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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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  • 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.

    lapizistik@social.tchncs.deL This user is from outside of this forum
    lapizistik@social.tchncs.deL This user is from outside of this forum
    lapizistik@social.tchncs.de
    schrieb zuletzt editiert von
    #117

    @RantingCanuck @Mikal @jeneralist

    I think this only be one step in how the whole pharmaceutic market works. We can do better if we manage to focus on helping people but profits. And I am not sure what role companies can and should have in this at all.

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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.

      weekend_editor@mathstodon.xyzW This user is from outside of this forum
      weekend_editor@mathstodon.xyzW This user is from outside of this forum
      weekend_editor@mathstodon.xyz
      schrieb zuletzt editiert von
      #118

      @jeneralist

      Just wrote a blog post about this.

      Apparently Prasad wanted to redo the whole thing, using high-dose flu vax as the control. This is (a) medically inappropriate for trial participants under 65, and (b) unavailable in Europe at any age.

      Moderna has cancelled several vax projects, since they can no longer navigate the US approval system.

      https://www.someweekendreading.blog/fda-nixes-mrna-flu-vax/

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      • peturdainn@mastodon.socialP peturdainn@mastodon.social

        @adipoeserPursch yes, that's the point the CEO was making
        @jeneralist

        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
        #119

        @jeneralist @peturdainn So why stop then? That's my point. There's still money to make – and/or lives to be saved...

        100% = let's do it
        60% = Hell, nay
        ???

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

          @jeneralist @peturdainn So why stop then? That's my point. There's still money to make – and/or lives to be saved...

          100% = let's do it
          60% = Hell, nay
          ???

          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
          #120

          @jeneralist @peturdainn Always this "all or nothing"! 🤦🏾‍♂😤

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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.

            lexinova@cyberplace.socialL This user is from outside of this forum
            lexinova@cyberplace.socialL This user is from outside of this forum
            lexinova@cyberplace.social
            schrieb zuletzt editiert von
            #121

            @jeneralist maybe time to move out to EU, so you can have return on invest ... by selling it without tariff, ans since US is not interested go sell it where we are.

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            • endicottauthor@mastodon.socialE endicottauthor@mastodon.social

              @jeneralist The only reason would be that competing companies have bought their way into favor with the DJT administration, and Moderna is on the outside looking in.

              largess@mastodon.auL This user is from outside of this forum
              largess@mastodon.auL This user is from outside of this forum
              largess@mastodon.au
              schrieb zuletzt editiert von
              #122

              @EndicottAuthor @jeneralist

              Australia's CSL is also struggling with vaccination approvals in the US.

              The rise and rise of stupid. I once dismissed anti vaccination as nonsense that is overwhelming unsupported by the data. What I didn't count on is the stupidity factor. It's similarly seen in #ClimateChange etc

              Cipolla was right, a stupid person is the most dangerous of people.

              ponygirl@mastodon.socialP 1 Antwort Letzte Antwort
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              • ancientsounds@mastodonapp.ukA ancientsounds@mastodonapp.uk

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

                drwho@masto.hackers.townD This user is from outside of this forum
                drwho@masto.hackers.townD This user is from outside of this forum
                drwho@masto.hackers.town
                schrieb zuletzt editiert von
                #123

                @ancientsounds @jeneralist No, BioNTech. To take advantage of Moderna's stumble. They're pretty nimble as pharmacorps go.

                ancientsounds@mastodonapp.ukA 1 Antwort Letzte Antwort
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                • mirth@mastodon.sdf.orgM mirth@mastodon.sdf.org

                  @drwho @ujay68 @jeneralist Eyeballing some news articles they pay maybe something like $100M/year in bonuses? Not insignificant, but proportionally also probably doesn't change the overall financial picture by a whole lot.

                  drwho@masto.hackers.townD This user is from outside of this forum
                  drwho@masto.hackers.townD This user is from outside of this forum
                  drwho@masto.hackers.town
                  schrieb zuletzt editiert von
                  #124

                  @mirth @ujay68 @jeneralist Depends on how many execs are getting that class of bonus. The shareholders don't seem to mind a whole lot.

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                  • nikatjef@mastodon.acm.orgN nikatjef@mastodon.acm.org

                    @geonz
                    No, there is a bit more to it. Moderna was the first to announce the possibility of using mRNA to build the vaccine, they announced it either just after Chump lost in 2020 or just after Chump left the white house in 2021. And then they had the audacity to lose to Pfizer to market launch, so to Chump it is very personal, which means to RFKjr it is personal.

                    @EndicottAuthor @jeneralist

                    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
                    #125

                    @nikatjef @EndicottAuthor @jeneralist Oh, that's right!!!!

                    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.

                      lispi314@udongein.xyzL This user is from outside of this forum
                      lispi314@udongein.xyzL This user is from outside of this forum
                      lispi314@udongein.xyz
                      schrieb zuletzt editiert von
                      #126
                      @jeneralist Why are they so focused on USA market? Just because the USA is making bad decisions doesn't meant they can't market their vaccines in Canada or Mexico.
                      clarablackink@writing.exchangeC 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.

                        clarinerd@mastodon.socialC This user is from outside of this forum
                        clarinerd@mastodon.socialC This user is from outside of this forum
                        clarinerd@mastodon.social
                        schrieb zuletzt editiert von
                        #127

                        @jeneralist Well there goes my hopes for a vaccine for Lyme disease ever coming back...

