Regulatory Open Forum

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  • 1.  COVID Vaccine Timeline

    Posted 23-Jun-2020 09:09
    Hi everyone,

    I am currently trying to do a possible timeline for a COVID vaccine with well-founded time frames, but I haven't been able to find about time frames for the EUA nor know in which stage of the development of a vaccine can be used.
    I have seen in various posts about it taking from 12 to 18 months, but I don't really understand where does that number come from.
    Does anyone has a clearer picture than me?

    I would appreciate your help and arguments on how much time a vaccine approval would take.

    Best wishes,

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    Amanda Céspedes,
    Chile
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  • 2.  RE: COVID Vaccine Timeline

    Posted 24-Jun-2020 10:35
    I think that the fastest development to approval of a vaccine was around 4 years so far. This 18 month timeline is very optimistic and actually no one knows! The development needs lot of short-cuts from the Regulatory scientific authorities (& collaboration with other functions/manufacturing etc) to enable a success in 18 month time-frame. Also factor in the class of vaccines.....mRNA, regular prophylactic vaccine type etc.......it gets complicated

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    GRSAOnline
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  • 3.  RE: COVID Vaccine Timeline

    Posted 24-Jun-2020 11:20
    But, for example, does anyone know how much time does an EUA takes or in which stage a drug must be at to start with the process?
    I think that kind of information that I haven't been able to find in the FDA webpage could help a lot to develop a tentative timeline.

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    Amanda Céspedes
    Vitacura
    Chile
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  • 4.  RE: COVID Vaccine Timeline

    Posted 25-Jun-2020 23:34
    Edited by Julie Omohundro 26-Jun-2020 11:52
    I personally would not pursue a vaccine for sale in the US. It's a political quagmire.

    As far as I can tell, there is no 12-18 months, nor any other number of months. There is no guarantee there will ever even be a COVID-19 vaccine, except maybe in the sense of it being a vaccine because the government says it's a vaccine.

    If I had to place a bet on what we are more likely to have in the US by this time next summer, COVID-19 Congressional hearings or a COVID-19 vaccine, I'd take the former.  If I had to bet on a dark horse to come out the winner in this whole mess, it would be the anti-vaxxers.

    But you know me, ever the optimist. :)

    I will be interested to see if others here have a different perspective.


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    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
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