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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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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Clayton State Preparing Students and Faculty for Possible Swine Flu Outbreak

Clayton State University’s University Health Services is encouraging the Clayton State faculty and students to be prepared for flu season.

In an all-campus email communication, Dr. Julia Spinolo, director of University Health Services and assistant professor of Nursing, had a very basic message for the faculty…

“If a student has flu like symptoms (a fever of 100.5 or greater, sore throat, runny nose, and cough) please tell them to stay home!”

Spinolo also encourages faculty members to send students who appear to be ill to University Health Services (UHS) and to plan ahead.

“Develop a plan for notification of illness. Inform your students how you wish to be notified if they have the flu. Develop a contingency plan for how you will handle the continuation of instruction should you be ill and are unable to attend or conduct class for up to two weeks,” she said. “Review your attendance policies, penalties, and make up procedures for students work. Please consider that we WANT students to stay home if they are sick, so please be lenient regarding students missing class for illness.

“Consider needed changes in your syllabus and your attendance policies. Schedule make up days for tests and project/paper due dates. Consider alternative on line assignments that do not require class attendance as an option.”

Spinolo also reminds faculty about some of the basic prevention techniques, including using hand sanitizer and proper cough technique (coughing in the inner elbow instead of hands).

A similar message will be going out to the student body early next week, in conjunction with the start of fall semester classes.

A unit of the University System of Georgia, Clayton State University is an outstanding comprehensive metropolitan university located 15 miles southeast of downtown Atlanta.
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Central State Hospital Taking Precautions After Confirming Case of H1N1 Virus

Central State Hospital is taking measures to prevent the spread of the H1N1 virus among its patients and staff after one consumer was confirmed to be infected with the virus Tuesday night. The consumer was taken to a local medical center where doctors there identified the virus and admitted the patient for further treatment and observation. Following long-standing protocols to deal with just such a case, Central State administrators isolated the unit at the mental hospital where the patient had been cared for and have reinforced staff training to prevent the spread of the disease.

“It’s our responsibility to provide a safe environment for clients, staff, and visitors,” said Marvin Bailey, Regional Hospital Administrator for Central State Hospital. “We have a protocol in place to address incidents like the H1N1 virus and other pandemic outbreaks. Our main focus now is making sure our staff knows what to do and is taking the necessary precautions.”

The unit of the state mental hospital where the patient was being treated houses 25 consumers. As part of the isolation protocol, those consumers are receiving treatment in the unit instead of travelling to other places on the hospital campus. They’re also eating meals there, using disposable utensils to limit the exposure of other patients and staff to the virus.

Central State Hospital (CSH) and the other six state-run behavioral health facilities have documented protocols in place to prevent the spread of infectious diseases, including pandemic influenza. Those plans are revised annually to address health concerns and new threats as they arise. CSH has provided protocol and preventive methods to all staff members as a standard precaution. The hospital has also taken additional safety measures by emphasizing proper covering when coughing and sneezing, keeping surfaces clean and reinforcing hand washing. CSH staff members are encouraged to remain at home if they show symptoms of illness.

For more information on H1N1 virus, please visit www.cdc.gov/h1n1flu/ .
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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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Swine Flu (H1N1) Infectivity to Increase Markedly and Lethality to Remain Low According to Latest Replikin* Peptide Genomic Data

/PRNewswire/ -- Amid all the speculation over what course the Swine Flu epidemic will take, Boston-based biotech firm Replikins Ltd. (www.replikins.com) last week analyzed the most recent peptide genomic sequence data available and determined that the infectivity of the H1N1 virus will increase markedly, while its lethality will remain relatively low for the immediate future.

The company's quantitative analysis of the most recent sequence data available on PubMed, a standard scientific repository for published papers, showed an increase of 46% in the Replikin Count* over the past five months. This points to a marked increase in infectivity in humans. At the same time, while the total number of replikins has gone up significantly, their composition appears to have changed in a way that makes them more closely resemble their counterparts in earlier pandemics.

