Bird flu in US Bush asked Congress for $7,1 billion to fund preparations - 15 march 2006 - 13:55
BIRD FLU - President Bush asked Congress for $7.1 billion to fund preparations, and in December 2005 Congress appropriated $3.8 billion to help the Nation prepare. Of that, $3.3 billion was allocated to HHS. This report outlines how that funding is being used to help achieve HHS's five primary objectives.”We are in a race. We are in a race against a fast moving virulent virus with the potential to cause an influenza pandemic. In November when President Bush announced the National Strategy for Pandemic Influenza, the highly pathogenic H5N1 avian flu virus was confirmed in birds in 16 countries. It was known to have infected 122 people and 62 – half of those infected – died.
Today, four months later, H5N1 has spread to 37 nations on three continents; 175 people have been infected and 96 of them have died. To date, most of those people were exposed to infected poultry. Fortunately, there has been no sustained human-to-human transmission of the disease, but the rapid spread of H5N1 is reason for concern. We are in a race, a race against a quick changing virus, for H5N1 has not only spread, it has evolved.
Bird flu in US Bush asked Congress for $7,1 billion to fund preparations
There are now two main variants, or clades, of H5N1 and it is this second, newer clade that is spreading across western Asia into Europe, the Middle East and Africa. This second clade has killed over 60 percent of those it is known to have infected.Countries with Avian Influenza and Cumulative Human Deaths - Bar Chart me be very clear. It is only a tter of time before we discover N1 in birds in America. The gration patterns of the wild l that carry the virus make its pearance here almost inevitable. e arrival of the first H5N1 bird America should not be cause alarm or panic. It does not an that a pandemic is at our orstep. It should, however, tivate us to pick up the pace, to ew pandemic preparations on ry front at every level.
Message from the Secretary Michael Leavitt, HHS “Flu Terms DefinedSeasonal (or Common) flu is a respiratory illness thatcan be transmitted person to person. Most people havesome immunity, and a vaccine is available.Avian (or bird) flu is caused by influenza viruses thatoccur naturally among wild birds. The H5N1 variant is deadly to domestic fowl and can be transmitted from birds to humans. There is no human immunity and novaccine available.Pandemic flu is virulent flu that causes a globaloutbreak, or pandemic, of serious illness. Because thereis little immunity, the disease can be spread easilyfrom person to person. Currently, there is no pandemicflu.” “Let me be clear. It is only a matter of time before we discover H5N1 in America. The migration patterns of the wild fowl that carry the virus make its appearance here almost inevitable.” “President Bush asked Congress for $7.1 billion to fund preparations, and in December 2005 Congress appropriated $3.8 billion to help the Nation prepare. Of that, $3.3 billion was allocated to HHS. This report outlines how that funding is being used to help achieve HHS's five primary objectives : Monitoring disease spread to support rapid response ; Developing vaccines and vaccine production capacity ; Stockpiling antivirals and other countermeasures ; Coordinating federal, state and local preparation ; Enhancing outreach and communications planning.”
“We are in a race, a race against time and complacency. There is a role for everyone and we must count on everyone to fulfill their role. By definition a pandemic is defined as a global event. In reality, a pandemic is a local crisis worldwide. It can happen in every state and every city and every town at almost the same time. A pandemic is not like a hurricane or an earthquake, where resources and help can be shifted from one area to another. Should it occur, every community will need to rely on its own planning and its own resources as it fights the outbreak. Preparation is a continuum. Each day we prepare brings us closer to being ready. We are better prepared today than we were yesterday. And we must be better prepared tomorrow than we are today.”
Pandemic Influenza Plan Funding - 2006 Appropriations: HHS Allocation ($3.3B) (Dollars in Millions) Pie Chart“We are better prepared today than we were yesterday. And we must be better prepared tomorrow than we are today.” “Our first line of defense is early detection. It is critical that we know immediately if the H5N1 influenza virus becomes capable of sustained human-to-human transmission. Early detection will give us the opportunity to respond, to attempt containment and to quickly gain the virus samples necessary for the development of a true pandemic vaccine. Early detection is a race against time. Containing or slowing an influenza pandemic demands that a nascent outbreak anywhere in the world be recognized and confirmed within 1 to 2 weeks.”
“This is a big job. For HHS, it means putting experts on the ground in numerous nations spread across a vast landscape. It means working shoulder to shoulder with our federal colleagues. Early detection requires international collaboration. It means working closely with the World Health Organization (WHO), the United Nations Food and Agriculture Organization, the World Organisation for Animal Health, the Institute Pasteur, and numerous national governments. Together, we are tracking the spread of the disease, conducting epidemiological studies of human infection, training local specialists and providing them with the tools for early and accurate detection. CDC and USAID will soon enter into an agreement with the Wildlife Conservation Society to provide additional monitoring.”
