Flu Vaccine Distribution Flawed, CDC Contends

By Stephen Smith, The Boston Globe

Jan. 25–ATLANTA — The nation’s top disease tracker yesterday acknowledged that there are significant flaws in the flu vaccine-distribution system in the United States and pledged to consider expanding the federal government’s role in buying and tracking shots.

For the current flu season, the US Centers for Disease Control and Prevention bought about 11.5 million doses — out of 86 million produced by private manufacturers — with much of it then resold to state health departments.

“Since we don’t own the supply, it’s very difficult for us to put our weight behind supporting appropriate distribution,” said Julie Gerberding, CDC director, speaking at a major summit on the flu vaccine supply and its distribution. “Certainly,” she said, “government could purchase more vaccine.”

Next year, manufacturers are likely to produce as many as 120 million shots, company representatives disclosed yesterday at the Atlanta summit.

But doctors and public health authorities voiced continued concern about the patchwork system of public agencies and private doctors, pharmacies, and big-box retailers that now provide flu vaccine.

Health authorities said they are particularly dismayed by the failure to establish a network that would follow every shot from the time it left a manufacturer to the time it was administered. Those worries loom larger amid fears that a global epidemic could be ignited by the avian flu virus, which has infected millions of birds and more than 100 people in Asia and Eastern Europe.

“God help us if we have a pandemic with a distribution system as disorganized” as the current system, said Don Williamson, state health officer in Alabama. “There has to be some organized system to know where vaccine is and the ability to move it around.”

A detailed tracking system, public health officials and doctors said yesterday, has the potential to ease a persistent supply-demand mismatch that results most years in millions of vaccine doses being squandered.

The CDC is studying such a tracking system, and summit participants are expected to offer recommendations on how a network could be structured.

But Dr. Raymond Strikas, a leading flu vaccine specialist at the agency, acknowledged that further discussions with vaccine makers and distributors are necessary before a registry could be implemented.

“It’s a challenge we have to work on with them,” Strikas said. “What will happen this fall, I’m not sure. It’s too easy to say, ‘We’re working on it.’ But we’re working on it.”

Pharmaceutical industry executives have long expressed fears that providing the CDC with too much information might jeopardize their competitive edge. And when Williamson yesterday asked a panel of manufacturers and distributors whether they would be willing to provide health agencies with information on shot orders, he was greeted mostly with silence.

Jennifer Alfisi, an executive with the Health Industry Distributors Association, said her industry is concerned that providing information to the CDC could breach confidentiality agreements with doctors, who may not want details of their practice disclosed to the government. But association members are discussing how they can be more helpful.

Flu, and its complications, kills about 36,000 people in the United States each year, mainly the elderly and younger patients whose ability to fight disease was already compromised. And the expansion of flu vaccinations has been hailed as a public health triumph: Two decades ago, the number of doses given each year was under 20 million.

But efforts to expand flu shot campaigns have been hobbled by economic and scientific challenges.

In recent years, drug makers abandoned the flu vaccine business, leaving just two companies, Chiron Corp. and Sanofi Pasteur Inc., supplying shots to the United States in 2004. That year, British regulators shuttered Chiron’s plant, spawning a severe shortage.

Patients clamoring for shots lined up at pharmacies in 2004, and a third drug maker, GlaxoSmithKline Inc., sensed opportunity and in 2005 began providing flu shots. “The message from our organization is we are committed,” said Andrew MacKnight, an executive at Glaxo, which expects to increase its production for the US market from about 7.5 million doses for the current flu season to as many as 30 million doses for the next.

But even with the addition of Glaxo, doctors and patients had trouble finding shots. That was largely because Chiron did not begin shipping vaccine for this flu season until October, providing just 14.6 million doses — substantially less than originally projected.

The result: “It was a huge betrayal of trust for physicians having to address their patients and saying, ‘It’s coming, it’s coming, it’s coming,’ ” said Robin Flagg, an executive with the California Medical Association. “And then it never came.”

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