AstraZeneca Covid-19 Vaccine Study Put on Hold (statnews.com) 123
phalse phace writes: A large, Phase 3 study testing a Covid-19 vaccine being developed by AstraZeneca and the University of Oxford at dozens of sites across the U.S. has been put on hold due to a suspected serious adverse reaction in a participant in the United Kingdom. A spokesperson for AstraZeneca, a frontrunner in the race for a Covid-19 vaccine, said in a statement that the company's "standard review process triggered a pause to vaccination to allow review of safety data." In a follow-up statement, AstraZeneca said it initiated the study hold. The nature of the adverse reaction and when it happened were not immediately known, though the participant is expected to recover, according to an individual familiar with the matter. The spokesperson described the pause as "a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials." The spokesperson also said that the company is "working to expedite the review of the single event to minimize any potential impact on the trial timeline." An individual familiar with the development said researchers had been told the hold was placed on the trial out of "an abundance of caution." A second individual familiar with the matter, who also spoke on condition of anonymity, said the finding is having an impact on other AstraZeneca vaccine trials underway -- as well as on the clinical trials being conducted by other vaccine manufacturers.
What was the reaction? (Score:3, Interesting)
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Re:What was the reaction? (Score:5, Informative)
Myelitis has been correlated with actual COVID-19 infections and the linked article does not at all confirm the diagnosis:
A person familiar with the situation, who spoke on the condition of anonymity, said that the participant who experienced the suspected adverse reaction had been enrolled in a Phase 2/3 trial based in the United Kingdom. The individual also said that a volunteer in the U.K. trial had received a diagnosis of transverse myelitis, an inflammatory syndrome that affects the spinal cord and is often sparked by viral infections. However, the timing of this diagnosis, and whether it was directly linked to AstraZeneca’s vaccine, is still unknown.
Transverse myelitis can result from a number of causes that set off the body’s inflammatory responses, including viral infections, said Dr. Gabriella Garcia, a neurologist at Yale New Haven Hospital. But, she added, the condition is often treatable with steroids.
AstraZeneca declined to comment on the location of the participant and did not confirm the diagnosis of transverse myelitis. “The event is being investigated by an independent committee, and it is too early to conclude the specific diagnosis,” the company said.
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"... the linked article does not at all confirm the diagnosis:"
You actually RTFA?
Welcome to our forum.
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They must be new around here
The odds of getting Transverse Myelitis... (Score:2, Interesting)
If the diagnosis of Transverse Myelitis is confirmed, I consider that vaccine candidate dead.
Re:The odds of getting Transverse Myelitis... (Score:5, Informative)
If the diagnosis of Transverse Myelitis is confirmed, I consider that vaccine candidate dead.
They may have been in the control group and gotten COVID-19. The incidence of transverse myelitis among COVID-19 patients is way higher than the general stats.
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If the diagnosis of Transverse Myelitis is confirmed, I consider that vaccine candidate dead.
They may have been in the control group and gotten COVID-19. The incidence of transverse myelitis among COVID-19 patients is way higher than the general stats.
People having had COVID-19 would probably not have qualified as test persons for such a vaccine trial. (And the higher incidence was observed with COVID-19 patients that were severe cases.)
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If they were in the control group, they could catch it after the trial begins. For that matter, vaccinated people might catch it. It's still a trial, after all.
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must... grasp... at... straws...
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Just trying to maintain the appropriate level of certainty here. We can't definitively say anything without a confirmation. There's a number of possibilities - some make the vaccine bad, some may mean a botched study.
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They may have not been in the control group and just been infected with Covid. If nobody in the vaccinated gets infected the vaccine will be even more effective than we hoped.
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Or that this patient wasn't the cause of the trial being suspended. The info is coming thirdhand, so it's only suspected to be the reason the trial was suspended.
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And look. The trial had been resumed. So much for the jumping to conclusions for no reason.
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The problem with that reasoning is that there are thousands of rare, one in a million diseases. The probability of one person out of 20k catching a random rare disease is not at all that small.
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If the diagnosis of Transverse Myelitis is confirmed, I consider that vaccine candidate dead.
