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Medicine

Moderna On Track to Report COVID-19 Vaccine Late-Stage Trial Data in November (usnews.com) 91

Posted by EditorDavid from the hopeful-news dept.
This week Moderna "said it is on track to report early data from a late-stage trial of its experimental COVID-19 vaccine next month, reports Reuters, "offering the clearest timeline yet for when the world will know whether it is effective." The company, one of the front-runners in the global race to produce vaccines to protect against COVID-19, said an independent data monitoring committee is expected to conduct an interim review of its ongoing 30,000-person trial in November... The company said it is preparing to distribute the vaccine, known as mRNA-1273, and expects to be able to produce 20 million doses by the end of the year, and between 500 million and 1 billion in 2021. Moderna said infection rates in the trial were on track with expectations...

Moderna said it expects two-month follow-up safety data, as required by the U.S. Food and Drug Administration, in the second half of November, after which it will file for an emergency use authorization.
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Moderna On Track to Report COVID-19 Vaccine Late-Stage Trial Data in November More

Moderna On Track to Report COVID-19 Vaccine Late-Stage Trial Data in November

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    • Re:A fast-track vaccine? (Score:4, Insightful)

      by phantomfive ( 622387 ) on Saturday October 31, 2020 @05:52PM (#60669962) Journal
      What risk are you worried about with regards to their safety procedures? What steps did they skip? Or did you see the words "fast-track" and vaguely feel it must be bad? Very rational.

      • I saw Moderna reporting that it is going to report. A tad unseemly, don't you think?

        • They said "our trials will be completed soon, and we'll let you all know the results when we're done".

          What's the problem here?

          • Why not actually be complete and then simply report the results? Rhetorical question. It's to build anticipation. This is a promotion. You know that as well as I do.

            • Ok, and that affects safety and efficacy how exactly?

              • That rush to promote is powerful motivation to cut corners and "shape" the report in ways that maximize profit. (Just ignoring your obvious disingenuousness.)

            • Re: (Score:2)

              by GuB-42 ( 2483988 )

              This is a serious, placebo controlled study, and it is currently underway.
              The data needs to be checked, privacy of the participants have to be taken care of, and precautions must be taken to avoid reveling results that will affect the study.
              So I guess if means they have the results, they are confident with them, but they are now working on the administrative details.

        • A company is telling you that they will follow the rules and you think that is unseemly? What shithole country do you live in!

      • What steps did they skip?

        Time is the step they skipped. "Fast" track implies that.

        1. After a vaccine, waiting for the patients to get infected is one of the most popular testing plans. No major company is deliberately infecting their test subjects (and controls) to test how they "perform".

        Safety is traded off against efficacy, hence I am bringing in efficacy into the argument.

        2. The effects of the vaccine might develop in some time. That time is skipped here. If "you first" means I wait for 6 months after you get a vaccine in which

        • 1. After a vaccine, waiting for the patients to get infected is one of the most popular testing plans

          Yes, they are waiting until a lot of patients get infected. What is the surprise here?

          2. The effects of the vaccine might develop in some time.

          What effects are you worried about here? You think the vaccine might cause cancer?

          • What effects are you worried about here? You think the vaccine might cause cancer?

            '
            Are you aware of adverse events evaluation ? Listed / unlisted, varying levels of causality ?

            This question makes it seem you are not aware, but asking just for the sake of conversation.

            • Yes, I have to take training in that every year as part of my job.

              You didn't answer the question, what effects are you worried about?

              • Ok, let me give a software example.

                If there is a software being created, not tested yet, you start planning testing for it. And someone asks you : "What bugs are you worried about here? You think the software might crash ?". Especially when the other person is questioning people worried about "fast-tracking" of that software testing ?

                What would you reply ? Or would you ask them if they know the basics of software development ?

                • Sounds like you don't know about software development anymore than you know about medical studies. I recommend reading this book to improve your software skills [amazon.com].

