Why It's a Big Deal If the First COVID-19 Vaccine Is 'Genetic' (wired.com) 245
An anonymous reader shares an excerpt from Wired: On Monday morning, when representatives from the drug company Pfizer said that its Covid-19 vaccine appears to be more than 90 percent effective, stocks soared, White House officials rushed to (falsely) claim credit, and sighs of relief went up all around the internet. [...] The arrival of an effective vaccine to fight SARS-CoV-2 less than a year after the novel coronavirus emerged would smash every record ever set by vaccine makers. "Historic isn't even the right word," says Larry Corey of the Vaccine and Infectious Disease Division at the Fred Hutchinson Cancer Center. A renowned virologist, Corey has spent the last three decades leading the search for a vaccine against the virus that causes AIDS. He's never seen an inoculation developed for a new bug in under five years, let alone one. "It's never happened before, never, not even close," he says. "It's just an amazing accomplishment of science."
And perhaps even more monumental is the kind of vaccine that Pfizer and BioNTech are bringing across the finish line. The active ingredient inside their shot is mRNA -- mobile strings of genetic code that contain the blueprints for proteins. Cells use mRNA to get those specs out of hard DNA storage and into their protein-making factories. The mRNA inside Pfizer and BioNTech's vaccine directs any cells it reaches to run a coronavirus spike-building program. The viral proteins these cells produce can't infect any other cells, but they are foreign enough to trip the body's defense systems. They also look enough like the real virus to train the immune system to recognize SARS-CoV-2, should its owner encounter the infectious virus in the future. Up until now, this technology has never been approved for use in people. A successful mRNA vaccine won't just be a triumph over the new coronavirus, it'll be a huge leap forward for the science of vaccine making.
[I]n the last decade, the field has started to move away from this see-what-sticks approach toward something pharma folks call "rational drug design." It involves understanding the structure and function of the target -- like say, the spiky protein SARS-CoV-2 uses to get into human cells -- and building molecules that can either bind to that target directly, or produce other molecules that can. Genetic vaccines represent an important step in this scientific evolution. Engineers can now design strands of mRNA on computers, guided by algorithms that predict which combination of genetic letters will yield a viral protein with just the right shape to prod the human body into producing protective antibodies. In the last few years, it's gotten much easier and cheaper to make mRNA and DNA at scale, which means that as soon as scientists have access to a new pathogen's genome, they can start whipping up hundreds or thousands of mRNA snippets to test -- each one a potential vaccine. The Chinese government released the genetic sequence of SARS-CoV-2 in mid-January. By the end of February, BioNTech had identified 20 vaccine candidates, of which four were then selected for human trials in Germany. [...] Genetic vaccines might be proving they can work -- but it's still not definitive, and they may not yet work for everyone. That's why experts say it's so crucial to continue supporting ongoing trials for the more than 60 other vaccine candidates still in various stages of human testing. What older technologies lack in terms of speed, they make up for in durability.
And perhaps even more monumental is the kind of vaccine that Pfizer and BioNTech are bringing across the finish line. The active ingredient inside their shot is mRNA -- mobile strings of genetic code that contain the blueprints for proteins. Cells use mRNA to get those specs out of hard DNA storage and into their protein-making factories. The mRNA inside Pfizer and BioNTech's vaccine directs any cells it reaches to run a coronavirus spike-building program. The viral proteins these cells produce can't infect any other cells, but they are foreign enough to trip the body's defense systems. They also look enough like the real virus to train the immune system to recognize SARS-CoV-2, should its owner encounter the infectious virus in the future. Up until now, this technology has never been approved for use in people. A successful mRNA vaccine won't just be a triumph over the new coronavirus, it'll be a huge leap forward for the science of vaccine making.
[I]n the last decade, the field has started to move away from this see-what-sticks approach toward something pharma folks call "rational drug design." It involves understanding the structure and function of the target -- like say, the spiky protein SARS-CoV-2 uses to get into human cells -- and building molecules that can either bind to that target directly, or produce other molecules that can. Genetic vaccines represent an important step in this scientific evolution. Engineers can now design strands of mRNA on computers, guided by algorithms that predict which combination of genetic letters will yield a viral protein with just the right shape to prod the human body into producing protective antibodies. In the last few years, it's gotten much easier and cheaper to make mRNA and DNA at scale, which means that as soon as scientists have access to a new pathogen's genome, they can start whipping up hundreds or thousands of mRNA snippets to test -- each one a potential vaccine. The Chinese government released the genetic sequence of SARS-CoV-2 in mid-January. By the end of February, BioNTech had identified 20 vaccine candidates, of which four were then selected for human trials in Germany. [...] Genetic vaccines might be proving they can work -- but it's still not definitive, and they may not yet work for everyone. That's why experts say it's so crucial to continue supporting ongoing trials for the more than 60 other vaccine candidates still in various stages of human testing. What older technologies lack in terms of speed, they make up for in durability.
