HHS Takes Additional Steps Toward Development of Vaccine for the Novel Influenza A (H1N1)

HHS Secretary Kathleen Sebelius announced today that the department will
take important steps necessary to prepare for potential commercial-scale
production of a candidate vaccine for the novel Influenza A (H1N1). The
Secretary is directing approximately $1 billion in existing funds that
will be used for clinical studies that will take place over the summer
and for commercial-scale production of two potential vaccine ingredients
for the pre-pandemic influenza stockpile.

"Preparation and planning are critical to keep Americans safe in the
face of a potential pandemic," Secretary Sebelius said. "Our goal
throughout this new H1N1 outbreak has been to stay one step ahead of the
virus. An important part of this effort has been our work to develop a
potential vaccine because vaccines can help prevent and control
influenza virus outbreaks. The actions we are taking today will help us
be prepared if a vaccine is needed."

The funds will be used to place new orders on existing contracts with
companies that hold U.S. licenses for flu vaccines. With these orders,
they will produce a bulk supply of vaccine antigen and adjuvant. Antigen
is the active ingredient in a vaccine that causes the human body's
immune system to develop antibodies that help fight an invading virus.
Depending on the results of clinical studies, adjuvants could be added
to a vaccine to improve the immune system's response and potentially
reduce the amount of antigen necessary for the body to recognize and
fight a virus.

Having both antigen and adjuvant on hand provides maximum flexibility in
a future immunization program, if a program is recommended. For example,
if needed these ingredients could be used in vaccine to help protect
health providers and other members of the critical workforce, as
recommended by the National Strategy for Pandemic Influenza.

With these funds manufacturers will also prepare pilot lots of potential
vaccine for use in clinical studies to determine the proper dose for a
vaccine, determine if adjuvants are appropriate and ensure a vaccine is
safe and effective. The U.S. government will share as much information
as possible from the results of these clinical studies with the World
Health Organization and the global community so that other countries can
benefit from the U.S. efforts to determine dosage, safety and
effectiveness.

-----
Community News You Can Use
www.georgiafrontpage.com
Georgia Front Page
www.fayettefrontpage.com
www.artsacrossgeorgia.com
www.politicalpotluck.com

Video: Pandemic Imminent

-----
www.georgiafrontpage.com
Georgia Front Page
www.fayettefrontpage.com
Fayette Front Page
Follow us on Twitter

Pandemic Flu Models Show How Illness Would Spread in Georgia

This simulation result shows where active cases of the flu would be located 40 days after the start of a pandemic if the initial infection location was Fulton County, Georgia – the county where the city of Atlanta is located. (Image: Pinar Keskinocak)

The 1918 flu pandemic killed more than 40 million people worldwide and affected persons of all age groups. While it is difficult to predict when the next influenza pandemic will occur or how severe it will be, researchers at the Georgia Institute of Technology have developed models to help organizations like the American Red Cross and Georgia Department of Education prepare emergency response plans.

“The models are flexible so that multiple scenarios can be investigated to see which options meet a certain goal,” said Pinar Keskinocak, an associate professor in Georgia Tech’s H. Milton Stewart School of Industrial and Systems Engineering (ISyE). “This goal can be different for various groups, such as serving the most people given the availability of limited resources or minimizing the number of people infected while not negatively affecting businesses.”

Details of the models, developed with ISyE associate professor Julie Swann and graduate student Ali Ekici, were presented on October 12 at the Institute for Operations Research and the Management Sciences Annual Meeting.

Knowing how many people will need food, how many food distribution facilities will be necessary, where the facilities should be located and how the resources should be allocated among the facilities is very important, according to Marilyn Self, who is the manager of disaster readiness for the Metropolitan Atlanta Chapter of the American Red Cross. Self has been collaborating with Georgia Tech researchers on this project.

“These models have provided solid food distribution data that has helped us formulate the questions we have to ask and the decisions that we have to make about food distribution during a pandemic on a local and statewide level,” said Self.

- Watch a video showing where active cases of the flu would be located during a pandemic if the initial infection location was Fulton County, Georgia – the county where the city of Atlanta is located - here (QuickTime-30 Megs). The video begins 10 days after the start of the pandemic and ends 180 days after the start of the pandemic.
- Watch a video showing where active cases of the flu would be located during a pandemic if the initial infection location was Atkinson County, Georgia – a rural county in southern Georgia - here (QuickTime-30Megs). The video begins 10 days after the start of the pandemic and ends 180 days after the start of the pandemic.

The Georgia Department of Education is using Georgia Tech’s models to investigate whether or not schools should be closed during a pandemic.