The firm, which had predicted a year ago the likelihood of the current H1N1 outbreak, used its proprietary FluForecast(TM) software program to make these determinations. "The dual differentiation of these properties may provide advance warning of the future course of H1N1," noted Samuel Bogoch MD PhD, chairman and founder of Replikins Ltd. "Our understanding of the protein chemistry of rapid replication enables us to develop synthetic vaccines specifically tailored to destroy or restrict replication of the targeted virus strains prior to an outbreak."

Earlier this month, Replikins announced that it had succeeded in synthesizing the first H1N1 influenza vaccine, which is now ready for testing. It used the same approach to produce a peptide H5N1 (avian flu) vaccine that successfully blocked low path H5N1. It has not previously been possible to correlate virus structures with a virus outbreak or cessation of outbreak, let alone to predict six to 12 months ahead of the outbreak or its cessation. In 2001, Drs. Samuel and Elenore Bogoch first demonstrated this correlation retrospectively for whole-organism replikin counts in outbreaks and pandemics of the common influenza strains over the past century.

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Positive H1N1 (Swine Flu) Confirmed in Georgia

The Georgia Department of Public Health (GDPH) confirmed today Georgia’s first human case of swine influenza virus Type A (H1N1) disease in Troup County. The person is currently under treatment.

“What we know at this point is this patient recently traveled to Mexico” said GDPH Acting Director Sandra Elizabeth Ford, MD. At this time, we do not know if or how many more cases of H1N1 there are in this area or in the state. We are active participants in the collection of samples based on the CDC case definitions and those samples are being forwarded to the State Public Health Lab for testing.

"Georgia Public Health is actively engaging and addressing this issue with its many community, state and federal partners,” said Michael Brackett, M.D. District 4 Medical Director. “We are already looking for other cases. We have not found any. This case diagnosis is one result of that rapid and highly coordinated effort to protect Georgians from this novel virus. These efforts will continue unabated until this threat is resolved."

Although this is Georgia’s first human case, the total number of US cases has risen to 110 with 7 of the cases resulting in hospitalization.

“I want to stress that there is no need for panic, locally or otherwise. We are further evaluating the situation and will continue to do so. The medical staff and hospital staff have done an excellent job at keeping the community safe,” said Brackett.

The symptoms of swine flu in people are similar to the symptoms of regular human flu and include fever, cough, sore throat, body aches, headache, chills and fatigue. Some people have reported diarrhea and vomiting associated with swine flu. In the past, severe illness (pneumonia and respiratory failure) and deaths have been reported with swine flu infection in people. Like seasonal flu, swine flu may cause a worsening of underlying chronic medical conditions. If you become ill with influenza like symptoms seek medical care. There is medication available that can help.

There is no vaccine available right now to protect against swine flu. There are everyday actions that can help prevent the spread of germs that cause respiratory illnesses like influenza. Take these everyday steps to protect your health:

• Cover your nose and mouth with a tissue when you cough or sneeze. Throw the tissue in the trash after you use it.
• Wash your hands often with soap and water, especially before you eat or after you cough or sneeze. Alcohol-based hand cleaners are also effective, if needed.
• Avoid touching your eyes, nose or mouth. Germs spread this way.
• Try to avoid close contact with people who are sick with flu-like symptoms.

If you get sick with influenza, CDC recommends that you stay home from work or school; and limit contact with others to keep from infecting them.

GDPH and the LaGrange Public Health District strongly recommend Georgia residents to:

1) Contact your health care provider if you are not feeling well and have recently traveled to areas that have high numbers of confirmed cases of swine flu.

2) Keep up healthy behaviors –such as washing hands, coughing or sneezing in tissue or crook of elbow, staying at home when you are feeling sick, and following your health care provider’s recommendations.

3) Develop or update your Emergency Preparedness plan and Emergency Preparedness kit. Visit www.ready.ga.gov/register to access online tools that will provide step-by-step guidance on how to create a plan and an emergency kit.

Regular updates are also ongoing on the CDC’s website http://www.cdc.gov/swineflu.

