India Approves World's First DNA Covid Vaccine (bbc.com) 136
An anonymous reader quotes a report from the BBC: India's drug regulator has approved the world's first DNA vaccine against Covid-19 for emergency use. The three-dose ZyCoV-D vaccine prevented symptomatic disease in 66% of those vaccinated, according to an interim study quoted by the vaccine maker Cadila Healthcare. The firm plans to make up to 120 million doses of India's second home-grown vaccine every year. Previous DNA vaccines have worked well in animals but not humans. Cadila Healthcare said it had conducted the largest clinical trial for the vaccine in India so far, involving 28,000 volunteers in more than 50 centers. This is also the first time, the firm claimed, a Covid-19 vaccine had been tested in young people in India -- 1,000 people belonging to the 12-18 age group. The jab was found to be "safe and very well tolerated" in this age group.
DNA and RNA are building blocks of life. They are molecules that carry that genetic information which are passed on from parents to children. Like other vaccines, a DNA vaccine, once administered, teaches the body's immune system to fight the real virus. ZyCoV-D uses plasmids or small rings of DNA, that contain genetic information, to deliver the jab between two layers of the skin. The plasmids carry information to the cells to make the "spike protein," which the virus uses to latch on and enter human cells.
ZyCov-D is also India's first needle-free Covid-19 jab. It is administered with a disposable needle-free injector, which uses a narrow stream of the fluid to penetrate the skin and deliver the jab to the proper tissue. Scientists say DNA vaccines are relatively cheap, safe and stable. They can also be stored at higher temperatures -- 2 to 8C. Cadila Healthcare claims that their vaccine had shown "good stability" at 25C for at least three months -- this would help the vaccine to be transported and stored easily.
DNA and RNA are building blocks of life. They are molecules that carry that genetic information which are passed on from parents to children. Like other vaccines, a DNA vaccine, once administered, teaches the body's immune system to fight the real virus. ZyCoV-D uses plasmids or small rings of DNA, that contain genetic information, to deliver the jab between two layers of the skin. The plasmids carry information to the cells to make the "spike protein," which the virus uses to latch on and enter human cells.
ZyCov-D is also India's first needle-free Covid-19 jab. It is administered with a disposable needle-free injector, which uses a narrow stream of the fluid to penetrate the skin and deliver the jab to the proper tissue. Scientists say DNA vaccines are relatively cheap, safe and stable. They can also be stored at higher temperatures -- 2 to 8C. Cadila Healthcare claims that their vaccine had shown "good stability" at 25C for at least three months -- this would help the vaccine to be transported and stored easily.
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Who said that? India makes 20 percent the globe's pharmeceuticals and it's no surprise they're getting into genetic pharmy
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Right, like the U.S. space program hasn't had colossal failures of rockets and probes along the way, including body count to get to the moon.
Russians had the first soft landing on the moon.
India will pass up the USA in GDP by 2030.
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They're in 2001, obviously.
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Well, frankly, if it can't stop the spread, since it doesn't even stop "asymptomatic infection", it's not much of a vaccine, now is it? Then again, neither are any of the other vaccines, from what I heard. ;)
(To be fair, reducing the spread is already nice. But still, my definition of a vaccine is still the old, correct one, where it actually prevents infections and hence spreading.)
No vaccine prevents infections, and hence, spreading. They all just reduce it by a certain percentage. If that percentage is high enough to lower the reproductive number (I'll call this the "effective R0") below 1, then each successive transmission cycle results in fewer and fewer cases until there are no more cases.
Even the very first vaccine, the smallpox vaccine (from whose scientific name, vaccinia, we got the word "vaccine"), did not fully prevent infection. Rather, by infecting people with a relate
Benefit? (Score:4, Interesting)
Re:Benefit? (Score:5, Insightful)
120 million doses a year, 3 doses per person, 40 million vaccinated a year. That's helpful but still a drop in the bucket in a country with more than a billion people. If they can scale up by a factor of 10 or more that would be a lot better.
