PRESS RELEASE – PhageVax creates (proposed) 1-dose H1N1 Vaccine

Download PDF Version Here – Press Release (July 7th, 2009) — US based company has developed a new vaccine production method for combating emerging infectious diseases – including the novel H1N1 swine flu and the deadly H5N1 avian flu. These various sub-types of Influenza may merge in the 2nd and 3rd Pandemic Waves and become easily transmissible from human to human and deadly. Newark, Ohio July 1, 2009 – PhageVax has created a novel platform to produce vaccines against infectious diseases – from pathogen identification to the scaled manufacture of vaccine – in one-quarter the time as current technologies. This process allows for millions of doses to be produced and distributed in a matter of 4 to 6 weeks for both civilian and military personnel. Traditional vaccine generation, using eggs or other cell-culture or other insect-cell media, typically takes from 4 to 6 months. In a time where pandemics can move around the globe at the speed of a jetliner, the ability to develop and manufacture large amounts of vaccine quickly is vital. A key concern is that within the time-frame of traditional vaccine manufacture the pathogen often has mutated, thus rendering the proposed [egg-based or cell-based] vaccines useless. Recent reports from Denmark show that the novel H1N1 was resistant to the anti-viral called Tamiflu. This may become a trend.
PhageVax’s Bacteriophage-DNA Vaccine Platform represents a “just in time” manufacturing process for combating rapidly evolving infectious diseases. The company’s platform technology allows for production of a vaccine (from the initial identification of a pathogen to a cGMP lot of vaccine capable of protecting tens of millions of people) in 4 to 6 weeks; literally in one-quarter the time of traditional methods and at a fraction of the US Tax-payer’s cost compared to egg-based Flu Vaccines.  Why is this important? On June 11, the World Health Organization declared a Phase Six global novel H1N1 (swine) Flu Pandemic. A Phase Six pandemic declaration is based on the sustained worldwide spread of said virus. In addition, it has been learned the deadly H5N1 virus involved in the Flu outbreaks (in Egypt) is Tamiflu-resistant, although the virus was never exposed to Tamiflu (the primary anti-viral stockpiled against a flu epidemic in the US). The novel H1N1 may merge with the deadly H5N1 from Southeast Asia and/or merge with the deadly H5N1 from Egypt. Each of these H5N1 viruses are distinct from each other, thus raising the complexity of any human protection. The traditional vaccine production time-frame; flexibility; volume simply cannot respond quickly enough to combat these unforeseen pathogenic organisms. PhageVax has made arrangements for clinical trials at three research labs to confirm its findings and is currently negotiating with the National Institute of Health, and the CDC and the FDA for implementation and production of vaccines to combat swine flu, avian flu and malaria.
Research suggests that the vaccines may be sufficiently effective where one dose may protect against infection from wild-type disease.

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