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Statement of Governor Sonny Perdue Regarding Confirmed H1N1 Flu Case in Georgia

Governor Sonny Perdue issued the following statement today regarding the first H1N1 flu case in Georgia being confirmed by the Centers for Disease Control:

“Today’s confirmed case of the H1N1 flu in Georgia is a reason for precaution, not panic. I want to stress that it is an isolated case appearing in a woman visiting our state for an event who had also recently traveled to Mexico. The State of Georgia has worked diligently over the past several years to prepare for a situation like this, and we are partnering with local and federal officials to respond appropriately. I encourage Georgians to follow the advice of public health professionals and take the recommended precautions to protect themselves and their families. At this stage, the simplest things – washing hands and using disinfectants – can be the most effective safeguards. I am confident in our planning and preparation and our ability to respond over the coming days.”

The most up-to-date information on H1N1 flu developments in Georgia is available at the Division of Public Health's website at http://health.state.ga.us/swineflu/.
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K-State Researcher Finds That the 1918 Spanish Flu Virus Can Infect Swine and Resulted in Current Lineage of H1N1 Swine Influenza Viruses

/PRNewswire / -- In 1918 a human influenza virus known as the Spanish flu spread through the central United States while a swine respiratory disease occurred concurrently. A Kansas State University researcher has found that the virus causing the pandemic was able to infect and replicate in pigs, but did not kill them, unlike in other mammalian hosts like monkeys, mice and ferrets where the infection has been lethal.

Juergen A. Richt, Regents Distinguished Professor of Diagnostic Medicine and Pathobiology at K-State's College of Veterinary Medicine, studied the 1918 Spanish flu pandemic with colleagues from the Canadian Food Inspection Agency, U.S. Department of Agriculture and Mount Sinai School of Medicine.

Their research supports the hypothesis that the 1918 pandemic influenza virus and the virus causing the swine flu were the same. Richt said the virus was able to infect and replicate in swine and cause mild respiratory disease. The 1918 virus spread through the pig population, adapted to the swine and resulted in the current lineage of the H1N1 swine influenza viruses. The researchers' study is published in the May 2009 Journal of Virology.

"This study emphasizes that an influenza virus, which is known to induce a lethal infection in ferrets and macaques, is not highly virulent in pigs, indicating a potential resistance of swine to highly virulent influenza viruses," Richt said. "It also suggests that pigs could have played a role in maintaining and spreading the 1918 human pandemic influenza virus."

Swine flu is a respiratory disease of pigs caused by type A influenza that regularly causes outbreaks of influenza among the animals and can be transmitted to humans. It is a typical zoonotic agent. While swine flu was first recognized as a disease in 1918, there also were reports of the influenza occurring in the Midwest in 1930.

For the study, the researchers used the 1918 pandemic virus and a 1930 H1N1 influenza virus for experimental infections in swine. The 1930 virus was chosen as a virus because it is thought to be a descendent of the 1918 virus, Richt said.

The researchers did not find a significant difference in effects from the 1918 and 1930 viruses in infected pigs. This was surprising, since the 1918 virus killed more than 20 million people and was lethal to ferrets, mice and macaques. Another surprising finding from the study was the rapid antibody response in the animals infected with the 1918 virus, which is not typically reported for the swine influenza virus.

Richt said he plans to conduct a follow-up project that will study what makes a swine flu virus a pandemic flu virus.

The researchers conducted the study in the biosafety-level 4 laboratory and animal cubicle at the National Centre for Foreign Animal Disease in Canada.

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Public Health Laboratories To Assume Primary Responsibility for Confirmatory Testing of Swine Flu

/PRNewswire / -- Approximately sixty-five state and local public health laboratories around the United States will assume primary responsibility for confirmatory testing of Human Influenza A H1N1 of Swine Origin, or "Swine Flu," within the next week. Previously, all swine flu specimens had to be sent to CDC laboratories in Atlanta for final confirmatory testing, which identifies specimens to the strain level.

The rRT-PCR swine flu panel diagnostic test kits are being shipped this week from the Centers for Disease Control and Prevention (CDC), which developed the assay. Public health laboratories are slated to begin testing late next week following on-site validation of the test.

Deployment of the test was made possible via an emergency use authorization (EUA) issued by the U.S. Food and Drug Administration (FDA) on April 27 in response to a request from CDC.

