Why were Covid vaccine trials so fast?

(clinicaltrialsabundance.blog)

21 points | by salonium_ 3 hours ago ago

64 comments

  • techteach00 an hour ago

    There are benefits and costs associated with fast tracking drugs to treat a pandemic.

    That should be the debates starting point.

    • tinfoilhatter an hour ago

      [flagged]

      • softwaredoug an hour ago

        His claims are that because of this sequence of events “Fauci caused Covid”

        - Fauci led NIAID

        - NIAID funded EcoHealth (an external non profit)

        - EcoHealth sent some money to Wuhan labs

        - Maybe Covid comes from a leak of Wuhan labs

        You can decide for yourself if Fauci is just a boogeyman or has personal responsibility in this chain of “maybes”

        By this logic Trump cause Covid because he was President at the time.

        • basch an hour ago

          and even if the maybes are yes, it's still a debate whether an accident negates taking future risk. eg does a nuclear meltdown lead to no new nuclear power plants?

          a lab leak doesnt in and of itself prove that gain of function research isnt worth further pursuit, if better care can be taken. there is clearly risk/reward calculations, and not everyone will agree what risk in a pool of risks is worse.

        • consumer451 an hour ago

          In a way, it's a shame that the gp comment is flagged. It is batshit crazy from my pov, but this is a very commonly held opinion by the people now setting health policy for the USA.

          I kind of wish there was a different flag-like option for cases like this. That would mean that it was more than down-voted, but not hidden.

      • tbrownaw an hour ago

        How so? I would think that "whose fault is it" and "what can be done about it" are independent questions.

      • gumby271 an hour ago

        Truly the most accurate username I've encountered here.

      • thiht an hour ago

        Where the fuck do you get your info from?

  • add-sub-mul-div an hour ago

    Shouldn't we expect that in an emergency we cut through red tape, reprioritize, etc? Isn't government inefficiency one of the major complaints of the types who call the vaccine "rushed"? If that was ever a good faith argument they should have seen this as a win!

    • tinfoilhatter an hour ago

      [flagged]

      • add-sub-mul-div an hour ago

        If you jumped off the last topic immediately when it was trivially disproven why would I spend any time engaging with the next one you jump to?

        • throwitaway222 an hour ago

          Wow, 2 minutes and content already flagged and downvoted into oblivion. I guess we're STILL doing this years later - people still can't have a discussion about this. That's pretty unbelievable HN.

          • tbrownaw an hour ago

            Still doing what, flagging attempts to derail threads into off-topic flamefests?

        • tinfoilhatter an hour ago

          What was trivially disproven again?

      • johng an hour ago

        Or completely violated the law by deleting emails. Using personal emails on purpose to avoid FOIA requests. Then lying to Congress about it. Getting caught red handed in all of the above and still getting a golden parachute. Really sad to see, anyone that lies to Congress should be punished for it.

        • throwitaway222 an hour ago

          My whole thoughts on this is simple: Ask him to congress again and simply ask the same questions. I'm not sure exactly how this works but Fauci's pardon makes him compelled to not use the 5th, but if you simply ask him the same questions, I don't think Fauci will tell the truth again. He'll be stuck either lying again, and being prosecutable, or he'll have to publicly tell the truth. It's a perfect win-win.

          • tinfoilhatter an hour ago

            If only the majority of our congress wasn't also corrupt and busy enabling people like Anthony Faucci and his friends...

        • selfmodruntime an hour ago

          And after all that blatant corruption, people will still call you a conspiracy nut if you think human error might may have been a bigger part in it

        • freediddy an hour ago

          Why is this being downvoted? Everything said above has been proven true.

          • johng 17 minutes ago

            Some people can't face the truth because a large part of their identity is based on their beliefs or politics. It's pretty par for the course here and at Reddit. For "liberal" thinkers it should be easy to open your mind to other possibilities. For example, I like to watch many news channels and get my news from many sources, from both sides. It's the only way to find the truth which lies in the middle. I know people that refuse to watch or read news that disagrees with their views. I believe it's because they feel better thinking they are in the right and that is more important to them then being informed and knowing the facts.

  • davydm 2 hours ago

    And they were rushed out, and many people still sit with the issues they caused. Not a win - at the very least, they reduced the confidence of average people in vaccines and gave credence to the anti-vaxxers. Well done.

    • chimprich an hour ago

      > And they were rushed out

      This implies that corners were cut. They were not. They went through the full regulatory procedures.

      > many people still sit with the issues they caused

      Few medicines are entirely without side effects. The effects of the virus were in general far worse. Millions of lives were saved from the vaccines.