And this is why the vaccine strategy was a very bad idea to fight SARS-COV-2 in the short to medium term. All those opinion leaders, benefactors à la Bill Gates, "scientists" who pushed for a vaccine as the solution are dumb criminals. Vaccine research takes years and the outcome is uncertain, instead they all banked on a working vaccine, available much sooner than usual. That is nuts. All the money and resources spent for those vaccines should have been spent on more hospitals, more personnels, more i
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benefactors à la Bill Gates, "scientists" who pushed for a vaccine as the solution are dumb criminals.
A single person got sick, not even necessarily from the vaccine, and you consider that pushing for a vaccine makes you a criminal?
Something is wrong with your head.
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Re: The odds of getting Transverse Myelitis... (Score:2)
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Pushing for a vaccine is not a criminal act.
You'll see in a couple of months, when the flu season kicks in and a vaccine will not be there.
In America we still have free speech.
Where there is cancel culture, there is not free speech. More on topic, you still have the same messy health system, that was ravaged by the coronavirus months ago.
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More on topic, you still have the same messy health system, that was ravaged by the coronavirus months ago.
Switching to single-payer or socialized medicine would not have improved health outcomes for coronavirus.
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We have no therapies and no expense has been spared in searching for therapies. ICUs help but we haven't ended up having a large constraint on hospitals or staff. You also can't just make new doctors in 3 months for more personnel. Every field hospital deployed has been thankfully unneeded.
The vaccine strategy is the only strategy to get us out of this without mass casualties. And even if 1/30,000 people had an adverse reaction, that is still far lower than the adverse reactions of the alternative: Cov
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I'm not saying it's wrong - just that it's not confirmed. And providing other possible explanations.
The fact is, a lot of the complications of COVID-19 seem to be autoimmune-related. So the vaccine itself, in mimicking proteins, could trigger the same types of autoimmune responses.
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"Inquiring minds want to know. It seems to be top secret."
I'm curious too, but what can we do?
We can't possibly RTFA, that would make us newbies.
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Re:What was the reaction? (Score:4, Insightful)
This happens all the time with vaccine trials. In those cases however there was not a media circus surrounding them. All the news articles on this one seem to be torn between two personalities: it's all normal, but here is what we know, it's normal, will this delay the vaccine, it's normal, it may affect the election, it's normal, stop worrying, follow these links for more!
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Good (Score:5, Insightful)
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Safety of participants IS safety of end users as they are drawn from the same pool. We've seen what can happen when you cut corners on safety.
https://helix.northwestern.edu... [northwestern.edu]
Refusing to cut corners is no committing a crime against humanity, it's doing the job that a scientist is supposed to do. So let us do our jobs properly and be damned careful that gung-ho idiots don't do a LOT of harm.
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Let's stop the dodging and be straight. How many dead are you willing to sacrifice on the altar of your grandstanding before you admit wrongdoing? Because your link with example of "what can happen when you cut corners on safety" had total victims of about 10.000 horribly damaged with no deaths. It takes about two days to have this many people DEAD from novel coronavirus. Today.
And that's just dead. There appear to be an even larger pool of people who are permanently damaged after surviving it.
So tell me. H
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You should answer this. You're the one promoting a possibly dangerous/ineffective vaccine.
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Which vaccine am I promoting?
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So you're commenting without even reading the summary? More of your typical shit.
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More slander, growing increasingly incoherent with zero evidence. I guess next you'll tell me I praised nazis as "fine people".
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You're the only one who doesn't know what we are talking about here. I can only assume that it's because you didn't read the fine summary, which would have brought you up to speed. The alternative is that you are developmentally disabled, in which case I salute your courage.
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Did you just tell yourself to fuck off?
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So you can't find one I'm promoting can you?
Because there isn't one.
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10k dead from coronavirus costs a company producing a vaccine less money than 1 dead from an illness that it can be proved their vaccine caused.
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Except that it's all but certain that no, it won't. Because just like there have been waivers issued for development, there will be waivers on top of already existing allotments for the small handful of countries where legal systems make this a problem.
And even then, you can simply avoid deploying in US and avoid the ridiculous damages.