"Testing will now proceed more rapidly, because we will have sites around the country that can fully characterize the virus, rather than only one at CDC in Atlanta," said Frances Pouch Downes, DrPH, APHL president, and director, Michigan Public Health Laboratory, Michigan Department of Community Health. "Public health labs are receiving considerable attention in connection with the deployment of the swine flu test, but this is really business as usual for us. We're there in the community, ready to protect the public's health as the situation warrants."

Each year state and local public health laboratories conduct routine surveillance to monitor circulating strains of influenza. Their findings are used to develop the influenza vaccine for the following season and to control the spread of the disease in the current year. Additionally, public health laboratories subtype influenza specimens received from clinical and hospital labs. Test results support decisions regarding patient treatment and measures to control the spread of disease.

Yet even though influenza surveillance and diagnostics are routine functions at public health laboratories, this year's outbreak poses particular challenges. "Lab folks are resilient, but even they have limits in how long they can manage to do more with less," said APHL Executive Director Scott Becker. "The economic downturn has really taken a toll on state and local health departments. I am seriously concerned about staff burnout if this outbreak continues more than a couple of months."

Results of a first quarter 2009 APHL survey indicate that the public health laboratory workforce, which numbers only 6500 nationwide, has been reduced by at least 500. These reductions apply to administrative and IT support as well as to laboratory staff. Survey results also show deep cuts to laboratory budgets -- sometimes requiring the elimination of entire public health programs, mandatory furloughs and reductions in funding for essential equipment and supplies. More cuts and staff reductions are anticipated in coming months based on initial responses to APHL's second quarter survey on the impact of the economic downturn.

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CDC Guidelines for Screening Swine-Origin Influenza A (H1N1)

Interim Guidance for Screening for Swine-Origin Influenza A (H1N1) by State and Local Health Departments, Hospitals, and Clinicians in Regions with Few or no Reported Cases of Swine Influenza A (H1N1)

This document provides interim guidance for state and local health departments, hospitals, and clinicians in regions with few or no reported cases of swine-origin influenza A (H1N1) (S-OIV) regarding which patients to evaluate for possible infection with swine influenza A (H1N1). As of April 29 1:00 PM, there were 91 laboratory confirmed cases of S-OIV infection identified in 14 states in the United States. Human cases of S-OIV infection also have been identified internationally. Based on the rapid spread of the S-OIV thus far, public health officials believe that more cases will be identified over the next several weeks, including in regions that currently have few or no reported cases.

CDC recommends that state and local health departments, hospitals, and clinicians in regions with few or no reported cases of S-OIV consider the following recommendations for testing of the following persons for S-OIV infection with a nasopharyngeal swab by PCR:

Patients presenting to providers participating in the US Outpatient Influenza-like Illness Surveillance Network (ILINet) who meet the case definition of influenza-like illness (ILI), or
Patients with an ILI who have traveled within 7 days to a community either within the United States or internationally where there are one or more confirmed swine influenza A (H1N1) cases, or
Patients admitted to the hospital with an ILI.
ILI is defined as fever (temperature of 100°F [37.8°C] or greater) and a cough and/or a sore throat in the absence of a KNOWN cause other than influenza.

Specimen Collection and Testing
If swine flu is suspected, clinicians should obtain a respiratory swab for S-OIV testing and place it in a refrigerator (not a freezer). Once collected, the clinician should contact their state or local health department to facilitate transport and timely diagnosis at a state public health laboratory. State public health laboratories should perform subtype testing on all influenza A positive samples identified. State public health laboratories should submit all specimens that cannot be subtyped as human influenza A (H1N1) or (H3N2) to CDC for identification. Please notify CDC of all pending shipments by email at eocsciresource@cdc.gov or if email is not available, by phone at 404-553-7724. Please include shipment tracking information.

Investigation of Cases
Officials should conduct thorough case and contact investigations to determine the source of the swine influenza virus, extent of community illness and the need for timely control measures.