Smashing records? (Score:2, Interesting)
He's never seen an inoculation developed for a new bug in under five years, let alone one.
The H1N1 timeline:
April 15 - first human infection
July 22 -- clinical testing beings
Sep 15 - FDA approves 4 vaccines
October 5 - vaccination begins
https://www.cdc.gov/flu/pandem... [cdc.gov]
So what am I missing here? What was different about H1N1 that it doesn't count in this context?
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its the flu, and with flu virus most of the problems are already solved and its just a matter of testing, rather than developing an entirely new solution and testing it
Re:Smashing records? (Score:4, Insightful)
its the flu, and with flu virus most of the problems are already solved and its just a matter of testing, rather than developing an entirely new solution and testing it
No mod points for the cowherds on /. any more? Because that was a stellar little tweet of a post. I wish I had that level of diplomatic skills.
Ain't got points because I have been pointing out the fact that covid-19 is not a conspiracy or a non trivial disease as the man in orange would have his cohorts of brain washed myrmidons and sycophants believe. If herd immunity is not achieved within 2 years it will be as bad as the 1918 "spanish flu" Extrapolate that to the new population of the planet and the numbers of dead will be in the hundreds of millions within 3 years. Certainly it will kill a much smaller proportion of the younger population than that of the over 50 crowds but in turn we will lose a great many people who still could have contributed to society in meaningful ways .
If we go on to you lose a significant portion of the older medical workers whose wisdom and compassion compelled them to help the dying our society will certainly be poorer for it. All these things are possible with this pandemic and there is even the distinct possibility of social chaos and collapse. Unfortunately until January 2021 a pathological liar with the social skills of Adolf Hitler has a foot ball to fall back on, let us just hope that he does not have the power to put the squeeze on his associates to nuke the electoral college!
Re:Smashing records? (Score:5, Informative)
This is a radically new approach, and even making the drug involves lots of new processes. Hence the amazement at how fast we appear to have done it.
Disclaimer, in case it isn't obvious, I am not a drug researcher, just an interested observer (after all, my life may depend on it).
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Not aware of any human coronavirus vaccines that made it to market (correct me if I'm wrong); some work was done during the 2003+ SARS outbreak, and some number of animal vaccines exist for other coronaviruses, which I'm sure have some relevance to development... but this all pales in comparison to the body of w
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Re: Smashing records? (Score:2)
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H1N1 wasn't a new virus. It's influenza, with a few specific proteins shuffled a bit, the way every other human-infecting flu virus is.
HIV was a completely new virus, and in fact a member of an entire genus that we didn't really have much experience with.
The COVID-19 virus is kind of in the middle. It's more dissimilar from the original SARS and MERS viruses than different flu strains are, but it's not nearly as novel as HIV was.
It is a bit disingenuous to say the vaccine was developed in under a year. Some
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SARS-CoV-2: indeed no ready-made pipeline (needed) (Score:2)
It's not comparable to making an entirely new vaccine for an entirely different virus.
Yup exactly.
(Though, like other have pointed out, the SARS-CoV-2 vaccine isn't entirely new and slightly benefit from past experience learn from SARS and MERS.
BUT....)
As TFA points out, the process of using mRNA that several labs are relying upon (Pfizer, Moderna, etc.) is a brand new process which will be used for production vaccine right now for the first time ever in the history of modern biotechnology.
So yeah, you're right that's definitely not the "use the same approach as we do each year, and this yea
Re:SARS-CoV-2: indeed no ready-made pipeline (need (Score:5, Interesting)
I don't think people will freak out because I don't think that the average person has any clue what RNA is.
Regardless, re this:
This is actually one of the cool things about our immune system. CD8+ (killer) T-cells are "trained" in the thymus as to what a normal cell is supposed to look like. Cells naturally degrade proteins inside them into 8-amino-acid segments, transport them to the surface, and bind them to a surface receptor. Basically waving them around and going, "Hey, look at this!". CD8+ cells have different binding affinities for different surface proteins. In the thymus, those which bind weakly (but not strongly) to these are selected for - e.g. "I care enough to investigate you, but not to kill you." When an invader attacks the body, fragments of their proteins will get taken to the surface and "waved around" for investigation. A minority of T cells will have a strong binding affinity for these foreign proteins and trigger an immune response to them. Reproduction of these T-cells then becomes favoured, including mutant variants which may or may not bind more strongly to the target antigen.
