re: something of interest

Dank

Yep another one at it

That story been around for yonks. But as spotty saids even crackpots have a say. But I tend to the line. Get Bent.

They are all naive people who don't know the resemblance of truth if it bit them in the b u m .

But I digress to my facist ways once more.


Dank

On to something quite interesting. I found this on one of my searches. A bit of info about a 200 million dollar pool of money going into developing new antivirals.

LANI spung to mind and I sent the info off to Damian. Submissions are being made now. Heres the whole PDF which i have managed to copy. Sorry about the size.

Cheers



Department of Health and Human Services
Pandemic Planning
Update



A Report from Secretary Michael O. Leavitt
March 13, 2006DHHS Logo“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. 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
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.”
–Secretary Michael Leavitt, HHS
Our Five Priorities
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.
2
Message from the Secretary (continued) 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.
International Collaboration and Monitoring
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.
Detection at Home
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.
3
Monitoring and Surveillance
$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.
Vaccines
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.
4
2004 – H5N1 reference strain created
by reverse genetics from H5N1 virus isolated from Vietnam
April 2005 – RFP for cell-based vaccine contract issued
Summer 2005 – Preliminary results from H5N1
vaccine clinical trials in healthy adults aged 18-64 indicate an
immune response predictive of protection against the H5N1
September 2005 – International Partnership on Avian
and Pandemic Influenza launched
November 2005 – Issuance of HHS Pandemic Influenza Plan
November 2005 – WHO Global Meeting
October 2005 – Southeast Asia fact-finding mission
led by HHS Secretary and State Department
2004 April - November 2005
Monitoring and Surveillance (continued)
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.
5
Vaccines (continued) GraphicDecember 2005 – Passage of the Public Readiness
and Emergency Preparedness Act (PREP Act)
December 2005 – Enrollment for clinical trials with H5N1 vaccine
in healthy adults (>65 years of age) was completed
December 2005 – Convening of States Summit,
in Washington, DC
December 2005 – Release of State and Local
Pandemic Influenza Checklist
December 2005 – Release of
Business Pandemic Influenza
Checklist
December 2005 – First State Summit, Minnesota
December 2005 –Tabletop public affairs exercises with
US Departments and representatives from Canada and the UK
December 2005 –WHO Global Pandemic Communications Meeting
in Switzerland, HHS led US delegation
December 2005
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.
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.
Vaccines (continued)
6 Graphic of Increased Vaccine Supply Increasing Vaccine Capacity
The current U.S. capacity for manufacturing egg-based vaccines is not sufficient
to supply our entire population. HHS is working with industry to determine ways
to increase that capacity, including developing new facilities and expanding
production in existing facilities. A request for formal proposals will be issued in
April 2006.
The threat of liability has been a major obstacle to developing a strong domestic
vaccine industry. HHS worked with the Department of Justice and Congress
to address the problem. As a result, Congress adopted legislation (PREP Act)
providing industry with limited liability when meeting a declared public health
emergency.
Current egg-based vaccine manufacturing methods are complex, difficult to
expand rapidly to meet increased demand, and subject to failure if the vaccine
strain does not grow efficiently in eggs. HHS is supporting research into cell-
based vaccine manufacture, which holds the promise of a reliable, flexible, and
easily scalable method of producing vaccine domestically. In April
2005, HHS announced a $97 million contract for the development of
cell-based flu vaccine, and we expect to award additional contracts
for developing cell-based vaccines this spring.
There is also research into ways to increase the effectiveness
of vaccines by exploring antigen-sparing technologies such as
adjuvants, substances that increase either the efficacy or potency
of a vaccine. If successful, they extend a given supply of vaccine to
protect more people.
If a pandemic occurs prior to licensure of a vaccine, the FDA can use its
Emergency Use Authorization authority to permit the use of unapproved
products (or to permit unapproved uses for previously approved products) if
there’s a reasonable belief the products may be effective and if the benefits
would outweigh risks.