Interim Guidance
Interim Guidance is available, including:
Case definitions to be used for swine influenza A (H1N1) cases
Antiviral recommendations for patients with confirmed or suspected S-OIV infection and close contacts
Infection control for care of persons with confirmed or suspected S-OIV infection in a healthcare setting
S-OIV biosafety guidelines for laboratory workers.

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FDA Authorizes Emergency Use of Influenza Medicines, Diagnostic Test in Response to Swine Flu Outbreak in Humans

The U.S. Food and Drug Administration, in response to requests from the U.S. Centers for Disease Control and Prevention, has issued Emergency Use Authorizations (EUAs) to make available to public health and medical personnel important diagnostic and therapeutic tools to identify and respond to the swine flu virus under certain circumstances. The agency issued these EUAs for the use of certain Relenza and Tamiflu antiviral products, and for the rRT-PCR Swine Flu Panel diagnostic test.

The EUA authority allows the FDA, based on the evaluation of available data, to authorize the use of unapproved or uncleared medical products or unapproved or uncleared uses of approved or cleared medical products following a determination and declaration of emergency, provided certain criteria are met. The authorization will end when the declaration of emergency is terminated or the authorization revoked by the agency.

Currently, Relenza is approved to treat acute uncomplicated illnesses due to influenza in adults and children 7 years and older who have been symptomatic for less than two days, and for the prevention of influenza in adults and children 5 years and older. Tamiflu is approved for the treatment and prevention of influenza in patients 1 year and older.

The EUAs allow for Tamiflu also to be used to treat and prevent influenza in children under 1 year, and to provide alternate dosing recommendations for children older than 1 year. In addition, under the EUAs, both medications may be distributed to large segments of the population without complying with the label requirements otherwise applicable to dispensed drugs, and accompanied by written information pertaining to the emergency use. They may also be distributed by a broader range of health care workers, including some public health officials and volunteers, in accordance with applicable state and local laws and/or public health emergency responses.

In authorizing an EUA for the rRT-PCR Swine Flu Panel diagnostic test, the FDA has determined that it may be effective in testing samples from individuals diagnosed with influenza A infections, whose virus subtypes cannot be identified by currently available tests. This EUA allows the CDC to distribute the swine flu test to public health and other qualified laboratories that have the needed equipment and the personnel who are trained to perform and interpret the results.

The test amplifies the viral genetic material from a nasal or nasopharyngeal swab. A positive result indicates that the patient is presumptively infected with swine flu virus but not the stage of infection. However, a negative result does not, by itself, exclude the possibility of swine flu virus infection.

The EUA authority is part of Project BioShield, which became law in July 2004.

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CDC: Swine Flu Update April 27, 2009

Human cases of swine influenza A (H1N1) virus infection have been identified in the United States. Human cases of swine influenza A (H1N1) virus infection also have been identified internationally. The current U.S. case count is provided below.

U.S. Human Cases of Swine Flu Infection
(As of April 27, 2009 1:00 PM ET)

State	# of laboratory confirmed cases
California	7 cases
Kansas	2 cases
New York City	28 cases
Ohio	1 case
Texas	2 cases
TOTAL COUNT	40 cases

An investigation and response effort surrounding the outbreak of swine flu is ongoing.

CDC is working very closely with officials in states where human cases of swine influenza A (H1N1) have been identified, as well as with health officials in Mexico, Canada and the World Health Organization. This includes deploying staff domestically and internationally to provide guidance and technical support.

CDC activated its Emergency Operations Center to coordinate the agency's response to this emerging health threat and yesterday the Secretary of the Department Homeland Security, Janet Napolitano, declared a public health emergency in the United States.

This will allow funds to be released to support the public health response. CDC's goals during this public health emergency are to reduce transmission and illness severity, and provide information to assist health care providers, public health officials and the public in addressing the challenges posed by this newly identified influenza virus. To this end, CDC has issued a number of interim guidance documents in the past 24 hours. In addition, CDC's Division of the Strategic National Stockpile (SNS) is releasing one-quarter of its antiviral drugs, personal protective equipment, and respiratory protection devices to help states respond to the outbreak. Laboratory testing has found the swine influenza A (H1N1) virus susceptible to the prescription antiviral drugs oseltamivir and zanamivir. This is a rapidly evolving situation and CDC will provide updated guidance and new information as it becomes available.