(There's also CD4+ (helper) T-cells which help mediate the immune response; B-cells, which make antibodies; dendritic cells, which go around the body nibbling on everything these see (even your own cells), to collect up protein samples and wave them around to try to trigger responses from other cells; and my favorite, natural killer cells, which go around and attack everything they find that's not waving around enough protein fragments, in case some attacker decided to try to disable that mechanism ;) )
Basically... if you get some foreign mRNA in your cells, it'll create its target protein, it'll get degraded, the fragments will get transported to the surface, cells will recognise, "Hey, this isn't from a normal cell I was "trained" to!", and the immune cascade will get set in motion against it.
Re:Smashing records? (Score:4, Insightful)
Wow, amazing - every other medical expert missed what you picked up on, fantastic!
Or perhaps your are just an asshole. Did you notice I didn't call the guy in the article an idiot? I simply pointed out an counter-example and asked why that counter-example was not relevant. And you know what, some other slashdotters kindly answered that question for me without being an asshole about it. Damn, not only did an Anonymous Coward beat you to the answer, but he wasn't a prick about it
Naive question (Score:2)
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Well why not? They aren't producing much of it anyway. All kinds of crap proteins are produced in huge quantities in the body I wouldn't worry about a few spike proteins being made continuously. Sadly though, even the self amplifying mRNA (which makes a protein that keeps making copies of the mRNA) doesn't last forever -- it degrades eventually (months or even years in the case of saRNA). If RNA didn't degrade, our cells would explode or something given how much of it is being produced. Ironic we are even t
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Why not? Because it is never a smart idea to change a running system in novel ways. Otherwise you could justify literally almost any change with that, until statistical likeliness of it being very bad becoming 100%.
So we *do* need a reason, before introducing perpetual changes to our protein expression. (And you to stay level-headed though this. :)
Of course only if we assume it has a bad effect in the first place. (Anyone with an *actual* clue, not just triggered arrogance, who can tell us?)
And with the imm
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I'm no expert (so I will defer to anyone that is), but my guess is that since most cells in the body die off quickly (days to weeks), that means once the injected mRNA has all been consumed, you wait for the consuming cells to die off and the replication halts.
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Since this particular sequence is not self-replicating (as a virus is), it will eventually be broken down by the body.
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While I'm not an expert in this field, messenger RNA, like all RNAs, is degraded by RNAses, and there's specific complexes of proteins (such as the exosome complex) that target messenger RNA specifically for destruction. If you don't have anything producing more mRNA in the cell, then, eventually the injected mRNA will be degraded and no more translation of it will occur. Because this vaccine isn't rewriting the cell's DNA (unlike the virus itself), there's nothing to produce further mRNA encoding the spike
mRNA (Score:3, Insightful)
Let's introduce manufactured genetic code into our own bodies. What could possibly go wrong?
Re:mRNA (Score:4, Insightful)
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So, he does not pretend to know. He specifically hints at what we do *not* know. In a slightly humorous way.
The point is for you to tell him, if you can. Instead of being a triggered dick about it, like you have been here. Which also more likely hints at you not knowing either, so why are you typing?
Re:mRNA (Score:5, Interesting)
What could? No, I'm actually asking since you are pretending to know so can you outline specifically what could go wrong, I mean I'm sure you're not just fearmongering right?
The RNA ends up inserted into another virus where it combines with RNA from that virus to build a new spike protein similar to but different in shape from the protein in SARS-COV-2. This new virus is now able to replicate like SARS-COV-2 but at the same time, due to the other material in the spike it is able to mutate rapidly to avoid the immune system. Using the SARS-COV-2 spike the newly created virus becomes airborne whilst retaining the existing virus's ability to survive for days on surfaces. It's extremely unlikely, sure, but you asked what could go wrong.
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It has the same effect though, as it still effectively produces the proteins that it would if it was introduced into the DNA.
The difference probably being that it doesn't stay forever, as those cells are killed.
Which contains two fallacies, unfortunately:
1. You cannot kill all cells, as that would mean death. And most likely, not all cells altered that way either. And not instantly anyway. So if those "spikes" have any effect on the body, other than killing that cell, they will have an effect.
2. If the immu
Re: mRNA (Score:2)
mRNA is unstable, it will vanish quickly with or without help. You would be in serious trouble if it didn't, with cells locked into processing messages long after it's needed. Unstable enough to need storage at _80F.
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It's a protein, it's not a retrovirus. It's not going to get copied into your DNA. It doesn't even come with mechanisms to copy things into your DNA (like HIV comes with).
