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As Pandemic Concerns Grow, White House Aims to Boost Vaccine Production at Home

Wall Street Journal
October 6, 2005
By Bernard Wysocki Jr

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WASHINGTON -- Amid growing concerns about bird flu spreading to humans, the Bush administration says it plans to bolster vaccine production in the U.S., purchase huge quantities of antiviral drugs and lay out a detailed system to coordinate federal, state and local response efforts to a pandemic.

In an interview, Health and Human Services Secretary Michael Leavitt said an administration plan to be put forth in coming weeks is designed to ensure a far more robust domestic vaccine industry, with expanded U.S. manufacturing capacity. White House and congressional officials have said the request to Congress will be in the range of $6 billion to $10 billion.

The U.S. once boasted a large vaccine industry. But in recent decades drug makers have exited the business, for reasons including low profit margins, exposure to lawsuits and manufacturing difficulties. As a result, the U.S. has lost much of its capacity to produce vaccines for seasonal flu, leaving it largely dependent on a plant in Pennsylvania, which is owned by Paris-based Sanofi-Aventis Group.

Increasingly, bird flu, or avian influenza, has stoked worries among world health officials of a global pandemic as it has devastated poultry flocks in Asia and begun spreading to migratory birds and humans. Since late 2003, more than 60 human deaths in Asia have been blamed on the current strain of the flu, known as H5N1.

Adding to the concerns, a group of scientists yesterday said they had shown that the 1918 Spanish flu epidemic blamed for 50 million deaths had started among birds and then mutated and spread to humans. (See related article.8)

Researchers said the discovery, while frightening in its implications, also could help researchers track and perhaps contain a major outbreak. "We have been able to unmask the 1918 virus, and it's revealing to us some of the secrets that will help us prepare for a pandemic," said Julie Gerberding, director of the Centers for Disease Control and Prevention.

That process is very much a work in progress, officials admit. "We are not prepared for a pandemic, and it is important that we become prepared," said Mr. Leavitt, who has become the administration's point person on the subject, immersing himself in the issue and in the history of pandemics. "Pandemics require the full measure of our attention. We have to improve our readiness."

There remains considerable uncertainty about a possible pandemic. It's unclear whether human-to-human contact of the virus ever will be widespread. Even if that happens, advance preparations could be effective or futile depending on how the virus mutates. Mr. Leavitt noted that he had studied carefully the swine-flu episode of 1976, which despite widespread fear, didn't turn into a devastating killer.

Efforts to develop a vaccine for the H5N1 strain are continuing. In August, the National Institutes of Health reported that the first human trials of an avian-flu vaccine made by Sanofi-Aventis were effective.

But at the time, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, cautioned that many hurdles remain before a vaccine will be available for widespread use, including producing enough to meet potential demand.

The administration already has received much attention for its effort to have 20 million treatments of an avian-flu vaccine stockpiled and on hand to inoculate U.S. citizens. Sanofi-Aventis has received six contracts to develop and manufacture some quantity of its vaccine, including a $100 million award in September to bolster the manufacturing capacity for avian-flu vaccine in the U.S.

Mr. Leavitt didn't discuss many other details of his plan, but said he plans to put in place a comprehensive surveillance system to track the pandemic. He is traveling to Southeast Asia next week to countries grappling with the flu.

In the wake of criticism over its response to Hurricane Katrina, the administration is taking pains to highlight its efforts to prepare for a possible pandemic. In recent days, several prominent Democrats have accused the White House of failing to prepare for a pandemic. President Bush spoke at length on pandemic flu plans during a news conference Tuesday, discussing a possible quarantine of citizens -- perhaps even using the military -- and saying he is in touch with NIH.

Besides Sanofi-Aventis, a number of big drug companies could benefit from the expanded effort being pushed by the administration and Congress. Switzerland's Roche Holding AG, for instance, has received orders from more than 30 countries for treatments of Tamiflu, an antiviral medicine that is in high demand but short supply. Most of the big orders would be staggered over two to three years, analysts say.