January 2006 – Roughly 5 million courses in SNS stockpile
January 2006 – 6 State Summits AZ, VT, WV, RI, GA, KY
January 2006 – RFI issued on advanced
development of promising antivirals
January 2006 – RFI issued on increasing
egg-based vaccine capacity
January 2006 – Release of Individuals and
Families Pandemic Influenza Checklist
January 2006 – Bilateral teams sent to Turkey, Armenia, Azerbaijan,
Georgia, Romania, Ukraine and Nigeria to assess avian flu outbreaks
January 2006 – International Pledging Conference in Beijing;
$334M in US grants and technical assistance to aid global effort
January 2006 –Tokyo WHO conference to draft WHO pandemic plan
January 2006
January 2006 – First State Summit with signing of a
Planning Agreement, Vermont
Antivirals are drugs that lessen the impacts of flu. There are currently two
FDA-approved antivirals that have shown effectiveness against the H5N1
virus, Tamiflu, and Relenza. Both must be taken within 48 hours of the onset of
flu symptoms. (Note that there are two other approved flu antivirals, but CDC
studies show H5N1 to be resistant to them.)
We are building a national stockpile of these two antivirals. 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. Achieving this goal depends on future pandemic flu appropriations,
manufacturing capacity and participation by the states.
Antiviral Stockpiling
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.
7
Antivirals
$731M
Antiviral Purchases12/08 81 million courses12/06 26 million courses03/06 20 million courses** a course is the number of doses needed to treat one person.
February 2006 – 11 State Summits CT, IA, MA, FL, OH, NV, DE, AL,
MO, NE, MD
February 2006 – Enrollment in a pediatric H5N1 vaccine
clinical trial (children aged two to nine years) was completed
March 2006 – RFP to be issued on
advanced development for antigen
sparing technologies
January 2006 – Release of Faith-based & Community
Organizations Pandemic Influenza Checklist
February 2006 – Risk Communications Preparedness
Workshop hosted by CDC in Thailand
February 2006 – Meeting with UN Coordinator for avian and
pandemic influenza on how to best assist UN efforts
February 2006 March 2006
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.
New Antivirals Needed
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.
State and Local Preparedness
State and local preparedness is the foundation of pandemic readiness.
The challenges that we will face in a pandemic will be vastly different from
other response situations. An influenza pandemic is likely to occur almost
simultaneously across countries and communities. It will demand that every
aspect of our communities be self-sufficient, able to deal with the outbreak of
illness should it hit. Political leaders, employers, school leaders, healthcare
leaders, faith-based and community organizations, families and the media must
all be informed, engaged, and actively involved.
8
Antivirals (continued)
We are committing
$200 million to
the development of additional antivirals.Congress allocated $350 million this year to assist local and state preparedness. Pie ChartMarch 2006 – 20 State Summits SC, SD, ND, WY, WI, PA, IL, Wash DC,
NC, VI, VA, IN, PR, CO, UT, ID, TX, NM, OR, CA
March 2006 – Purchase of 12.4 million courses of Tamiflu and
1.75 million courses of Relenza
March 2006 – Guidance released on State purchase of Antivirals
with a 25% Federal Subsidy
March-April 2006 – Expected contract award for cell-based vaccine
March 2006 – Release of Home Healthcare Checklist
March 2006 – Pandemic Flu Supplemental Guidance sent to states
March 2006 – States receive initial grant funding
for pandemic preparedness
March 2006 Mar-Apr 2006
To that end, President Bush directed and we convened a state and local
preparedness process. We are working to help states, tribes, cities, schools,
businesses, churches, and families throughout our nation plan for these unique
challenges. We are collaborating with governors’ offices in every state to hold
pandemic planning summits and exercises. To date, we have completed 23
summits and planned an additional 20: we expect to visit the remaining states
and territories this spring (see map). I am hearing from governors and local
officials that the summits are helpful, and the process is working.
Congress allocated $350 million this year to assist local and state preparedness. We are awarding $100 million to states right now. The remaining $250 million will
be distributed later according to benchmarks we establish to measure progress. I am asking governors to make sure that their pandemic influenza plans are an
integral element of and coordinate effectively with the National Response Plan
and the National Incident Management System.
I am asking them to establish a Pandemic Preparedness
Coordinating Committee that represents all relevant
stakeholders in their jurisdiction. These collaborative