What is being inserted into the body is not a protein. It's an RNA sequence which codes for a protein. That makes it a bit more interesting and there have been legitimate concerns [independent.co.uk] about after effects like inflammation [nature.com]. It's not an RNA virus but it's not just a protein.
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Let's introduce manufactured genetic code into our own bodies. What could possibly go wrong?
You‘re writing a post on Slashdot. What could possibly go wrong?
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I have to accept the possibility that you're just joking because this phrase is commonly used as a joke. But there are plenty of dumb people out there who think that this is making a very good argument against doing something new.
Science, at least when done properly, has obligatory precautions for such cases where extensive trials need to be conduc
Now make a vaccine for the common cold (Score:2)
since it's also a coronavirus. I imagine it will be released any day now.
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The common cold is not a virus, but rather a set of symptoms caused by many different viruses (which includes coronaviruses). So it may be possible to adapt this to handle coronavirus cold variants, but that leaves everything else. A quick check of wikipedia says
The common cold is a viral infection of the upper respiratory tract. The most commonly implicated virus is a rhinovirus (30–80%), a type of picornavirus with 99 known serotypes.[29][30] Other commonly implicated viruses include human coronaviruses ( 15%),[31][32] influenza viruses (10–15%),[33] adenoviruses (5%),[33] human respiratory syncytial virus (orthopneumovirus), enteroviruses other than rhinoviruses, human parainfluenza viruses, and human metapneumovirus.[34] Frequently more than one virus is present.[35] In total, more than 200 viral types are associated with colds.[3]
So perhaps we could eliminate 15% of colds, but given how insignificant colds generally are, I doubt we'd bother giving it priority.
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So perhaps we could eliminate 15% of colds, but given how insignificant colds generally are, I doubt we'd bother giving it priority.
There is active research on the topic, but as you mention, it doesn't get as much funding as cancer.
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And this is how you become a successful virus, dear Corona!
2 doses and new storage chain (Score:2)
This vaccine is not ideal. It requires 2 doses and liquid nitrogen storage both of which create logistic headaches. Thankfully, there are over 300 vaccines in development. By the time a few million doses are actually available for this one, others will likely be within a month of achieving the same.
As to this being attributable to Trump, it is a worldwide effort. They were developing this one and many others months before Trump gave any money.
What we really need to be working on is figuring out how we are g
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New pharma to test on the willing masses (Score:2)
Sounds as the wet dream of any Pharma CEO.
Who cares about side effects?
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Sounds as the wet dream of any Pharma CEO.
Indeed, a global market with governments willing to pay up front for millions of doses does sound like a goldmine.
Who cares about side effects?
I guess it depends on the side effect, no? And on the risks the disease poses. I recall reading about a treatment for tuberculosis that can cause colorblindness. Untreated tuberculosis kills half of those infected, or at least that's what Wikipedia tells me. Even if the treatment has a near certainty of permanent colorblindness then who would not take that?
For people under the age of 65 year
Resident Evil reboot (Score:4, Funny)
What are the downsides? (Score:2)
Sounds great, but I'm very wary of anything completely one-sided. And this lists exclusively positive properties.
Which is also no good because it gives certain people, you know who, an argumentative advantage. It's better to be upfront about the negative properties too, to prevent that.
So... what are the downsides?
Without that information, guesses are that cells don't usually just accept random mRNA floating in intracellular space. And that it doesn't just do that one genetic alteration, but out of necessit
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Brute-force hasn't gone away either (Score:2)
Thanks to robotics, you don't have to run experiments manually in a single test tube any more. If, say, you want to find a drug that interferes with the action of a a particular protein, you can do that experiment hundreds of thousands of times with libraries of hundreds of thousands of differen
Don't celebrate yet (Score:3)
Most people hearing about this particular vaccine and it's requirements are having conniptions. I'd wondered what was so unusual about it, now I know.
Apparently, this vaccine has to be stored at -75C (that's -103 for Fahrenheit fans). Damned few, if any, medical facilities have the ability to store any kind of quantity at that kind of temperature... and then, apparently, it's a double-dose vaccine (not unusual), so you take one dose, and then another some number of weeks later, which doubles the storage requirements.
Add to that the fact that we haven't tried this kind of vaccine before, so we don't know what, if any, long term effects there are going to be... and I'm a little bit concerned by this one. I think I might wait for a slightly more old-fashioned approach. :)
Isn‘t it the ‘Muslim Vaccine’? (Score:3)
The vaccine was developed by “German Company” BioNtech founded by a Turkish migrant and his wife, the child of Turkish migrants. Their Names are Özlem Türeci and Uur ahin.
The development was supported by German tax payer with $455 Mio.
