NIH Awards $10 Million to Develop Microneedle Vaccine Patch

The National Institutes of Health (NIH) has awarded $10 million to the Georgia Institute of Technology, Emory University and PATH, a Seattle-based nonprofit organization, to advance a technology for the painless, self-administration of flu vaccine using patches containing tiny microneedles that dissolve into the skin.

The five-year grant will be used to address key technical issues and advance the microneedle patch through a Phase I clinical trial. The grant will also be used to compare the effectiveness of traditional intramuscular injection of flu vaccine against administration of vaccine into the skin using microneedle patches. In animals, vaccination with dissolving microneedles has been shown to provide immunization better than vaccination with hypodermic needles.

"We believe that this technology will increase the number of people being vaccinated, especially among the most susceptible populations of children and the elderly," said Mark Prausnitz, a professor in the Georgia Tech School of Chemical and Biomolecular Engineering, and the project's principal investigator. "If we can make it easier for people to be vaccinated and improve the effectiveness of the vaccine, we could significantly reduce the number of deaths caused every year by influenza."

Vaccine-delivery patches contain hundreds of micron-scale needles so small that they penetrate only the outer layers of skin. Their small size would allow vaccines to be administered without pain -- and could allow people to apply the patches themselves without visiting medical facilities.

While the ability to immunize large numbers of people without using trained medical personnel is a key advantage for the microneedle patch, the researchers have learned that administering the vaccine through the skin creates a different kind of immune response -- one that may protect vaccine recipients better.

"We have seen evidence that the vaccine works even better when administered to the skin because of the plethora of antigen presenting cells which reside there," said Ioanna Skountzou, co-principal investigator for the project and an assistant professor in Emory University's Department of Microbiology and Immunology. "This study will allow us to determine how we can optimize the vaccine to take advantage of those cells that are important in generating the body's immune response."

Among the issues to be addressed in the five-year study are:

• Developing an administration system that will be simple to use, intuitive and reliable. "Our goal is to make these patches suitable for self-administration, so that anybody could take a patch out of an envelope, put it on, and have it work with high reliability," Prausnitz said.

• Studying the long-term stability of vaccine used in the patches, and optimizing technology for incorporating it into the dissolving microneedles. "We need to put the vaccine into a dry form in this patch," said Prausnitz. "That will require different processing than is normally done with vaccines. We expect that this dry vaccine will provide enough stability that the patches can be stored without refrigeration."

• Evaluating the economic, regulatory, social and medical implications of a self-administered vaccine. PATH, an international nonprofit organization, will assist with this work, and will help strategically address any issues. "We will be assessing the barriers that may exist to introduction of a self-administered flu vaccine so we can anticipate those issues and develop possible solutions," said Darin Zehrung, leader of the vaccine delivery technologies group at PATH.

The funding will come from the Quantum program of the National Institute of Biomedical Imaging and Bioengineering (NBIB), which is part of the NIH. The initiative is designed to bring new medical technologies into clinical use.

While the funding focuses specifically on influenza vaccination, the lessons learned may advance other microneedle applications -- including vaccination efforts in developing countries where skilled medical personnel are limited and concerns about re-use of hypodermic needles are significant.

Additional design and development of the microneedle patch will largely be done at Georgia Tech, with vaccine development, immunological studies and the Phase I trial carried out at Emory University. The trial, to be conducted by the Hope Clinic of the Emory Vaccine Center, is expected to take place during the final year of the grant, setting the stage for Phase II and Phase III clinical trials that would be required to obtain FDA approval.

Ultimately, the goal will be to produce an influenza vaccine delivery patch that could be made widely available. Prausnitz expects that will be done by an established company with the ability to manufacture and market the devices.

Microneedle drug and vaccine delivery systems have been under development at Georgia Tech and elsewhere since the 1990s. The technology got a significant boost in July of 2010 with publication of a study in Nature Medicine that showed mice vaccinated with dissolving microneedles were protected against influenza at least as well as mice immunized through traditional hypodermic needle injections.

The patches used in that study contained needles just 650 microns long, assembled into arrays of 100 needles. Pressed into the skin, the needles quickly dissolved into bodily fluids thanks to their hydrophilic polymer material, carrying the vaccine with them and leaving only a water-soluble backing. In contrast, use of hypodermic needles leaves the problem of "sharps" disposal.

Prausnitz hopes that the $10 million in NIH funding will help accelerate development of the microneedle patches to make them available for general use within five to ten years.

"This research will focus on optimizing the microneedle-based delivery of vaccines into the skin and understanding how this method affects immune responses both at the mucosal surfaces of the body and through the systemic response inside the body," added Skountzou. "Combined with the convenience of self-administration, painless application and absence of sharps waste, this novel immunization route could make the microneedle patch a powerful new weapon against infectious diseases."

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FDA Expands Use of CSL Limited’s Seasonal and H1N1 Vaccines to Infants and Children

The U.S. Food and Drug Administration has approved the use of the CSL Limited’s seasonal and 2009 H1N1 influenza vaccines to include children ages 6 months and older. These vaccine were previously approved for use in adults, ages 18 years and older

“Because children are among those most vulnerable to the 2009 H1N1 virus, having a broader range of vaccines available for use in children is an important step in responding to the H1N1 outbreak,” said Margaret A. Hamburg, M.D., commissioner of food and drugs.

The company’s 2009 H1N1 vaccine is manufactured and tested using the same well-established licensing processes that have been in place for many years for the company’s seasonal flu vaccine.

The approval was based on a study of the company’s seasonal flu vaccine in children, showing both the vaccine's safety and its ability to induce antibodies expected to protect against influenza. These findings supported approval under FDA's accelerated approval regulations, which help safe and effective medical products for serious or life-threatening diseases to become available sooner to the public.

Common adverse events experienced by children after administration of seasonal and H1N1 vaccines typically include pain, redness and swelling at the injection site as well as, in some cases, irritability, loss of appetite and drowsiness.

As with any medical product, unexpected or rare serious adverse events may occur. FDA is collaborating with the U.S. Department of Health and Human Services, including the Centers for Disease Control and Prevention, and other government agencies to enhance the capacity for adverse event safety monitoring during and after the 2009 H1N1 vaccination program.