      > Not a win

      Apart from the millions of lives that were saved.

      > at the very least, they reduced the confidence of average people in vaccines and gave credence to the anti-vaxxer

      This was thanks to scientific illiteracy, cynical political opportunism, and rancid leadership. The vaccines were a huge success by any reasonable measure.

      • selfmodruntime an hour ago

        > They went through the full regulatory procedures.

        This is a non-argument if you decide to adjust regulatory procedures for that one case.

        • CountHackulus an hour ago

          If you read the article, you'll see that they did in fact meet the full requirements by August 2021. The EAU plus criteria were met quickly, but they did meet every criteria normally used.

          • freediddy an hour ago

            All the doctors and medical professionals were forced to get vaccinated in early 2021. If something went wrong, the very people that we depend on could have suffered mass casualties. And many of them did suffer from effects from the vaccine, even though they likely had already contracted COVID beforehand and a vaccine was unnecessary. This is the problem with mandates and anti-science thinking.

            • basch an hour ago

              >many of them did suffer from effects from the vaccine

              what does many in this sentence mean? are you claiming that a large percent of health professionals "suffered effects"?

      • ralusek an hour ago

        > This implies that corners were cut. They were not. They went through the full regulatory procedures.

        That's absolutely not true. The standard for new vaccines, iirc, required a period of something on the order of 7 years. Time, in this case, is not a function of procedure that can be expedited in an emergency, but is actually an important element in and of itself. Many issues do not manifest immediately and actually need follow up over time.

        The crazy thing about these vaccines was that both mRNA vaccines and the viral vector vaccines were completely new platforms, never deployed at scale. They work entirely differently than all other vaccines. Up until this point, vaccines all delivered the antigen in one of 3 ways: you get a weakened virus, you get a dead virus, or you get the antigen itself (subunit protein like Novavax). Both the mRNA (Pfizer & Moderna) and the viral vector (J&J) vaccines worked by getting either mRNA or DNA (viral vector) into your cells, and then having your own cells produce and express the antigen themselves. Basically the difference between server generated code or shipping the JS for you to run the SPA on your own client.

        One of the crazy things about this was that it wasn't obvious what the implications would be of having our own cells expressing the antigens (and thus flagging themselves for destruction by our immune system). This was particularly concerning because the cells that were shown to be doing this, despite the complete lie that kept being repeated of the vaccine staying localized at the injection site, were found all over the body. In the case of the viral vector vaccines, at least they were being delivered by a vessel (living adenovirus) that our bodies have had billions of years of evolution to determine where they might end up. In the case of the mRNA vaccines, though, the vessel was a lipid nanoparticle with an exceptional ability to deliver payloads basically anywhere in the body. Note: the attention these lipid nanoparticles had received prior to their use in mRNA was their ability to deliver payloads to places that are notoriously difficult to reach, notably their ability to cross the brain blood barrier. So you have delivery mechanisms delivering a payload that makes our cells into antigen factories, shown to be producing them all over the body, and targeting themselves for destruction by the immune system/causing an increased immune response in these areas.

        And then, for the icing on the cake, there was mounting evidence that the antigen itself was actually likely destructive/problematic.

        I could go off forever on this topic. The amount of obfuscation and gaslighting was insurmountable for anybody that was even remotely interested in figuring out what was happening. From a personal perspective, my trust in many institutions was permanently shaken.

        • freediddy 29 minutes ago

          They also said that the spike proteins produced by the vaccine would be gone within a few days or weeks, and new studies show that they were detected multiple years afterwards. This was "guaranteed" to not happen. The trials were too short to pick this up and what does that actually mean for the health of people afterwards.

        • chimprich 36 minutes ago

          > That's absolutely not true. The standard for new vaccines, iirc, required a period of something on the order of 7 years.

          I'm going to stop you there. "That's absolutely not true" versus "iirc". You're making a vehement argument based on remembered nonsense.

          There was no such requirement. And if there was, then you should have no problem citing it.

          > I could go off forever on this topic

          Please don't.

          > The amount of obfuscation and gaslighting

          Such irony.

      • freediddy an hour ago

        The trials missed the fact that younger males under 40 have a material increased risk myocarditis from the vaccine. And when reports of that started coming out, the media and "medical establishment" fought against those reports and said the people who were saying this were "anti-vaxxers". But finally the CDC acknowledged this and added it to their communication without accountability or apologies.

        Their reaction was anti-science and driven by ideology and things like this is why trust in the media and medical establishment was destroyed because it was highly visible.

        • bryanlarsen an hour ago

          COVID itself causes a significant increase in the risk of myocarditis, substantially higher than the vaccines.

