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  3. The FDA decided not to even review Moderna's mRNA flu vaccines for approval, even though the studies the FDA would be reviewing were conducted the way the FDA told Moderna to do them.

The FDA decided not to even review Moderna's mRNA flu vaccines for approval, even though the studies the FDA would be reviewing were conducted the way the FDA told Moderna to do them.

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modernamrnavaccines
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  • jeneralist@med-mastodon.comJ jeneralist@med-mastodon.com

    @adipoeserPursch

    Some back-of-the-envelope calculations: new vaccines are generally introduced to more affluent countries first, especially for diseases that aren't immediately fatal. The market for vaccines against EBV, HSV, and VZV would be in this category.

    EU: 450M people
    Canada: 40M
    US: 350M
    Australia & NZ: 30M

    Without US, the market is about 40% smaller.

    tessarakt@mastodon.socialT This user is from outside of this forum
    tessarakt@mastodon.socialT This user is from outside of this forum
    tessarakt@mastodon.social
    schrieb zuletzt editiert von
    #102

    @jeneralist @adipoeserPursch in terms of health care, is the US an affluent country ?

    1 Antwort Letzte Antwort
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    • I ireland4ever@mastodon.social

      @jeneralist

      Can Moderna sue the FDA ? If they conducted their studies the way FDA wanted them done, then it's a breach of contract by the FDA, isn't it?

      tessarakt@mastodon.socialT This user is from outside of this forum
      tessarakt@mastodon.socialT This user is from outside of this forum
      tessarakt@mastodon.social
      schrieb zuletzt editiert von
      #103

      @Ireland4Ever @jeneralist "contract"? Isn't this rather an administrative procedure?

      I 1 Antwort Letzte Antwort
      0
      • jeneralist@med-mastodon.comJ jeneralist@med-mastodon.com

        The FDA decided not to even review Moderna's mRNA flu vaccines for approval, even though the studies the FDA would be reviewing were conducted the way the FDA told Moderna to do them.

        Now #Moderna expects that none of its other #mRNA #vaccines will be reviewed, and has halted studies on vaccines for EBV, HSV, and shingles.

        A lot of people with herpes would be angry if they found out.

        A lot of people who have family members with #MS -- now thought to be caused in part by EBV -- will be livid.

        nikatjef@mastodon.acm.orgN This user is from outside of this forum
        nikatjef@mastodon.acm.orgN This user is from outside of this forum
        nikatjef@mastodon.acm.org
        schrieb zuletzt editiert von
        #104

        @jeneralist
        It would be a real shame if people boosted this and embarrassed the Chump regime...

        petealexharris@mastodon.scotP 1 Antwort Letzte Antwort
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        • jeneralist@med-mastodon.comJ jeneralist@med-mastodon.com

          The FDA decided not to even review Moderna's mRNA flu vaccines for approval, even though the studies the FDA would be reviewing were conducted the way the FDA told Moderna to do them.

          Now #Moderna expects that none of its other #mRNA #vaccines will be reviewed, and has halted studies on vaccines for EBV, HSV, and shingles.

          A lot of people with herpes would be angry if they found out.

          A lot of people who have family members with #MS -- now thought to be caused in part by EBV -- will be livid.

          rrb@infosec.exchangeR This user is from outside of this forum
          rrb@infosec.exchangeR This user is from outside of this forum
          rrb@infosec.exchange
          schrieb zuletzt editiert von
          #105

          @jeneralist https://files.mastodon.social/media_attachments/files/116/063/438/357/085/875/original/7992ec7e1506894c.mp4

          1 Antwort Letzte Antwort
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          • regordane@mastodon.me.ukR regordane@mastodon.me.uk

            @pa27 @jeneralist

            The US won't buy if the FDA won't license, regardless of where the product is developed and made

            tessarakt@mastodon.socialT This user is from outside of this forum
            tessarakt@mastodon.socialT This user is from outside of this forum
            tessarakt@mastodon.social
            schrieb zuletzt editiert von
            #106

            @regordane @pa27 @jeneralist just fly to Cuba or any other nearby Carribbean island to get the shot.