Because CSL’s seasonal and H1N1 monovalent vaccines contain a small amount of egg protein, they should not be administered to anyone allergic to eggs or egg products.

The vaccines will be available both in single-dose, preservative-free, pre-filled syringes and in multi-dose vials that contain thimerosal, a mercury derivative, as a preservative.

Both vaccines are manufactured by CSL Ltd. of Australia.

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Alert: Two Overdoses of Tamiflu in Pediatric Patients in Pennsylvania

/PRNewswire/ -- Two pediatric patients in Pennsylvania hospitals received overdoses of the drug Tamiflu to treat their flu symptoms because of unawareness among staff as to the concentration of the drug given in an alternative liquid form. Both children were unharmed as a result of the errors, but details of the near misses have been published in a supplementary Pennsylvania Patient Safety Advisory to raise awareness of the issue.

For patients who have trouble swallowing Tamiflu capsules (usually elderly and children), a liquid form of the drug is available. For facilities that have a shortage of Tamiflu in liquid form, the U.S. Food and Drug Administration has approved directions listed in the product labeling for using the powder in the Tamiflu capsule to make a liquid form, which is a different concentration. However, reports show staff are unaware of the differences in the concentrations of these two products.

As of October 20, 2009, the Pennsylvania Patient Safety Authority has received two reports describing the dosage errors related to the varying Tamiflu concentrations. In each case, physicians prescribed 12 mg of the product to the patient in liquid form. However, due to shortages of the liquid form, which is available in a 12 mg/mL concentration, pharmacists compounded and dispensed a liquid form made from the powder of available capsules as a 15 mg/mL concentration, which was administered without adjusting the dose.

"We believe hospital staff -- prescribers, nurses, and pharmacists -- may be unaware of the potential for dosage errors due to the shortage of the drug in liquid form," Mike Doering, executive director of the Pennsylvania Patient Safety Authority said. "Doctors who are prescribing the Tamiflu in a liquid are unaware that the manufacturer-produced liquid form of the product is not available."

The Authority's subcontractor, the Institute for Safe Medication Practices (ISMP), alerted healthcare professionals on October 15, 2009, about the risk of overdoses and under doses.

"In light of flu season, this is a real-time problem so the Authority and ISMP are working to get the word out as quickly as possible so that healthcare professionals across the board are aware of the potential risks of compounding their own liquid form of the drug," Doering said. "Some strategies previously released by ISMP to help healthcare providers reduce and eliminate the risks are also provided in the Advisory."

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FDA Approves Seasonal Influenza Vaccine Fluarix for Pediatric Use

The U.S. Food and Drug Administration today approved use of the seasonal influenza vaccine Fluarix for children ages 3 years to 17 years. Previously, this vaccine, which contains inactivated (killed) influenza A and B viruses, had been approved for use in adults, ages 18 years and older.

The safety and effectiveness of Fluarix for use in children ages 3 years and older is documented by a U.S. study comparing 2,115 children who received Fluarix with 1,210 children who received Fluzone, a different influenza vaccine already licensed by the FDA for use in children ages 6 months and older. Study results showed that children 3 years and older vaccinated with Fluarix and Fluzone produced similar amounts of antibodies in the blood at levels considered likely to be protective against seasonal influenza.

Fluarix is a seasonal influenza vaccine not intended to protect against the 2009 H1N1 influenza virus.

"This approval of an additional seasonal influenza vaccine for children provides help in protecting them against influenza,” said Karen Midthun, M.D., acting director of the FDA’s Center for Biologics Evaluation and Research. “Children are very vulnerable to the influenza virus and are more likely to be hospitalized for associated problems.”

With today’s approval, there are now four companies approved by the FDA to manufacture seasonal influenza vaccine for use in children.

Influenza is far more dangerous than the common cold for children, who often require medical care, especially if they are younger than 5 years. It is best to vaccinate children each fall, but vaccination also can occur in the winter months when influenza season often peaks.

Common adverse events experienced after administration of Fluarix are typical of those for flu shots and include pain, redness, and swelling at the injection site as well as irritability, loss of appetite, and drowsiness.

Because Fluarix contains a small amount of egg protein, it should not be administered to anyone allergic to eggs or egg products.

Fluarix is manufactured by GlaxoSmithKline Biologicals of Dresden, Germany.

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H1N1 Vaccine Priority Groups Expanded

District 4 Public Health has received the first shipment of H1N1 vaccine at county health departments. Georgia's initial shipment of 54,800 doses of H1N1 vaccine was earmarked for young children. However, vaccine administration is now open on a first come, first serve basis to:

· Children and young adults ages 2-24 years
· Healthcare providers
· Emergency Responders
· Contacts or caregivers of infants less than 6 months of age

2009 H1N1 vaccine is CURRENTLY available at all health departments in District 4 in the form of nasal-spray flu vaccine, also known as LAIV for live attenuated influenza vaccine. No appointment is needed and vaccine will be given on a first come, first serve basis. H1N1 vaccine is being provided free of charge by Public Health, although administration fees may be charged to insurance, Medicaid or Medicare.

Additional nasal spray vaccine and a shipment of H1N1 injectible vaccine is expected soon but no delivery date has been given at this time.2009 H1N1 nasal spray is approved for people from 2 through 49 years of age with the following exceptions:

· pregnant women,
· anyone with a weakened immune system,
· anyone with a long-term health problem such as - heart disease - kidney or liver disease - lung disease - metabolic disease such as diabetes - asthma - anemia and other blood disorders
· children younger than 5 years with asthma or one or moreepisodes of wheezing during the past year,· anyone with certain muscle or nerve disorders (such as cerebral palsy) that can lead to breathing or swallowing problems,· anyone in close contact with a person with a severely weakened immune system (requiring care in a protected environment, such as a bone marrow transplant unit),
· children or adolescents on long-term aspirin treatment.

“Our first shipment of H1N1 shots will be given to pregnant women and people in the current priority group who cannot receive nasal spray flu vaccine,” said Dr. Michael Brackett District 4 medical director.

