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Vical Incorporated Message Board

  • raya_q8 raya_q8 Oct 24, 2009 11:23 AM Flag

    president declare

    state emergency on H1N1 flu

    big week ahead, hope the navy result is ready by week end

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    • The Navy doesn't even have the vaccine yet from Vical. Vical stated it would be 4 to 6 weeks after they get the grant to just make the vaccine. Then it will take 3 to 4 weeks to hear any results. I am looking at the end of November for the results of the flu tests. Also looking for Japan approval, A-7 fully enrolled announcement, maybe some news from sanofi on their trial. If Navy test goes well, I am hoping some other countries use that information to place orders for vicals flu drug. Then end of the year and next year will make or break vical.

      • 1 Reply to fredoil
      • Are you a scared short or something ?This is i fact what was said.............. UPDATE 1-Vical gets funds from US Navy to produce H1N1 vaccine
        Thu Oct 1, 2009 7:41am EDT Email | Print | Share | Reprints | Single Page [-] Text [+]
        .

        Oct 1 (Reuters) - Vical Inc (VICL.O) said it received a contract for about $1.3 million from the U.S. Navy to support manufacturing and clinical studies of its vaccine for the H1N1 swine flu, sending its shares up as much as 22 percent.

        The trials will be conducted in collaboration with the U.S. Naval Medical Research Center (NMRC), a biomedical research organization within the Navy, the DNA-vaccine maker said in a statement.

        In May, Vical entered into a cooperative research and development agreement with NMRC to develop its Vaxfectin-formulated DNA vaccine for H1N1 influenza.

        Vaxfectin is the company's experimental influenza product.

        Last month, the company, which has already initiated manufacturing activities, said it would start human clinical trials within four to six weeks of receiving funding from the U.S. Navy.

        The company's flu vaccine showed strong immune responses in animals against the virus strains isolated from the recent outbreaks in California, Mexico and Texas.

    • He had to do something, they were expecting 120 million doses of vaccine by now, got only about 11. Below is the email I sent to the NVAC Aug 20.

      Drs. Butler, Robinson and Bell:

      Dear Sir and Maam:

      There were reports in the LA Times today of continuing delays in the pace of flu vaccine production, particularly for Novel H1N1 vaccine, if two shots are needed for adequate protection. If these reports are valid,

      First, are HHS and CDC considering alternative means and types of vaccines to overcome the delivery issues,(such as alternative growth media from eggs, as well as alternative vaccine creation methods, ie methods which make use of conserved virus segments such as DNA plasmid vaccines and virus like particles?) I believe HHS has made an initial grant of about $30+ million to Protein Sciences, but is this merely covering the waterfront theoretically or is it a measured calculation of the potential contribution of new approaches in view of their potential deliverability and efficacy?

      Second,are there clinical trials of such vaccines underway to determine such basic facts as whether a one shot novel H1N1 vaccine can be formulated using such more modern biotechnology techniques because of increased efficacy of vaccines from such approaches? It appears that at least the Navy has agreements under consideration to speed trials of such new vaccines to test safety and efficacy. Initial safety testing of other proposed H1N1 vaccines at VTEU's around the country appears to take no more than three weeks. It seems if the availability of vaccines, even new types, could be expedited, people might welcome the choice of one shot of a more effective vaccine.

      Third, and finally, if the fall novel H1N1 spread is more rapid and vigorous, with levels of mortality that warrant expedition in protection of the population, is HHS and CDC prepared to utilize EUA authority to provide additional vaccines,as suggested by the Aug 12 H1N1 update at MILVAX, including new types of vaccines to address this novel virus and difficult two flu/three shot situation and its threats to public health?

      Fundamentally, are we using the most effective technology available, in addition to relying upon conventional approaches which may not match the pace of the developing disease and its impacts.

      • 1 Reply to mesondk
      • FDA approves emergency use of intravenous peramivir against swine flu
        October 24, 2009 | 9:20 am
        Responding to a request from the Centers for Disease Control and Prevention, the Food and Drug Administration on Friday approved emergency use of the experimental intravenous antiviral drug peramivir to treat hospitalized patients with pandemic H1N1 influenza.

        Tamiflu, the primary drug used to treat swine flu, is given orally, and Relenza, also used, is given as a nasal spray. Some experiments have been conducted with an intravenous form of Relenza and it has been credited with saving at least one swine flu patient's life, but it is considered more experimental than peramivir.

        The problem with existing drugs is that some people have difficulties tolerating the oral Tamiflu and that the nasal spray Relenza may not get deep enough into the lungs to reach the swine flu virus when it causes viral pneumonia. The emergency use authorization says peramivir can be used when other drugs have failed or when delivery by a route other than intravenous is not expected to be feasible.

        Peramivir, manufactured by BioCryst Pharmaceuticals Inc., is still in Phase 2 clinical trials. Known side effects include diarrhea, nausea, vomiting and decreases in white blood cell count, all of which stop when its use is halted. It has not been tested in pregnant women.

        -- Thomas H. Maugh II

 
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