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>you're the one arguing that we should risk unknown side effects of a vaccine to be administered to a large fraction of the world's population.
And when called to answer for your bullshit, you immediately go to slander. Show me anywhere where I suggested that any vaccine should be administered to a large fraction of world's population.
Because I never suggested anything that could be even tangentially taken as such. All I did was point out the blatant lying about "good, they're maintaining safety protocols
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I literally didn't state a single thing about an existing vaccine. Not even one. I fully and completely focused on talking about lying about the process of manufacturing a vaccine that isn't even close to being ready, and addressed the BS such as that "we aren't cutting corners in the process", which is supposedly "good".
Your turn. Are you really this stupid, or are you a bot?
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Yes, that is the self evident reason as to why everyone has not behaved the way GP claims they have.
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Even if this were the only vaccine in phase 3 trials, ignoring safety protocols would be a bad choice. It could happen; people make bad choices all the time, But it shouldn't.
But since there are many different vaccines in phase 3, ignoring safety protocols in one of them would be blindingly moronic, pointless, and nonsensical.
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As I said, since there are many vaccines in phase 3 (nine worldwide, I think I read), delaying one won't change anything (unless the other eight are garbage and THIS ONE is the only working one; not impossible, I guess, but not likely). All we need is one working vaccine, not all nine.
Besides, if it's worth ignoring safety protocols to save lives, then why are we holding rallys without masks, re-opening schools, and trying to indemnify companies who expose their employees to covid? That's like putting thr
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>ignoring safety protocols would be a bad choice
There are quite a few major potential vaccine trials ongoing right now. The amount of trials that haven't ignored many safety protocols of that group is zero.
Reason for this is quite simple. We're losing around 5000 people every day on average to this virus, with even more being damaged by it for life. It's deemed a significant threat to humanity as a whole that we're initiated draconian society-destroying measures, which are going to kill and damage lives
The scariest part (Score:4, Interesting)
is a quote from Matt Hancock via Reuters [investing.com]
Rushed vaccine development, what could possibly go wrong!?!
Re:The scariest part (Score:5, Insightful)
And of course the more we hear about this the more its grist to the mill for the anti vaxxer fuckwits who conveniently won't differentiate between vaccine trials and a vaccine released for public use.
Re:The scariest part (Score:4, Interesting)
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It's been pointed out that for a vaccine to work, the person has to be able to mount an immune response.
If they are old and weak, they may not be able to do that, so a vaccine won't help them.
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Governments insist? how about basic decency and economic self-interest insists? Yeah let's all the youngsters not get vaccinated so the oldies (we're talking 50's here, still very productive people, probably still supporting a youngster) won't go out to spend their money or will cease to be productive. Your advice is monumentally stupid and infantile on a societal scale.
The way to address the concerns you bring up is through drug trials. That is literally one of their primary purposes.
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On the other hand delay vaccine development means more deaths and long term health problems for other people. I signed up to be a volunteer for this (not called up yet) because I'm willing to take the risk.
It's looking like we won't get a vaccine this winter. Even if everything goes right with the trials it won't be ready this year. Meanwhile the number of injured and dead keeps increasing.
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On the other hand delay vaccine development means more deaths and long term health problems for other people. I signed up to be a volunteer for this (not called up yet) because I'm willing to take the risk.
It's looking like we won't get a vaccine this winter. Even if everything goes right with the trials it won't be ready this year. Meanwhile the number of injured and dead keeps increasing.
If a vaccine that has a significant chance of causing an adverse reaction and you forge ahead with wide rollout anyway, then once the news hits, people will refuse the vaccine, and worse, distrust any future vaccine. You'll also give a huge boost to the anti-vax movement. Pulling back is absolutely the right thing to do despite the frustration and the near term human cost.
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And since this is just one of many vaccines in this stage, it won't even have a near-term human cost.
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Rushed vaccine development, what could possibly go wrong!?!
What I heard (from BBC radio news) is that in a trial of 30k patients, it's statistically inevitable that the background noise of infrequent but serious issues in the general population will crop up also amongst some of the people in the trial.