“Closing schools affects both families and businesses because parents will have to stay home and take care of children,” said Garry McGiboney, associate state superintendent at the Georgia Department of Education. “We have to worry about important emergency workers like hospital staff members and law enforcement officers not being able to work because they have to tend to their children because schools are closed.”

To estimate the number of meals required for a given area or determine if closing schools would be beneficial, the researchers first needed to determine how many people and/or households would be infected. To do this, they constructed a generic disease spread model, which described how the influenza disease would spread among individuals.

The researchers used U.S. Census Bureau tract data – including household statistics, work flow data, classroom sizes and age statistics – to test the model. Crowded areas, including Atlanta and its suburbs, were always affected around the same time regardless of where the disease initiated. However, the time required for the disease to spread to rural areas depended on where the disease started.

With this information, the Georgia Tech researchers used the disease spread model as a forecasting tool to calculate the number of meals that would be required in metropolitan Atlanta during a flu pandemic. They tested three major scenarios: feeding every household with an infected individual (someone symptomatic or hospitalized), every household with an infected adult, or every household with all adults infected.

The simulations showed that the 15 counties surrounding Atlanta would require approximately 2.2 million, 1.4 million or 150,000 meals per day for the respective scenarios during the peak infection period. For the entire pandemic, the number of meals would reach 62, 38 or 3.8 million for the three scenarios respectively.

The researchers also determined the number of meals that would be necessary if only those households that fell below a certain income level were fed. The results showed that 200,000; 120,000 or 14,000 meals per day would be required for the respective scenarios during the peak infection period in that case.

Interventions such as voluntary quarantine or school closures could also affect food distribution by changing the number of infected individuals.

“Voluntary quarantine means that if an individual is sick in a household, everyone in that household should stay home,” explained Keskinocak. “However, we realize that not everyone will follow this rule, so the model assumes that only a certain percentage of infected individuals will stay home.”

The researchers investigated the effects of voluntary quarantine on disease spread, as well as the best time to begin the quarantine and how long it should last.

The results showed that the number of people infected at the peak time and the total number of individuals infected decreased as the length of the quarantine was extended, but there was a diminishing rate of return. The researchers determined that an eight-week quarantine was the most effective in terms of reducing the number of individuals infected during the peak time if it was implemented at the beginning of the fourth week.

“These results are important because during a pandemic, communities have limited resources, including food and volunteers to distribute the food,” noted Swann. “If fewer people require the resources, especially during the peak time period, organizations like the American Red Cross can meet the needs of more people.”

The researchers also compared the two interventions – quarantine and school closure. The results showed that closing schools reduced the number of people infected with the virus. However, a four-week voluntary quarantine was found to be at least as effective as a six-week school closure for reducing the percentage of the population infected with the virus and the number of people infected at the peak time.

The Georgia Department of Education and the Metropolitan Atlanta Chapter of the American Red Cross have used the models to gain insight into the best ways for their organizations to respond to a flu pandemic.

“Running all of these different scenarios has helped us realize that we will have a lot more people to feed in metropolitan Atlanta during a pandemic flu than we imagined. The models have provided us with a realistic idea of where we’ll need to locate community food distribution facilities and how many we might need to have given certain assumptions and decisions,” said Self.

The researchers plan to conduct future work in two areas – developing models for other states and extending the model to also include vaccine distribution. The model may also be useful for other purposes such as estimating hospital capacity needs, according to Keskinocak.

“While we hope that a pandemic never occurs, our models will help Georgia and other states across the United States prepare response plans for the potential,” added Keskinocak.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page

News to Use in Fayetteville, Atlanta, Savannah, Valdosta, Peachtree City and all of Georgia

FDA Clears New CDC Test to Detect Human Influenza

The U.S. Food and Drug Administration (FDA) today cleared a new test
developed by the U.S. Centers for Disease Control and Prevention (CDC)
to diagnose human influenza infections and the highly pathogenic
influenza A (H5N1) viruses.

The device, called the Human Influenza Virus Real-Time RT-PCR Detection
and Characterization Panel (rRT-PCR Flu Panel), uses a molecular biology
technique to detect flu virus and differentiate between seasonal and
novel influenza.

The device is used to isolate and amplify viral genetic material present
in secretions taken from a patient's nose or throat. The viral genetic
material is labeled with fluorescent molecules, which are then detected
and analyzed by a diagnostic instrument called the Applied Biosystems
7500 Fast Dx, also cleared today by the FDA for diagnostic use
simultaneously with the CDC's rRT-PCR Flu Panel.