District 4 Public Health has activated a regional public health hotline (888.899.9788) that provides callers with H1N1 vaccine availability information. People can also get information on H1N1 vaccine availability at www.district4health.org. Health departments will be closed on Monday, October 12, 2009 in observance of the Columbus Day holiday but will reopen Tuesday at 8:00 a.m. For more information on seasonal and H1N1 flu visit www.flu.gov.
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HHS Unveils New Features on Flu.gov

HHS Secretary Kathleen Sebelius today unveiled several new resources on the federal government's one-stop resource for flu information -- www.flu.gov. The Web site now features a new H1N1 Flu Self-Evaluation guide for adults 18 and older along with a new Flu Myths and Facts section, which provides the public with the latest and most accurate information about the flu.

"Flu.gov is a one-stop clearinghouse for the latest news about the flu," said Secretary Sebelius. "These new resources on flu.gov will help individuals get critical information on how to protect themselves and their families from the H1N1 virus. They will also help us to get accurate information out into the public realm so people know what the facts are about the flu."

The new Flu Myths and Facts section on www.flu.gov debunks some of the myths about the H1N1 virus and vaccine, and provides accurate information on vaccinations, the flu, and public health.

The H1N1 Flu Self-Evaluation guide (http://www.flu.gov/evaluation/) on flu.gov will give individuals 18 and older more information about what they can do to take care of themselves, prevent the spread of the flu to other members of their families, and identify the warning signs of more serious flu symptoms -- symptoms that require the attention of a medical professional.

The information in the H1N1 Flu Self-Evaluation guide is designed for educational purposes only and is not a substitute for your doctor's advice. It does not capture identifiable information in any manner and is completely anonymous. Organizations providing public health education, blogs, and members of the media can add it to their Web sites.

"One way that we can help relieve some of the burden on the states and local providers this flu season is by helping people understand what the warning signs are when it comes to the flu," said Secretary Sebelius. "In addition to the Self-Evaluation guide, we have also created some
handy one-page information sheets called Flu Essentials that people can share with family, friends and neighbors."

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MAG Promoting Both Seasonal Flu and H1N1 Vaccinations

The Medical Association of Georgia (MAG) is reminding Georgians to get their annual flu vaccination, and the leading voice for physicians in the state also says that patients should get vaccinated for the H1N1 flu as soon as the vaccine is available.

“The seasonal flu vaccine is different from the H1N1 swine flu vaccine,” MAG president M. Todd Williamson, M.D., explains. “We’re talking about different viruses, so you need to get both vaccines to be fully protected this year.”

Dr. Williamson is encouraging patients to consult with their primary care physician to determine specifically when they should get vaccinated based on their age and health profile, as well as the availability of the vaccines. He says the seasonal flu and H1N1 vaccines can be administered on the same day, though he adds that it will still be several weeks before the H1N1 vaccine is available. He also points out that the H1N1 vaccination might require two injections for children nine and younger – pending the outcome of some clinical trials that are underway.

Dr. Williamson says the priority groups for the H1N1 vaccination include people six months to 24 years; people who live with or care for children younger than six months; pregnant women; health care and emergency medical services personnel; and people 25 to 64 who have health conditions associated with higher risk of medical complications from influenza.

Dr. Williamson explains that influenza is a contagious respiratory illness that is caused by influenza viruses. Most people who get the flu will recover in a matter of days, but he stresses that more serious complications like pneumonia can occur. Dr. Williamson says that the flu can include a variety of symptoms, including a high fever, headache, extreme tiredness, dry cough, sore throat, muscle aches, and stomach symptoms such as nausea, vomiting, and diarrhea.

Dr. Williamson says the flu shot and the nasal-spray vaccine are effective preventative measures when it comes to the seasonal flu.

In terms of advice, Dr. Williamson says, “The best ways to protect yourself from the flu are to wash your hands on a regular basis and to get your flu vaccinations from your primary care physician as part of your overall health maintenance program.”

Go to www.flu.gov for additional information on the flu and flu vaccines. Go to www.mag.org for additional information on MAG.
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Ten Flu Prevention PSA Contest Finalists Chosen; Now the Public Votes for the Winner!

Help us select a winner! It's time for the public to vote for the best video in the HHS Flu Prevention Public Service Announcement (PSA) Contest. The producer of the winning video gets a $2,500 cash award, and the winning PSA will be broadcast on national television!

When HHS Secretary Kathleen Sebelius announced our contest asking people to help promote flu prevention, we had no idea what to expect. The response to the contest was amazing! Some 240 video PSAs were uploaded on YouTube!

All videos were reviewed for adherence to message and length criteria. More than 100 videos qualified for the next step: review by a panel of expert judges. Their review is complete, we are down to the final 10, and now it is your turn to select the best.

Keep in mind as you watch the PSAs that we need to reach as many people as we can. We are entering the fall flu season, and the 2009 H1N1 flu could impact all of us, so getting the message out on how we can best avoid the flu is critical. Think young and old; students and mothers;
and those most vulnerable -- then tell us which video delivers the flu prevention message best.

Voting starts on YouTube at 12:01 a.m. Eastern time, Saturday, Aug. 29, and runs through 11:59 p.m. Eastern time, Wednesday, Sept.16.

Information on the contest and how to vote is available at www.flu.gov.

You will find a wide range of seasonal and H1N1 (swine) flu information at www.flu.gov; we suggest you visit it often to get the latest information and guidance for home, school, business, faith-based organizations and so much more. Sign up for regular updates and let us know what your questions are.

Go online and vote; then stay tuned for the results!

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Federal Guidelines Encourage Employers to Plan Now for Upcoming Influenza Season

Recommendations Range from Encouraging Hand Washing to Allowing Some Employees to Stay Home

Department of Commerce (DOC) Secretary Gary Locke, Department of Health and Human Services (HHS) Secretary Kathleen Sebelius, and Homeland Security (DHS) Secretary Janet Napolitano today announced new guidance for businesses to plan for and respond to the upcoming flu season.

The guidance, released by the Centers for Disease Control and Prevention (CDC), is designed to help employers prepare now for the impact of seasonal and 2009 H1N1 influenza could have this fall and winter on their employers and operations.

Employers' plans should address such points as encouraging employees with flu-like symptoms or illness to stay home, operating with reduced staffing, and possibly having employees who are at higher risk of serious medical complications from infection work from home, according
to the CDC guidance.

