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White House Urges Drug Companies To Increase Vaccine Production

October 10, 2005
The U.S. currently lacks the manufacturing capacity to develop large amounts of flu vaccine on short notice, a potentially deadly shortfall should a feared pandemic outbreak occur.

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Health and Human Services Secretary Michael Leavitt says its no secret that America's ability to produce vaccines is "not where we need it to be."

President Bush met over the weekend with executives from several major pharmaceutical firms, urging them to increase their production infrastructure.

The expression of high-level concern stems not only from worries about the possibility of a bird flu pandemic, but also from last year's loss of half the regular flu vaccine, due to production contamination at Chiron Pharmaceutical's British plant. White House officials say the Bush Administration has been taking steps over the last year to make sure the U.S. is better prepared for a flu outbreak.

"We've been working to expand our antiviral stockpile. We are significantly increasing that stockpile," White House spokesman Mark McClellan said.

McClellan said the major area of concern at the moment is the lack of manufacturing capacity to develop vaccine. He said the president used the weekend meeting with pharmaceutical representatives to make the case for expanded production, so that last year?s supply interruption won't occur again.

Public health professionals, meanwhile, have been sounding the alarm for some time. Dr. Michael T. Osterholm, director of the Center for Infectious Disease Research and Policy, says production of a vaccine would take a minimum of six months after isolation of the circulating strain, and given the capacity of all the current international vaccine manufacturers, supplies during those next six months would be limited to fewer than a billion monovalent doses.

"Since two doses may be required for protection, we could vaccinate fewer than 500 million people -- approximately 14 percent of the world's population," he wrote in a May 2005 article in the New England Journal of Medicine. "And owing to our global 'just-in-time delivery' economy, we would have no surge capacity for health care, food supplies, and many other products and services."

"For example, in the United States today, we have only 105,000 mechanical ventilators, 75,000 to 80,000 of which are in use at any given time for everyday medical care; during a garden-variety influenza season, more than 100,000 are required. In a pandemic, most patients with influenza who needed ventilation would not have access to it," he wrote.

A pandemic could easily make previous flu-related crises look insignificant in comparison. U.S. health officials were thrown into a near panic last year as Chiron announced it had lost half its supply of vaccine, just as the 2004-2005 flu season got underway. The shortage led to a number of charges of price gouging for the remaining vaccine, with at least two states -- Florida and Kansas -- filing charges against distributors.

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