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Novavax, Inc. Message Board

mistersir2005 9 posts  |  Last Activity: Dec 11, 2014 10:36 AM Member since: Apr 3, 2006
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  • mistersir2005 by mistersir2005 Dec 11, 2014 10:36 AM Flag

    topic for next springs MD Tech Council conference...

    8:30 - 9:30 Vaccine Market Outlook / Next Billion Dollar Vaccine

    Moderator: TBD
    Speaker:
    Stan Erck, CEO, NovaVax

    followed by...

    9:30 - 10:00 Policy Priorities

    Speaker:
    Senator Barbara Mikulski, US Senator, United States Senate , Invited

  • mistersir2005 by mistersir2005 Dec 8, 2014 11:57 AM Flag

    Lou Fries has stated that...the neuraminidase alone...unique to the novavax seasonal vaccine...has been shown to be protective...
    so it would be interesting to see them test against this years 'drifted strain'... but I'm sure they are way ahead on this...the results could be news worthy...and show superiority over existing vaccines being used

  • Reply to

    Problems with other Ebola Vaccines...pt 1

    by mistersir2005 Nov 13, 2014 4:12 PM
    mistersir2005 mistersir2005 Nov 13, 2014 5:56 PM Flag

    third attempt to post...

    pt 2
    Novavax publicly announced it’s Ebola program 3 days later…
    And specifically mentioned certain advantages…

    “The Novavax EBOV GP Vaccine may also address other key requirements for a successful vaccine against this viral threat:

    (1) like Novavax' other recombinant vaccines, it appears to not require frozen storage allowing for easier transport and more efficient global distribution;

    (2) manufacturing could be rapidly scaled to millions of doses a month, based on the Company's experience in scale-up and manufacturing with its other nanoparticle vaccine candidates, and;

    (3) the preclinical data suggest that the Matrix-M adjuvant enhances immunogenicity with lower doses of antigen, which would further leverage the company's ability to manufacture and supply significant doses.”

  • This is from the WHO High-level meeting on Ebola vaccines on Oct 23…

    First….The two most advanced vaccines…
    “GSK identified sterile filling capacity as the most critical issue. As the vaccine used a genetically modified organism, sterile filling must be done in a biosafety level 2 facility.

    If alternative sterile filling capacity could not be found, and GSK was forced to use its own capacity to produce an Ebola vaccine, its production of several other essential public health vaccines, including those for rotavirus and measles, mumps and rubella, would suffer. These vaccines protect against some of the world’s biggest killers of infants and young children.”

    Then…
    With the Canadian vaccine from the NewLink Genetics company , “side effects should be monitored very closely for a live attenuated vaccine. Even transient fever could be a significant drawback in countries where early diagnosis of multiple diseases, including Ebola, depended on detection of fever. This type of vaccine was also likely to face special regulatory challenges.”

    A third…Johnson and Johnson seems to be behind…
    “the J&J vaccine encountered many of the same barriers, special problems, and potential needs faced by the GSK and Canadian vaccines.”

    “Questions needing answers included the very low storage temperatures to ensure stability, the degree of protection, and the length of time that lasts. The company estimated that clinical trials could being in Africa in May of next year.”

    “Site selection criteria within affected countries were reported to include an ability to identify and enroll a sufficient study population… and the ease of vaccine cold chain logistics, ideally within a four-hour drive from the study site, with secure vaccine storage.”

    Novavax publicly announced it’s Ebola program 3 days later…
    And specifically mentioned certain advantages…

  • mistersir2005 mistersir2005 Oct 29, 2014 10:08 PM Flag

    the reason for the fast track might have to do with the expiration of the current contracts...

    "Currently, five vaccine manufacturers are under contract for the Medical Countermeasures for Pandemic Influenza Preparedness and Response program with HHS until September 2015 when the contracts awarded in 2012 expire. These five companies, along with other qualified manufacturers, will be permitted to compete for the new contracts."

  • "Australia-based vaccine maker CSL Biotherapies secured a contract with the U.S. government to strengthen the country's supply of pre-pandemic and pandemic vaccine antigens in the event of an outbreak.

    The contract between CSL and the U.S. Department of Health and Human Services (HHS) is worth about $1.5 billion, according to CSL. The Australian speculates that about one-third of the figure will be spent on pre-pandemic planning, with the rest going toward pandemic demand (if one actually occurs).

    CSL will manufacture and store antigens that can be used against influenza strains with pandemic potential. The vaccine maker will also be asked to develop virus "seeds" for other manufacturers, and to formulate, fill and finish bulk stored antigen, as requested by the national government."

  • mistersir2005 mistersir2005 Oct 27, 2014 8:39 AM Flag

    Wow!....I'm trying to remember exactly what BARDA told Lou Fries....from the analysts call back in Sept...

    Something like..."we know this is going to work"...and..."we want to have Novavax ready as a 'Gun in the holster' when the need arises"...

  • mistersir2005 mistersir2005 Oct 26, 2014 10:43 AM Flag

    seems like the company would have to release something publicly about this presentation...

    Smith, G.
    Novavax Inc, USA
    2014 guinea ebola virus recombinant glycoprotein (GP) nanoparticle vaccine was highly immunogenic and cross-neutralized 1976 ebola virus GP pseudovirus
    Sunday, 26 October 2014: Breakout Session 2: Vaccines against Viral Pathogens - 13:30-15:25
    14:10-14:25

  • I know there are some here that have a great degree of experience in this area that can help…

    Let’s say hypothetically that 1600 subjects over the age of 60…in facilities all over the country receive one of two shots…either vaccine or placebo…800 in each group…

    After being followed through the RSV season we find that 50-55 subjects in the placebo arm suffer from medically-attended RSV…

    My question is what would the number of medically-attended rsv subjects have to be in the vaccine arm in order to be seen as having a high level of statistical significance.

    Also...what would a very clear level of statistical significance mean as far as the FDA's decision on how to move forward in phase III ...would it be seen as an unmet need? Breakthrough? ...and so worthy of being reviewed in an abrieviated fashion?
    tia

NVAX
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