Researchers Find Common Respiratory Virus Hijacks Lung Cells to Stay Alive

/PRNewswire/ -- Approximately one-half of all infants are infected with the respiratory syncytial virus (RSV) during the first year of life, and almost all children have been infected at least once by the time they reach their second birthday. Researchers at West Virginia University have discovered what makes RSV such a severe and persistent illness.

Senior author Giovanni Piedimonte, M.D., and his team have discovered that RSV prompts the release of a molecule that keeps the invaded cells alive despite the infection. The mechanism allows infected cells to survive for a longer period of time while they continue to produce viral particles, thus contributing to the severity and persistence of the infection.

Research results are published in the current issue of the journal PLoS ONE.

Inflammation of the airways caused by RSV often results in wheezing, cough and respiratory distress, creating the most common respiratory infection in infancy or childhood. Each year, an estimated 125,000 infants in the United States are hospitalized with RSV, the leading cause of infant hospitalization.

"There is still no effective therapy or medical treatment for RSV infection. While often mild, it still is responsible for the deaths of hundreds of infants in the United States each year," said Dr. Piedimonte, chair of the WVU Department of Pediatrics and physician-in-chief of WVU Children's Hospital. "The virus also strikes in nursing homes and causes deaths in the elderly population, so understanding how it works is critical."

Piedimonte said up to 500 infants may die of the infection each year. RSV may also predispose children to long-term health problems such as asthma. Other groups at high risk for severe RSV disease include the elderly, adults with underlying respiratory or cardiac disease, and those with a compromised immune system.

"Viruses must find a way to survive inside the host, and in this case RSV has found a way of keeping alive the cells that they infect," Piedimonte explained. "The virus invades the cell, which then produces a small molecule called NGF, or nerve growth factor. NGF allows the cell to survive while the virus reproduces itself. Finally, the cell explodes releasing new viral particles ready to infect the neighboring cells."

In determining how the virus instructs the infected cell to prolong its life, the researchers may have established a blueprint for development of new anti-viral drugs aimed at interfering with the action of NGF, Piedimonte said. He added that RSV may prefer the lower respiratory tract specifically because the smaller airways there allow for more efficient production of NGF.

"The interesting part of the RSV infection is that the viruses induce NGF production within an hour of coming into contact with the human cells - that is, even before they start multiplying," said the paper's lead author, Sreekumar Othumpangat, Ph.D., a researcher in the WVU Pediatric Research Institute.

Children born prematurely as well as those with chronic lung or heart disease are at higher risk for severe RSV infections.

The laboratory studies were done using human cells. Now that Piedimonte's team has discovered how RSV prolongs the life of its host cell, they are proceeding with other studies to see if they can pinpoint the same mechanism in common cold and influenza viruses.

The paper's other authors are Laura F. Gibson, deputy director of the Mary Babb Randolph Cancer Center at WVU, and Lennie Samsell, a research assistant in the Pediatric Research Institute.

The article, "NGF Is an Essential Survival Factor for Bronchial Epithelial Cells during Respiratory Syncytial Virus Infection," is available online at http://dx.plos.org/10.1371/journal.pone.0006444.

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FDA Approves New Influenza Vaccine Production Facility

The U.S. Food and Drug Administration (FDA) today announced that it has approved a new manufacturing facility used to produce influenza virus vaccines. The facility is approved for seasonal influenza vaccine production and could be used for the production of vaccine against the new 2009 H1N1 influenza strain.

As part of its overall pandemic influenza preparedness efforts, the FDA meets with vaccine manufacturers to guide the efficient establishment of influenza vaccine facilities that comply with agency requirements. The agency promptly reviews applications and manufacturing supplements that could increase both the number of manufacturers and the overall supply of vaccine.

The facility, located in the United States, is owned and operated by sanofi pasteur, which manufactures Fluzone Influenza Virus Vaccine. This new facility will greatly increase sanofi pasteur’s production capability.

“This approval represents an important step towards increasing the availability of influenza vaccines,” said Karen Midthun, M.D., the FDA’s acting director of the Center for Biologics Evaluation and Research.

“Increased manufacturing capacity for influenza vaccine is critical to our preparedness for an influenza pandemic,” said Jesse Goodman, M.D., M.P.H., the FDA’s acting chief scientist and deputy commissioner for scientific and medical programs. “This action also enhances the ability to produce and provide vaccines to protect the public from seasonal influenza, still estimated to cause more than 30,000 deaths per year. Thanks to strategic investments by the federal government and proactive efforts and engagement by the FDA and the vaccine industry, our nation’s preparedness has come a long way over the last five years.”

The FDA has interacted with the company throughout the regulatory process to help ensure compliance with applicable requirements.

The bulk manufacturing facility will be used for the production of Fluzone, sanofi pasteur’s egg-based influenza vaccine.

