Key Source of Flu Vaccine Shut Down

By Denise Gellene and Melissa Healy
Times Staff Writers,1,2363069.story?coll=la-home-headlines  (must register to view original article)
October 5, 2004

U.S. public health officials warned of serious flu vaccine shortages Tuesday after the company that supplies half the nation's flu shots suddenly announced it could provide no vaccine this season.

Authorities urged healthy people to forgo their shots so more would be available for those most in need -- babies between six and 23 months, adults over 65, people with chronic illnesses and healthcare workers.

The warning came after British health authorities Tuesday effectively shut down a factory in Liverpool, England owned by Chiron Corp. for three months because of unspecified manufacturing problems. The plant makes Chiron's entire U.S. supply of vaccine.

Emeryville, Calif.-based Chiron said the surprise shutdown means the company won't be able to ship vaccine before the flu season ends.

Chiron and Aventis Pasteur are the only providers of flu shots to the United States. A third company, MedImmune, makes an inhaled flu vaccine, but only about 1 million doses will be available and it is not recommended for children or the elderly.

U.S. health officials were caught off guard by the sudden announcement. Health and Human Services Secretary Tommy Thompson said the shortage was "very disappointing news that creates a serious challenge to our flu vaccine supply."

The decision by British authorities, said Thompson, came after an inspection of the Chiron plant late last week. Thompson said United States officials had only been notified of their decision Tuesday morning.

"This is going to be harsh on everybody," said Dr. David Ramin, a Culver City, Calif., doctor who administered 400 shots last year. "We're going to have more people with influenza this year than any other year. This means more hospitalizations and more deaths from influenza than any other year."

According to the Centers for Disease Control and Prevention, 5 percent to 20 percent of the U.S. population annually contracts influenza. In an average year, the disease is responsible for 200,000 hospitalizations and 36,000 deaths.

Chiron and Aventis had stepped up vaccine production this year because last year an early and hard flu season led to shortages. The companies had planned to deliver 100 million doses, nearly 20 percent more than last year's flu season. Now just 54 million doses will be available.

Because it takes many months to manufacture flu shots -- a process that involves growing live virus in thousands of chicken eggs -- Aventis Pasteur can't make up the shortfall. Aventis told government officials it can't begin work on new vaccine until November, when its current orders are filled. The company has already shipped 30 million of the 54 million doses it plans to produce.

The shortage underscores the pitfalls of relying on just two manufacturers for flu vaccine, according to public health experts.

"This exposes the fragility of the vaccine supply in the United States," said Neal Halsey, director of the Institute for Vaccine Safety at Johns Hopkins Bloomberg School of Public Health. "We should not have to depend on one or two manufacturers."

Halsey said a better strategy was needed to maintain an adequate supply of vaccine and increase "our potential to deal with the possibility of a pandemic."

CDC director Dr. Julie Gerberding urged Americans not "to rush out and look for vaccine today," but to wait and allow physicians, pharmacists and federal and state health officials to assess how much vaccine they have in hand, where it will be needed, and by whom. "It's not an emergency," said Gerberding. "We'll work through this."

Gerberding said that while the population recommended to receive flu vaccine is about 180 million people, "we never vaccinate anywhere near" that many. Subtracting those who would likely not seek a dose of vaccine anyway, she reckoned the "50-some million doses we have now will come close to meeting this demand."

One bright spot is that the newest additions to the list of those recommended to receive a flu shot -- babies between six and 23 months -- will likely not have problems obtaining a dose of vaccine. Aventis-Pasteur was the only producer of the flu vaccine formulation designed for babies.

Asked whether federal officials have the power to commandeer vaccine supply that has already been distributed to clinics, pharmacies, hospitals and physicians, Thompson said, "I don't think that would be practical."

However, CVS Corp., the second-largest U.S. drug store chain, said Tuesday it won't offer flu shots at its stores this year because of the shortage. The company said it was trying to determine how to make its supply of vaccine available to those most in need of it.

Chiron Chairman and Chief Executive Howard Pien said he learned of the British government's actions at 3 a.m. from employees in Liverpool who had just received a letter from Medicines and Healthcare Products Regulatory Agency, the British counterpart to the FDA. The agency said it was suspending the factory's license for three months for what Pien called "issues with systems and processes" at the factory. He said the actions by British regulators were "completely unexpected."

"I cannot overemphasize how profoundly we regret that we will be unable to meet the public health needs this season," he said.

Chiron's troubles began in August, when the company announced it needed to destroy 4 million doses of vaccine that was contaminated with a bacterium called serratia. Chiron said it was delaying shipment of all other flu vaccine until it learned how the contamination occurred.

Pien said the company concluded that human error was to blame and that the remaining batches of vaccine were safe. The company planned to begin shipping vaccine this month, he said.

As recently as early last week Pien told the U.S. Senate Special Committee on Aging that his company expected to begin delivering 46 million to 48 million doses of flu virus to the U.S. market in early October. He told the committee that the shipment of an additional 2 million doses to a U.S. government stockpile also was on schedule.

CDC director Gerberding said U.S. officials "had been optimistic" that Chiron had isolated the contamination of flu vaccine to a batch of 6 million-8 million doses. In recent months, according to U.S. officials, the FDA was relying primarily on Chiron's analysis of the cause of contamination and its assessment that it was limited.

In late summer, said FDA's Dr. Jesse Goodman, an FDA inspection team visited Chiron's facility for other purposes and made some additional inspections in light of the flu vaccine contamination reports.

"We were waiting for a complete analysis of the situation to be forwarded to us at FDA and then we would respond to that appropriately," said Goodman on Tuesday. Goodman said that in their communications with U.S. regulators, Chiron officials reported "they believed they had isolated the cause of the problem and the affected lots."

However, Pien said British regulators inspected the plant and found faulted the company's manufacturing "system and process." Pien did not provide details on what the British inspectors found. "I think this reflects a regulatory philosophy that it is not just the end product that a supplier can say is safe," he said.

Pien said the company expected to begin talks with British regulators Wednesday. However, he held out little hope that the matter would be resolved in time for this year's flu season, and said that he believed that British regulators had final authority over the plant.

"I think it is reasonable to assume that the vaccine we had hope to supply to the U.S. is gone," he said.

Times staff writers Myron Levin and Jia-Rui Chong contributed to this report.