                  • Awesome, software and vaccines don't need to be tested because : zero bugs. If anyone asks for testing, ask what issues do you expect, and give one of the million types of possible issues as an example. Since all the million types are individually unlikely, illiterate readers would think you have a clue.

                      I rest my case.

                    • Awesome, software and vaccines don't need to be tested because : zero bugs.

                      The vaccine is being tested, and whether you test your software is up to you.

                      Since you seem to like software analogies, I'll give you this: Imagine you "fast-tracked" your release by running your automated test suite in parallel. Would that make you worry?

                    • Great . So you can get a woman to deliver a baby in 1 month by putting 9 men on the job. After all, it is only 9 man-months of work. Multi-threading humans.

                    • No, but you can get nine babies in nine months.

                    • Yes - that is what "you first" people are saying. To take the trillionth Covid-19 vaccine dose in year(s) rather than the millionth one in month(s) which was "fast tracked".

                    • Oh yeah, I forgot you were responding with your comments.

                      Basically, there are some parts in a process that can be skipped without reducing the safety of the tests. I don't know why you fail to understand this.

                    • There are some aspects of effects on human bodies that cannot be fast tracked without affecting safety analysis. I don't see why you fail to understand this in spite of the HPV and pregnancy examples.

                      The effect that takes 2 years to appear, cannot be tested in 2 months. We can try finding its precursors, which is an error prone enterprise.

        • Re: (Score:2)

          by AmiMoJo ( 196126 )

          The Cambridge trial in the UK is deliberately infecting people now.

          Still won't be ready until well into next year though.

      • Exactly, I'm not a scientist but I know there's been a process for vaccines that has been in place for a long time. Suddenly, we found a safe way to fast track vaccine development? To paraphrase a Boy Scouts motto, if the shortcut worked it wouldn't be the shortcut it would be the way.

        I'm also extremely disturbed that a mere weeks after vaccine tests have been paused because of unexplained illnesses, they've suddenly been corrected and cleared?

        Not to mention the current issues with the other "fast tracked

    • Re:A fast-track vaccine? (Score:5, Insightful)

      by Local ID10T ( 790134 ) <ID10T.L.USER@gmail.com> on Saturday October 31, 2020 @05:52PM (#60669964) Homepage

      You first

      Damn right... I deal with the public, tourists mostly -hundreds of strangers and their kids every day.

      I will line up right behind the medical workers (doctors, nurses, etc.) for my vaccination. I don't want to catch this crap or spread it further.

      • Yep, I will also try to get the vaccine as soon as it is available to the general public.

        • Re: (Score:3)

          by pjrc ( 134994 )

          I'll also get it just as soon as it's available, though I'm happy to see medical people & high risk folks get early access. They truly do need it first.

          And if a bunch of crazy conspiracy nuts forgo the vaccine, I honestly do hope the rest of us will bring enough herd immunity to protect those ungrateful bastards. Nobody should have to suffer preventable disease.

      • Re: (Score:3)

        by ffkom ( 3519199 )

        I don't want to catch this crap or spread it further.

        Your first reason is plausible, your second is not: The first generation of vaccines currently on trial is not expected to provide sterilizing immunity, so after vaccination you can still be infected, you can still spread the disease, you will just most likely not suffer from systemic illness or symptoms.

        Given that without symptoms you won't notice an infection, you may even be more "dangerous" to non-vaccinated people around you, as the time window in which you can spread the virus may be longer.

        • Re: (Score:2)

          by SnowZero ( 92219 )

          not expected to provide sterilizing immunity

          This Nature news article [nature.com] seems to indicate as of August that researchers were hopeful from early results, very different from what you are implying. Also, B and T cell responses are quite typical for vaccines after long periods, and still work pretty rapidly; antibodies dropping after a couple months is common. If you've got a reference as to why that will not affect replication factor, I would love to see it.