Pfizer was contracted to make, test and deliver the vaccine at scale.
I understand that for some US people paying money and promising to pay money is the same, whether for political rallies or for medical products, as is invention and talking about inventions.
- https://en.m.wikipedia.org/wik... [wikipedia.org]
- https://en.m.wikipedia.org/wik... [wikipedia.org]Özlem_Türeci
(Yes, the likely religious affiliation of those brilliant people is irrelevant to a grade :-)
First - For a very small value of first (Score:2)
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people are stupid, admit it (Score:2)
It's a big deal (Score:2)
For Chinese medical fridge manufacturers, since the vaccine has to be kept at -80 degrees Celsius at ALL time.
I fear unforeseen consequences (Score:3, Insightful)
Given big pharma's history of greed and deceit, is this really wise?
I think that the risk of unforeseen consequences is tremendous.
Someone is rewriting history for China. (Score:5, Informative)
A Chinese scientist gave his team's findings to an Australian professor, who posted them - https://virological.org/t/nove... [virological.org]
The Chinese government didn't release those findings, they had to be passed off to someone outside of China who released them on the researchers' behalf. The Chinese government was not thrilled. They shut down the lab two days after the sequence was released.
So, why change the facts to make the Chinese government look like it wasn't suppressing vital information? They went after the guy who released the code just like they went after the doctor who first identified the outbreak, but from the excerpt you'd think they were playing nice and helping everyone else out.
It really is a big deal (Score:4, Interesting)
The mRNA vaccine technology could be absolutely huge. Not only has it decreased development time to under a year in this case, but it has the promise to enable us to churn out new vaccines with amazing rapidity and even potentially to shortcut the testing process. It's not inconceivable that we could gain the ability to distribute a vaccine for a new pathogen mere weeks after isolating and sequencing it.
The thing about this approach is that it gives us the ability to create a single retargetable vaccine. The base platform can be exhaustively tested to a degree that almost no vaccines have, because it's a reusable transport. They payload is just a bit of mRNA that builds a specific protein to stimulate the immune response, which means that we only need to test that mRNA and the resulting protein for safety and efficacy. The simplicity also means that as we further develop our models we may get to a point where the vast majority of that safety and efficacy testing can be done in simulation.
Furthermore, one problem with vaccines today is that every different vaccine has different production processes and different distribution requirements. This could eliminate all of that variability. Standardized vaccine factories could churn out any new vaccine given nothing more than an mRNA sequence file and distribution and delivery could be standardized as well. Or perhaps we can even build desktop vaccine "printers", which every doctor's office and pharmacy could own, able to produce vaccines on-demand, from platform stock and a library of mRNA samples, or even descriptions.
Finally, if there are some downsides to the base platform -- bad responses in some people, annoyingly-low temperatures required for transport, requiring injection rather than a more convenient delivery mechanism (e.g. oral)... we can work on gradually optimizing the base platform to have the cost, production, transport, delivery and bio-effect characteristics that we want. There will be challenges and limitations, of course, but because the platform's only job is delivery of a bit of mRNA, we can engineer the rest.
If it works out, this could truly revolutionize vaccination, enabling humanity to respond to new pathogens with incredible rapidity, and at very low cost.
any fresh and soon to be parents amongst the sampl (Score:3)
Re:Was not a false claim (Score:5, Informative)
There is a meaningful distinction between an advance-purchase agreement and federal funds backing the basic R&D. Of course, I don't object to either in this context. But let's not act like being 'part of it' is the same thing in every case.
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There is a meaningful distinction between an advance-purchase agreement and federal funds backing the basic R&D.
What is the difference? Someone has to pay for the stage 3 testing, that isn't cheap.
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The difference is whether someone has paid or not, I should think. In the advance purchase agreement, has the federal government actually forked over any cash yet?
Re:Was not a false claim (Score:5, Insightful)
I don't think so. Pfizer's press release specifically says that the cash is due on delivery of X million doses of a tested, working vaccine.
That's the big difference. Warp Speed has two components. The first are development grants to create and test a vaccine. The second is funding to produce and distribute doses of a working vaccine. Pfizer was involved in the second part, but not the first.
As for a purchase agreement being incentive, I suppose it is, but I seriously doubt Pfizer would have had any doubts about their ability to sell a COVID-19 vaccine.
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"three experts contacted by CNN said the US federal government likely played a significant role in the progress of the vaccine. (Another expert disagreed.)"
Who even knows what that means.
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Do you have some stupid idea that because a company made a profit LAST year, the products they make THIS year have no cost? Are you really that stupid?
