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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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  • 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?

    rantingcanuck@mstdn.caR This user is from outside of this forum
    rantingcanuck@mstdn.caR This user is from outside of this forum
    rantingcanuck@mstdn.ca
    schrieb zuletzt editiert von
    #9

    @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.

    regordane@mastodon.me.ukR hosford42@techhub.socialH lapizistik@social.tchncs.deL 3 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.

      ujay68@mastodon.worldU This user is from outside of this forum
      ujay68@mastodon.worldU This user is from outside of this forum
      ujay68@mastodon.world
      schrieb zuletzt editiert von
      #10

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

      jeneralist@med-mastodon.comJ svavar@masto.svavar.comS 2 Antworten Letzte Antwort
      0
      • jeneralist@med-mastodon.comJ jeneralist@med-mastodon.com

        @EndicottAuthor Sadly, that's a more hopeful interpretation than mine: the administration is pursuing an anti-vaccine agenda, and is doing what it can to make EVERY vaccine manufacturer pack up and leave. Moderna is just the first.

        heartofcoyote@neuromatch.socialH This user is from outside of this forum
        heartofcoyote@neuromatch.socialH This user is from outside of this forum
        heartofcoyote@neuromatch.social
        schrieb zuletzt editiert von
        #11

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

        rndanger@infosec.exchangeR 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.

          masek@infosec.exchangeM This user is from outside of this forum
          masek@infosec.exchangeM This user is from outside of this forum
          masek@infosec.exchange
          schrieb zuletzt editiert von
          #12

          @jeneralist I am as furious at the CEO of Moderna as I am at the brainworm and his boss.

          The CEO is taking the rest of the world hostage so they please bribe Trump for him.

          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.

            brianvastag@mas.toB This user is from outside of this forum
            brianvastag@mas.toB This user is from outside of this forum
            brianvastag@mas.to
            schrieb zuletzt editiert von
            #13

            @jeneralist EBV is also a common trigger for the lifelong illness known as ME/CFS.

            https://www.mdpi.com/2076-2607/13/4/702

            jeneralist@med-mastodon.comJ 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.

              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
              #14

              @jeneralist "You cannot make a return on investment if you don't have access to the U.S. market" is a scary phrase.

              lonelocust@mastodon.socialL 1 Antwort Letzte Antwort
              0
              • 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?

                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
                #15

                @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.

                ariaflame@masto.aiA ujay68@mastodon.worldU 1000millimeter@chaos.social1 3 Antworten Letzte Antwort
                0
                • jeneralist@med-mastodon.comJ jeneralist@med-mastodon.com

                  @Mikal

                  A vaccine manufacturer would normally apply for approval in many jurisdictions.

                  But for 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

                  Without US, the market is AT LEAST 40% smaller. Is it still worth it do to the studies?

                  c0dec0dec0de@hachyderm.ioC This user is from outside of this forum
                  c0dec0dec0de@hachyderm.ioC This user is from outside of this forum
                  c0dec0dec0de@hachyderm.io
                  schrieb zuletzt editiert von
                  #16

                  @jeneralist @Mikal the US overpays for meds, so that 40% probably accounts for a majority of their profit. I’d be surprised if they truly wouldn’t make a profit, but I can’t rule it out with certainty.

                  drwho@masto.hackers.townD regordane@mastodon.me.ukR 2 Antworten Letzte Antwort
                  0
                  • brianvastag@mas.toB brianvastag@mas.to

                    @jeneralist EBV is also a common trigger for the lifelong illness known as ME/CFS.

                    https://www.mdpi.com/2076-2607/13/4/702

                    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
                    #17

                    @brianvastag Yep! And I really want any potential vaccine to evaluate the effect on ME/CFS. Is it the pathogen that causes problems, or the immune system's response to the pathogen? Could a poorly-designed vaccine make things worse?

                    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.

                      alienghic@timeloop.cafeA This user is from outside of this forum
                      alienghic@timeloop.cafeA This user is from outside of this forum
                      alienghic@timeloop.cafe
                      schrieb zuletzt editiert von
                      #18

                      @jeneralist

                      $&#&@% death cult enagelical Christians and their crazed belief that god micromanages who gets infected

                      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.