The administration also plans to buy 20 million doses of Tamiflu for the U.S., though Mr. Leavitt wouldn't specify how or when they would be available. Today, the U.S. has enough Tamiflu on hand to treat 4.3 million people. (The department also recently agreed to spend $2.8 million for quantities of another antiviral made by GlaxoSmithKline.)

There has been some controversy around Tamiflu, and Mr. Leavitt, a former three-term governor of Utah and ex-head of the Environmental Protection Agency, said he considered purchasing the drug to be akin to an automobile seat belt.

"It doesn't eliminate wrecks but it helps you survive when they occur," Mr. Leavitt said. He said he was aware about recent scientific reports suggesting that Tamiflu might be only modestly effective against the H5N1 virus.

Roche doubled manufacturing capacity of Tamiflu in 2004 and again in 2005 and said it will further increase manufacturing capacity in 2006. "We're bringing manufacturing capacity to the U.S. for the first time at a number of facilities," said spokesman Terence Hurley. "We'll now have the capability to produce Tamiflu from start to finish for the first time on U.S. soil this quarter. That's important if borders are closed; HHS asked us to do this."

Indeed, Mr. Leavitt said there needs to be a focus on producing vaccines in the U.S. so as to potentially prevent the infection instead of treating those already infected. Today, the only major flu-vaccine manufacturing facility in the U.S. is the Swiftwater, Pa., plant owned by Sanofi-Aventis, which produces seasonal flu vaccines.

One U.S. company, Emoryville, Calif.-based Chiron Corp. produces flu vaccine for the U.S. at a United Kingdom plant, although that supply was curtailed last year after contamination problems surfaced at the plant. In addition, MedImmune Inc., of Gaithersburg, Md., produces an inhaled flu vaccine, for healthy people ages 5 to 49. Last week, MedImmune said it will work with NIH to develop a vaccine to be used against strains of influenza that could cause widespread outbreaks, including avian flu that has appeared in Southeast Asia.

Though infectious diseases are huge killers, with about 35,000 to 40,000 Americans dying each year from seasonal flu, big drug companies are largely ignoring investing in vaccines. Instead, they are placing their bets on chronic diseases or on lifestyle drugs with big profit potential, resulting in a growing public-health problem.

HHS officials warn that tight vaccine supply could be further strained if needs for seasonal flu occur at the same time a pandemic requires huge extra production to meet a crisis. Experts also say a beggar-thy-neighbor policy could occur in a crisis, in which governments "nationalize" their supplies, so that non-U.S. production would quickly be grabbed by those countries and unavailable outside their borders.

Congress already has been taking up the U.S.'s lost vaccine production capacity. A bill introduced this summer by Sen. Judd Gregg, a New Hampshire Republican, would give liability protection to drug companies that produce either biodefense drugs or countermeasures to combat pandemic flu. Other plans would give tax breaks to companies that make vaccines. Some members of Congress are proposing laws that would offer the same incentives for companies to develop countermeasures against either man-made or naturally occurring pathogens such as flu.

An important part of the government's plan, Mr. Leavitt said yesterday, is to clearly delineate the roles of federal, state and local officials in the event of a pandemic crisis -- a source of much contention in the response to Hurricane Katrina.

"What if this were happening in Seattle and Portland, Maine, and Chicago and Omaha and Santa Fe and Miami and Austin and Salt Lake City and 500 other places -- all at the same time?" Mr. Leavitt said. He said that response would have to be managed by local public-health authorities, not by the CDC, which is based in Atlanta.

He also said, though, that state and local preparations need bolstering, quickly. Last December, Trust for America's Health, a nonprofit advocacy group based in Washington, concluded that only six states had achieved "green" status for the Strategic National Stockpile, meaning they were adequately prepared to distribute vaccines and antidotes in an emergency. It found that two-thirds of the states can't track diseases electronically and 60% of states don't have the scientists needed to test for anthrax or plague.

--Marilyn Chase contributed to this article.

Write to Bernard Wysocki Jr. at bernie.wysocki@wsj.com10

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