 500,000 doses of its flu vaccine after two shipments bound for use in a childhood immunization program in New York were found frozen.

Freezing can inactivate influenza vaccine, making it ineffective but not dangerous.

The actual number of doses affected was about 18,600. They froze while in the possession of Cardinal Health, a distributor that handles all the flu vaccine Novartis sells through the federal Vaccines for Children (VFC) program. The vaccine was discarded, and none was used in shots.

When Novartis learned of the problem it decided to replace all 500,000 doses of vaccine it sells through the federal program, which provides free or cut-rate vaccine to children of low-income households.

"We have not gotten any reports from any other places of frozen vaccine," said Eric Althoff, a spokesman for Novartis. "But as a precautionary measure we are replacing all the doses we provided" to the VFC program, he said. The new vaccine, which will be shipped through a different distributor, should arrive by early November.

Maryland's health department recalled 10,700 doses of Novartis vaccine, which is about 7 percent of the amount it bought through the VFC program, said spokesman John Hammond. How much vaccine might be affected in the District and Virginia was not immediately known yesterday

The recall covers only a small fraction of the 110 million doses expected to be available in the United States this flu season. About 40 million doses had been shipped to health departments, doctors' offices and clinics by the end of last week, according to the Centers for Disease Control and Prevention in Atlanta. The VFC program ordered 5.6 million doses.

Cardinal Health does not distribute any flu vaccines for public or private use other than the doses it handles for the VFC program.

Flu season has not started yet. Two states last week reported "local" outbreaks of the viral infection, and six reported "sporadic" cases. The rest reported none.

The vaccine problem was discovered when workers taking delivery of vials at the New York State Department of Health saw that the liquid was frozen and had been incorrectly packed, a spokesman there said. It had apparently been shipped from a Cardinal Health distribution center in Nashville.

The vaccine was made in Liverpool, England. It must be kept at between 35 and 46 degrees Fahrenheit to maintain potency. Its temperature was monitored by sensors during the transatlantic flight, and it was not frozen when it was turned over to the distributor, a Novartis official said.

Cardinal Health spokesman Jim Mazzola said: "We believe that it was packed according to the instructions that were received from the manufacturer. Obviously that the product was frozen is of great concern to us, and we are conducting a full investigation."

The vaccine is sold under the Chiron name even though it is now a Novartis product. Novartis bought Chiron, a California biotech company, in April, and relabeling of the vaccine is not finished, Althoff said.

Chiron was the object of a major vaccine debacle two years ago when all of its flu vaccine -- about 45 million doses -- was impounded and kept off the market because of problems with contamination. That loss cut the nation's supply of flu shots nearly in half that year.