                        stekopf@mstdn.socialS This user is from outside of this forum
                        stekopf@mstdn.socialS This user is from outside of this forum
                        stekopf@mstdn.social
                        schrieb zuletzt editiert von
                        #19

                        @jeneralist

                        »In August of 2025, following the successful completion of the Phase 3 efficacy trial in which mRNA-1010 met all pre-specified primary endpoints, Moderna held a pre-submission meeting with CBER [Center for Biologics Evaluation and Research]. CBER requested that supportive analyses be included … Moderna provided the additional analyses … At no time in the pre-submission written feedback or meeting did CBER indicate that it would refuse to review the file.«

                        https://feeds.issuerdirect.com/news-release.html?newsid=7346090610333866&symbol=MRNA

                        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.

                          scaletheory@mastodon.socialS This user is from outside of this forum
                          scaletheory@mastodon.socialS This user is from outside of this forum
                          scaletheory@mastodon.social
                          schrieb zuletzt editiert von
                          #20

                          @jeneralist

                          Oligarchy = Devolution, regression, deregulation, subversion = revolution

                          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.

                            hellomiakoda@pdx.socialH This user is from outside of this forum
                            hellomiakoda@pdx.socialH This user is from outside of this forum
                            hellomiakoda@pdx.social
                            schrieb zuletzt editiert von
                            #21

                            @jeneralist I live in a first world shithole

                            1 Antwort Letzte Antwort
                            0
                            • 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.

                              ariaflame@masto.aiA This user is from outside of this forum
                              ariaflame@masto.aiA This user is from outside of this forum
                              ariaflame@masto.ai
                              schrieb zuletzt editiert von
                              #22

                              @jeneralist @ujay68 If they have shareholders anyway. I think non-profits and closely held (I think that's the term) don't have that restriction. But I don't think that applies to any pharmaceutical company.

                              jeneralist@med-mastodon.comJ 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.

                                sassinake@mastodon.socialS This user is from outside of this forum
                                sassinake@mastodon.socialS This user is from outside of this forum
                                sassinake@mastodon.social
                                schrieb zuletzt editiert von
                                #23

                                @jeneralist

                                I mean... rich people will still get them.

                                regordane@mastodon.me.ukR 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.

                                  A This user is from outside of this forum
                                  A This user is from outside of this forum
                                  ansiblegames@mastodon.social
                                  schrieb zuletzt editiert von
                                  #24

                                  @jeneralist here is a (brief) source on Reuters for anyone looking https://www.reuters.com/business/healthcare-pharmaceuticals/moderna-curbing-investments-vaccine-trials-due-us-backlash-ceo-tells-bloomberg-2026-01-22/

                                  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.

                                    fruitcakesareyum@mastodon.socialF This user is from outside of this forum
                                    fruitcakesareyum@mastodon.socialF This user is from outside of this forum
                                    fruitcakesareyum@mastodon.social
                                    schrieb zuletzt editiert von
                                    #25

                                    @jeneralist

                                    If there's one thing that can be said about the current US administration is that it's airing out all the dirty laundry of the world.

                                    The fact that a pharmaceutical company puts profit over human lives is an abomination. The fact that one single country can hold the rest of us hostages because they allowed themselves to be scammed rather than have universal healthcare is an abomination.

                                    If they ever get out of this, I hope Americans fix their stuff.

                                    crazyeddie@mastodon.socialC 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.

                                      gracicot@mastodon.socialG This user is from outside of this forum
                                      gracicot@mastodon.socialG This user is from outside of this forum
                                      gracicot@mastodon.social
                                      schrieb zuletzt editiert von
                                      #26

                                      @jeneralist that keeps people in doctor's office and hospitals. Good for the friends of the administration.

                                      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.

                                        jcutting@mastodon.socialJ This user is from outside of this forum
                                        jcutting@mastodon.socialJ This user is from outside of this forum
                                        jcutting@mastodon.social
                                        schrieb zuletzt editiert von
                                        #27

                                        @jeneralist
                                        Squandering what is probably the most important medical breakthrough of my lifetime because the most unqualified, narcissistic sociopaths somehow got elected because they were the right sort of bigots.
                                        It's so tragic. It's like reading about the collapse of the Roman or Mongol empires due to easily avoidable systematic issues except we're living it.

                                        crazyeddie@mastodon.socialC 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.

                                          spirit@cybernetic.monsterS This user is from outside of this forum
                                          spirit@cybernetic.monsterS This user is from outside of this forum
                                          spirit@cybernetic.monster
                                          schrieb zuletzt editiert von
                                          #28

                                          @jeneralist They want to depopulate the US. This is just another policy tool to achieve that goal.

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