Prevention Of Avian Influenza Infection
FDA Approves First U.S. Vaccine for Humans Against the Avian Influenza Virus H5N1
The U.S. Food and Drug Administration (FDA) today announced the first approval in the United States of a vaccine for humans against the H5N1 influenza virus, commonly known as avian or bird flu.The vaccine could be used in the event the current H5N1 avian virus were to develop the capability to efficiently spread from human to human, resulting in the rapid spread of the disease across the globe. Should such an influenza pandemic emerge, the vaccine may provide early limited protection in the months before a vaccine tailored to the pandemic strain of the virus could be developed and produced.
The U.S. Food and Drug Administration (FDA) today announced the first approval in the United States of a vaccine for humans against the H5N1 influenza virus, commonly known as avian or bird flu.The vaccine could be used in the event the current H5N1 avian virus were to develop the capability to efficiently spread from human to human, resulting in the rapid spread of the disease across the globe. Should such an influenza pandemic emerge, the vaccine may provide early limited protection in the months before a vaccine tailored to the pandemic strain of the virus could be developed and produced.
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"The threat of an influenza pandemic is, at present, one of the most significant public health issues our nation and world faces," said Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs. "The approval of this vaccine is an important step forward in our protection against a pandemic." The H5N1 virus is one version of the influenza A virus commonly found in birds. Unlike seasonal influenza, where infection ranges from mild to serious symptoms in most people, the disease caused by H5N1 is far more severe and happens quickly, with pneumonia and multi-organ failure commonly seen.
"The threat of an influenza pandemic is, at present, one of the most significant public health issues our nation and world faces," said Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs. "The approval of this vaccine is an important step forward in our protection against a pandemic." The H5N1 virus is one version of the influenza A virus commonly found in birds. Unlike seasonal influenza, where infection ranges from mild to serious symptoms in most people, the disease caused by H5N1 is far more severe and happens quickly, with pneumonia and multi-organ failure commonly seen.
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While there have been no reported human cases of H5N1 infection in the United States, almost 300 people worldwide have been infected with this virus since 2003 and more than half of them have died. To date, H5N1 influenza has remained primarily an animal disease but should the virus acquire the ability for sustained transmission among humans, people will have little immunity to this virus and the potential for an influenza pandemic would have grave consequences for global public health.
While there have been no reported human cases of H5N1 infection in the United States, almost 300 people worldwide have been infected with this virus since 2003 and more than half of them have died. To date, H5N1 influenza has remained primarily an animal disease but should the virus acquire the ability for sustained transmission among humans, people will have little immunity to this virus and the potential for an influenza pandemic would have grave consequences for global public health.
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"The timing and severity of an influenza pandemic is uncertain, but the danger remains very real," said Jesse L. Goodman, M.D., M.P.H., Director of FDA's Center for Biologics Evaluation and Research. "We are working closely with other government agencies, global partners and the vaccine industry to facilitate the development, licensure and availability of needed supplies of safe and effective vaccines to protect against the pandemic threat."
"The timing and severity of an influenza pandemic is uncertain, but the danger remains very real," said Jesse L. Goodman, M.D., M.P.H., Director of FDA's Center for Biologics Evaluation and Research. "We are working closely with other government agencies, global partners and the vaccine industry to facilitate the development, licensure and availability of needed supplies of safe and effective vaccines to protect against the pandemic threat."
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The vaccine was obtained from a human strain and is intended for immunizing people 18 through 64 years of age who could be at increased risk of exposure to the H5N1 influenza virus contained in the vaccine. H5N1 influenza vaccine immunization consists of two intramuscular injections, given approximately one month apart. The manufacturer, sanofi pasteur Inc., will not sell the vaccine commercially. Instead, the vaccine has been purchased by the federal government for inclusion within the National Stockpile for distribution by public health officials if needed. The vaccine will be manufactured at sanofi pasteur's Swiftwater, Pa., facility.
The vaccine was obtained from a human strain and is intended for immunizing people 18 through 64 years of age who could be at increased risk of exposure to the H5N1 influenza virus contained in the vaccine. H5N1 influenza vaccine immunization consists of two intramuscular injections, given approximately one month apart. The manufacturer, sanofi pasteur Inc., will not sell the vaccine commercially. Instead, the vaccine has been purchased by the federal government for inclusion within the National Stockpile for distribution by public health officials if needed. The vaccine will be manufactured at sanofi pasteur's Swiftwater, Pa., facility.
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A clinical study was conducted to collect safety information and information on recipient's immune responses and to determine the appropriate vaccine dose. A total of 103 healthy adults received a 90 microgram dose of the vaccine by injection followed by another 90 microgram dose 28 days later. In addition, there were approximately 300 healthy adults who received the vaccine at doses lower than 90 micrograms and a total of 48 who received a placebo injection.
A clinical study was conducted to collect safety information and information on recipient's immune responses and to determine the appropriate vaccine dose. A total of 103 healthy adults received a 90 microgram dose of the vaccine by injection followed by another 90 microgram dose 28 days later. In addition, there were approximately 300 healthy adults who received the vaccine at doses lower than 90 micrograms and a total of 48 who received a placebo injection.
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The vaccine was generally well tolerated, with the most common side effects reported as pain at the injection site, headache, general ill feeling and muscle pain. The study showed that 45 percent of individuals who received the 90 microgram, two-dose regimen developed antibodies at a level that is expected to reduce the risk of getting influenza. Although the level of antibodies seen in the remaining individuals did not reach that level, current scientific information on other influenza vaccines suggests that less than optimal antibody levels may still have the potential to help reduce disease severity and influenza-related hospitalizations and deaths. Additional information on this H5N1 influenza vaccine is being collected on safety and effectiveness in other age groups and will be available to FDA in the near future.