You keep referring to the $1.95B as if Pfizer has that money. IT DOES NOT. That number just represents the amount the government has committed to spend to PURCHASE x number of doses of the vaccine IF the vaccine turns out to be effective. Pfizer still has to, you know, actually manufacture those doses, and that costs money.
Where do you think Pfizer got th
Re:Credit where credit is due (Score:5, Insightful)
Thanks to the German government we may have a vaccine.
No, it's thanks to "big pharma" that we may have a vaccine. The same people that get blamed for many of the world's problems.
Is it impossible for people to recognize the net good that "big pharma" provides to society? That's not saying they don't need oversight by government and private consumer protection organizations. This isn't some kind of denial of any harms from "big pharma" either.
I believe we need a "right to try" law that protects drug companies and allows greater freedoms for people to try experimental drugs. One problem with health care today is from the government denying people access to drugs out of some misguided claim of safety. It took a global epidemic for many people to realize just how fucked up our drug laws have become. It gets easier to clear the obstacles to new drugs on the market when legislators and regulators see their own necks on the line from a disease.
Remember that when Biden tries to claim credit for it. And he will. Bet on it. His whole life has been one of plagiarizing and taking credit for the work of others.
I have no doubt a lot of people will try to claim credit. The people that deserve the most credit are those that did the hard work in developing the vaccine. Politicians can clear out some regulatory obstacles, but it's those same politicians that put those obstacles in the way in the first place.
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Everybody loves to demand faster drug approvals, until something goes wrong. Like using SSRIs off label on kids, who then kill themselves. Or thalidomide.
The FAA is kind of the same situation, except without the emotional involvement. Ease the certification process, less burden on industry, faster, easier innovation. Everybody wins! Oh shit.
Re:Credit where credit is due (Score:4, Insightful)
There are people willing to experiment with these drugs because they are running out of options. But the FDA will not allow it because the drugs have not yet been proven effective.
You're either horribly misinformed or trying to push an agenda. Compassionate exceptions and entries into experimental trials are routine. "I'm dying and the guy in the labcoat has a possible cure but isn't allowed to give it to me" is not a realistic scenario.
What does it take to prove a drug is effective? People have to take the drug and the results need to be documented.
This is a catch-22 that the FDA created for themselves and there is no way to break it but to remove this nonsensical policy enacted because an unsafe drug came to market.
There's no catch-22; that's what drug trials are for. You don't just throw drugs around like candy and see what happens.
You're actually arguing that effectiveness shouldn't be a criteria for drug approval?! So as long as I can prove that my sugar cube isn't directly harmful, I can sell it as a cancer cure, thereby preventing people from seeking out actual working medicine?
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We also know that putting new drugs into pregnant women is riskier.
You can have faster drugs at increased risk. But if you pay attention during the roll out, as if it is experimental, you should be able to nip problems earlier.
But people continue to die as successful drugs are delayed a year or five. This could easily add up to millions, vs. a few hundreds or thousands here or there as some get to market too quickly before being halted. But the latter you have lawyers and screetching politicians, while n
Re:Credit where credit is due (Score:4, Informative)
Heavens. Imagine, requiring that a drug be proven effective! Those monsters!
There is a *very* good reason why the system is set up as it is. It's because this statement: "What does it take to prove a drug is effective? People have to take the drug and the results need to be documented." is wrong.
In order to demonstrate that a medical treatment is effective, people need to take the drug under controlled circumstances. Specifically, a double blinded controlled trial.
This issue was actually demonstrated during the COVID pandemic. There was difficulty enrolling patients in controlled trials for things like chloroquine. Who wants to take the risk of getting a placebo, or all the other inconveniences of a trial, when you can just get the drug? Especially when the president of the USA says it works great?
Individuals experimenting with drugs is *worse* than useless for demonstrating their efficacy.
Patients don't seem to realize that their chances with an existing treatment are *better* than they are with an experimental treatment. In the very few cases where no effective treatment exists, enrolment in a trial is not an option, and the seriousness of the disease is such that the possible benefit of the drug outweighs the significant risk of harm, the FDA, as well as most other health agencies, has compassionate use procedures. Individual physicians also have wide latitude for administering whatever the hell they feel like in such circumstances.
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Correction: They *claim* we have a vaccine. The kind of people you cannot trust with a water pistol. The kind of people who literally created an entire fake journal for doctors to read full of fake studies to get them to prescribe their drugs. (Merck, via Elsevier.) The kind of people who set up stands at schools to give "free samples" of literally Speed to children. (Eli Lilly.)
The kind of people who until recent genetic advances literally got most of their drugs by going into the jungle, asking witch doct
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BioNTech, the company that actually developed the vaccine, has around 1,100 employees so isn't quite in the realm of "big pharma" just yet, but might be after this. Also they took nearly half a billion Euros from the Germany government for development of this vaccine, so thanks to the German tax-payer.
