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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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  • 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.

                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.

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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"! 🤦🏾‍♂😤

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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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                            • endicottauthor@mastodon.socialE endicottauthor@mastodon.social

                              @jeneralist The only reason would be that competing companies have bought their way into favor with the DJT administration, and Moderna is on the outside looking in.

                              largess@mastodon.auL This user is from outside of this forum
                              largess@mastodon.auL This user is from outside of this forum
                              largess@mastodon.au
                              schrieb zuletzt editiert von
                              #122

                              @EndicottAuthor @jeneralist

                              Australia's CSL is also struggling with vaccination approvals in the US.

                              The rise and rise of stupid. I once dismissed anti vaccination as nonsense that is overwhelming unsupported by the data. What I didn't count on is the stupidity factor. It's similarly seen in #ClimateChange etc

                              Cipolla was right, a stupid person is the most dangerous of people.

                              ponygirl@mastodon.socialP 1 Antwort Letzte Antwort
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                              • ancientsounds@mastodonapp.ukA ancientsounds@mastodonapp.uk

                                @drwho @jeneralist
                                Do you mean Moderna relocating assets (maybe)?

                                drwho@masto.hackers.townD This user is from outside of this forum
                                drwho@masto.hackers.townD This user is from outside of this forum
                                drwho@masto.hackers.town
                                schrieb zuletzt editiert von
                                #123

                                @ancientsounds @jeneralist No, BioNTech. To take advantage of Moderna's stumble. They're pretty nimble as pharmacorps go.

                                ancientsounds@mastodonapp.ukA 1 Antwort Letzte Antwort
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                                • mirth@mastodon.sdf.orgM mirth@mastodon.sdf.org

                                  @drwho @ujay68 @jeneralist Eyeballing some news articles they pay maybe something like $100M/year in bonuses? Not insignificant, but proportionally also probably doesn't change the overall financial picture by a whole lot.

                                  drwho@masto.hackers.townD This user is from outside of this forum
                                  drwho@masto.hackers.townD This user is from outside of this forum
                                  drwho@masto.hackers.town
                                  schrieb zuletzt editiert von
                                  #124

                                  @mirth @ujay68 @jeneralist Depends on how many execs are getting that class of bonus. The shareholders don't seem to mind a whole lot.

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

                                    @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 This user is from outside of this forum
                                    geonz@mathstodon.xyzG This user is from outside of this forum
                                    geonz@mathstodon.xyz
                                    schrieb zuletzt editiert von
                                    #125

                                    @nikatjef @EndicottAuthor @jeneralist Oh, that's right!!!!

                                    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.

                                      lispi314@udongein.xyzL This user is from outside of this forum
                                      lispi314@udongein.xyzL This user is from outside of this forum
                                      lispi314@udongein.xyz
                                      schrieb zuletzt editiert von
                                      #126
                                      @jeneralist Why are they so focused on USA market? Just because the USA is making bad decisions doesn't meant they can't market their vaccines in Canada or Mexico.
                                      clarablackink@writing.exchangeC 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.

                                        clarinerd@mastodon.socialC This user is from outside of this forum
                                        clarinerd@mastodon.socialC This user is from outside of this forum
                                        clarinerd@mastodon.social
                                        schrieb zuletzt editiert von
                                        #127

                                        @jeneralist Well there goes my hopes for a vaccine for Lyme disease ever coming back...

                                        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.

                                          wgo@toot.ioW This user is from outside of this forum
                                          wgo@toot.ioW This user is from outside of this forum
                                          wgo@toot.io
                                          schrieb zuletzt editiert von
                                          #128

                                          @jeneralist

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