          I'm sure this first crop of vaccines won't be perfect, but all we need to do is get the R01, and

          • Re: (Score:2)

            by ffkom ( 3519199 )
            I think you misunderstand the term "sterilizing immunity".
            This is not about whether vaccines will provide only short-term or long-term protection against disease, indeed the current vaccine candidates have a good chance of providing long-term protection. But being protected against disease does not mean the virus cannot enter your mucosa, replicate there, and be transmitted to other people. See also: https://www.thelancet.com/jour... [thelancet.com]

            A good example for this is the i.m. applied Polio vaccine, which protec

        • The first generation of vaccines currently on trial is not expected to provide sterilizing immunity, so after vaccination you can still be infected, you can still spread the disease, you will just most likely not suffer from systemic illness or symptoms.

          Source?

      • Re: (Score:2)

        by Octorian ( 14086 )

        I'm decently able to avoid people on a day-to-day basis, so I'm probably going to wait until at least a few hundred thousand others (perhaps millions of others) have gotten it first. That way I'll be less worried about side-effects that might not show up with the population size being used for the current Phase 3 trials.

    • Yep, me first. I signed up to be part of the stage 3 trial, to be first, because I don't want to bring COVID home to my wife and my daughter.

      At this point it's mostly evaluating how well the vaccine works. Maybe it would reduce my risk by 25%, maybe by 85%. Safety is fairly well covered in the previous three stages.

    • You first

      I will gladly go first.

    • Re: (Score:2)

      by GuB-42 ( 2483988 )

      I will definitely take the first vaccine that is available to me.

      Yes, there is a risk, but Covid-19 is a risk too, and a much bigger one. A few vaccines had nasty side effects, but none did as much damage overall as Covid-19 does in one day. And while I am not particularly at risk, I want to be able to see my grandparents without killing them, I want to be able to party with other people, to travel the world without being quarantined at every stop, and give Covid-19 the middle finger it deserves. And if a v

  • What happened to the vaccines? (Score:4, Funny)

    by quonset ( 4839537 ) on Saturday October 31, 2020 @05:53PM (#60669966)

    In September, the Chief of Staff to the con artist said they were aiming to have100 million vaccines ready the end of October [tumblr.com]. Today is the 31st and last day of October and yet, no vaccines in sight.

    You don't suppose the con artist was lying, do you?

    • The 100 million doses are actually ready - they just got locked in the Lincoln Bedroom with the main copy of the president's amazing Obamacare-replacement healthcare plan, and William Barr accidentally swallowed the key.

      • Re:What happened to the vaccines? (Score:4, Informative)

        by iggymanz ( 596061 ) on Saturday October 31, 2020 @06:18PM (#60670018)

        You do know Moderna started manufacturing the vaccine in July, (which could be useless or harmful, I'm not shilling their stock or product). They did that in parallel with their clinical trials. They were supposed to have 100 million doses ready now for when approval is given.

        https://www.fiercepharma.com/p... [fiercepharma.com]

        • Re: (Score:2)

          by ffkom ( 3519199 )
          And Moderna is not the only company that, thanks to in-advance payments from various governments, has already produced millions of vaccine doses.

          This is a very unique situation - never before such amounts of vaccines where manufactured before they got approval.

          • Re: (Score:2, Redundant)

            by Tough Love ( 215404 )

            Creating a powerful incentive to push them through to market even if a few issues need to be downplayed along the way. One word: Thalidomide.

            • Re: (Score:3)

              by ffkom ( 3519199 )
              Well the Cutter Incident [nih.gov] would be the nearer example than the Thalidomide story, but with the current mRNA vaccine candidates two important things are very different: The risk of the vaccines failing approval is mostly covered by public money, meaning that the companies have less incentive to downplay side effects than usual. And secondly, there is not just one country and one governmental body looking into the results of the tests. The company would have to conspire with a multitude of institutions in seve

              • Gildead ignored and/or downplayed negative results of remdesivir trials.