The other promising Western vaccine is a join development with Oxford University.
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No, it's thanks to "big pharma" that we may have a vaccine.
[...]
Is it impossible for people to recognize the net good that "big pharma" provides to society?
It is impossible for you to recognize that it would be better done by someone else? Big Pharma spends more than 50% of its operating expenses on advertising. That doesn't need to happen at all. They could be doing twice as much good if not for that.
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I find it disgraceful politicians lay shit on the companies that save untold millions of lives every year, because it aids them gathering together a sufficient mass of yokels to seize power.
They drag life saving things into existence from nothingness, and the moment it does, some politician starts screaming to their fans how evil they are because it costs money.
This is the king in Humpty Dumpty, and his men, who could not put Dumpty together again, and crap on those who can.
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Re:Credit where credit is due (Score:5, Informative)
The German government gave $455 Mio to develop the vaccine and the Trump administration signed a contract to buy a number of doses *when (and if) the vaccine is ready*.
When you pre-order a book at Amazon you don‘t get to claim that you wrote it.
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There was zero danger of not selling a working vaccine for what is currently the most important disease on the planet; that and Pfizer's good name is sufficient to secure funding, in the business world.
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If Pfizer built the factory in the US, Asia, or Australia, things might have worked out rather different.
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The statistics aren't poor, and they're not secret. You can read most of the details on the registry page (all clinical trials to be considered by the FDA are required to be pre-registered). https://clinicaltrials.gov/ct2... [clinicaltrials.gov]
The actual numbers are currently secret from everybody, including Pfizer, because the trial isn't over yet. Only a handful of people pre-designated to be on the interim analysis committee are allowed to see them. They'll be released when the trial is over and the blinding is no longer n
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Why exactly would they hide key data, but out of fear for how we would react?
If the statistics were great, you know they'd use them to brag and put them front and center and show them to ALL the people as advertisement.
It reeks of sneaky behavior. I don't plan to downmod you either, but I am curious why you would not think so? Never been disappointed in your life?
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Well, do tell us! This is Slashdot! Half the readers don't ever read TFA. And the other half doesn't know that such a thing even exists! ;)
Oh come on, Slashdot! (Score:2)
You cannot be THAT predictably triggerable!
(The comment is at (0, Troll) currently.)
How about you answer some questions, or shut up if you can't? Instead of moderating like an anonymous coward. (Why are people even allowed to moderate without commenting why?)
Re:Read your "evidence" again (Score:5, Insightful)
Because you quote-mined and cut off the part which says they agreed to a contract in July, i.e. the pharma company gets to be paid once the vaccine clears the FDA. So yeah, the $445M in September goes a lot further than $0 in July to fund its development cycle.
On your last quip, if anyone doesn't have "TDS" at this point, they're braindead. Can't believe anybody can unironically use that term.
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Oh, and business accounting can be complex, so it is understandable that you might not know that a $2 billion contract is almost as good as cash. The price and demand for your stock shoots up, and you can borrow against it with very favorable terms.
Re:Read your "evidence" again (Score:5, Informative)
Merriam Webster defines buy as "to acquire possession, ownership, or rights to the use or services of by payment especially of money". What payment did the Trump administration give? They gave zero up front payment. They gave a promise of payment if Pfizer comes through. Of course, anyone who knows Trump knows how good one of his promises is.
Sorry, but Pfizer (and the companies working under them) were the ones taking all the risk (up until Germany give them some money). I person laying out $5 to preorder a video game has more skin in the game than Operation Warp Speed had in this vaccine development
Re:Read your "evidence" again (Score:4, Insightful)
This is an alarming trend I've noticed with increased frequency among people nowadays. They absolutely refuse to acknowledge when something done by someone they philosophically oppose achieves a good result. It's like they think their way is the only way which can produce success, and therefore all other ways must only produce failure. What happened here was essentially a gamble, which could've gone either way. It succeeding does not threaten the validity of anyone's philosophical opposition to Trump. Unless that opposition is based on the premise that everything Trump does is wrong.
Or more succinctly, you cannot blame Trump for "wasting" money on lots of potential COVID-19 treatments which turned out to be ineffective [slashdot.org], while simultaneously refusing to give him credit when a treatment he helped fund turns out to be effective. Either he is responsible for the bad ones, and must be given credit for the good ones. Or he doesn't deserve credit for the good ones, nor the blame for the bad ones.
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Republican commentators could only see Solyndra, but supporters of the president realized that you need to look at the successes, too.
