dothedd
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Joined: Dec 27, 2010 20:43:28 GMT -5
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Post by dothedd on Feb 3, 2011 21:33:04 GMT -5
 Influenza Vaccines
Novavax is targeting its research efforts initially on various strains of viral influenza. These include H1N1 pandemic influenza referred to as "swine flu", H5N1 pandemic influenza, often referred to as “bird flu,” and seasonal influenza, the flu strain that circulates each year. Novavax’s clinical data show the company’s VLP vaccines provide broad protection against a variety of influenza viral strains. Human clinical studies using Novavax's pandemic VLP vaccine began mid-2007.
Novavax’s collaborators on the influenza vaccines programs include the University of Pittsburgh and the Southern Research Institute, which is one of a handful of U.S. research facilities approved to handle live H5N1 avian influenza virus.
Flu Facts
Seasonal Influenza, is a viral infection that attacks the respiratory tract including the nose, throat and occasionally the lungs. The infection, which usually lasts about a week and is highly contagious, is characterized by fever, headache, muscle aches, cough and sore throat.
Each year epidemic (seasonal) influenza infects between three million and five million people worldwide and results in 250,000 to 500,000 deaths. Most of these deaths are associated with complications from pneumonia. The elderly are the most vulnerable.
H1N1 "Swine" flu, 2009 H1N1 influenza virus was detected in people in Mexico, United States and Canada in April 2009. This virus is spreading from person to person worldwide, probably in much the same way that regular seasonal influnenza viruses spread. On June 11, 2009 the World Health Organization (WHO) declared that a pandemic of 2009 H1N1 influenza was underway.
This virus was originally referred to as "swine flu" because laboratory testing showed that many of the genes in the virus were very similar to influenza viruses that normally occur in pigs (swine) in North America. But further study has shown that the 2009 H1N1 is very different from what normally circulates in pigs in Europe and Asia and bird (avian) genes and human genes. Scientists call this a "quadruple reassortant" virus.
H5N1 "Avian" flu, is a virus that normally affects only birds. However, sometimes influenza viruses that infect animals may adapt to infect people. In 1997, the first case of H5N1 avian influenza to infect humans was documented in Hong Kong. Since then, the H5N1 virus has spread across Asia, has mutated and has infected hundreds of people, killing approximately half of those infected. Avian influenza in humans is characterized by an unusually high mortality rate, including otherwise healthy people of all ages, and is believed to have pandemic potential.
The H5N1 avian influenza virus is rapidly evolving into antigenically distinct clades, or families. H5N1 clade 1 flu viruses were identified in Vietnam in 2003; by 2005 a second clade was identified in Indonesia. Novavax scientists have succeeded in making a vaccine candidate designed to protect against the H5N1 clade 2 influenza virus.
Recent Avian Influenza Strains That Have Infected Humans
H5N1 Identified in 1997 in Hong Kong, since detected in Cambodia, China, Indonesia, Thailand and Vietnam
H7N7 Identified in 2003 in the Netherlands
H9N2 Identified in 1999 in Hong Kong
H7N3 Identified in 2004 in Canada
Influenza pandemics are rare but typically recur every 10 to 50 years. A pandemic occurs when:
•A novel subtype of influenza infects humans who are immunologically naïve to the virus
•The virus causes severe mortality in humans; and
•The virus spreads efficiently from human to human
Influenza Pandemics of the 20th Century
1918 The Spanish flu caused approximately 40 million deaths
1957 The Asian flu caused approximately 2 million deaths
1968 The Hong Kong flu caused approximately 1 million deaths
2009 The Swine flu caused approximately 16,460 deaths and infected about 55 million people between April 2009 through to December 12, 2009, according to the Centers for Disease Control and Prevention (CDC).
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Respiratory Syncytial Virus (RSV) Vaccine
Comparison of antibody responses to RSV G Protein after
immunization with VLP-H/G, UV-RSV and live RSV
Respiratory syncytial virus (RSV) is the primary cause of serious respiratory disease in infants and young children worldwide. The virus is also increasingly recognized as a significant pathogen in elderly populations. Bronchiolitis or pneumonia results in 25-40% of RSV infections of infants and between 0.5 and 2% of these infections result in hospitalization. Despite the incidence and severity of these infections, there is no RSV vaccine available. Immunoprophylaxis remains the only effective defense against this viral disease.
Virus- like particles (VLPs) are increasing being considered as safe, effective vaccine candidates. VLPs are particles released from cells expressing the major structural proteins of a virus. These particles are structurally similar to authentic virus and possess native conformational epitopes displayed in an array typical of virus particles. However, VLPs do not contain a genome and are, therefore, incapable of a spreading infection.
We have previously demonstrated that cells expressing the major structural proteins of Newcastle disease virus (NDV) release VLPs very efficiently and these VLPs stimulate robust immune responses in mice.
RSV presentation December, 2009
Varicella Zoster Virus (VZV) Vaccine
VZV is responsible for over 1 million cases of herpes zoster (shingles) in the US each year.
Primary complication is post-herpetic neuralgia (PHN), which occurs in ~65% of affected patients.
Large market with only one vaccine supplies:
•Government has issued a universal recommendation for all US citizens >60 years of age to be vaccinated against VZV
Current vaccine provides ~50% efficacy against shingles and ~66.5% efficacy against PHN.
Potential advantages of Novavax’s VZV vaccine:
•Broad immune response
•Potential safety advantages because of lack of replication
•Manufacturing efficiencies: live VZV not needed for process
•Vaccine is currently in discovery/preclinical development
HIV
Novavax has created a VLP-based vaccine to protect against human immunodeficiency virus (HIV), the virus that causes AIDS, with funding support from the National Institutes of Health. Scientific collaborators at Harvard Medical School, Emory University and the University of Alabama - Birmingham, have conducted pre-clinical testing using the vaccine. Further evaluation is under way.
Other Vaccine Opportunities
Novavax’s VLP approach has many potential applications and could be used to address a number of other common infectious diseases.  Andrea Bocelli - Besame Mucho (2006) www.novavax.com/go.cfm?do=Page.View&pid=20
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