              • The risk of the vaccines failing approval is mostly covered by public money, meaning that the companies have less incentive to downplay side effects than usual

                Which makes it more dangerous - "failing approval" is in the hands of the government. And governments want to be called "smart", "forward thinking". If they gave some money to some company to manufacture unproven vaccines / drugs , they might push for their approval in spite of certain issues, thus getting undeserved votes in elections.

                Media, scientific publications, civil society, judiciary can all be "managed". Investigate cases against them, call them unpatriotic, cancel their licenses if their businesse

        • Well maybe they were supposed to, but then why would the company say...

          The company said it is preparing to distribute the vaccine, known as mRNA-1273, and expects to be able to produce 20 million doses by the end of the year, and between 500 million and 1 billion in 2021.

          so it sounds to me like they will have 20m doses available by the end of the year according to them. It is in the summary and the article.

        • You do know Moderna started manufacturing the vaccine in July, (which could be useless or harmful, I'm not shilling their stock or product).

          Yeah, I believe that's also true of another half-dozen or so competitors' vaccine candidates. As I recall, at least some of that early production was backed by the Gates Foundation so the companies don't completely lose their shirts if their vaccines don't pan out.

          But there was no way to work that all into the joke.

      • The dog ate those doses.

      • The 100 million doses are actually ready - they just got locked in the Lincoln Bedroom with the main copy of the president's amazing Obamacare-replacement healthcare plan, and William Barr accidentally swallowed the key.

        Why not simply disembowel Barr? To get to that key. Or just for fun.

    • You are the liar, the vaccines are already manufactured in parallel with ongiong clinical trials, look it up.

      • Read what is said. The CoS said ready to go by the end of October and they would be giving them out to the most vulnerable.

        First, there are not 100 million doses ready, not even in a clinical trial. Second, they are certainly not being distributed right now, which is what was said. Third, it would at least a month to make 100 million doses, and that is only if a plant already existed to make the vaccine [msn.com]. Which there isn't. Fourth, the earliest approval could have been given was the middle of October whic

        • Re: (Score:3)

          by ffkom ( 3519199 )
          You are wrong. A significant part of those 100 million doses that BioNTech had announced to manufacture has already been manufactured and is sitting in deep-freezer storage waiting for its deployment. See also: https://www.wsj.com/articles/g... [wsj.com]

        • Re: (Score:2)

          by AmiMoJo ( 196126 )

          Presumably the doses they do produce will not be exclusively sold to the US either, especially as it's a partnership with a German company.

        • Nope, manufacturing by Moderna started in July. The 100 million does exist now, whether useful or useless. Trump the buffoon actually spoke the truth in this particular case. You read into his words with your head canon but that's another matter.

    • In September, the Chief of Staff to the con artist said ...

      That's "Con Artist in Chief" -- show some respect.

    • You don't suppose the con artist was lying, do you?

      You don't need a vaccine. Trump's administration highlighted Ending the COVID-19 pandemic was one of their greatest achievements this year. They used past tense.

      You're fine. Go outside and lick the subway seats. You're safe now, no need for a vaccine.

  • The testing plan is to administer the vaccine (or placebo) to a lot of people, wait until a certain percentage of them get coronavirus, and then look at how many of those were vaccinated.

    That is why there is no set end date, because they can't force people to get sick.

    • Re: (Score:2)

      by ffkom ( 3519199 )

      That is why there is no set end date, because they can't force people to get sick.

      They cannot force them, but certainly Trump helps convincing them :-)

  • Instead of calling it "third stage" they call it "late stage" to sex it up and distract from the fact that they have a long way to go with their third stage trials? Might this have anything to do with stock price?

  • I'm only getting Moderna. Crossing my fingers something gets mixed up in the mRNA instructions and I get to be Quicksilver.
  • Without understanding the different factors of COVID 19, it cannot be prevented. The latest news is that a proper vaccine is developed and is starting mass production. But we also should maintain the proper PPE for our own protection. Still, all should wear masks, washable gowns Canada [arrowsafetycanada.com], face shield, others to be protected from the exposure of virus-containing droplets.

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