          Symptoms similar but milder and less frequent is a general expectation of any vaccine, especially early forms of the vaccine. Early vaccines were deactivated or variant forms of the actual disease, and modern vaccines generally contain fragments of the actual disease.

          • freediddy 34 minutes ago

            No. Risk of myocarditis for males under 40 after the 2nd dose of Moderna was at >4X higher than the risk of myocarditis. This is indisputable. There is a clear signal that the vaccines caused injury that weren't detected until years after the "trials".

            https://www.ahajournals.org/doi/epdf/10.1161/CIRCULATIONAHA....

            • bryanlarsen 23 minutes ago

              If it was detected, would it or should it have changed anything? On the one hand we have a disease causing millions of deaths, on the other hand we have this rare risk.

              No trial can detect rare long term risk. It can only bound that risk. And we shouldn't ask for anything more. Everything is risky, but the risk bounds are acceptable.

              • freediddy 16 minutes ago

                What are you talking about? This isn't talking about long term risk at all. This is within 28 days of the 2nd dose. That is well within the reach of a clinical trial. The clinical trial should have detected this, but it was rushed. Plain and simple.

                The narrative was that everyone should be vaccinated. The data and science showed that not only did young people have an incredibly low, almost non-existent risk from COVID, there was a material risk to all young men from myocarditis from the vaccine.

                The reason why there is so much distrust about the medical establishment and the media is because what they were telling us didn't make sense and it was obvious they were lying to us just to get us to take the vaccine. Why were they so desperate for us all to get the vaccine when science proved that it didn't work by end of 2021?

            • chimprich 22 minutes ago

              "Indisputable". Actually, it is disputed.

              https://pmc.ncbi.nlm.nih.gov/articles/PMC10076766/

    • softwaredoug an hour ago

      The only real risk I’ve been able to find in literature of mRNA vaccines is myocarditis in young men

      Occurring in roughly 8 out a million doses. (https://www.fda.gov/vaccines-blood-biologics/safety-availabi...)

      You make your own risk assessment, but that seems extremely low risk as a drug that prevents millions of deaths

      • basch 41 minutes ago

        epidemiological risk of myocarditis from COVID-19 infection is from seven to over forty times higher than the risk associated with receiving an mRNA vaccine.

    • JumpCrisscross an hour ago

      > many people still sit with the issues they caused

      From the vaccines? Is there any clinical basis for this category of long-term vaccine harm?

      • linuxftw an hour ago

        You're aware that the J&J was pulled from the market due to cardiac issues, right? It's not a theory that actual people were actually harmed by the products, the only question is risk/reward.

        • jedberg an hour ago

          More cardiac issues than the other vaccine options but far less than the virus. If it were the only option it would still be on the market. It was only pulled because better options showed up.

          • basch 38 minutes ago

            it was blood clotting, not cardiac

          • linuxftw an hour ago

            > far less than the virus

            Unfortunately, this isn't a claim that can be made. We don't know how many people got the virus, or how many times. And IIRC, the cardiac issues of the virus were mostly in older demographics, the J&J was affecting young a healthy people.

            • JumpCrisscross 36 minutes ago

              > the cardiac issues of the virus were mostly in older demographics, the J&J was affecting young a healthy people

              I have a friend who got Type 1 diabetes after Covid attacked his pancreas. (And he got infected in March 2020, so this isn't someone choosing to be diseased getting their just desserts.)

        • JumpCrisscross an hour ago

          > the J&J was pulled from the market due to cardiac issues, right?

          Yes. I'm saying now that we've had time to examine those cases and look at the data, how many people are clinically agreed to have actually suffered long-term harms? (I don't believe the myocarditis was a long-term effect.)

        • basch 41 minutes ago

          J&J was not an mRNA vaccine either. the J&J vaccine gave further evidence that mRNA vaccines are the safer path.

          it was blood clotting issues.

    • techteach00 an hour ago

      The communication to the public wasn't honest enough. My parents are very much by the book. They follow instructions. They were very surprised to get Covid 3 times after following their vaccination and booster schedule.

      It wasn't made clear enough to the public that these shots were not sterilizing vaccines.

      • hobonation an hour ago

        The sometimes said the opposite, sadly:

        CDC Director Rochelle Walensky- March 2021 statement:

        Walensky told MSNBC: "Our data from the CDC today suggests that vaccinated people do not carry the virus, don't get sick. And that it's not just in the clinical trials but it's also in real world data."

