Chiron Corp., which produces half of the nation's supply of flu vaccine, today said it will not ship any vaccine during the upcoming flu season after health officials in Britain, where the vaccine is made, shut down production because of contamination problems.
The decision was announced as health officials in the United States were preparing to begin immunizing 100 million Americans in preparation for the influenza season.
The U.S. Department of Health and Human Services said in a statement that the loss of the vaccine "poses a serious challenge to our vaccine supply for the upcoming flu season."
HHS said it anticipates having 54 million doses of vaccine from Aventis and 1 million to 2 million doses of FluMist nasal spray. HHS had planned for a supply of about 100 million doses this season, after a demand of about 87 million doses last flu season.
"Our immediate focus will be on making sure that the supply we do have reaches those who are most vulnerable," the statement said. The CDC is convening a committee to prioritize its recommendations on who should get the vaccine.
If not enough vaccine can be found, "we have to develop public policy, first how to prioritize so it's not a free for all," said Martin Blaser, who chairs the department of medicine at New York University's medical school and is president-elect of the Infectious Disease Society of America.
For example, it's uncertain who would be at the top of a vaccine list: a 2-year-old or the wife of someone with chronic lung disease.
"When you have a shortage, you really have to ask these questions," Blaser said.
Public awareness of influenza increases every year, he said. Last year there were long lines for vaccines because people feared it would be a rough year. While the season "got off to an early start, it was an average year, it wasn't a terrible year," Blaser said.
There could be problems in other countries as well. "The implications may be significant," said Dr. Klaus Stohr, influenza chief the World Health Organization.
Emeryville, Calif.-based Chiron said none of the 48 million doses of its Fluvirin vaccine destined for U.S. outlets had been distributed, and that a recall would not be necessary.
Chiron said it was meeting with the Food and Drug Administration and the U.S. Centers for Disease Control and Prevention over the impact of the company's decision.
In Britain, where Chiron has about 20% of the flu vaccine market, the company will replace Fluvirin with other vaccines approved for use in the United Kingdom but not in the United States.
"Chiron deeply regrets that we will be unable to meet public health needs this season," company President Howard Pien said in a statement. "Chiron believes in the value of influenza vaccination, and we are committed to taking all necessary actions to ensure an adequate vaccine supply for the 2005-2006 influenza season."
The company said that British health regulators suspended its license to manufacture Fluvirin for three months at a plant in Liverpool after determining that the company's manufacturing process "does not comply with UK Good Manufacturing Practices regulations."
In August, similar concerns raised by British health authorities forced the company to destroy 4 million doses of the vaccine and delay shipments by one month.
In late September, Chiron said it anticipated that it would start shipping Fluvirin to health facilities in early October after addressing what it considered were isolated problems. But after reviewing company test data and manufacturing methods, the British Medicines and Healthcare Products Regulatory Agency suspended the Liverpool facility's license to make the vaccine.
"No assurances can be given that additional issues with respect to Fluvirin or Chiron's manufacturing generally will not arise in the future or that the MHRA will not further suspend or revoke the license to Chiron's Liverpool facility," the company said in a statement.
Chiron entered the U.S. flu business a year ago with the acquisition of PowderJect Pharmaceuticals of Oxford, England, making Chiron one of this country's two primary flu vaccine makers.
The company said that halting flu shipments will slash its profits by about half this year. On Wall Street, Chiron shares plunged more than 17% on the Nasdaq. Trading in the stock had been temporarily suspended in the morning.
Blaser noted that in an average year, 35,000 to 40,000 people die of the flu.
"One of the things that we're concerned about is that there's no big national policy on influenza. It hasn't moved to the center of the agenda," he said.
The CDC has recommended that the following people get a flu vaccine for the 2004-05 season: those over 50; those who live in nursing homes and long-term care facilities; those with chronic heart or lung conditions including asthma; children on long-term aspirin therapy; women who will get pregnant during the flu season; children ages 6 to 23 months old; some healthcare workers; and some other groups.
Times staff writer Julie Tamaki and Associated Press contributed to this report.