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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

    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.

    pip@infosec.exchangeP This user is from outside of this forum
    pip@infosec.exchangeP This user is from outside of this forum
    pip@infosec.exchange
    schrieb zuletzt editiert von
    #76

    @jeneralist

    https://en.wikipedia.org/wiki/Social_murder

    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.

      netraven@hear-me.socialN This user is from outside of this forum
      netraven@hear-me.socialN This user is from outside of this forum
      netraven@hear-me.social
      schrieb zuletzt editiert von
      #77

      @jeneralist Eugenics

      1 Antwort Letzte Antwort
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      • heartofcoyote@neuromatch.socialH heartofcoyote@neuromatch.social

        @jeneralist @EndicottAuthor Yup. With a side of shakedown as a distraction.

        rndanger@infosec.exchangeR This user is from outside of this forum
        rndanger@infosec.exchangeR This user is from outside of this forum
        rndanger@infosec.exchange
        schrieb zuletzt editiert von
        #78

        @Heartofcoyote @jeneralist @EndicottAuthor
        You're always in a better position to negotiate if you are willing to walk away. So Trump teamed up with people who do not care for the systems they are put in charge of -- their goal is to walk away. Now it's just a matter of how much Trump can extract from everyone else while they do that

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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.

          shadower@mastodon.socialS This user is from outside of this forum
          shadower@mastodon.socialS This user is from outside of this forum
          shadower@mastodon.social
          schrieb zuletzt editiert von
          #79

          @jeneralist MS-haver here. Beyond furious.

          1 Antwort Letzte Antwort
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          • jcutting@mastodon.socialJ jcutting@mastodon.social

            @crazyeddie
            Yeah. There are shades of both. We have the obviously inept senate PLUS the obviously unhinged Caligula destroying a world leading economy for no gain (or negative gains due to petty grievances).

            F This user is from outside of this forum
            F This user is from outside of this forum
            forkidork@theforkiverse.com
            schrieb zuletzt editiert von
            #80

            @jcutting @crazyeddie why does everyone keep bringing up Caligula? Isn't he more like Nero?

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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.

              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
              #81

              @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 1 Antwort Letzte Antwort
              0
              • drwho@masto.hackers.townD drwho@masto.hackers.town

                @mirth @ujay68 @jeneralist I don't know. I don't have access to their internal accounting system.

                mirth@mastodon.sdf.orgM This user is from outside of this forum
                mirth@mastodon.sdf.orgM This user is from outside of this forum
                mirth@mastodon.sdf.org
                schrieb zuletzt editiert von
                #82

                @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 1 Antwort Letzte Antwort
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                • mikal@sfba.socialM mikal@sfba.social

                  @jeneralist

                  Is there any reason they couldn't apply for approval in Europe or Canada or some other place that hasn't lost his mind?

                  kataphractoi@kpop.socialK This user is from outside of this forum
                  kataphractoi@kpop.socialK This user is from outside of this forum
                  kataphractoi@kpop.social
                  schrieb zuletzt editiert von
                  #83

                  @Mikal @jeneralist
                  I think they were targeting a market that they could make a lot of money out of. US regs tend to favor price engineering - or at least it's permissible to it.

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                  • michael_w_busch@mastodon.onlineM michael_w_busch@mastodon.online

                    @adventure_tense @jeneralist

                    Moderna has its new influenza vaccine under review in the EU, Canada, and Australia: https://www.nbcnews.com/health/health-news/fda-declines-review-modernas-mrna-flu-shot-rcna258436

                    But that does not make what Trump and those with him are doing any less deadly.

                    adventure_tense@mapstodon.spaceA This user is from outside of this forum
                    adventure_tense@mapstodon.spaceA This user is from outside of this forum
                    adventure_tense@mapstodon.space
                    schrieb zuletzt editiert von
                    #84

                    @michael_w_busch @jeneralist Very true. My comments were a bit insensitive and callous, especially to all of us whom are affected by our current admin.