“In February, the FDA approved a new laboratory test capable of diagnosing H5N1 influenza strains within four hours of receiving a sample. The new test cuts days from the time needed to confirm human infection. FDA is also providing scientific and regulatory assistance to diagnostic manufacturers to speed the development and deployment of new detection products.”
$258M Map showing H5N1 in wild birds, poultry and birds humans“For a couple of weeks, it was raining dead swans all over Europe.” –Jan Slingenberg, UNFAO As the avian infection moves closer to America, the Departments of Agriculture, Interior and Health and Human Services are stepping up the monitoring and testing of migratory birds. This surveillance is essential to provide early warning so the disease does not spread to people, poultry and pets and to insure the safety of the nation's food supply. To monitor possible human infection, CDC is strengthening local laboratory capacity and capability, improving reporting systems and accelerating implementation of the national BioSense program, which collects real-time data from hospitals and other clinical-data sources.”
For him, “The best defense against influenza is vaccination. It is also the most difficult defense to achieve. A fully effective vaccine cannot be developed until the virus strain it must protect against has evolved and been identified. And once developed, there must be the production capacity to manufacture enough vaccine to protect the population. HHS, through its National Institute of Allergy and Infectious Diseases (NIAID), is addressing the problem in a number of ways. These include the development of pre-pandemic vaccines based on current lethal strains of H5N1 and collaboration with industry to increase the Nation's vaccine production capacity, as well as seeking ways to expand or extend the existing supply. We are also doing research in the development of new types of influenza vaccines.”
At the International Pledging Conference on Avian and Human Influenza in Beijing in January 2006, the US committed $334 million in US grants and technical assistance to aid global effort. $1,781M. In early 2004, NIAID researchers applied a technology called reverse genetics to the H5N1 virus isolated from a patient in Vietnam to create an H5N1 reference vaccine strain. Working with industry, NIAID was able to create an inactivated H5N1 virus vaccine for clinical testing. In this testing, conducted in the summer of 2005, the vaccine induced an immune response predictive of protection against the H5N1 virus. We then contracted with two companies to manufacture nearly 8 million doses of this vaccine for strategic stockpiling. Vaccine for a Changing Virus
“However, all influenza viruses evolve, or “drift” genetically over time. By 2005/2006 winter the H5N1 strain had drifted enough to result in a second distinct strain of H5N1. This strain, also lethal, is now circulating in Europe, Africa and parts of Asia. Its appearance dictates that we begin developing a second pre-pandemic vaccine.”
The CDC has already taken the first step by producing the reference virus that will serve as a seed from which a second vaccine might be developed. It is probable that H5N1 will continue to evolve, making it necessary to develop a series of vaccines. There is simply no way to predict which strain, if any, might produce a virus capable of mass human-to-human transmission – or which vaccine will be most effective against it. For this reason it is prudent to maintain stockpiles against each of the main circulating H5N1 strains.
In March, FDA released draft guidance for clinical data that are needed to show safety and effectiveness for new seasonal and pandemic influenza vaccines. The FDA also outlined an approach for an accelerated approval of these vaccines.
Because Tamiflu is also approved for prevention, treatment for an additional 6 million people is also being stockpiled. This will be used in an effort to help contain a first outbreak of potential-pandemic influenza. The concept is to blanket the area of the initial outbreak, giving Tamiflu to as many people as possible to prevent the flu's spread before it gets out of control. In March, HHS purchased more than 14 million courses of Tamiflu and Relenza, which will increase the national inventory to nearly 20 million courses. The total targeted stockpile is 81 million courses by the end of 2008. HHS will purchase 50 million out right and subsidize (by 25 percent) the states' purchase of 31 million courses. (A course is the number of doses needed to treat one person – ten capsules in the case of Tamiflu.) Antivirals will be distributed among the states and territories on a per-capita basis.
FDA is monitoring Tamiflu shipments to identify potential counterfeits, and is actively investigating companies selling fraudulent, unapproved influenza products. The immediate goal is to stockpile enough antivirals to treat 20 million people. The longer-term goal is to be able to treat 75 million people, or 25 percent of the U.S. population. Influenza viruses can develop resistance to antivirals over time. New antivirals will be needed in the event H5N1 develops resistance to Tamiflu or Relenza. We are committing $200 million to the development of additional antivirals. HHS expects to request formal proposals later this spring and to award contracts for the advanced development of promising antivirals by September 2006. It is not enough to stockpile antivirals; there needs to be a plan to distribute them. HHS is discussing with the states whether the antivirals should be centrally located or warehoused locally. To receive funding, 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. In addition to stockpiling antivirals, $162 million will be used to procure essential medical supplies for a pandemic. Planned purchases this year include 6000 ventilators, 50 million surgical masks, 50 million N95 respirators, and face shields, gloves and gowns.
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