It is not known whether the 2009 H1N1 influenza virus will cause more illness or more severe illness in the coming months, but the CDC recommends that everyone be prepared for influenza. Because seasonal and 2009 H1N1 influenza pose serious health threats, employers should
work with employees to develop and implement plans that can reduce the spread of flu, and to encourage seasonal flu vaccination as well as H1N1 vaccination when that vaccine becomes available.

Secretary Locke suggested businesses set the right tone in the workplace. That means implementing common sense measures to reduce the risk of spreading the flu and encouraging workers who are sick to stay home.

"The President has mobilized the federal government to get America prepared," DOC Secretary Locke said. "But government can't do it alone. For this effort to be successful, we need the business community to do its part." Making the right decisions will not only improve public
health, it also has the potential to protect economic productivity: Employees who are sick and stay home will not spread the flu in the workplace.

"This new guidance will help our private sector partners continue to prepare for the upcoming flu season to keep our economy functioning and our critical infrastructure secure," said DHS Secretary Napolitano. "Ensuring business continuity is important to our cooperative efforts to
keep Americans safe."

There are many actions that can be taken to help reduce the spread of flu. The guidance notes the importance of using these actions, including regular and frequent hand washing and routine cleaning of commonly touched surfaces.

"One of the most important things that employers can do is to make sure their human resources and leave policies are flexible and follow public health guidance,'' said HHS Secretary Kathleen Sebelius. ``If employees are sick, they need to be encouraged to stay home. If people begin to
experience flu-like symptoms at work, they should be sent home and possibly encouraged to seek medical treatment. ''

Employers should review sick leave policies and ensure employees understand them, according to the guidance. Employers should try to make sick leave policies flexible for workers who may have to stay home with ill family members or if a child's school is closed, the CDC says.

Employers should consider offering vaccine against seasonal flu, and encourage employees to be vaccinated against seasonal and H1N1 flu, the guidance says.

Employers also might cancel non-essential face-to-face meetings and travel, and space employees farther apart, the report says. And employees who are at higher risk for flu complications might be allowed to work from home or stay home if the flu is severe, it says.

"Keeping our nation's workers safe is a top priority," said Deputy Secretary of Labor Seth Harris, who participated in the announcement. "Faced with a renewed H1N1 challenge during the coming flu season, we are developing tools that will help ensure America's workers stay
healthy and our businesses remain viable."

For more information, visit www.flu.gov.

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Flu-Like Illness Being Reported in Communities District-Wide

District 4 Public Health wants parents and employers to know that flu-like illness is being reported in communities within the 12 county Region. Because only a small portion of persons with respiratory illness are tested for novel H1N1, confirmed and probable case counts represent a significant underestimation of the true number of novel H1N1 flu cases. Because of the low testing rate, we should not use these as indicators of the presence of H1N1 in our community.

We should be proactive and conduct ourselves as if this virus is already in our communities. Therefore, it is important for everyone to take steps to prevent contracting the flu and follow recommendations to prevent the further spread of illness.

Currently, the CDC is recommending that anyone with a flu-like illness stay at home for 24 hours after the last sign that fever is subsiding without the use of fever-reducing medicine. However, any ill persons who work in a health care setting are being asked to isolate themselves for up to seven days until feeling better.

“Public Health has been working closely with school systems and many other partners, some of these partners are also reporting incidents of flu-like illness,” said Michael Brackett, M.D., director of District 4 Health Services. “Novel H1N1 is confirmed in some parts of our District, so we are not surprised to see clusters popping up as schools reopen. This was predicted.”

The symptoms of novel H1N1 are similar to regular seasonal flu and include fever, lethargy, lack of appetite and coughing. Some infected people have also reported runny nose, sore throat, nausea, vomiting and diarrhea. Most people who get it recover at home in approximately a week, the same as with seasonal flu.

“There is no vaccine available yet to protect people from catching novel H1N1. Until a vaccine has been developed and proven safe, our best course of action is to take steps to prevent the spread of illness in our schools – not just novel H1N1 but any kind of virus,” said Brackett.
“Some of the medical recommendations will change as we learn more about this virus. These are everyday actions you and your children can take to stay healthy.”

• Do not send your child to school with a fever. Keep childrenwith flu-like illness at home so they don’t infect others.• Sick children should not return to school or participate in any activities putting them in contact with others until their fever has been gone for at least 24 hours without the use of fever-reducing medication.

• Cover your nose and mouth when you cough or sneeze (using your sleeve is good). If you use a tissue to cover coughs or sneezes, throw it in the trash after you use it. Teach your children to do the same.

• Avoid giving children aspirin and products that contain aspirin. Aspirin use with a virus has been associated with a rare medical problem called Reyes Syndrome.

• Wash your hands often with soap and water, especially after you cough or sneeze and before you eat. Alcohol-based hands cleaners are also effective if regular soap and water is not available. Be a good role model for your children.

• Avoid touching your eyes, nose or mouth. Germs spread that way.

• Try to avoid close contact with sick people.

• Have your family – including your children – vaccinated against regular seasonal flu.

People who develop severe illness should contact their local healthcare provider immediately. Most cases of novel H1N1 illness have been consistent with regular flu and should be treated similar to regular flu. People who have underlying at-risk medical conditions who develop flu-like symptoms or who think they were exposed but don’t have any symptoms should seek medical advice.

From what we know now, Public Health is NOT recommending schools close when novel H1N1 infections occur in students and/or faculty. However, we are working closely with Local, State and Federal Health experts and other partners to monitor the situation. Recommendations will change as the disease spreads and as we learn more about it or if the virus changes in severity.
For more information about novel H1N1, contact your local county health department or go online, www.cdc.gov or www.flu.gov.
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Avian Influenza Strain Primes Brain for Parkinson's Disease

/PRNewswire/ -- At least one strain of the H5N1 avian influenza virus leaves survivors at significantly increased risk for Parkinson's disease and possibly other neurological problems later in life, according to new research from St. Jude Children's Research Hospital.