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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.

                      hosford42@techhub.socialH This user is from outside of this forum
                      hosford42@techhub.socialH This user is from outside of this forum
                      hosford42@techhub.social
                      schrieb zuletzt editiert von
                      #85

                      @RantingCanuck @Mikal @jeneralist

                      We would do even better if these companies were cooperatives driven by community benefit instead of publicly traded corporations driven by profit. Profit (as opposed to wages) is intrinsically extractive -- the antithesis of healthcare or anything else related to customer well-being.

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                      • ariaflame@masto.aiA ariaflame@masto.ai

                        @jeneralist @ujay68 So basically it's confirming that people in the USA are paying far too much for their medication. And the Pharmaceutical companies don't care too much, because if the people survive to old age they will make bank on them.

                        hosford42@techhub.socialH This user is from outside of this forum
                        hosford42@techhub.socialH This user is from outside of this forum
                        hosford42@techhub.social
                        schrieb zuletzt editiert von
                        #86

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

                        nikatjef@mastodon.acm.orgN 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.

                          oldfartrant@mstdn.caO This user is from outside of this forum
                          oldfartrant@mstdn.caO This user is from outside of this forum
                          oldfartrant@mstdn.ca
                          schrieb zuletzt editiert von
                          #87

                          @jeneralist most likely RFK Jr has a homeopathy treatment that will be FDA approved and he'll make millions while people suffer.

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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?

                            A This user is from outside of this forum
                            A This user is from outside of this forum
                            azurearmageddon@mastodon.online
                            schrieb zuletzt editiert von
                            #88

                            @LoneLocust @jeneralist Maybe not, but ceasing to be an outlier might push average prices up globally.

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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?

                              hosford42@techhub.socialH This user is from outside of this forum
                              hosford42@techhub.socialH This user is from outside of this forum
                              hosford42@techhub.social
                              schrieb zuletzt editiert von
                              #89

                              @LoneLocust @AzureArmageddon @jeneralist

                              In our current economic system, it probably would. (And we are about to find out, because the US is on a terrible trajectory right now and on course to cease being a major player.)

                              That's why profit shouldn't be the driver for medical research. If these companies were consumer cooperatives, their purpose and focus would be to benefit their customers, not to extract money from their customers' pockets and put it into shareholders' hands. Then it wouldn't matter if the drug was profitable. It would matter if it was affordable and worthwhile to develop, manufacture, and deliver it.

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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.

                                xs4me2@mastodon.socialX This user is from outside of this forum
                                xs4me2@mastodon.socialX This user is from outside of this forum
                                xs4me2@mastodon.social
                                schrieb zuletzt editiert von
                                #90

                                @jeneralist Too crazy for words, pure madness…

                                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.

                                  danbrotherston@types.plD This user is from outside of this forum
                                  danbrotherston@types.plD This user is from outside of this forum
                                  danbrotherston@types.pl
                                  schrieb zuletzt editiert von
                                  #91

                                  @jeneralist this absolutely sucks. But it also shows how we need to (as a world) move beyond the US.

                                  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.

                                    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
                                    #92

                                    @jeneralist Why is the US market more "important" than Asian, European etc. markets?

                                    #DiD

                                    jeneralist@med-mastodon.comJ 1 Antwort Letzte Antwort
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                                    • ujay68@mastodon.worldU ujay68@mastodon.world

                                      @jeneralist They could still develop vaccines for the other 8 billion people on this planet, couldn’t they? If they wanted to? No?

                                      svavar@masto.svavar.comS This user is from outside of this forum
                                      svavar@masto.svavar.comS This user is from outside of this forum
                                      svavar@masto.svavar.com
                                      schrieb zuletzt editiert von
                                      #93

                                      @ujay68 @jeneralist

                                      They could, they don't want to.

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

                                        @jeneralist Why is the US market more "important" than Asian, European etc. markets?

                                        #DiD

                                        jeneralist@med-mastodon.comJ This user is from outside of this forum
                                        jeneralist@med-mastodon.comJ This user is from outside of this forum
                                        jeneralist@med-mastodon.com
                                        schrieb zuletzt editiert von
                                        #94

                                        @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.

                                        adipoeserpursch@troet.cafeA tessarakt@mastodon.socialT 2 Antworten 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.

                                          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
                                          #95

                                          @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 1 Antwort Letzte Antwort
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