Leavitt vows action on flu vaccine technology

Mar 15, 2006 (CIDRAP News) – Health and Human Services (HHS) Secretary Mike Leavitt, reporting this week on preparations for a possible influenza pandemic, promised to act soon to boost US flu vaccine production capacity and promote cell-based vaccine technology.

In a 12-page report, Leavitt said HHS will request proposals from the industry next month on ways to boost production with the existing egg-based technology and will award contracts this spring for the development of cell-based vaccines.

In addition, HHS intends to award contracts by September for developing new flu antiviral drugs, he said.

Vaccines claim most funding
Of HHS's $3.3 billion share of pandemic funds appropriated by Congress in December 2005, more than two thirds will go for vaccines and antivirals, according to Leavitt's "Pandemic Planning Update." The emphasis on vaccines and antivirals is in keeping with the thrust of the HHS pandemic preparedness plan published last November.

HHS plans to allocate $1.781 billion to vaccine development and $731 million to antivirals, Leavitt's report says. Other allocations include $350 million for state and local preparedness; $162 million for medical supplies; $133 million for domestic surveillance, quarantine, lab capacity, and rapid tests; $125 million for international activities; and $38 million for risk communication.

The nation currently lacks the capacity to make enough egg-based flu vaccine to supply the entire population, Leavitt noted in his report. "HHS is working with industry to determine ways to increase that capacity, including developing new facilities and expanding production in existing facilities," he wrote. "A request for formal proposals will be issued in April 2006."

He added that cell-based vaccine technology promises to be more reliable, flexible, and expandable than egg-based methods, with which production takes about 6 months. HHS awarded a $97 million contract in April 2005 for development of a cell-based flu vaccine, and the agency expects "to award additional contracts for developing cell-based vaccines this spring," Leavitt wrote. The 2005 contract went to Sanofi Pasteur. When the pandemic plan was released last fall, HHS officials predicted it would take 4 to 5 years to bring cell-based flu vaccines to the point of usability.

In other comments, Leavitt said it will probably be necessary to develop "a series of vaccines" against the H5N1 avian flu virus as it evolves. He noted that HHS has contracted with two companies (Sanofi Pasteur and Chiron Corp.) to make about 8 million doses of vaccine based on a strain of the H5N1 virus that infected humans in Vietnam in 2004. Last week HHS announced plans to begin working on a second "pre-pandemic" vaccine, based on a 2005 strain of H5N1 from Indonesia.

However, in releasing his report this week, Leavitt noted that no vaccine precisely matching the virus will be available for the first 6 months of a pandemic. "We will be dependent upon traditional public health measures to contain and limit it," a Mar 13 Associated Press (AP) report quoted him as saying.

Goals for antiviral drugs
HHS hopes to have 81 million treatment courses of the antivirals oseltamivir (Tamiflu) and zanamivir (Relenza), enough to treat about 25% of the population, by the end of 2008, Leavitt reported. But the states would have to buy 31 million of those courses, with HHS paying 25% of the cost, he said.

Because the H5N1 virus could become resistant to the two drugs, HHS is committing $200 million for developing new antivirals, Leavitt said. "HHS expects to request formal proposals later this spring and to award contracts for the advanced development of promising antivirals by September 2006."

HHS is discussing with the states whether the antivirals should be stored centrally or dispersed around the country, Leavitt reported. To receive their share of pandemic funds, "states are being required to develop distribution plans now, so that if a pandemic erupts, it will be clear where the drugs are to go and how they will get there," he wrote.

In releasing the report, Leavitt said his biggest concern about a pandemic is the problem of rapidly distributing drugs to those who need them, according to the AP report. "Doing anything millions of times is hard. Doing it fast makes it even more difficult," he was quoted as saying.

The report said the $162 million for medical supplies will be used to buy 6,000 ventilators, 50 million surgical masks, 50 million N95 respirators, and face shields, gloves, and gowns.

Sounding a theme he has emphasized in recent state "summit" meetings on pandemic preparedness, Leavitt said that in a pandemic, "Every community will need to rely on its own planning and its own resources as it fights the outbreak."

Of $350 million that Congress appropriated for state and local preparedness, "We are awarding $100 million to states right now," Leavitt wrote. "The remaining $250 million will be distributed later according to benchmarks we establish to monitor progress."

All states are being asked to conduct simulation exercises to test their pandemic plans by the end of this year, he added. States will be invited "to participate in a nationwide pandemic planning exercise within the next 12 months."

Virus expected to reach US
In other observations, Leavitt wrote that the H5N1 virus now exists in two major variants or clades and that the newer clade is the one spreading in western Asia, the Middle East, Europe, and Africa. "This second clade has killed over 60 percent of those [humans] it is known to have infected," he stated.

"It is only a matter of time before we discover H5N1 in birds in America," Leavitt predicted. "The migration patterns of the wild fowl that carry the virus make its appearance here almost inevitable."

On the international front, Leavitt said, HHS is "putting experts on the ground in numerous nations spread across a vast landscape" to help monitor avian flu. But he gave no details on the numbers of people or countries involved.

The Centers for Disease Control and Prevention and the US Agency for International Development will soon sign an agreement with the Wildlife Conservation Society to cooperate on monitoring the virus, the report says.

See also:

Leavitt's "Pandemic Planning Update"
http://www.flu.gov/professional/pdf/panflu20060313.pdf

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