John Taylor, the FDA’s associate commissioner for regulatory affairs, told the Wall Street Journal that the 2003 Liverpool inspection showed “systemic quality-control issues” at the Chiron facility. The Journal summarized Taylor’s remarks by stating that FDA inspectors concluded, “Chiron wouldn’t necessarily be able to discover problems, identify the root cause and take steps to prevent similar issues from arising again.” […the FDA did not reinspect the Liverpool plant between the 2003 inspection and October 2004, the FDA relied on Chiron’s assurances that everything was OK…]

Records at Britain’s Department of Health show that the plant’s owner, Chiron Corp., warned officials of the U.S. Food and Drug Administration and the British Medicines and Healthcare Products Regulatory Agency on Sept. 13 that potential contamination problems remained unresolved at the plant, according to Alison Langley, a senior spokeswoman at the department. The British account is at odds with statements by U.S. health officials that they were caught by surprise by the British regulatory agency’s decision this week to suspend vaccine manufacturing for three months at the Liverpool plant… Jason Brodsky, an FDA spokesman, provided an agency statement disputing the British account, saying: “None of the Center for Biologics Evaluation and Research (CBER) staff who were in regular communication with Chiron since August 25, 2004, were notified by Chiron that there was an increased level of concern regarding the company’s investigation of the bacterial contamination.” Furthermore, according to the statement, there had been no communication between CBER and the British agency until that agency suspended Chiron’s license. That decision was reached last weekend, and Chiron was informed Tuesday…

This year’s flu vaccine shortage could cost the nation up to $20 billion in lost productivity — almost twice as much as in a typical year — depending on the severity of the outbreak, according to one estimate… This year’s flu vaccine shortage could cause deaths to spike by 25 percent, said Dr. John Treanor, an infectious disease expert at the University of Rochester Medical Center. In a typical year, 36,000 Americans die from the flu. That mortality figure rises to 51,000 when flu-related complications, such as heart attacks and strokes, are included.

…”If we can’t deal with something as simple as flu vaccine, what are we going to do if we have biological warfare under this president?” [former [NH] Gov. Jeanne Shaheen, Kerry’s national campaign chairwoman] said.
…The GAO [reports] noted that purchase, distribution, and administration of flu vaccine were mainly private-sector responsibilities, so it recognized any government planning had to rely heavily on collaboration between the public and private sectors…

Bob, we relied upon a company out of England to provide about half of the flu vaccines for the United States citizen, and it turned out that the vaccine they were producing was contaminated. And so we took the right action and didn‘t allow contaminated medicine into our country… [perhaps vaccines will come from Canada…] My call to our fellow Americans is if you‘re healthy, if you‘re younger, don‘t get a flu shot this year. [CDC is prioritizing who gets the flu vaccine… Bush didn’t get a flu shot… blames suits for driving producers out of market, says legal reforms are necessary…] But the best thing we can do now, Bob, given the circumstances with the company in England is for those of us who are younger and healthy, don‘t get a flu shot.

…”We have a (vaccine supply) system that is the best in the world, but it’s rather fragile,” says Bruce Gellin, assistant professor of preventive medicine at Nashville’s Vanderbilt University and director of the National Network for Immunization Information. “Unless we start paying attention to it, we might find ourselves in a crisis situation.”

…”If you had to pick a vaccine whose infrastructure is shaky,” says [Paul Offit, chief of infectious diseases at Children’s Hospital in Philadelphia], “it would be the influenza vaccine.”

Chiron, in a shift from last year, invested heavily this year in lobbying federal officials now investigating its role in the flu vaccine meltdown.