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I think the people at AstraZeneca know that, which means that they stopped the trial for serious reasons.
IMHO not the leading candidate. (Score:3)
... for some values of "leading". (Qualifies as "ahead in the race".)
As I understand it, the AstraZenica/Oxford immunization works by getting the patient's cells to decorate their surfaces with SARS-CoV-2 spike protein. And it does them by infecting them with an edited adenovirus. Poten
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Two words (Score:1)
flipper babies
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I'm stocking up on Charleston Chews!
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Two more words (counting the number as one word) (Score:2)
Two words ... flipper babies
Two more words (counting the number as one word): "100,000 Dead"
That was the headline from a Wall Street journal article abut the excess deaths from the FDA's delay of the approval of beta blockers for prevention of second heart attacks while the European research was repeated in the US under FDA rules. (If you read the text, though, you'd see that the number was actually more like 400,000. The WSJ was just being conservative - and setting things up so that a challenge to the h
What went wrong... (Score:5, Informative)
According to In the Pipeline [sciencemag.org] (which anyone who wants a good rundown on what's going on with COVID vaccine research these days should read) it was a case of Transverse Myelitis that caused the trials to be halted. This was also potentially a second case of the disease during the trial (it was unclear from the available information coming from the company). Either way, 1 or 2 cases in a 30,000 patient trial is much higher than the standard occurrence in the population (< 5/million).
Re:What went wrong... (Score:4, Insightful)
Either way, 1 or 2 cases in a 30,000 patient trial is much higher than the standard occurrence in the population (< 5/million).
The occurrence in COVID-19 cases is much higher than in the standard population. More likely, a diagnosis of transverse myelitis would be caused by an actual COVID-19 infection.
However, if an autoimmune reaction is caused by the spike proteins and the vaccine mimics the spike proteins, then a vaccine could cause many of the same problems as the illness.
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Best I can tell - and I'm no expert and too lazy to dig carefully - is that the vaccine in question is identified as AZD1222 and it used no adjuvants, at least in the chimpanzee portion early on. I assume the formulation would remain the same throughout, but can't find any details on that whereas most other trials do list adjuvants.
And in reading about it, I did confirm that the vaccine creates the spike proteins as the mechanism to stimulate the immune response. So it very well could be causing autoimmun
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The majority of Transerse Myelitis cases are idiopathic. In other words, they can't figure out the cause. Probably shouldn't get too worked up about this until (1) Transerse Myelitis is actually confirmed, and (2) this case is confirmed to have been a reaction to the vaccine. At any rate, is it really valid to say the occurrence in the trial is much higher than in the overall population, when a single case drives it from zero to an order of magnitude higher than the standard rate?
I suppose you can say it's
Don't worry America (Score:1)
Find the adverse effects [Re:Don't worry America] (Score:2, Insightful)
Don't worry America, you can buy vaccines from China and Russia in 2022, once they are done immunizing everybody else.
Good idea, let them find the adverse side effects on their own people.
Let's just hope they take good lab notes on that massive experiment on human subjects that they are planning to do. "Oh, yeah, now that you mention it, looking back we see that there was a sudden spike of unexplained cardiac arrest exactly at the same time we vaccinated a million people, but we didn't keep track of that, we only kept records of whether they got COVID-19" is not good enough.
Re: Find the adverse effects [Re:Don't worry Ameri (Score:2)
Don't hold your breath.
China's Covid19 numbers are ridiculous; they claim complete eradication since early March, which is simply impossible.
The Russians? Shall I remind us what's the 'official' death toll from Chernobyl?
Really, one should not believe anything 'official' coming from these societies. They've always been like that....that's why they will always play second violin on the world's stage despite how much money and bombs they've got.
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Maybe the Chinese are genetically superior to the US population and naturally resistant to SARS-COV-2 virus?
Look at Slovakia, which is in the exact centre of Europe and which had 33 deaths due to Covid19. Not 33 thousand. Not 33 hundred. Just 33. Many other European countries have equally low death rates due to this infection.
It is mainly a problem of about 10 countries in South Western Europe and the Americas. The rest of the world is doing fine.
