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HHS Buys Vaccine, Antiviral to Combat Potential Flu Pandemic

Secretary voices support of International Partnership on Avian and Pandemic Influenza

Sept. 15, 2005 - HHS Secretary Mike Leavitt today announced the purchase of vaccine and antiviral medications that could be used in the event of a potential influenza pandemic. He also affirmed his commitment to the International Partnership on Avian and Pandemic Influenza announced by President Bush yesterday at the United Nations General Assembly.

(Read the statement on the international partnership below news story)

 

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The department has awarded a $100 million contract to sanofi pasteur, the vaccines business of the sanofi-aventis Group, to manufacture avian influenza vaccine designed to protect against the H5N1 influenza virus strain, which has caused an epidemic of avian flu in Asia. The number of individuals who could be protected by the newly contracted vaccine is still to be determined by ongoing clinical studies.

In addition, HHS has awarded a $2.8 million contract to GlaxoSmithKline for 84,300 treatment courses of the antiviral drug zanamivir (Relenza).

These purchases build on the department’s plans to buy enough vaccine for 20 million people and enough antivirals for another 20 million people. These supplies of vaccine and antiviral treatment will be placed in the nation’s Strategic National Stockpile where they will be available for use should an influenza pandemic occur.

“These countermeasures provide us with tools that we have never had prior to previous influenza pandemics,” Secretary Leavitt said. “Never before have we possessed the wealth of knowledge on the problem and the ability to prepare for it. These new contracts are part of our aggressive, multi-pronged approach to planning for pandemic influenza.”

Initial clinical studies of the sanofi pasteur vaccine in humans have shown that two 90-microgram doses of the vaccine are required to stimulate a level of immune response that researchers anticipate would provide protection for an individual against the H5N1 strain that has been spreading among birds in Asia. However, further clinical testing is underway, including the evaluation of techniques that may reduce the amount of antigen (active ingredient) per dose needed to achieve effective individual protection. The H5N1 strain is considered a potential threat that could lead to a global human influenza pandemic.

The agreement with GlaxoSmithKline will provide HHS with an initial supply of zanamivir, an antiviral medication that is effective in reducing the severity of symptoms of human seasonal influenza. This antiviral purchase builds upon HHS’ efforts to stockpile oseltamivir (Tamiflu), another antiviral medication that is effective in treating the symptoms of human seasonal influenza. The H5N1 virus that is circulating in Southeast Asia appears to be sensitive to the antiviral activities of these drugs. HHS has received the full shipment from this order.

Earlier this year, Secretary Leavitt established an HHS-wide Influenza Task Force to coordinate all HHS activities affecting the public health preparedness for seasonal influenza outbreaks and an influenza pandemic. Long term objectives include an effective and efficient global surveillance network for outbreaks of influenza-like illness in humans and animals, and interoperable local, state, and federal government response plans for influenza outbreaks within the United States -- including strategies and plans for effective coordination with response partners, public and private and timely communication with the public.

These investments are part of a comprehensive U.S. approach to prepare for an influenza pandemic. HHS supports pandemic influenza preparedness in several other areas such as enhanced surveillance in Southeast Asia and improved vaccine production methods and capacity. These measures can provide early warning and additional time for vaccine production should a pandemic emerge.

Evacuees staying in a home or church that has access to the Internet, or who can visit a nearby public library with Internet access, can also get information on available benefits by going to www.govbenefits.gov.

Statement by Mike Leavitt Secretary of Health and Human Services

International Partnership on Avian and Pandemic Influenza United Nations General Assembly

I’m pleased to affirm my commitment to the International Partnership on Avian and Pandemic Influenza announced by President Bush yesterday at the United Nations General Assembly. The announcement was a critically important step in our collective efforts to prepare for a possible influenza pandemic. The partnership will help us improve international surveillance, transparency, timeliness and response capabilities. It is one of many, many steps we must take to reduce the risk of suffering and loss of life because of a flu pandemic.

The human cost of an uncontained influenza pandemic would be heart-wrenching. We have a humanitarian obligation at all levels of government, and as individuals, to do our part to be prepared now and respond rapidly, once a threat presents itself. Our actions are guided by a sense of perspective about the seriousness of this situation. The probability of a pandemic occurring soon is uncertain, but the signs are worrisome.

An influenza virus strain with potential to harm millions of people around the world could emerge with little or no warning, at any time, in almost any part of the world. When a pandemic virus strain emerges, even if the infection rate is no higher than the 10-20 percent we see in most regular flu seasons, millions of people could be infected and a substantial number of lives could be lost.

To date, the avian flu has spread to 10 countries and led to the death of over 140 million birds. Through migratory birds the virus has now spread to Russia and is approaching Europe, with no sign of slowing.

Of greatest concern is that the virus has shown an ability to infect people. Half of the 112 persons who have been affected have died. If the spread of the virus becomes efficient and spreads person to person -- like the seasonal flu -- an unprecedented pandemic could occur. There is no pre-existing human immunity to this virus. None. Which is why pandemics can be so devastating.

Pandemics are not new to us: three swept the globe in the past Century: 1918, 1957 and 1968. The 1918 flu killed approximately 20-40 million people worldwide. It was a global health catastrophe. Our task now is to make sure that when the next pandemic strikes, as it surely will, that the global community will be ready and the global network deployed.

Pandemics are diseases without borders. The influenza virus will not respect political or geographic boundaries -- a threat against one nation is a threat against the entire world.

This is why this International Partnership is so important. The Partnership recognizes that we live in a global network. Pathogens take advantage of this network to spread from one corner of the globe to another with record speed. We have to use this same global network -- our connection one to another -- to detect and contain the threat. Computer-to-computer, person-to-person, in the global network, speed is life.

On the international front, we must have complete transparency. We must have joint rapid response capabilities. We must conduct cooperative surveillance. We must share epidemiological data and samples with each other and with the World Health Organization. We must have commitment from the highest political levels in countries around the world to adhere to these principles. And we must use our collective best science to protect our people -- the world’s people.

I will be leading a delegation from the U.S. next month to Thailand, Cambodia, Laos and Vietnam to meet with Heads of States and Ministers of Health. I will be seeking their critical involvement and personal commitment to preparedness and response.

State Department Under Secretary Dobriansky will be coming with me, and I have also invited Dr. Lee, Director General for the World Health Organization, to join us. I am reaching out to the heads of the United Nations Food and Agriculture Organization and the World Animal Health Organization to see if they might be able to come with us as well.

In Southeast Asia, I will be negotiating agreements with the most-affected nations to offer assistance to build their capacity to identify outbreaks and respond rapidly when needed. We feel a common and genuine sense of urgency.

Here in the United States, we have adopted a simple rule for our preparedness: prepare as if the pandemic strikes tomorrow. This way, we do everything we can, everyday, to be ready. And, our job is never done; we can always do more.

We’ve all learned in the past few weeks, that bad things can happen very fast. This is why the new International Partnership on Avian and Pandemic Influenza is so critical. We simply must improve global readiness in an unprecedented way. Through these and other efforts, we will respond to this threat and do our part to improve our readiness, with the ultimate goal of reducing suffering and loss of life.

Evacuees staying in a home or church that has access to the Internet, or who can visit a nearby public library with Internet access, can also get information on available benefits by going to www.govbenefits.gov.

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