In the August 10 online early edition of the Proceedings of the National Academy of Sciences, researchers reported that mice which survived infection with an H5N1 flu strain were more likely than uninfected mice to develop brain changes associated with neurological disorders like Parkinson's and Alzheimer's diseases. Parkinson's and Alzheimer's involve loss of brain cells crucial to a variety of tasks, including movement, memory and intellectual functioning. The study revealed the H5N1 flu strain caused a 17 percent loss of the same neurons lost in Parkinson's as well as accumulation in certain brain cells of a protein implicated in both diseases.

"This avian flu strain does not directly cause Parkinson's disease, but it does make you more susceptible," said Richard Smeyne, Ph.D., associate member in St. Jude Developmental Neurobiology. Smeyne is the paper's senior author.

"Around age 40, people start to get a decline in brain cells. Most people die before they lose enough neurons to get Parkinson's. But we believe this H5N1 infection changes the curve. It makes the brain more sensitive to another hit, possibly involving other environmental toxins," Smeyne explained.

Smeyne noted the work involved a single strain of the H5N1 flu virus, the A/Vietnam/1203/04 strain. The threat posed by other viruses, including the current H1N1 pandemic flu virus, is still being studied.

Early indications are that the H1N1 pandemic strain carries a low neurologic risk, said Richard Webby, Ph.D., director of the World Health Organization Collaborating Center for Studies on the Ecology of Influenza in Animals and Birds, which is based at St. Jude. Webby, who is also an associate member of the St. Jude Department of Infectious Diseases, was not involved in the H5N1 study led by Smeyne.

This study also supports the theory that a hit-and-run mechanism is at work in Parkinson's disease. The investigators believe the H5N1 infection sparks an immune response that persists long after the initial threat is gone, setting patients up for further devastating losses from a second hit, possibly from another infection, drug or environmental toxin. In this case, researchers believe the flu virus is the first hit that sets up development of Parkinson's at a later time.

An estimated 4.1 million Americans, including 1 to 2 percent age 55 and older, have Parkinson's. Many suspect both genetic and environmental factors play a role in its development. The disease is linked to the death of dopamine-secreting cells in an area of the midbrain known as the substantia nigra pars compacta (SNpc). Dopamine is a neurotransmitter responsible for stimulating the motor neurons that control movement. Parkinson's is usually diagnosed after individuals lose 70 to 80 percent of the dopamine-producing cells. Treatment is available, but there is no cure.

Flu is primarily a respiratory disease, but indirect evidence dating back to 1385 links it to neurological problems, including the brain inflammation known as encephalitis. The association between flu and brain disorders like Parkinson's was strengthened by an outbreak of encephalitic lethargic, also known as von Economo's encephalopathy, following the 1918 Spanish flu pandemic. Some of those patients developed Parkinson's symptoms.

St. Jude researchers launched this study nearly three years ago in response to the threat posed by avian flu. Smeyne said there was concern about possible long-term neurological risks facing H5N1 survivors.

Previous studies had isolated H5N1 in the nervous system. But this is the first to show the path the virus takes to enter the brain as well as the aftermath of the infection. Smeyne said the virus' path from the stomach through the nervous system and into the brain is reminiscent of how Parkinson's unfolds.

In this study, mice were infected with an H5N1 flu strain isolated in 2004 from a patient in Vietnam. Robert Webster, Ph.D., said the strain remains the most virulent of the avian flu viruses. Webster, a co-author of the study, holds the Rose Marie Thomas Chair in Infectious Diseases at St. Jude.

About two-thirds of the mice developed flu symptoms, primarily weight loss. After three weeks there was no evidence of H5N1 in the nervous systems of the mice that survived.

But the inflammation the infection triggered within the brain continued for months. It was similar to inflammation associated with inherited forms of Parkinson's. Although the tremor and movement problems disappeared as flu symptoms eased, investigators reported that 60 days later mice had lost roughly 17 percent of dopamine-producing cells in SNpc, a structure found in the midbrain.

Researchers also found evidence that the avian flu infection led to over-production of a protein found in the brain cells of individuals with both Alzheimer's and Parkinson's diseases. The protein, alpha-synuclein, collected in H5N1-infected cells throughout the brain, including the midbrain where key dopamine-producing cells are located. There was little protein accumulation in the brain cells of uninfected mice.

The study marks the first time scientists were able to naturally trigger the protein build-up in an experimental Parkinson's system. "The virus activates this protein," Smeyne explained.

Other authors in this paper include Haeman Jang, David Boltz and Yun Jiao (St. Jude); and Katharine Sturm-Ramirez and Kennie Shephard (formerly of St. Jude).

This work was supported in part by the National Institute of Allergy and Infectious Diseases, National Parkinson's Foundation, Michael J. Fox Foundation, National Institutes of Health and ALSAC.

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Vaccinations of Volunteers Start in First H1N1 Clinical Trial

Emory University researchers began vaccinating volunteer participants Aug. 10 in the first of several planned clinical trials of a new H1N1 vaccine.

The clinical trials are being conducted by the eight Vaccine and Treatment Evaluation Units (VTEUs), supported by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH).

Emory began signing up several hundred interested volunteers about two weeks ago and has been screening the volunteers to make sure they fit certain criteria. Volunteers will receive their first vaccinations over the first week of the trial and will return several times over the course of nine weeks to receive additional vaccinations and blood tests.

The Emory clinical trial will evaluate the safety and immune response to an H1N1 vaccine and also help determine how the pandemic flu shot should be given along with the seasonal flu shot to make it most effective. Participants will receive two H1N1 vaccinations concurrent with, before, or after, the seasonal flu shot.

The trials are being conducted in a compressed timeframe because of the possible fall resurgence of pandemic H1N1 flu infections that may coincide with the circulation of seasonal flu strains in the Northern Hemisphere.

The trials are expected to gather critical information that will allow the NIH to quickly evaluate the new vaccines to determine whether they are safe and effective in inducing protective immune responses. The results will help determine how to begin a fall 2009 pandemic flu vaccination program.

The U. S. government declared the H1N1 outbreak a public health emergency in April and two months later, the World Health Organization classified the outbreak a pandemic, reflecting its widespread nature.

