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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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  • 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.

              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.

                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
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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.

                    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
                        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.

                          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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                          • 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.

                            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
                            #96

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

                            peturdainn@mastodon.socialP 1 Antwort Letzte Antwort
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                            • drwho@masto.hackers.townD drwho@masto.hackers.town

                              @ancientsounds @jeneralist They're probably relocating assets for this. I don't know for sure, I got laid off last October and bounced from the industry.

                              ancientsounds@mastodonapp.ukA This user is from outside of this forum
                              ancientsounds@mastodonapp.ukA This user is from outside of this forum
                              ancientsounds@mastodonapp.uk
                              schrieb zuletzt editiert von
                              #97

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

                              drwho@masto.hackers.townD 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.

                                rvlara23@mastodon.socialR This user is from outside of this forum
                                rvlara23@mastodon.socialR This user is from outside of this forum
                                rvlara23@mastodon.social
                                schrieb zuletzt editiert von
                                #98

                                @jeneralist

                                Jesus fucking christ

                                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.

                                  momo@social.linux.pizzaM This user is from outside of this forum
                                  momo@social.linux.pizzaM This user is from outside of this forum
                                  momo@social.linux.pizza
                                  schrieb zuletzt editiert von
                                  #99

                                  @jeneralist
                                  Just to point it out: This is shelved WORLDWIDE because if it can't be sold in the US, it won't hit ROI even if sold in the rest of the world.

                                  And THIS is outright wrong!

                                  1 Antwort Letzte Antwort
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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 ?

                                        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
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