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Why were Covid vaccine trials so fast? (clinicaltrialsabundance.blog)
33 points by salonium_ 81 days ago | hide | past | favorite | 94 comments


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

That should be the debates starting point.


[flagged]


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.


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.

I feel like it is very important that the disclosure of "bad" opinions should be allowed to be very openly tarred and feathered. BTW, some of those opinions could me mine, fair play.


[CRACKPOT] flag or something


Oh no! Someone sees the world differently. Instead of attempting to understand why, I'll just toss a pejorative at them, because I'm not emotionally or mentally capable of anyone thinking differently than I do.


I literally argued that your comments should not be hidden. Instead, they should be very openly ridiculed.

However, I do get it. From a moderation POV, you come off like a troll. That does suck for moderation stress.


You're the one trolling - you're literally suggesting that anyone who engages in wrong think should be ridiculed. I sincerely hope you score more good boy points with the moderators of this garbage website.


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.


Trump was certainly in on it, as was Biden, along with the rest of their Jesuit pals.


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


What can be done about it includes holding the people responsible for it accountable, which you can only do if you know whose fault it is. Not to mention, it probably would have helped to have all the information that was conveniently "lost" at the Wuhan Institute of Virology just before knowledge of the virus became public.


Truly the most accurate username I've encountered here.


Such an original reply!


Omg thx bbg!


Where the fuck do you get your info from?


Certainly not people like Anthony Fauci and his Jesuit buddies.


Way to deflect


Why should I even engage with you? Clearly you believe that anyone who doesn't parrot the mainstream, accepted narrative regarding Fauci and Covid is worth ridiculing / hurling obscenities at. Do you even know anything about the man, who he associates with, his history, where he studied, etc...? Clearly you don't, because if you did, you wouldn't be asking questions like who tf do you get your information from. Like I said, I certainly don't trust the Freemason / Jesuit-trained Fauci or any of his Jesuit buddies in the Biden or Trump administrations. You probably don't even know what a Jesuit is or the history of the Society of Jesus and their fondness for toppling governments and deceiving the citizenry of sovereign nations.


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!


Just because something happened fast(new forms of vaccine approval), doesn’t make it efficient.

I believe “the types” are generally opposed to government overreach.

The government forcing people to adhere to medical regiments against their will is valid to be concerned about.


[flagged]


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?


What was trivially disproven again?


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.


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


How exactly is discussing the origin of the virus that these vaccines (that were rushed through trials) were developed for, off-topic? That's an extremely silly, bordering on absurd suggestion. It was flagged, because whomever did the flagging didn't want to allow any discussion of the origin of the virus. Let's be honest at least.


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.


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.


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


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


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


[flagged]


> the truth which lies in the middle.

I don't think that assumption holds.


One wonders why this was flagged. It appears to be a high quality and non-combative analysis of how we were able to advance vaccine development so quickly without losing safety or efficacy?


Because there a bunch of social media deluded asshats that want to argue about it in bad faith. See also: "Fauci caused COVID"

Unfortunately social media deluded asshats is the prevailing theme of the United States on this 250 year anniversary. See also: "Trumpty Dumpty somehow isn't a corrupt incompetent fraud."

The nice way to put it: this has, unfortunately, become a political lightning rod.


It's not bad faith


What @daveguy said, it talks about Covid and vaccines, two conspiracy-theory hot buttons so of course it'll get flagged the minute it's posted. If you also throw in Epstein, Soros, and Hunter Biden's laptop it'll practically make it self-flagging.


There should be a rule against flagging articles without looking at them first based purely on an uneducated guess using only the title. :/


[flagged]


> 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.


> They went through the full regulatory procedures.

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


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.


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.


>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"?


Myocarditis and blood clots aren't a side-effect, they are life altering and ending.


> 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.


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

In Europe, it can take years, but because of organizational reasons and economic incentives. The whole process was completed as far as possible, but companies when through the same steps as always.


In the US, the long-term safety testing is 3-5 years, excluding any beaurocracy.

Pfizer's short-term safety testing was also cut from 6 months to 3 months IIRC.


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.


I don't believe this, do you have a source?


Claude only found one un-reviewed paper that couldnt link the symptoms to spike proteins but a small sample detected spike proteins.


> 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.


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.


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.


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....


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.


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?


> The narrative was that everyone should be vaccinated

And that's still true for everyone that lives in human society. The disease killed ~7 million people and would have killed far more without the vaccine. Almost all of the deaths were in the vulnerable, like is the case for most diseases. Vaccinating the entire population protects the vulnerable. The moral choice as one of the not-vulnerable is to either get vaccinated or be a hermit.