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Plasmid DNA is super cheap and easy to produce.
You just use bacteria in a broth, then purify.
I'd guess the limitations on production here will be based on adjuvants and packaging/certification.
Blame the West (Score:1, Insightful)
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Pfizer and Moderna are not easy to distribute. I don't think patents are the bottleneck.
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They're not being enforced already. Moderna has gone on record in October [statnews.com] that they won't enforce their patent for the duration of the pandemic. At least as of May it seems that no one had copied it. These RNAs aren't easy to copy from my understanding.
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The WTO gives rights for countries to force compulsory licensing of patented pharmaceuticals for a government set fair rate. The patents aren't the blocker here, as others have said it is more likely the storage requirements preventing wider use of the RNA vaccines in developing countries.
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The WTO gives rights for countries to force compulsory licensing of patented pharmaceuticals for a government set fair rate. The patents aren't the blocker here, as others have said it is more likely the storage requirements preventing wider use of the RNA vaccines in developing countries.
Doesn't that use of force also involve liability waivers? IIRC there was a kerfuffle about some countries that wanted forced licensing, but wanted to be able to sue if there were problems.
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Re:Blame the West (Score:4, Informative)
Sounds logical, if you force licensing then you carry the burden in case there is any problem. That sounds like how everything works.
Certainly how it should work. Here's a nice pdf regarding some of the issues. https://administrativestate.gm... [gmu.edu]
There are issues for the makers, and the users. India even got in on some of this when it started diverting it's vaccines internally, instead of exporting them. That really pissed some other countries off https://www.reuters.com/busine... [reuters.com] https://thewire.in/health/covi... [thewire.in]
Logic does not apply. These other countries insist that Indians die so their people can get the Covid 19 vaccine ( they do not say it in those words, but the effect is exact whatever words they use.
Overall, the very people who develop these vaccines are hated because they don't give them to the poorest countries.
Now I'll probably have triggered a lot of people with that last, but it's simply how things work. Countries are working on as widespread vaccination as they can, but the hatred generated by some is a bit over the top. What is the solution? Not creating vaccines is kind of a bad solution, although that would avoid the rich country/poor country problem. Have the poor countries develop the vaccine? Not enough resources.
Hoomuns are friggin idiots.
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Speculating here, but most likely Oxford University could not carry the high costs of performing the Phase I-III trials and needed someone with manufacturing facilities in the scale of hundreds of millions of doses per year. Then Bill and Melinda comes in with funding and points to AstraZenica as a good partner but that AstraZeneca then requires exclusive rights to the patents.
AFAIK the profit margins of vaccines are so low (since the price have to be low in have enough people consider it for the vaccine to
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It's always more complicated than the simple "evil gates foundation" angle you're buying into. Specifically in this case a very large overriding challenge was that the companies *capable* of producing the vaccine weren't interested in doing it for lack of profit. Hell there's a reason for the 80% reduction in companies producing vaccines over the past 30 years. In addition to actual capability there's also a very real expense of complex clinical trials and certification of facilities that comes into the equ
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But it still surprises me that they would defend it, and do so vehemently. Same for some of the EU leaders.
For the greater good. As it is with the massive power and resources of big pharma we struggled to roll out the vaccine in the west, and the 3rd world has seen f-all to date. Imagine having even less production.
The local corner shop may build you a custom PC, but Dell is only interested in a design it will sell to thousands of people. Same thing applies. We'd be fools to pen the hopes of the species on the altruism of a major pharmaceutical company. This is after all an industry where aside from COVID-19 all
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Re:Benefit? (Score:5, Informative)
so my natural immunity is just as good as any vaccine
The new evidence shows that protective antibodies generated in response to an mRNA vaccine will target a broader range of SARS-CoV-2 variants carrying “single letter” changes in a key portion of their spike protein compared to antibodies acquired from an infection.
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...and other lies you can tell yourself?
