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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.

    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.

                                1 Antwort Letzte Antwort
                                0
                                • ariaflame@masto.aiA ariaflame@masto.ai

                                  @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 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
                                  #29

                                  @ariaflame @ujay68

                                  Moderna has shareholders. It's on the NASDAQ, stock symbol MRNA.

                                  ariaflame@masto.aiA 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.

                                    humanhorseshoes@mastodon.worldH This user is from outside of this forum
                                    humanhorseshoes@mastodon.worldH This user is from outside of this forum
                                    humanhorseshoes@mastodon.world
                                    schrieb zuletzt editiert von
                                    #30

                                    @jeneralist A junkie that snorts cocaine off toilet seats is behind this

                                    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.

                                      helle@tacobelllabs.netH This user is from outside of this forum
                                      helle@tacobelllabs.netH This user is from outside of this forum
                                      helle@tacobelllabs.net
                                      schrieb zuletzt editiert von
                                      #31

                                      @jeneralist even without MS, EBV is itself such a mess, had it as an adult and I have had my long term health so significantly affected by it

                                      it is such a mess that the USA is handling this badly as a country and that commercial interests are also involved instead of just the good of everyone on the planet 😕

                                      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.

                                        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
                                        #32

                                        @jeneralist
                                        I wonder if a state or two could step in. Pritzker????

                                        1 Antwort Letzte Antwort
                                        0
                                        • frieke72@mastodon.socialF frieke72@mastodon.social

                                          @Mikal This!
                                          Like so many other science or tech stuff going on in usa... Let's profit of it's stupidity to expand European knowledge/market!

                                          @jeneralist

                                          G This user is from outside of this forum
                                          G This user is from outside of this forum
                                          goedelchen@mastodontech.de
                                          schrieb zuletzt editiert von
                                          #33

                                          @Frieke72 @Mikal @jeneralist BioNTech (the German company that developed the mRNA Covid19 vaccine distributed by Pfizer) is developing vaccines against HSV, Mpox, HIV...

                                          One competitor less, now.

                                          musevg@23.socialM 1 Antwort Letzte Antwort
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