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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

    @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
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    • 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
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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.

          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
                                      0
                                      • jcutting@mastodon.socialJ jcutting@mastodon.social

                                        @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 This user is from outside of this forum
                                        crazyeddie@mastodon.socialC This user is from outside of this forum
                                        crazyeddie@mastodon.social
                                        schrieb zuletzt editiert von
                                        #34

                                        @jcutting @jeneralist Feels to me more like the crisis of the roman republic than the fall of the empire that replaced it.

                                        jcutting@mastodon.socialJ 1 Antwort Letzte Antwort
                                        0
                                        • fruitcakesareyum@mastodon.socialF fruitcakesareyum@mastodon.social

                                          @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 This user is from outside of this forum
                                          crazyeddie@mastodon.socialC This user is from outside of this forum
                                          crazyeddie@mastodon.social
                                          schrieb zuletzt editiert von
                                          #35

                                          @fruitcakesareyum @jeneralist We won't. We're being held hostage by Texas.

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