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China's Covid19 numbers are ridiculous; they claim complete eradication since early March, which is simply impossible.
First of all: it is not impossible.
More important: they did not claim that but reported several new outbreaks.
That you are so uninformed, one could consider impossible, but obviously it its neither.
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Don't worry America, you can buy vaccines from China and Russia in 2022, once they are done immunizing everybody else.
While Russians probably may take it early, Americans on the contrary will very likely take the vaccine before most Chinese do.
Every Covid-19 vaccine being developed are doing so on a highly accelerated schedule, *except* the Chinese. Everyone is rushing/hoping for a 2020 year-end target date, Chinese vaccine is on a schedule for year-end *2021* target, a whole year later, doing it the established safe way *because they can wait*.
Americans (and Russians to a smaller extend), on the other hand, are literally
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Starting phase 3 trial doesn't mean they will rush to finish it. Watch for when they plan to *complete* the trial and have the vaccine approved for use.
Adenoviral vector (Score:4, Interesting)
Look, when talking about the Russian vaccine I pointed out some of the problems of adenoviral vector vaccines but the adenovirus fans and Russian agents still modded me down .. also nobody bothered to fax or telegram my reasoning to Astra Zeneca which could have avoided this problem by canceling this forn of vaccine before this incident .. https://slashdot.org/comments.... [slashdot.org]
Reposting .. note the italicized part of the third reason it's a bad idea.
"First, they are using an adenoviral vector .. that is a bad idea. Adenovirus vectors Ad5 and Ad26 (booster) are being used .. those are some of the best vectors we have, especially for in vivo transfection, (except maybe Ad35) .. but, the problem is that THEY ARE ONE SHOT VECTORS. When you take a shot, your immune system develops antibodies against the vector itself .. so next time you take an Ad5 or Ad26 based vaccine it will get destroyed by the immune system. That means if we get a worse pandemic than Covid-19, or, you need gene therapy .. and you took this vaccine you're fucked and will have to use a shittier vector.
Second, some people may have already gotten similar adenoviruses (a fairly common virus), that means this vaccine won't work for them because their body will destroy the vaccine before it does its job.
Third, when an adenovirus based HIV vaccine was tested about 10 years ago, it actually increased susceptibility to HIV in humans and in primates (apparently by fucking with the innate immune system and/or enhancing the uptake of the virus into APCs though the latter might not be the vector's itself's fault).
No adenoviral vector vaccine has been shown to work properly in humans, let alone been approved for use in humans (although, there's an approved rabies vaccine for dogs)."
Re: Adenoviral vector (Score:2)
Re: Adenoviral vector (Score:2)
Re:Adenoviral vector (Score:5, Informative)
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also nobody bothered to fax or telegram my reasoning to Astra Zeneca which could have avoided this problem by canceling this forn of vaccine before this incident
Armchair engineer is upset people consider him an armchair engineer instead of someone with actual direct intimate knowledge to the specific circumstances at hand. News at 11.
Cue the Walkers (Score:2)
Next up comes Rick Grimes.
AstraZeneca LOSERS! (Score:2)
AstraZeneca's ratings are in the toilet and they're a horrible company. They're following science like suckers!
Russia's going to have a tremendous vaccine like you've never seen before and I'm hearing from lots of people that it will be available by November 2.
Peanut oil? (Score:2)
They probably shouldn't have made the vaccine out of peanut oil, milk, and eggs.
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They were gonna use snake oil, but couldn't get enough snakes to milk.
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I'm pretty sure they have a full legal team on retainer.
I predict (Score:1)
I predict the viruses we create testing vaccines for COVID-19 will be far worse than COVID-19.
History will not be kind to the idiots who release such devastation on our civilization.
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Sometimes it is better to be silent, and thought a fool, than to open your mouth and remove all doubt
In particular, people who face direct threats from famine and plague have MORE children than people who do not face those threats. This is a fairly ancient patter, and even the US saw family sizes of 10 children when any variety of common illnesses could wipe them out. US family sizes have dropped significantly since death from childhood diseases have been greatly reduced
It is Gate's intention to remove thes
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Oh no! The chip in my head just exploded!