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Swine Flu: Infection Control in Hospitals Will Be Critical

/PRNewswire / -- In response to confirmed cases of swine flu in Mexico, Canada, and the United States, European Union health officials are advising against travel to North America. At airports in Japan and several other Asian countries, thermal scanners are being used to identify fever among passengers from North America.

But in the U.S. the disease is already among us. The severity and extent are unknown. The SARS outbreak (severe acute respiratory syndrome) in 2003 teaches that rigorous infection control in hospitals may be key to limiting deaths from swine flu in the U.S. Much will depend on what hospitals do when the first seriously ill victims arrive." If hospitals have effective infection controls in place, the disease can be prevented from spreading to visitors, healthcare workers and their families," warns Betsy McCaughey, Ph.D., and Chairman of the Committee to Reduce Infection Deaths (RID), a national organization that educates the public and medical community about preventing infection. McCaughey explains that "77% of the people who contracted SARS in the Canadian outbreak were patients, visitors or workers in hospitals. SARS was almost entirely a hospital infection epidemic."

SARS -- four letters that filled the headlines in the spring of 2003, and then disappeared. "A report issued after the fact by the government of Ontario (The SARS Commission, Spring of Fear, December 2006) shows how hospitals in one city thwarted an epidemic while hospitals in another city made deadly mistakes" says McCaughey, an expert on preventing infection.

Many hospitals in the U.S. are under-prepared for a similar challenge. As many as ten percent of patients contract infections in the hospital, according to the Centers for Disease Control and Prevention. Bacteria such as MRSA (methicillin-resistant Staphylococcus aureus) and Clostridium difficile race through hospitals, spread by unwashed hands and unclean equipment. How can hospitals that are failing to prevent ordinary infections spread by touch contain a new, unknown virus that can spread whenever someone coughs or sneezes?

"The best defense against swine flu and other unknown pathogens is rigorous hospital hygiene and routine infection prevention. That is the lesson of SARS," says McCaughey.

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HHS Declares Public Health Emergency for Swine Flu

The Department of Health and Human Services yesterday issued a nationwide public health emergency declaration in response to recent human infections with a newly discovered swine influenza A (swine flu) virus.

The formal declaration of a Public Health Emergency (PHE) is a tool that facilitates HHS’ preparation and mobilization for disasters and emergencies. For example, PHEs were recently declared for flooding in North Dakota, the Inauguration, and several 2008 hurricanes.

Yesterday’s declaration, made under section 319 of the Public Health Service Act, will help HHS prepare for prevention and mitigation activities by enabling Food and Drug Administration (FDA) emergency use authorizations of drugs, devices, or medical tests under certain circumstances.

Specifically, the PHE will enable the FDA to review and issue emergency use authorizations (EUAs) for the use of certain laboratory tests to help detect the newly discovered strain of influenza and for the emergency use of certain antivirals.

“HHS is taking these steps today to be proactive in responding to this new influenza virus by offering national tools in support of community-led preparedness and response efforts,” Acting HHS Secretary Charles Johnson said. “The declaration allows us the flexibility, while we learn more about the virus and its impact in the United States, to take additional steps to fully mobilize our prevention, treatment and mitigation capabilities should those actions become necessary.”

In addition to the declaration, HHS leaders are working together across operating divisions to coordinate response to the swine flu outbreak. For example, the FDA, the National Institutes of Health, and the Centers for Disease Control and Prevention are working together to develop a vaccine precursor that could be used to develop a vaccine for this swine flu virus.

To date, there have been 20 confirmed cases of swine Influenza A (swH1N1) in California, Texas, Kansas, New York, and Ohio. No deaths in the U.S. have been reported due to the illness. Additional cases of the virus have been confirmed in Mexico and Canada.

Swine flu is a respiratory disease of pigs caused by type A influenza that regularly causes outbreaks of influenza among pigs. Swine flu viruses do not normally infect humans; however, human infections with swine flu do occur, and cases of human-to-human spread of swine flu viruses have been documented.

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