            1 Antwort Letzte Antwort
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            • geonz@mathstodon.xyzG geonz@mathstodon.xyz

              @EndicottAuthor @jeneralist NOpe. They are anti-vaccine.

              nikatjef@mastodon.acm.orgN This user is from outside of this forum
              nikatjef@mastodon.acm.orgN This user is from outside of this forum
              nikatjef@mastodon.acm.org
              schrieb zuletzt editiert von
              #107

              @geonz
              No, there is a bit more to it. Moderna was the first to announce the possibility of using mRNA to build the vaccine, they announced it either just after Chump lost in 2020 or just after Chump left the white house in 2021. And then they had the audacity to lose to Pfizer to market launch, so to Chump it is very personal, which means to RFKjr it is personal.

              @EndicottAuthor @jeneralist

              geonz@mathstodon.xyzG 1 Antwort Letzte Antwort
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              • franksting@theblower.auF franksting@theblower.au

                @jeneralist @Taco_lad the point about ROI exposes the first principle for these organisations: massive profits. They should Give the research to another company that is interested in supporting human health first and profit second.

                mu@mastodon.nzM This user is from outside of this forum
                mu@mastodon.nzM This user is from outside of this forum
                mu@mastodon.nz
                schrieb zuletzt editiert von
                #108

                @franksting @jeneralist @Taco_lad yes, that's because these organisations currently operate in a capitalist context. Fixing that should be on the agenda, but you can't blame them for responding to the environment they are in.

                franksting@theblower.auF 1 Antwort Letzte Antwort
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                • tessarakt@mastodon.socialT tessarakt@mastodon.social

                  @Ireland4Ever @jeneralist "contract"? Isn't this rather an administrative procedure?

                  I This user is from outside of this forum
                  I This user is from outside of this forum
                  ireland4ever@mastodon.social
                  schrieb zuletzt editiert von
                  #109

                  @tessarakt @jeneralist

                  Assumed Moderna had a contract with FDA for these studies-maybe not. Moderna may need to just relocate their vaccine studies outside of the US.

                  1 Antwort Letzte Antwort
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                  • hosford42@techhub.socialH hosford42@techhub.social

                    @ariaflame @jeneralist @ujay68 We need consumer cooperatives in healthcare, not publicly traded companies. It's a massive conflict of interest.

                    nikatjef@mastodon.acm.orgN This user is from outside of this forum
                    nikatjef@mastodon.acm.orgN This user is from outside of this forum
                    nikatjef@mastodon.acm.org
                    schrieb zuletzt editiert von
                    #110

                    @hosford42
                    Yes, but it has to be targeted cooperatives. A coop is not going to be able to afford research into novel uses of mRNA vaccines. Coops cannot afford the protein synthesizers needed to make those novel mRNA vaccines into enough doses.

                    Now, if we instead taxed corporations / share holders profits the right way, they would be incentivized to spend the money that coops couldn't afford to spend.

                    @ariaflame @jeneralist @ujay68

                    glent@aus.socialG hosford42@techhub.socialH 2 Antworten Letzte Antwort
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                    • mu@mastodon.nzM mu@mastodon.nz

                      @franksting @jeneralist @Taco_lad yes, that's because these organisations currently operate in a capitalist context. Fixing that should be on the agenda, but you can't blame them for responding to the environment they are in.

                      franksting@theblower.auF This user is from outside of this forum
                      franksting@theblower.auF This user is from outside of this forum
                      franksting@theblower.au
                      schrieb zuletzt editiert von
                      #111

                      @mu @jeneralist @Taco_lad i absolutely can and I absolutely am. The population of the USA is ~5% of the world population

                      clarablackink@writing.exchangeC 1 Antwort Letzte Antwort
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                      • ujay68@mastodon.worldU ujay68@mastodon.world

                        @jeneralist Understandable. However, it doesn’t seem impossible to me to produce, at a profit, vaccines for the world’s population minus the US population. Not a really negligible target group. I’m no industry specialist, but there might also be … let’s say … other factors behind such a decision?