committees will help states to articulate strategic priorities
and oversee the development and execution of operational
pandemic plans.
One of the most important elements of the preparedness
response is practicing. We are assisting states in the
development and administration of tabletop exercises to
improve our Nation’s readiness to respond and recover from
a pandemic. We are asking states to exercise their plans
by the end of 2006, and will invite them to participate in a
nationwide pandemic planning exercise within the next twelve
months. These planning and response exercises will help public health and law
enforcement officials establish procedures and locations for quarantine, surge
capacity, diagnostics, communication and many other pandemic-related needs. 9
West Virginia is holding
seven Regional Pandemic
Flu Summits across
their state to plan for the
possibility of pandemic
flu and specific WV
preparedness needs – this is
a direct outcome of HHS/
WV summit held there in
January.
State and Local Preparedness (continued) HHS Pandemic Planning - State Summit OverviewApril-May 2006 – 4 State Summits TN, AK, WA, MT
April-May 2006 – RFP to be issued on advanced development
of promising antivirals
August -September 2006 – Contract
awards expected on advanced
development of promising antivirals
April-May 2006 – RFP to be issued on increased
egg-based vaccine capacity
Apr-May 2006 Aug-Sep 2006
10
Outreach Resources
During the 1918 influenza pandemic it was the newspapers and word of mouth
that carried the news and information. Today the media and web will be our
primary pre-pandemic and pandemic communication sources. Both must be
used responsibly to inform and educate — to help achieve a nation prepared,
but not in panic.
Today the media and web will be our primary pre-pandemic and pandemic communication sources.
Communications Communications and outreach are essential to preparedness. I am committed to telling people what we know when we know it; to inform the public without raising unnecessary alarm, and to collaborate with our public and private partners in a way that is fully transparent. It is my hope that every state and local partner will practice that principle as well — every person must be a communicator. We must all be ready to provide the best instructions and advice on what is happening, status of school, business and transportation impacts, home health care practices and basic infection control. Congress foresaw the role and value of communications and funded our efforts to further develop comprehensive science-based risk communication strategies for pandemic influenza — communications that will touch every part of our nation with medical, social and economic implications and information on avian and pandemic influenza. Checklists to aid in pandemic influenza preparations have been developed by CDC. These planning checklists provide specific guidance for state and local planning, businesses, health care providers, community organizations and individuals and families. Other checklists are being developed, along with toolkits that provide more specific guidance.The global nature of pandemic preparedness and the enormity of potential impacts are fostering a spirit of collaboration across the world. Common efforts include surveillance of the disease, planning across national boundaries and economic sectors, and sharing research and technology. The U.S. and world organizations are conducting tabletop exercises and participating in international risk communications workshops and conferences at many levels.
Available Checklists:��State and Local��Individuals and Families��Business��Schools (K-12)��Faith-based and Community Organizations��Medical Offices and Clinics��Home Health ServicesUpcoming Checklists:�Emergency Medical Services�Preschool�Colleges and Universities�Long Term Care�Travel Industry�Transportation
$38M
11
President Bush directed all federal agencies to establish a single,
comprehensive web site to be the official federal source of pandemic and avian
flu information. This web site, www.PandemicFlu.gov, hosts a vast array of
information designed to meet diverse audience needs. It links to specialized
information from federal agencies, states, international organizations and other
important resources.
New broadcast capabilities will allow us to reach media outlets more quickly and
ultimately provide information directly to the public via satellite. Convergence
technologies will be used to
integrate audio and video
production on the web. Video,
audio, multi-media and print
materials are being developed for
broad dissemination. Selected
materials will be translated as
appropriate.
We are working to communicate
to all the peoples of the world the
essential information they need to
plan, prepare and ultimately cope
with pandemic flu and its impacts.
Communications (continued) Example of Pandemic Flu website