This afternoon.

America’s Food and Drug Administration (FDA) has given full approval to Pfizer’s vaccine.

This will mean…

…more of this.

*cough*

Earlier: Well Worried

RollingNews

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39 thoughts on “Pfight

      1. Ghost of Yep

        Who said it wouldn’t be approved? I distinctly remember you posting like it had been but can’t remember anyone saying it wouldn’t.

        1. Cian

          I’m not sure if anyone said it would never be approved. Some of the BS merchants were saying that full approval could not happen until 2023 (or some other random date) because long term data.

          I posted that the application had been submitted and said application accepted: signifying that all necessary trials for full authorisation/approval had been completed.

          The BS anti-vaxxers were wrong about the vaccine needing “long-term data”.

          See MrT’s post below for the type of tripe I allude to.

  1. Mr T

    Pfizer have to get the approval before any long term data is out re: side effects and safety.

    Clinical trials dont finish until 2023 lol

      1. Mr T

        The given study dates for initial application and CMA applications end in 2023.
        Of course they monitor beyond that period – but they typically observe the primary study in its entirety before licensing such products.

  2. Mr T

    Given Pfizer vaccine is now approved – what does that mean for the conditional marketing authorization for Moderna/J&J?

        1. Chris Crehan

          Is this a bot account? I mean – I find it hard to believe that a human could ever reach adulthood when their only communicative responses are snarky indolent quips.

  3. GiggidyGoo

    ‘fully license the vaccine for people 16 and older”
    Not for under 16s then? So not actually fully licenced for under 16s

    As for all the talk about booster doses, the FDA’s licensure doesn’t cover those

    1. Cian

      Yes.
      The first set of trials were for adults. The safety data (and all other data) for these were compiled and sent to FDA for approval.

      There have been subsequent trials for children, these are separate. An application for full approval for under-16s would take longer to get to full approval (because the trials started later).

      They applied for the full approval for the adults as soon as they could.

      Similarly, an application for the booster will need separate trials and supporting documentation. This will be reliant on booster trials, so will take longer.

  4. GiggidyGoo

    ‘fully license the vaccine for people 16 and older”
    Not for under 16s then? So not actually fully licenced for all.

    As for all the talk about booster doses, the FDA’s licensure doesn’t cover those

    1. Cian

      Not for under 16s then? So not actually fully licenced for all.

      This is a strawman. The first person to mention “fully licenced for all.” is you.

      1. GiggidyGoo

        The words “fully licensed” are bandied about in the report. Only 3/4 way down do you get one sentence, almost hidden, about it being for over 16s. The heralding of it being ‘fully licensed’ refers to a group of people, not all. It’s not licensed for under 16s.
        I’d normally bow to your experience of the use of strawman, however the words ‘fully licensed’ is strawman-like itself.

        1. Cian

          Where exactly is “fully licenced” being bandied about?

          The reports I am reading are saying “full approval”. The only place that AP link uses the word licence is in the sentence: “the FDA also examined real-world safety evidence in deciding whether to fully license the vaccine for people 16 and older, those studied the longest. ” literally five words away from the bit about 16 and over.

          Now, go away pigeon.

          1. GiggidyGoo

            You’re doing a hell of a lot of disagreeing with your own posts these days, Cian. Must try harder eh?

      1. Sten

        Indeed a good read. The drop off in transmission blocking efficacy is definitely a concern. FT are reporting that more traditional vaccines like AZ that have lower efficacy initially seem to have similar efficacy to mRNA after 3/4 months.

        The question really is how the efficacy for serious illness is impacted over time. Israel decision to start 3rd shot programme seems to indicate Pfizer believe it’s necessary there also.

  5. Oro

    Good new to wake up to :)

    Hopefully this will alleviate some people’s concerns and result in more people putting themselves out of risk. The path to getting past this pandemic is one step further along.

    1. SOQ

      Ok so you are not in Ireland- makes sense.

      The ignorant aggressive posts would suggest US- California is it?

      1. Oro

        You’re as nosy.

        Tough to accuse someone of being aggressive or ignorant while concurrently demanding to know where they live – but you managed it!

        It won’t affect my good mood re the good news bb :) x

          1. Oro

            (for the cheap seats at the back) No I am not currently on the island of Ireland – are you ok? Step away from the bath salts!!!

            Also, correct me if I’m wrong on this but I think I recall you mentioning before that you’re from the north?

  6. f_lawless

    From 2017:

    https://www.npr.org/sections/health-shots/2017/05/09/527575055/one-third-of-new-drugs-had-safety-problems-after-fda-approval

    ..The Food and Drug Administration is under pressure from the Trump administration to approve drugs faster, but researchers at the Yale School of Medicine found that nearly a third of those approved from 2001 through 2010 had major safety issues years after the medications were made widely available to patients

    Seventy-one of the 222 drugs approved in the first decade of the millennium were withdrawn, required a “black box” warning on side effects or warranted a safety announcement about new risks,..

    ..President Barack Obama signed the 21st Century Cures Act into law on Dec. 13. It offers ways to speed drug approval by pushing the FDA to consider evidence beyond the three phases of traditional clinical trials. The new process has made some researchers worry that it will open the door for approvals of drugs that haven’t been adequately tested…

    ..”All too often, patients and clinicians mistakenly view FDA approval as [an] indication that a product is fully safe and effective,” says Dr. Caleb Alexander, co-director of the Johns Hopkins Center for Drug Safety and Effectiveness. “Nothing could be further from the truth..”

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