                        nikatjef@mastodon.acm.orgN This user is from outside of this forum
                        nikatjef@mastodon.acm.orgN This user is from outside of this forum
                        nikatjef@mastodon.acm.org
                        schrieb zuletzt editiert von
                        #112

                        @ujay68
                        I forget the actual number but Americans pay something like 160% more, resulting in higher profit margins, than the rest of the world. Many countries could not afford to pay US prices...

                        Hell the US can't really afford the US prices, but we pay it anyway because we have to .
                        @jeneralist

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                        • nikatjef@mastodon.acm.orgN nikatjef@mastodon.acm.org

                          @jeneralist
                          It would be a real shame if people boosted this and embarrassed the Chump regime...

                          petealexharris@mastodon.scotP This user is from outside of this forum
                          petealexharris@mastodon.scotP This user is from outside of this forum
                          petealexharris@mastodon.scot
                          schrieb zuletzt editiert von
                          #113

                          @nikatjef @jeneralist

                          They wouldn't be embarrassed, it's not an unintended or unwelcome outcome for them.

                          At this point, if someone leaked a memo that Peter Thiel has been trying all this time to bring about the end times by raising an antichrist to the presidency and instantiating the 4 horsemen of the apocalypse as US government policy, I'd barely raise an eyebrow.

                          The only surprising thing would be Trump hadn't boasted about it yet.

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                          • nikatjef@mastodon.acm.orgN nikatjef@mastodon.acm.org

                            @hosford42
                            Yes, but it has to be targeted cooperatives. A coop is not going to be able to afford research into novel uses of mRNA vaccines. Coops cannot afford the protein synthesizers needed to make those novel mRNA vaccines into enough doses.

                            Now, if we instead taxed corporations / share holders profits the right way, they would be incentivized to spend the money that coops couldn't afford to spend.

                            @ariaflame @jeneralist @ujay68

                            glent@aus.socialG This user is from outside of this forum
                            glent@aus.socialG This user is from outside of this forum
                            glent@aus.social
                            schrieb zuletzt editiert von
                            #114

                            @nikatjef @hosford42 @ariaflame @jeneralist @ujay68 Contrary view: the Wellcome Trust and vaccine development (eg: TB)

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                            • jeneralist@med-mastodon.comJ jeneralist@med-mastodon.com

                              The FDA decided not to even review Moderna's mRNA flu vaccines for approval, even though the studies the FDA would be reviewing were conducted the way the FDA told Moderna to do them.

                              Now #Moderna expects that none of its other #mRNA #vaccines will be reviewed, and has halted studies on vaccines for EBV, HSV, and shingles.

                              A lot of people with herpes would be angry if they found out.

                              A lot of people who have family members with #MS -- now thought to be caused in part by EBV -- will be livid.

                              praetor@mstdn.socialP This user is from outside of this forum
                              praetor@mstdn.socialP This user is from outside of this forum
                              praetor@mstdn.social
                              schrieb zuletzt editiert von
                              #115

                              @jeneralist Epstein herpes virus? Sounds about right.

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                              • adipoeserpursch@troet.cafeA adipoeserpursch@troet.cafe

                                @jeneralist Well, the US doesn't need any vaccines according to its Secretary of Disease. So, what market?

                                peturdainn@mastodon.socialP This user is from outside of this forum
                                peturdainn@mastodon.socialP This user is from outside of this forum
                                peturdainn@mastodon.social
                                schrieb zuletzt editiert von
                                #116

                                @adipoeserPursch yes, that's the point the CEO was making
                                @jeneralist

                                adipoeserpursch@troet.cafeA 1 Antwort Letzte Antwort
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                                • rantingcanuck@mstdn.caR rantingcanuck@mstdn.ca

                                  @Mikal @jeneralist

                                  They 100% could apply for approval in Europe or Canada but they won't because without access to the US market their isn't enough profit for them... and companies like Moderna don't care about people, they only care about profit.

                                  Europe, Canada, et al need to force the issue by changing patent law (at least for medical patents but honestly it would be best to cover all patents) to include a 'use it or lose it' clause. If companies don't pursue approval Government's should have the right to step in and use the companies patents to develop the drugs themselves.