It poured $660,000 into currying favor with Congress and the Health and Human Services Department in this year’s first half, public documents show. That is nearly five times what it spent all last year.
…Chiron is bolstering its defenses in other ways. It hired former federal prosecutor Robert Bennett, one of Washington’s power hitters, to lead its defense against the investigation and shareholder lawsuits. Bennett defended President Clinton against Paula Jones’ sexual-harassment lawsuit. His team at Skadden Arps Slate Meagher & Flom includes Colleen Mahoney, a former deputy director at the Securities and Exchange Commission, where she worked 15 years, and Sheila Birnbaum, an expert on product liability litigation…

“This shortage is a call to action,” Dr. Julie Gerberding, director of the Centers for Disease Control and Prevention…

… “There’s not a lot the government can do,” said [Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases], the government’s leading expert on infectious diseases. “Let’s talk about prices, the costs of vaccines. People are willing to spend hundreds of dollars on a drug they need to take, but they’re only willing to spend a few dollars on a vaccine.” …Incentives need to be provided for the industry to make vaccine production less risky, Fauci said.

Tommy Thompson, the secretary of the Department of Health and Human Services … [says:] “”I must reiterate the need for all of us to pursue more modern and efficient ways to produce flu vaccine… In the past two budgets, I have asked for $100 million to shift development to new cell culture technologies for making influenza vaccine, as well as to provide for the year-round availability of eggs for egg-based vaccines.” […he only received half that amount…]

“We’re in the middle of a crisis that could have been averted,” said Dr. Irwin Redlener, associate dean of the Mailman School of Public Health at Columbia University and director of its national center for disaster preparedness.

…Dr. Jesse Goodman, director of the branch of the Food and Drug Administration that oversees vaccines, acknowledged that it was risky to have only one or two suppliers for products so essential for public health. “The more quality, licensed manufacturers we have, the more protected the system is if a problem occurs with one of them,” he said.

…When companies began to leave the market, Dr. Redlener said, government health officials should have tried to find ways to keep them in it, in order to avoid shortages and dependence on too few suppliers.

Bill Pierce, a spokesman for Health and Human Services Secretary Tommy G. Thompson, acknowledged that vaccine supplies in the United States were vulnerable to disruptions. But he blamed years of neglect by previous administrations.

…The government cannot force companies to make vaccines, however. Legally, of course, manufacturers are free to quit the business. But, Dr. Redlener said, “When there is a vital public health issue at stake here like protection against the flu, that’s not good enough.” The government, he added, “had an ethical obligation to work with manufacturers.”

…At a news conference on Tuesday, the director of the Centers for Disease Control and Prevention, Dr. Julie L. Gerberding, apologized for the vaccine shortage, but had little to offer the public beyond a plea to people who get sick to stay home and cover their mouths when they cough.

“We’re sorry for the people who need flu vaccine and may not be able to get it this year,” Dr. Gerberding said. “That’s disappointing for all of us.”

…The problems this year are not a surprise. Indeed, on Sept. 28, exactly one week before Chiron’s license was suspended, the Government Accountability Office offered a prescient warning of potential disruptions in the flu vaccine supply. (PDF: Flu Vaccine: Steps Are Needed to Better Prepare for Possible Future Shortages)

With few suppliers, the report said, if one’s production was cut off there would be great imbalances, with some providers unable to vaccinate even those at highest risk and others able to hold mass immunization clinics even for people at low risk.

The report said that even though the disease control centers had begun monitoring the projected supply of flu vaccine more aggressively since the shortages of 2000, “there is no system in place to ensure that seniors and others at high risk for complications receive flu vaccinations first when vaccine is in short supply.”

[companies pulled out because of strict regulations that would have required unprofitable factory upgrades…] But Dr. Goodman of the F.D.A. defended its policies, saying that they were the “gold standard” for safety worldwide and that if companies could not measure up or chose not to, it might be better for them to pull out…

…The basic problem is that “we’ve lost most of our domestic manufacturers” of flu vaccine, said Richard Webby at St. Jude Children’s Research Hospital in Memphis. “When you’re relying on two manufacturers … and one goes down, you’re up the creek.”
[…suggestions for dealing with future problems…]