Re:Read your "evidence" again (Score:5, Informative)
Re:Read your "evidence" again (Score:4, Informative)
You've got to be kidding me. Fox News continually lambasted Obama. It wasn't light-hearted teasing, they were making him out to be an evil, anti-American, illegitimate power mad president (who was somehow simultaneously a socialist dictator, and weak and ineffective). You want to talk about mean-spirited and cruel? Tucker Carlson, Bill O'Reilly, et al.
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Jesus, nobody takes you fuckers seriously. Giving a US President credit for investments in a vaccine for a world-changing pandemic is like giving your secretary a bonus for typing up a memo for you.
Is it your contention that _any fucking President_ wouldn't have poured money into a vaccine?
Trump gets no credit, Berlin gets no credit - Pfizer and their employees and researchers get the credit.
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Oh big deal, he poured some money into researchers because literally ALL the people demanded it. AFTER openly saying it's all bullshit. OUR money, at that.
And of ALL the governments on the planet, *obviously* only yours is the big deal. I hope your shrine didn't become too much covered in your cum. --.--
You're like those morons who act like Elon Musk personally invents all the things, and downmod anyone who says he, you know, may just be the bigmouth top dog on the shoulders of actual inventors.
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Sure, and Canada, a country about 1/9th the size of America population wise also contracted to buy 56 million doses, compared to America's 100 million, with Europe ordering 600 million doses. America is just another customer, and considering how big America is, not even that big of a purchase.
https://www.en24news.com/2020/... [en24news.com]
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ALL of them.
It's the unwritten law, after all.
I don't know why, but there it is.
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No dude, you didn't build your Tesla. You're responsible for *all* the Teslas.
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Oct 30, Reuters: If all goes well, the first doses of a safe and effective coronavirus vaccine will likely become available to some high-risk Americans in late December or early January, Dr. Anthony Fauci, the top U.S. infectious diseases expert, said on Thursday.
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It also has to actually work as advertised. And *keep* working.
The pharma industry is not exactly known for their trustworthy and honest and non-evil nature. And from what I've been told, it will work for 6 months before you need a fully newly designed one (new mRNA for new spikes matching the new virus variety)(?). So perpetual shots. Perpetual payments. To organizations with a monopoly and shareholders demanding artificial scarcity for raising the price to "whatever the market can bear". So until it becom
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Hey OMBaby, you may think you're being sarcastic, but there is merit to this - who travels about the office more and touches more people's junk than the IT guy?
A few guesses would be nurses, physicians, surgeons, dentists, midwives, and therapists.
After that would be people in the services industry. People that work in theaters, restaurants, hotels, retail, groceries, banks, and so on.
Oh, wait, I forgot schools and daycare centers. That might rank higher than services.
Then there might be people that go to people's homes for things like appliance installations, plumbers, and just generally people that do home repairs.
Perhaps a close second to the "IT guy" are thos
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And before all that, all the high-risk elderly and ill people that would die from an infection.
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Your mom brings you food, right? So... well, you could ask any of your mom's a THOUSAND boyfriends. ;)
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I wouldn't go out and print t-shirts about this or get a tattoo just yet. It appears that after they started actually investigating this lead, the guy recanted. Project Veritas was offering $25k rewards for info on fraud and it seems that was too large an amount to pass up, so this guy ran his own fraud.
USPS employee who claimed mail-in ballot tampering in PA recants allegations [wbtw.com]
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Even if the story is true (apparently it's been retracted), it doesn't matter. *ALL* votes received in Pennsylvania after Nov. 3rd, if they were postmarked before Nov. 3rd, were put into a segregated pile, and whether they were counted or not, they were NOT added to the existing total number of votes. They're waiting on the outcome of the only almost-valid challenge to decide whether to count those ballots.
So Trump could wind up losing by a considerably larger margin in Pennsylvania if he's not careful.
It
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They wouldn't have an immature git like you.
Re:Do you trust B. Gates with your life ? (Score:5, Informative)
You're talking like mRNA vaccines alter your genes, but that's not how mRNA works. If mRNA impacted your genes, it would be useless at its biological purpose of transmitting genetic data, because it would be doing unwanted writes all over the place. One of the advantages of this kind of vaccine is that it doesn't enter the nucleus.
Additionally, triggering an adverse immune system reaction is a well known potential side effect. This is why we have safety trials.
Every new technology has had to go through a "never used on humans before" phase, and it's not entirely accurate in this case as the technology has had 3 decades of clinical trials in humans, including the trials required for this specific vaccine. By the time the general public is getting this vaccine, there will be plenty of humans who have had it. By the time it gets to younger people, an enormous number of older and at-risk people will have had it for a while.