                        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.

                          wgo@toot.ioW This user is from outside of this forum
                          wgo@toot.ioW This user is from outside of this forum
                          wgo@toot.io
                          schrieb zuletzt editiert von
                          #128

                          @jeneralist

                          1 Antwort Letzte Antwort
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                          • largess@mastodon.auL largess@mastodon.au

                            @EndicottAuthor @jeneralist

                            Australia's CSL is also struggling with vaccination approvals in the US.

                            The rise and rise of stupid. I once dismissed anti vaccination as nonsense that is overwhelming unsupported by the data. What I didn't count on is the stupidity factor. It's similarly seen in #ClimateChange etc

                            Cipolla was right, a stupid person is the most dangerous of people.

                            ponygirl@mastodon.socialP This user is from outside of this forum
                            ponygirl@mastodon.socialP This user is from outside of this forum
                            ponygirl@mastodon.social
                            schrieb zuletzt editiert von
                            #129

                            @largess @EndicottAuthor @jeneralist Stupid always has a price. It's never free.

                            momo@social.linux.pizzaM 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.

                              psistarpsiii@tacobelllabs.netP This user is from outside of this forum
                              psistarpsiii@tacobelllabs.netP This user is from outside of this forum
                              psistarpsiii@tacobelllabs.net
                              schrieb zuletzt editiert von
                              #130

                              @jeneralist just gonna call it now, if this shit continues, vaccine tourism is gonna become a thing

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                              • nikatjef@mastodon.acm.orgN nikatjef@mastodon.acm.org

                                @hosford42
                                Yes, but it has to be targeted cooperatives. A coop is not going to be able to afford research into novel uses of mRNA vaccines. Coops cannot afford the protein synthesizers needed to make those novel mRNA vaccines into enough doses.

                                Now, if we instead taxed corporations / share holders profits the right way, they would be incentivized to spend the money that coops couldn't afford to spend.

                                @ariaflame @jeneralist @ujay68

                                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
                                #131

                                @nikatjef @ariaflame @jeneralist @ujay68 coops (and the everyday people that are their members) can't fund major undertakings because for-profit corporations have extracted most of the wealth and handed it off to billionaires.

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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.

                                  omegapolice@hachyderm.ioO This user is from outside of this forum
                                  omegapolice@hachyderm.ioO This user is from outside of this forum
                                  omegapolice@hachyderm.io
                                  schrieb zuletzt editiert von
                                  #132

                                  @jeneralist If you need that broken, inflated medical market to turn a profit, and no new medication can be developed without expecting a profit, we're in trouble.

                                  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.

                                    kaetchi@mastodon.onlineK This user is from outside of this forum
                                    kaetchi@mastodon.onlineK This user is from outside of this forum
                                    kaetchi@mastodon.online
                                    schrieb zuletzt editiert von
                                    #133

                                    @jeneralist they want not only to reduce childhood vaccination, but stop them from being produced, only hope that the rest of the world continues development and production

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                                    • ponygirl@mastodon.socialP ponygirl@mastodon.social

                                      @largess @EndicottAuthor @jeneralist Stupid always has a price. It's never free.

                                      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
                                      #134

                                      @Ponygirl
                                      And the entire world has to pay it! Because Moderna said without the US market, they can't hit ROI. Means the entire world don't get mRNA vaccines if Trump says no. This is fucked.
                                      @largess @EndicottAuthor @jeneralist

                                      ramin_hal9001@fe.disroot.orgR 1 Antwort Letzte Antwort
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                                      • momo@social.linux.pizzaM momo@social.linux.pizza

                                        @Ponygirl
                                        And the entire world has to pay it! Because Moderna said without the US market, they can't hit ROI. Means the entire world don't get mRNA vaccines if Trump says no. This is fucked.
                                        @largess @EndicottAuthor @jeneralist

                                        ramin_hal9001@fe.disroot.orgR This user is from outside of this forum
                                        ramin_hal9001@fe.disroot.orgR This user is from outside of this forum
                                        ramin_hal9001@fe.disroot.org
                                        schrieb zuletzt editiert von
                                        #135
                                        @largess

                                        > "Cipolla was right, a stupid person is the most dangerous of people."

                                        I'm going to push back a bit on this. The most dangerous of all people are the ultra-wealthy who prey on stupid people to enrich themseves, especially when the wealthy use propaganda to rile masses of people to affect policy that will benefit the wealthy.

                                        That is what is why the ultra-wealthy are usually so anti-science. If too many people were more scintifically literate, they would start making demands of the politically powerful, like solving climate change, seeing minorities like trans people as human beings with human rights, and providing affordable health care (especially vaccines) for everyone. The only time they are ever pro-science is when they need people to develop new weapons and surveillance systems.

                                        @momo
                                        @Ponygirl @EndicottAuthor @jeneralist
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                                        • G goedelchen@mastodontech.de

                                          @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 This user is from outside of this forum
                                          musevg@23.socialM This user is from outside of this forum
                                          musevg@23.social
                                          schrieb zuletzt editiert von
                                          #136

                                          @Frieke72 @Mikal @jeneralist @goedelchen
                                          (I don't know whether BioNTech will be able to recover their research costs if the US market is gone. But if so...)

                                          Vaccination tourism may become a thing for Americans.

                                          (And then the US border patrol will check vaccination booklets at the airports and will detain and deport everyone vaccinated with mRNA to avoid "shedding")

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