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Bird flu vaccine hits the clinic

H5N1 shot in development for U.S.
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Novavax ($NVAX) saw a 5% climb in its share value on the announcement that it has started enrollment of a Phase I clinical trial of its A/H5N1 vaccine to prevent bird flu. The vaccine is part of the company's $179 million contract with the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority (HHS BARDA) to develop a vaccine against a potential bird flu pandemic. The aim is to develop a vaccine that has a production cycle of less than 12 weeks, so it can be produced quickly in response to a pandemic.

The study will enroll about 333 healthy adults. Each will receive two shots of the vaccine at varying doses, or a placebo, with or without an adjuvant, to check out its safety and efficacy. Each person will be followed for about 13 months. Initial results are expected in the fourth quarter.

Dr. Gregory Glenn, Novavax's senior vice president and chief medical officer, stated: "This is an important trial because it will help determine the most appropriate dose for future studies of our avian influenza vaccine candidate, as indicated by the safety of the vaccine, and how closely the vaccine meets the immunogenicity criteria for an accelerated approval of a potential pandemic influenza vaccine set by the FDA's Center for Biologics Evaluation and Research."

Novavax's A/H5N1 vaccine uses the company's virus-like particle technology (VLP). These recombinant particles mimic viruses or bacteria and so trigger a strong immune response. Unlike live vaccines, the particles do not contain any infectious agent so they cannot cause disease.

- read the press release

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