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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

    @ujay68

    I'm not the right person to be explaining the perverse intersection of healthcare and capitalism. The short answer is, most large companies won't do anything that loses money. In fact, in US law they are specifically prohibited from doing things that are expected to lose money.

    1000millimeter@chaos.social1 This user is from outside of this forum
    1000millimeter@chaos.social1 This user is from outside of this forum
    1000millimeter@chaos.social
    schrieb zuletzt editiert von
    #100

    @jeneralist @ujay68 To be fair, if they wouldn't care and do many things that loose money, they wouldn't be around very long, and then we wouldn't have (new) vaccines as well.

    1 Antwort Letzte Antwort
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    • lonelocust@mastodon.socialL lonelocust@mastodon.social

      @AzureArmageddon @jeneralist that really does make me wonder that if the United States ever fixed its medical system to be in line with the rest of the civilized world. Would that take away the actual impetus for medical research that has been improving the lives of people worldwide?

      adavid@aus.socialA This user is from outside of this forum
      adavid@aus.socialA This user is from outside of this forum
      adavid@aus.social
      schrieb zuletzt editiert von
      #101

      @LoneLocust @AzureArmageddon @jeneralist

      Moderna is the beneficiary of billions in govt funding, but in the end only the shareholders have primacy. The US government does not benefit the people either.

      1 Antwort Letzte Antwort
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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 ?

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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
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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.

            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

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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.

                              1 Antwort Letzte Antwort
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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)

                                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.

                                  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.

                                  1 Antwort Letzte Antwort
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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.

                                      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.

                                        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/

                                        1 Antwort Letzte Antwort
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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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