“We have had a tremendous response from volunteers wanting to participate in the clinical trials,” says Mark Mulligan, MD, principal investigator of the Emory VTEU and executive director of the Hope Clinic of the Emory Vaccine Center. “Hopefully this will make it much easier to have a vaccine available for the fall flu season. We are very appreciative of the efforts of our volunteers.”

This first adult clinical trial as well as subsequent pandemic vaccine clinical trials will be conducted at the Emory Vaccine Center’s Hope Clinic in nearby Decatur. Pediatric clinical trials will be initiated one week after the first adult trial and will be conducted at the Emory-Children’s Center on Emory University’s campus. Harry Keyserling, MD, and Paul Spearman, MD, co-directors of the Emory VTEU, lead the pediatric studies at Emory-Children’s Center.

The VTEUs were established in 1962 as a vital research component of the NIAID. The units conduct clinical trials for all infectious diseases other than HIV/AIDS. They have conducted hundreds of clinical studies over the past four decades. Emory was designated a VTEU site in 2007 and received a seven-year contract of approximately $23.7 million.

An important strength of the VTEUs is their ability to rapidly enroll large numbers of volunteers into trials and to immunize the volunteers in a safe, effective and efficient manner. This rapid-response capability is especially important for testing vaccines designed to combat pandemic influenza. Results are expected to be available weeks after the trials begin.

In addition to Emory, VTEU sites are Baylor College of Medicine, Houston; Children’s Hospital Medical Center, Cincinnati; Group Health Cooperative, Seattle; Saint Louis University, St. Louis; University of Iowa, Iowa City; University of Maryland School of Medicine, Baltimore; and Vanderbilt University, Nashville. They will be joined for these studies by Children’s Mercy Hospital in Kansas City and Duke University Medical Center.

For more information about the Emory flu clinical trials, call 877-424-HOPE (4673) for the adult and senior studies, or 404-727-4044 for the pediatric studies, or e-mail for further information about the upcoming trials.

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Study Says Pregnant Women Are More Severely Impacted by Novel H1N1 Influenza Virus

Pregnant women infected with 2009 novel H1N1 had a higher rate of hospitalization and greater risk of death than the general population due to the H1N1 flu, according to a study in the Aug. 8 issue of the British medical journal Lancet.

The data collected and analyzed by the Centers for Disease Control and Prevention (CDC) are the most comprehensive available to date on the impact of this novel H1N1 flu virus among pregnant women.

"The death of a pregnant woman is always heartbreaking, and unfortunately we have been hearing reports of otherwise healthy women dying from H1N1. If a pregnant woman feels like she may have influenza, she needs to call her healthcare provider right away," said CDC’s Dr. Denise Jamieson, lead author of the study. “Clinicians who treat pregnant women should have a system in place for triaging pregnant women with influenza-like symptoms and they should not delay in initiating appropriate antiviral therapy. Some clinicians hesitate treating pregnant women with antiviral medications because of concerns for the developing fetus, but this is the wrong approach. It is critical that pregnant women, in particular, be treated promptly. "

Six deaths of pregnant women with H1N1 were reported to CDC between April 15 and June 16, 2009, representing 13 percent of the total 45 deaths reported to CDC during that time period. All were healthy prior to infection of H1N1 and subsequently developed primary viral pneumonia leading to acute respiratory distress requiring mechanical ventilation. All pregnant women who died did not receive antivirals soon enough to benefit their treatment. CDC recommends that pregnant women with suspected or confirmed influenza infection receive prompt treatment with antiviral medication.

Based on past influenza pandemics and on seasonal influenza epidemics, pregnant women have increased rates of illness and death from influenza infection.

Despite recommendations from the Advisory Committee on Immunization Practices and the American College of Obstetricians and Gynecologists for inactivated flu vaccine for all pregnant women, seasonal flu vaccine coverage among pregnant women is very low (less than 14 percent).

CDC has posted clinical guidance for treatment and prophylaxis of pregnant women with suspected or confirmed pandemic H1N1 2009 influenza at http://www.cdc.gov.h1n1flu/clinician_pregnant.htm.
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Obama Administration Calls on Nation to Begin Planning and Preparing for Fall Flu Season & the New H1N1 Virus

The Obama Administration sent a strong message to the nation today that it is time to start planning and preparing for the fall flu season and the ongoing H1N1 flu outbreak and that the federal government is prepared to commit resources, training, and new tools to help state and
local governments and America's families get ready.

White House Homeland Security Advisor John Brennan, Secretary of Health and Human Services Kathleen Sebelius, Secretary of Homeland Security Janet Napolitano, Secretary of Education Arne Duncan joined with delegations from 54 states, tribes and territories today at the H1N1 Influenza Preparedness Summit at the National Institutes of Health in Bethesda, Md., to kick-off the government's nation-wide fall flu preparedness efforts.

"The President and the administration are actively engaged in mitigating the effects of the H1N1 flu virus and developing a national response framework and action plan that builds on the efforts and lessons learned from this spring's initial onset to prepare for the possibility of a
more serious fall outbreak of the virus," said White House Homeland Security Advisor Brennan in his address to summit participants.

"Over the course of coming weeks and months, we will move aggressively to prepare the nation for the possibility of a more severe outbreak of the H1N1 virus," said HHS Secretary Sebelius. "We ask the American people to become actively engaged with their own preparation and
prevention. It's a responsibility we all share."

"The federal government is working together with its federal, state, local and tribal partners to develop a nation-wide plan to combat the H1N1 flu that incorporates the lessons we learned this spring," said Homeland Security Secretary Napolitano. "The H1N1 Summit will allow us to continue this aggressive preparation for all possible H1N1 virus outbreak scenarios to ensure that we are doing everything possible to keep our country safe and healthy."

"Effectively dealing with a potential H1N1 outbreak requires all of us -- parents, educators, health providers, and local, state and federal governments -- working together on our emergency management plan," said Education Secretary Duncan. "Today's Flu Summit is an important step in that direction. Our primary goals at the Department of Education are the health and well being of students, faculty and staff, and ensuring that, in the event of any school closures, the learning process will continue."

Maryland Governor Martin O'Malley moderated a Governors panel with participation via videolink from Governor Jim Douglas of Vermont, Governor Jim Doyle of Wisconsin, Governor Mark Parkinson of Kansas, Governor John Baldacci of Maine and Governor Jodi Rell of Connecticut.