The test panel and diagnostic system can detect and identify commonly
circulating human influenza viruses as well as influenza A (H5N1)
viruses. Results can be available within four hours and the system can
test multiple samples at once.

"This is a significant achievement for public health surveillance," HHS
Secretary Mike Leavitt said. "The test allows us to better support
laboratories on the front line of influenza testing in the United States
and abroad."

"The application of the test to detect an emergent influenza virus would
be especially important in the early stages of a pandemic," Secretary
Leavitt added. "This breakthrough allows for a more timely detection of
a pandemic virus, which helps in determining when to begin broad control
strategies as well as life-saving mitigation measures, such as closing
schools, cancelling social gatherings and informing businesses to begin
work-at-home policies."

The test will be available to CDC-qualified laboratories for diagnosing
influenza this fall, and some laboratories will be able to obtain
reagents (certain substances used in the testing process) at no cost.
This test should help ensure the accuracy of influenza testing results
among the different qualified laboratories that conduct influenza
subtype testing.

"This new test provides us another tool in our toolbox to fight seasonal
influenza, a virus that unfortunately kills thousands of people each
year in the United States," said CDC Director Dr. Julie Gerberding.
"We'll now be able to detect influenza in the community faster, which
allows us to take steps more quickly to protect and save lives."

Since influenza viruses are always changing, test reagents need to be
evaluated regularly against circulating viruses to ensure the
sensitivity and specificity of the test to diagnose current influenza
viruses.

"Because the test can tell the difference between seasonal human
influenza viruses and novel viruses, it will also provide qualified
laboratories with a means to rapidly detect new influenza viruses that
have not been identified yet and that could pose a pandemic risk," said
FDA Principal Deputy Commissioner and Chief Scientist Dr. Frank Torti,
M.D., M.P.H.

The CDC, Applied Biosystems of Foster City, Calif., and the Association
of Public Health Laboratories collaborated on the development of this
new test. State public health laboratories in Virginia, Iowa,
California, Massachusetts, Wisconsin, and Washington performed clinical
evaluations of the new flu panel.

Scientists around the world are concerned that the H5N1 virus could one
day mutate and acquire the properties needed to quickly spread between
people, resulting in a pandemic. H5N1 viruses circulate widely in birds
in Asia, Africa and Europe and have caused human illness and death.
These viruses have never been detected in the Americas.

-----
www.fayettefrontpage.com
Fayette Front Page
Community News You Can Use
Fayetteville, Peachtree City, Tyrone
www.georgiafrontpage.com
Georgia Front Page

CDC Awards $24 Million for Pandemic Influenza Preparedness Projects

Georgia awarded over $770,000 in Project Money for Pandemic Influenza Preparedness.

The Centers for Disease Control and Prevention (CDC) has awarded $24 million to fund 55 projects in 29 state and local public health departments that could serve as innovative approaches for influenza pandemic preparedness.

“What is learned from these projects can benefit everyone because it could improve national, regional and local public health detection and response to a pandemic involving influenza,” said Richard Besser, MD, Director of CDC′s Coordinating Center for Terrorism Preparedness and Emergency Response. CDC intends for the recipients to implement promising practices or to develop effective approaches and models that can be replicated nationally, Dr. Besser said.

A total of 184 funding applications were submitted by state and local health departments in a competitive application process. Eligible applicants for the awards were limited to the 62 state, local and territorial public health departments that currently receive federal funding through CDC′s Public Health Emergency Preparedness (PHEP) Cooperative Agreement.

The 29 award recipients have one year to complete the projects, which begin on September 30, 2008. The projects focus on seven key areas and include:

1. Use of public engagement as part of the public health decision-making process
2. Electronic laboratory data exchange to support influenza pandemic monitoring
3. Integration of state-based immunization information systems to track distribution of influenza pandemic countermeasures.
4. Development of statewide electronic death reporting systems compliant with Public Health Information Network (PHIN) requirements
5. Collaborative planning among healthcare providers to ensure the delivery of essential services during an influenza pandemic
6. Development of interventions that promote preparedness for pandemic disease among identified vulnerable populations
7. Distribution and dispensing of antiviral drugs to self-isolated or self-quarantined persons in an influenza pandemic event

A list of the 29 award recipients and their projects can be found at http://emergency.cdc.gov/cotper/coopagreement/07/funding-schedule-pan-flu.asp.

The $24 million for the new projects are part of $600 million in PHEP supplemental funding appropriated by Congress to accelerate state and local influenza pandemic planning efforts. The focus of the funding, which was distributed in three phases beginning in 2006, was on practical, community-based procedures that could prevent or delay the spread of an influenza pandemic.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page