        • linuxftw 43 minutes ago

          And we know this was an outright lie, because the clinical trials did not include contracting the virus as an endpoint. In fact, in Pfizer's data, they only used PCR tests on symptomatic people, rather than periodic testing.

          So to say the clinical trials reflected absence of infection is a deliberate lie. Either they knew what the data said and lied, or they didn't know what the data said and stated they did, which is a lie.

      • basch 36 minutes ago

        definitely a lot of misinformation from the get go, from not needing masks, to waring masks to protect oneself (vs protecting others), to most of the scientific world needing to redefine airborn because of a bad assumption that permeated all of literature.

        I remember VERY early on in the covid timeline, I believe it was in germany, a study came out that said it wasnt surviving on surfaces, and we still oversanitized for eons instead of focusing on not breathing each others air.

    • ectoloph an hour ago

      Unfortunately, any viral infection can leave lasting damage too.

      One of the outcomes of COVID was more awareness of post-viral syndromes.

    • kreeves an hour ago

      Why wouldn't the author cover this if the issues the vaccine caused were so obvious? I mean, they mention (paired with some stats) the number of lives saved.

      Armed with that knowledge, you're suggesting that the number of people impacted negatively was so high that we should have forgone releasing these?

    • _ink_ an hour ago

      The thing is, that many people still sit with the issues caused by covid and you can estimate from the sample how many people were affected if you had delayed the vaccine.

    • notfromhere an hour ago

      hundreds of millions (billions?) of doses have been given out at this point. If there was evidence of harm it would be very obvious and you wouldn't need to lean on conspiracy

    • davydm 2 hours ago

      And the answer to the actual question posed by the article is simple: money. Big companies made huge bank by offloading risk onto people. Let's not pretend it was anything else.

      • bryanlarsen an hour ago

        Not the estimated 2 - 20 million lives that were saved by the COVID vaccine?

      • notfromhere an hour ago

        Covid killed lots of people, what are we even talking about. I was healthy and vaccinated when I got covid and that did a number on me, I don't know where I'd be today if i wasn't

        • linuxftw 42 minutes ago

          Well, that's because you didn't get your booster soon enough.

    • johng an hour ago

      Stuff like this shouldn't be downvoted simply because they disagree. See that on HN way too often.

      • WarmWash an hour ago

        It's incorrect though. It's not a matter of opinion that populations with higher vaccination rates saw fewer deaths and lower rates of hospitalization.

        • freediddy an hour ago

          This is completely false. Areas of the world with much lower vaccination rates like India and especially Africa has much lower death rates from COVID than Western countries with much higher rates of vaccination.

          During the pandemic, the media was talking about how much death there would be in these under-vaccinated countries, and then it turned out their death rates were much lower.

        • johng an hour ago

          What is incorrect? This is what he said: "And they were rushed out, and many people still sit with the issues they caused. Not a win - at the very least, they reduced the confidence of average people in vaccines and gave credence to the anti-vaxxers. Well done."

          So, let's break that down.

          1. Were they rushed out? I think we can all agree that yes, they were rushed out and sped up beyond what we had seen typically.

          2. Many people still sit with the issues they caused? I think we can all agree that yes, there were side effects that they didn't let us know about or didn't know about themselves. So, I think some people (maybe young, healthy people especially) wish they hadn't been forced to take the vaccine. I think this is likely... but even if you don't, you can't state that it's a fact that it's untrue.

          3. Your statement now, that populations with higher vaccination rates saw fewer deaths and hospitalizations? Yes, I think I can agree with that. That has nothing to do with points 1 and 2 above though. It doesn't invalidate either above point, and it won't invalidate point #4 below.

          4. At the very least, they reduced the confidence of average people in vaccines and gave creedence to the anti-vaxxers - not a win? -- I can agree with the above statement as well. Given I believe that all of the above are true, this statement is still true. It's not a win long term to have abused the process (even if the net was a positive) and hide information from people and you can't blame those people for now having doubts or reservations.

          I think all of the above can be true at the same time. Just my 2c.

        • linuxftw an hour ago

          Debatable. For one, many people believed the stats were cooked. Hospitals had financial incentives to claim corona cases. They routinely didn't test people for corona if they were vaccinated during the worst part of the outbreak.

          Even Pfizer's own trial data submitted to the FDA showed an all-cause mortality higher in the control group than the product group. Of course, they explain all the deaths away.

      • bryanlarsen an hour ago

        That's allowed according to pg. https://news.ycombinator.com/item?id=117171

        What's discouraged is complaining about downvotes.

      • ForHackernews an hour ago

        On the contrary, I'd prefer to see fewer content-free assertions of grievance on HN. That's something I see way too often.