                                  lapizistik@social.tchncs.deL This user is from outside of this forum
                                  lapizistik@social.tchncs.deL This user is from outside of this forum
                                  lapizistik@social.tchncs.de
                                  schrieb zuletzt editiert von
                                  #117

                                  @RantingCanuck @Mikal @jeneralist

                                  I think this only be one step in how the whole pharmaceutic market works. We can do better if we manage to focus on helping people but profits. And I am not sure what role companies can and should have in this at all.

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                                  • jeneralist@med-mastodon.comJ jeneralist@med-mastodon.com

                                    The FDA decided not to even review Moderna's mRNA flu vaccines for approval, even though the studies the FDA would be reviewing were conducted the way the FDA told Moderna to do them.

                                    Now #Moderna expects that none of its other #mRNA #vaccines will be reviewed, and has halted studies on vaccines for EBV, HSV, and shingles.

                                    A lot of people with herpes would be angry if they found out.

                                    A lot of people who have family members with #MS -- now thought to be caused in part by EBV -- will be livid.

                                    weekend_editor@mathstodon.xyzW This user is from outside of this forum
                                    weekend_editor@mathstodon.xyzW This user is from outside of this forum
                                    weekend_editor@mathstodon.xyz
                                    schrieb zuletzt editiert von
                                    #118

                                    @jeneralist

                                    Just wrote a blog post about this.

                                    Apparently Prasad wanted to redo the whole thing, using high-dose flu vax as the control. This is (a) medically inappropriate for trial participants under 65, and (b) unavailable in Europe at any age.

                                    Moderna has cancelled several vax projects, since they can no longer navigate the US approval system.

                                    https://www.someweekendreading.blog/fda-nixes-mrna-flu-vax/

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                                    • peturdainn@mastodon.socialP peturdainn@mastodon.social

                                      @adipoeserPursch yes, that's the point the CEO was making
                                      @jeneralist

                                      adipoeserpursch@troet.cafeA This user is from outside of this forum
                                      adipoeserpursch@troet.cafeA This user is from outside of this forum
                                      adipoeserpursch@troet.cafe
                                      schrieb zuletzt editiert von
                                      #119

                                      @jeneralist @peturdainn So why stop then? That's my point. There's still money to make – and/or lives to be saved...

                                      100% = let's do it
                                      60% = Hell, nay
                                      ???

                                      adipoeserpursch@troet.cafeA 1 Antwort Letzte Antwort
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                                      • adipoeserpursch@troet.cafeA adipoeserpursch@troet.cafe

                                        @jeneralist @peturdainn So why stop then? That's my point. There's still money to make – and/or lives to be saved...

                                        100% = let's do it
                                        60% = Hell, nay
                                        ???

                                        adipoeserpursch@troet.cafeA This user is from outside of this forum
                                        adipoeserpursch@troet.cafeA This user is from outside of this forum
                                        adipoeserpursch@troet.cafe
                                        schrieb zuletzt editiert von
                                        #120

                                        @jeneralist @peturdainn Always this "all or nothing"! 🤦🏾‍♂😤

                                        1 Antwort Letzte Antwort
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                                        • jeneralist@med-mastodon.comJ jeneralist@med-mastodon.com

                                          The FDA decided not to even review Moderna's mRNA flu vaccines for approval, even though the studies the FDA would be reviewing were conducted the way the FDA told Moderna to do them.

                                          Now #Moderna expects that none of its other #mRNA #vaccines will be reviewed, and has halted studies on vaccines for EBV, HSV, and shingles.

                                          A lot of people with herpes would be angry if they found out.

                                          A lot of people who have family members with #MS -- now thought to be caused in part by EBV -- will be livid.

                                          lexinova@cyberplace.socialL This user is from outside of this forum
                                          lexinova@cyberplace.socialL This user is from outside of this forum
                                          lexinova@cyberplace.social
                                          schrieb zuletzt editiert von
                                          #121

                                          @jeneralist maybe time to move out to EU, so you can have return on invest ... by selling it without tariff, ans since US is not interested go sell it where we are.

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