Sanofi Pasteur is located in Swiftwater, Pa.

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Emory/UGA Flu Center Is One of Six Centers Leading National H1N1 Research Response

In a multi-pronged attack against the H1N1 virus, researchers at Emory University are using a new method of rapidly producing highly targeted monoclonal antibodies to develop a diagnostic test as well as a temporary therapy to stave off the H1N1 (swine flu) virus. The antibodies, which can be isolated from a small amount of the blood of humans infected with the virus, could be targeted against H1N1 and rapidly reproduced to detect or attack the virus. The monoclonal antibody technology was described last April in the journal Nature and is being developed in collaboration with scientists at the University of Chicago.

In addition, Emory scientists, along with colleagues at the Centers for Disease Control and Prevention (CDC), are using virus-like particles (VLPs) to develop a quicker, more efficient alternative to the current method of making flu vaccine by growing it in chicken eggs. VLPs are empty shells that look like viruses but don’t reproduce. In March, the scientists described the effectiveness of their VLP vaccine in mice in the journal PLoS (Public Library of Science) One.

An Emory-University of Georgia Influenza Pathogenesis and Immunology Research Center (IPIRC) is a key component in a national scientific effort to address the H1N1 (swine flu) outbreak. The intensive U.S. research initiative, led by the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC), is centered in six national NIH Centers of Excellence for Influenza Research and Surveillance, including the one led by Emory University and UGA.

“Emory has one of the world’s leading groups of infectious disease experts, vaccine scientists, immunologists and microbiologists,” says David S. Stephens, MD, vice president for research in Emory’s Woodruff Health Sciences Center. “Our research and groundbreaking discoveries by scientists at the Emory Vaccine Center, the Yerkes National Primate Research Center, Emory University School of Medicine and collaborators at the University of Georgia provide a strong basis for our contribution to this coordinated national effort against H1N1.”

Emory scientists in the flu research center are conducting several key projects as part of the national research effort. These include determining how the H1N1 virus enters cells, is transmitted, and how that process might be interrupted; finding out whether prior exposure to other influenza viruses may help or hinder immune responses to the new virus; assessing possible pre-existing immunity to H1N1 in different age groups; analyzing the recovery of infected patients; developing a method to quickly make monoclonal antibodies targeted to the H1N1 virus; and beginning the initial stages of a new vaccine.

At the University of Georgia, scientists are studying how the H1N1 virus is transmitted between animals; finding out how the virus infects human airway cells; developing diagnostic tests to distinguish different virus strains; evaluating the stability of the virus; and testing vaccines and anti-viral drugs against the virus.

“Our scientific team is proud to be contributing to the public good as one of the six influenza research centers in the U.S.,” says Richard Compans, PhD, director of the Emory-UGA center. “The pairing of Emory's expertise with strengths at UGA in animal pathology creates a uniquely effective combination for studying crossover viruses such as 'swine flu.’ We expect to make significant contributions to this national research effort.”

The Emory-UGA IPIRC, along with the five other national flu centers, was established in April 2007 with a seven-year, $32.8 million contract from the NIH.

In the event of a public health emergency involving the emergence and spread of an influenza pandemic in humans, the network of centers is directed to “be on the frontline” to implement the NIAID Pandemic Public Health Research Response Plan.

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Sebelius Takes Two Key Actions On Strategic National Stockpile‏

Health and Human Services Secretary Kathleen Sebelius announced yesterday that the Federal government will purchase an additional 13 million treatment courses to help fight influenza, including the 2009 H1N1 flu virus. The additional treatment courses will be added to the Strategic National Stockpile. The Secretary also announced that HHS began moving 400,000 treatment courses to Mexico to help slow the spread of the H1N1 virus.

"As this flu virus outbreak expands across the country, we have been taking necessary steps to ensure states have the resources they need," said Sebelius. "The 13 million additional treatment courses that we will purchase will allow us to replenish our national stockpile and further
ensure we are prepared to provide the American people with the treatments they may need to stay healthy."

HHS has stockpiled approximately 50 million courses of antiviral drugs in the Strategic National Stockpile, and state stockpiles across the country include an additional 23 million more treatment courses. Earlier this week, HHS released a total of 11 million treatment courses to help
all 50 states. Today HHS began moving 400,000 treatment courses to Mexico to help stop the spread of the virus. The 400,000 courses represent less than 1 percent of the total American stockpile.

As a result of yesterday's action by the Secretary, HHS will spend an estimated $251 million to refill the Strategic National Stockpile and replace the 11 million treatment courses offered to states and to purchase an additional two million treatment courses. These additional two million treatment courses will be used to replace those that have been provided to Mexico or could also be available to respond to other outbreak needs.

"Flu viruses don't stop at the border, and it is imperative we do whatever we can to slow the spread of the virus and help stop this outbreak," said Sebelius.

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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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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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