The vaccine was generally well tolerated, with the most common side effects reported as pain at the injection site, headache, general ill feeling and muscle pain. The study showed that 45 percent of individuals who received the 90 microgram, two-dose regimen developed antibodies at a level that is expected to reduce the risk of getting influenza. Although the level of antibodies seen in the remaining individuals did not reach that level, current scientific information on other influenza vaccines suggests that less than optimal antibody levels may still have the potential to help reduce disease severity and influenza-related hospitalizations and deaths. Additional information on this H5N1 influenza vaccine is being collected on safety and effectiveness in other age groups and will be available to FDA in the near future.
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With the support of FDA, the U.S. National Institutes of Health and other government agencies, sanofi pasteur and other manufacturers are working to develop a next generation of influenza vaccines for enhanced immune responses at lower doses, using technologies intended to boost the immune response. Meanwhile, the approval and availability of this vaccine will enhance national readiness and the nation's ability to protect those at increased risk of exposure.
With the support of FDA, the U.S. National Institutes of Health and other government agencies, sanofi pasteur and other manufacturers are working to develop a next generation of influenza vaccines for enhanced immune responses at lower doses, using technologies intended to boost the immune response. Meanwhile, the approval and availability of this vaccine will enhance national readiness and the nation's ability to protect those at increased risk of exposure.
National Institute of Allergy andInfectious Diseases (NIAID) Initiates Trial of Experimental Avian Flu Vaccine
Fast-track recruitment has begun for a trial to investigate the safety of a vaccine against H5N1 avian influenza, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), announced today. Sites in Rochester, NY, Baltimore and Los Angeles will enroll a total of 450 healthy adults. The clinical sites are part of the NIAID-sponsored Vaccine and Treatment Evaluation Units (VTEU).
Fast-track recruitment has begun for a trial to investigate the safety of a vaccine against H5N1 avian influenza, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), announced today. Sites in Rochester, NY, Baltimore and Los Angeles will enroll a total of 450 healthy adults. The clinical sites are part of the NIAID-sponsored Vaccine and Treatment Evaluation Units (VTEU).
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“While there have been relatively few cases worldwide of H5N1 avian influenza infection in humans, the public health community is concerned that the virus will develop the capability of efficiently spreading from human to human and thus create a risk for a worldwide pandemic,” says NIAID Director Anthony S. Fauci, M.D. “NIAID has supported research on H5N1, the strain responsible for this deadly form of avian influenza, since 1997 when the first cases in humans were reported. The initiation of this vaccine trial marks a key advance in our efforts to prepare to respond to an avian flu pandemic,” adds Dr. Fauci.
“While there have been relatively few cases worldwide of H5N1 avian influenza infection in humans, the public health community is concerned that the virus will develop the capability of efficiently spreading from human to human and thus create a risk for a worldwide pandemic,” says NIAID Director Anthony S. Fauci, M.D. “NIAID has supported research on H5N1, the strain responsible for this deadly form of avian influenza, since 1997 when the first cases in humans were reported. The initiation of this vaccine trial marks a key advance in our efforts to prepare to respond to an avian flu pandemic,” adds Dr. Fauci.
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Sanofi pasteur, Swiftwater, PA, manufactured the trial vaccine, which is an inactivated vaccine made from an H5N1 virus isolated in Southeast Asia in 2004. Sanofi pasteur, formerly Aventis Pasteur, was awarded a contract by NIAID to manufacture the H5N1 vaccine in May 2004. This Phase I trial will test the vaccine’s safety and ability to generate an immune response in 450 healthy adults aged 18 to 64. If the vaccine is shown to be safe in adults, there are plans to test it in other populations, such as the elderly and children.
Sanofi pasteur, Swiftwater, PA, manufactured the trial vaccine, which is an inactivated vaccine made from an H5N1 virus isolated in Southeast Asia in 2004. Sanofi pasteur, formerly Aventis Pasteur, was awarded a contract by NIAID to manufacture the H5N1 vaccine in May 2004. This Phase I trial will test the vaccine’s safety and ability to generate an immune response in 450 healthy adults aged 18 to 64. If the vaccine is shown to be safe in adults, there are plans to test it in other populations, such as the elderly and children.
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H5N1 avian influenza leads to severe disease in both birds and humans. Between January 2004 and March 11, 2005, there were 69 confirmed cases of and 46 deaths from H5N1 infection in humans reported to the World Health Organization. To date, there has been a small number of cases where human-to-human transmission of the virus may have occurred. However, public health experts fear that the virus may evolve into one that is more easily transmitted between people. If this were to happen, a worldwide pandemic could follow.
H5N1 avian influenza leads to severe disease in both birds and humans. Between January 2004 and March 11, 2005, there were 69 confirmed cases of and 46 deaths from H5N1 infection in humans reported to the World Health Organization. To date, there has been a small number of cases where human-to-human transmission of the virus may have occurred. However, public health experts fear that the virus may evolve into one that is more easily transmitted between people. If this were to happen, a worldwide pandemic could follow.
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Influenza pandemics are global outbreaks that emerge infrequently and unpredictably and involve strains of virus to which humans have little or no immunity. H5N1 is one such flu virus strain. The last influenza pandemic swept the globe in 1968; many public health officials believe the world is overdue for another one.
Influenza pandemics are global outbreaks that emerge infrequently and unpredictably and involve strains of virus to which humans have little or no immunity. H5N1 is one such flu virus strain. The last influenza pandemic swept the globe in 1968; many public health officials believe the world is overdue for another one.
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posted by Pieter Djatmiko | 10:16
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