"When responding to a national pandemic or a national recession, the basic principles of smart government remain the same -- to increase efficiency, openness, and transparency in everything we do. Today's summit illustrates our collective commitment to that goal," said Maryland Governor Martin O'Malley. "The experience in the spring taught us that while earlier pandemic flu planning efforts were effective, there are also areas for improvement. Effective response requires accurate and timely information that is as close to real time as possible. We share the commitment of the Obama Administration to constantly monitor, evaluate and improve these processes as we continue to lead the world in emergency preparedness."

Throughout the one-day summit, Administration officials laid out specific ways that states and local governments could start their planning and preparation efforts and announced new programs and resources to help state and local governments, the medical community and every day America prepare for H1N1 and the fall flu season.

First, HHS will make available preparedness grants worth a total of $350 million. These grants were funded by Congress in the latest supplemental appropriations bill and they will give state and local public health offices and health care systems valuable resources to step up their
preparedness efforts.

Second, the federal government will centralize communications about H1N1 and seasonal flu on the federal government's new Web site www.flu.gov. This one-stop comprehensive site brings together flu-related information from across HHS and other federal agencies. The expanded site builds on the pandemic planning information long presented on www.pandemicflu.gov, and incorporates information about the novel H1N1 flu as well as the seasonal flu.

Finally, HHS is launching a new PSA campaign contest to encourage more Americans to get involved in the nation's flu preparedness efforts by making a 15-second or 30-second PSA. Officials at the summit stressed the idea of "shared responsibility" when it comes to combating the flu and the goal of the new HHS PSA campaign contest is to tap into the nation's creativity to help educate Americans about how to plan for and prevent the spread of H1NI influenza. HHS will evaluate submissions and will present the best PSAs back to the public so everyone can vote on their favorite submission. The winning PSA will receive $2,500 in cash and will appear on national television. Contest details as well more information about the larger effort to plan and prepare for the flu season are available at www.flu.gov.

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Video: Late Winter/Early Spring is Meningitis Peak Season: Is Your Preteen or Teen at Risk?

/PRNewswire/ -- What began for Gerald Pe as a pleasant day at the beach quickly turned into a fight for his life and resulted in him losing portions of his feet and suffering organ failure. Lynn Bozof's son, Evan, called home from college to say he had a terrible headache, and within hours was admitted to the Intensive Care Unit; Evan died 26 days later. Gerald and Evan contracted meningococcal disease, more commonly known as meningitis, and your preteen and teenage children may also be at risk. Meningitis peak season is here, and the National Meningitis Association (NMA) is urging parents to get their children vaccinated now to protect them against this devastating disease.

Meningococcal disease is a serious bacterial infection that can lead to death or permanent disability within hours. The disease can be easily misdiagnosed since early symptoms often mimic those of the flu. Given its quick progression and devastating nature, prevention is the best approach to treating meningococcal disease.

"It wasn't until my son, Evan, died that my family learned about a simple vaccination that could have saved his life," said Lynn Bozof, Executive Director of NMA. "Meningococcal disease can strike anyone at any time, but cases peak in late winter and early spring. With meningitis peak season upon us, I encourage parents to speak with their child's healthcare provider about meningococcal vaccination."

Preteens and teens are at greater risk for meningococcal disease, accounting for nearly 30 percent of the estimated 3,000 cases that occur in the U.S. each year. The good news is the majority of these cases can potentially be prevented through vaccination. This is why the Centers for Disease Control and Prevention recommends meningococcal vaccination for all preteens and teens 11 through 18 years of age and college freshmen living in dormitories.

"I knew the meningococcal vaccine was recommended for teens, but I didn't realize how serious meningococcal disease can be or that I was at increased risk so I never made an appointment to get vaccinated," said Gerald Pe, a meningococcal disease survivor. "I almost lost my life to meningococcal disease. I urge you to have your preteens and teens vaccinated now."

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CDC Statement on Oseltamivir (Tamiflu®) Resistance and Antiviral Recommendations

On December 19, 2008, CDC issued interim guidance for health care professionals on the use of influenza antiviral medications this flu season. The guidance was issued in response to early data from a limited number of states indicating that a high proportion of influenza A (H1N1) viruses are resistant to the influenza antiviral medication oseltamivir (Tamiflu®). Worldwide, the proportion of H1N1 viruses that are resistant to oseltamivir has been increasing so this development is not surprising.

Recent media reports may have led some to believe that these developments mean physicians are without influenza treatment options for the 2008-2009 flu season.

At this time, it’s not possible to predict how common H1N1 viruses will be during the rest of this flu season, as there are many different flu viruses and every influenza season is different. The current samples studied come from a handful of states, and may not be indicative of how the rest of the season will progress or what viruses will circulate in other states. However the circulation of oseltamivir-resistant viruses does have treatment implications for health care professionals. CDC is continuing to monitor this situation very closely, but has issued interim guidance for health care professionals to guide their treatment decisions in the current situation.

In fact, the interim CDC guidance provides advice for clinicians on how to treat patients with influenza antiviral medications this season. Clinicians can use influenza test results and information, if available, about which viruses are circulating, to help decide which antiviral(s) should be used. If H1N1 viruses are circulating in the community, or it’s not clear which viruses are circulating, health care providers are recommended to use an alternative antiviral, zanamivir (Relenza®), or to use combination therapy of oseltamivir and rimantadine. Use of zanamivir or dual therapy with oseltamivir and rimantadine would provide effective treatment against all circulating influenza viruses. In some instances, oseltamivir alone can still be used, such as when influenza B is diagnosed, or H1N1 viruses are not circulating.

It is important to remember that CDC recommends annual influenza vaccination as the first and best step in preventing the flu. It is not too late to get vaccinated and this year′s influenza vaccine is expected to be effective against currently circulating oseltamivir-resistant influenza A (H1N1) viruses.

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Flu Season is Tea Time

/PRNewswire/ -- January is National Hot Tea Month and is also the height of the dreaded "cold and flu season". The CDC estimates that there will be more than 200,000 Americans affected by the cold and flu this year, which leads to missing work, school and even social gatherings. So what can one do to avoid the cold and flu?