> Vaccinating the entire population protects the vulnerable.

Only if it prevents spread, which was still an open question while it was being pushed in early 2021 and known to not work by the end of 2021.


It didn't work well because the vaccination rate didn't reach herd immunity levels. It still helped.


> The clinical trial should have detected this, but it was rushed. Plain and simple.

No, that is wrong. Trials generally don't detect very rare side effect that only occur for some special subgroups. They would have to have tested 100.000 males <40 to detect that. That's generally not feasible for any medication or vaccine.

That's also only talking about one particular side effect, more interesting would be a comparison of all-cause mortality, because that's more likely what you are interested in: Does the vaccine increase or decrease my chance of dying soon?

For example I calculated back then that getting unvaccinated Covid-19 would increase my (very low, male of age <40 living in central Europe) likelihood of dying within the same year by the factor 7.

There's also a problem with the study - there's always a problem, that's why a singular study is never sufficient. Within a big data set - and tens of millions is huge in this context, you can always find significant results if you just test enough subgroups. That's called alpha error accumulation, because the more hypothesis you test, the more likely you will have 'significant' results by pure coincidence. That's why reporting significant results on (hypothetical example) "elderly people between 60 and 70 that don't own a TV" are always met with caution. It seems to me they tested at least around 50 hypothesis from what data they gathered (sex, age in 10 years bins, ethnicity etc), but they might effectively have tested more and from a first look it seems they didn't account for that.

PS:

> Why were they so desperate for us all to get the vaccine when science proved that it didn't work by end of 2021?

You talking about one vaccine in particular? Or some combination in particular? But only covid vaccines, I guess? Anyway, what you wrote is wrong. Every single one of them helped in the sense that people would be less contagious and would have less severe symptoms.


> That's also only talking about one particular side effect, more interesting would be a comparison of all-cause mortality, because that's more likely what you are interested in: Does the vaccine increase or decrease my chance of dying soon?

This is from memory but I think there were 16 deaths in the vaccine group and 14 or 15 in the control group in Pfizer's short-term safety trial of around 40k participants. None of the deaths were obviously vaccine related and it was statistically insignificant so the results were dismissed due to not being obviously bad.

They also lost track of a huge number of participants (like 200-400?), and never figured out why. It's entirely possible they died and the safety profile world be completely different if they were included.


> so the results were dismissed due to not being obviously bad.

Not sure if 'dismissed' is the correct phrasing. The results were statistically analyzed as it's always done with empirical studies.

> They also lost track of a huge number of participants (like 200-400?), and never figured out why. It's entirely possible they died and the safety profile world be completely different if they were included.

Sounds like that were the drop outs which is normal for empirical studies. <1% drop out sounds quite small (don't know for this type of study in particular, though). I wouldn't be surprised if the very question you are asking has been subject to research in the last decades as every medication goes through a very similar process.

In general, that phrasing sounds to me that somebody tries to frame something that's super normal (drop outs) to something questionable and mystical.

I don't mean you, but the source you used back then.


"Indisputable". Actually, it is disputed.

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


And males under 40 have a material increased risk of myocarditis from the virus itself. More-so than the vaccine. A friend under 40 is on beta blockers thanks to Covid.


> 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?


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.


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.


> 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.


> 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.)


it was blood clotting, not cardiac


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.


> 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.)


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


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.


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.


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."


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.


Pfizer didn't lie. If you go back to their press releases they were careful to distinguish SARS-CoV-2 from COVID-19, the result being that they said you wouldn't get sick while saying nothing of infection/spread. It was the media and politicians that started that.


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.


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?


Unfortunately, any viral infection can leave lasting damage too.

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


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.


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.


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


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


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


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


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


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.


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.


1. Moderna had a vaccine in January 2020. Its not 1950 anymore where development takes 10 years. Doing faux work to waste time to placate ludite observers who can only equate time to quality is dumb.

2. People have died because they were wearing a seatbelt, and people have lived because they weren't. Do you still buckle yours? Why does this logic make sense to you but "vaccine greatly reduces adverse outcomes in all populations" doesn't?


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.


[flagged]


India had the second highest number of cases and the third highest number of deaths.

And that's before you start taking into account the terrible record tracking and lack of testing.


Are you aware that places with poor resources and low/no record keeping have all sorts of crazy statistics?

Obviously when doing analysis we wanted to compare solid data with solid data. Not some NGO worker asking the tribal medicine man how many COVID deaths they have had..."6 witchcraft deaths, 4 bad spirits, and 3 might have been coughing?".


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


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

What's discouraged is complaining about downvotes.




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