The CDC strongly recommends an annual flu vaccine as the best way to reduce the chances that you will get the flu. In addition, drinking hot tea may also help you stay healthy during the cold and flu season.

Published research from Brigham and Women's Hospital and Harvard University indicates that theanine, an ingredient found naturally in tea, supports the immune system. A cup of tea contains an average of 20-25 mg of theanine. Drinking tea throughout the day may strengthen the immune system which is something important to do during the cold and flu season.

Drinking five cups of Black Tea a day for two to four weeks boosted the body's immune defense system by four times, according to the results of a human clinical trial. According to this study, the data suggests that drinking Black Tea boost's the body's natural resistance to infection.(1)

Tea also contains flavonoids, which are naturally occurring compounds known for their antioxidant properties. Antioxidants work to neutralize free radicals, which scientists believe damage elements in the body, such as genetic material and lipids, and contribute to many chronic diseases.

The CDC states that healthy adults have a 30% chance of contracting the flu even with an annual flu vaccination, and the vaccine may be somewhat less effective for children and the elderly. And while drinking tea may not keep you from getting sick this season, it can help your odds of staying healthy.

So why not do something good for your body while having a hot beverage ... help stay healthy this cold and flu season and drink your tea every day! For more information about the role of tea in a healthy diet and lifestyle, please visit www.TeaUSA.org.

(1) Kamath AB, Wang L, Das H, Li L, Reinhold VN, Bukowski JF. Antigens in tea-beverage prime human Vgamma 2Vdelta 2 T cells in vitro and in vivo for memory and nonmemory antibacterial cytokine responses. Proc Natl Acad Sci U S A. 2003 May 13;100(10):6009-14. Epub 2003 Apr 28.

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Families Fighting Flu and CDC Encourage Parents to Vaccinate Kids Against Flu

/PRNewswire-USNewswire/ -- Families Fighting Flu, Inc. (FFF), together with the Centers for Disease Control and Prevention (CDC) are designating today, December 9, the second annual Children's Flu Vaccination Day to remind parents that it's not too late to get their children vaccinated against influenza, or "the flu." The day highlights the critical need for all children aged six months through 18 years to get vaccinated against the flu. According to the CDC, vaccination is the single best means of protecting children from the flu and preventing the spread of influenza, which can lead to hospitalization and even death. Children's Flu Vaccination Day occurs during the CDC's annual National Influenza Vaccination Week (December 8-14, 2008).

"There is a misconception that after Thanksgiving it's too late to get children vaccinated against the flu. That is one of the reasons why we have designated today as Children's Flu Vaccination Day - to remind parents that it's not too late to get their children vaccinated. In fact, flu activity typically does not reach its peak until January or February, and it can occur as late as May," said Anne Schuchat, M.D. Assistant Surgeon General and Director, National Center for Immunization and Respiratory Diseases at the CDC.

Children die every year in the United States from influenza and its complications. In fact, over the past five flu seasons more than 400 children have died from influenza, and more than 20,000 children under the age of five are hospitalized due to influenza each year. Only 22 percent of children six to 23 months of age were fully vaccinated against influenza during the 2007-2008 flu season, even though the CDC recommends that all of these children get vaccinated every year.

But, it's not just kids who need to get immunized. Parents should also get vaccinated against the flu to better protect their family and loved ones from spreading the disease. A new national FFF survey of mothers of children in child care revealed that 56 percent of mothers said they have not received an influenza vaccination for themselves within the past two years.

"We know that come December many parents, unfortunately, think that flu season has already passed. But the reality is it hasn't even started in some areas of the country and is just starting in others. Our hope is that by designating today as Children's Flu Vaccination Day we will help remind parents that their children are still susceptible to getting the flu, and that the best way to help protect their family is to get themselves and their children vaccinated as soon as possible," said Julie Moise, FFF board member. Moise's 6-and-1/2-month-old son, Ian, died suddenly in December 2003 from influenza.

FFF has created a new e-card that's available at www.familiesfightingflu.org designed to be distributed starting today and throughout the rest of flu vaccination season (March 2009) to parents to remind them to get their children vaccinated against the flu. Contact your healthcare provider or local health department to find out when and where to get a flu vaccine.

Who Should Get Vaccinated?

The CDC recommends that all children aged six months through 18 years get vaccinated against the flu every year, as well as all persons who want to reduce the risk of becoming ill with the flu or transmitting it to others. This includes (but is not limited to): children with certain medical conditions; household contacts (parents, siblings, grandparents, etc.) and caregivers of children less than five years old; and household contacts of other high-risk individuals.

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Beneficiaries Should Get Vaccinated against Flu and Pneumococcal Disease

October through May is flu season and the Georgia Department of Human Resources, Division of Aging Services (DAS) Georgia Cares program is reminding Medicare beneficiaries to talk to their healthcare providers about getting vaccinated to prevent getting the flu and the pneumococcal disease, which is the cause of the most common form of pneumonia. The flu and pneumococcal vaccines are both covered by Medicare, so beneficiaries are not required to make a co-payment.

"One of the best ways to prevent getting the flu is to receive a flu vaccine," said Maria Greene, director of the Division of Aging Services. "Seniors who are on Medicare do not have to pay for the vaccine; Medicare should be billed for it. We encourage all Medicare beneficiaries to call GeorgiaCares toll-free at 1-800-669-8387 if anyone bills Medicare and attempts to charge them for a flu vaccine."

The flu, a contagious respiratory illness, can cause mild to severe illness and may at times lead to death. Getting a flu vaccination is the best way to prevent the flu. Older adults, young children, and people with certain health conditions such as diabetes, asthma, and heart disease are at high risk for serious flu complications, according to the Centers for Disease Control and Prevention (CDC).

Medicare beneficiaries should take the following precautions: avoid close contact with people who are sick; stay home when you are sick; frequently wash your hands; cover your mouth and nose when coughing or sneezing; and avoid touching your eyes, nose or mouth.

For information on the flu, visit the CDC website at http://www.cdc.gov/flu/keyfacts.htm. For information on Medicare coverage of flu vaccines for beneficiaries, contact GeorgiaCares at 1-800-669-8387.

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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.

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