Referenced paper does not even attempt to come to any conclusions about real world outcomes.
https://www.ncbi.nlm.nih.gov/p... [nih.gov]
Does anyone know of any? sources of statistical data for unvaxxed re-infection rates leading to severe illness, hospitalization and death?
This is all I've been able to find on the topic.
https://academic.oup.com/cid/a... [oup.com]
Instances of severe disease, hospitalization and death seem to be vanishingly small with most data coming from news reports and tallies.
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You know all the data that has looked at it
What does it mean for data to look at something?
Re: Benefit? (Score:5, Informative)
Re: Benefit? (Score:5, Insightful)
Oh come on dude, making shit up isn't how you win debates. Its not just any old blog, he posted from the NIH.
1) Moderna and Pfizer do not offer any experimental vaccines. Both however have Covid vaccines that are extremely well tested (via some of the largest stage 3 trials in medical history) and proven. Neither are experimental, because we already know that they work and are safe.
2) "All the data"? Lets evaluate that!
https://pubmed.ncbi.nlm.nih.go... [nih.gov] Shows that immunization acquired by vaccines are less likely to be bypassed by mutation. In otherwords, your more likely to get reinfected by delta if you had previous strains but not vaccinated, than if you are vaccinated and never had itt.
So... Kinda looking like your best bet is to get vaccinated and not get the life threatening disease.
Re: Benefit? (Score:4, Informative)
Is COVID-19 herd immunity becoming a myth? | Inside Story [youtu.be]
Scientists have long said 'herd immunity' is needed to control the COVID-19 pandemic.
But some experts now doubt it can be achieved because of the contagious Delta variant.
Infections are rising in countries with high vaccination rates, such as Israel and the U.S.
Herd immunity is far from being achievable in the developing world.
So will governments need new strategies?
"Herd Immunity" was championed at one time. That's why you hear it so much. But mutations have changed that tune.
Re: Benefit? (Score:5, Informative)
The herd immunity threshold is calculated by a somewhat simplistic model called SIR that divides people into three groups: Susceptible, Infected and Recovered. In the SIR model Recovered people cannot incubate and transmit the virus.
This neat little model has serious practical limitations when you talk about SARS-COV-2, which suppresses your initial "innate" immune response. Infected people can walk around for a long time looking like Susceptibles, and Recovered people can incubate enough virus to transmit to other people, especially as their antibody levels wane.
SIR has other limitations; the calculation assumes the basic reproduction rate (R0) is fixed, but in reality it depends on human behavior. If people congregate in unprotected crowds it will go up and along with it the herd immunity threshold; if people are cautious the reproduction rate goes down and the herd immunity threshold is lowered.
Between the biology and politics of COVID, you can't really point to a precise number beyond which the epidemic just disappears. The herd immunity doesn't work that way in any case; if the threshold is 70%, there will be very little noticeable difference between 69.9 and 70.1 percent; at 69.9 the epidemic will grow but very, very slowly; at 70.1 it will shrink but very very slowly.
Even so, the higher the level of immunization and lower the basic reproduction rate, the less impact and pandemic will have on people's lives. If we do a good enough job, it may even go away for practical purposes, although we can't count on it *staying* away. We can certainly reduce serious illness and deaths by orders of magnitude, but we don't have a nice neat number at which all suddenly becomes well.
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Herd immunity for COVID was always speculative. Many corona viruses only create a temporary immunity. This is true even without mutated strains. AFAIK we don't yet know whether COVID *can* create a permanent immunity. It's possible that it will turn out that the vaccines can and the infection can't, because of some magic it works on the immune system, but this also isn't known. The waning of the immune response isn't a hopeful sign, but it's also not proof. In the case of SARS the immune response was
Re: Benefit? (Score:5, Insightful)
https://pubmed.ncbi.nlm.nih.go... [nlm.nih.go] Shows that immunization acquired by vaccines are less likely to be bypassed by mutation. In otherwords, your more likely to get reinfected by delta if you had previous strains but not vaccinated, than if you are vaccinated and never had itt.
So... Kinda looking like your best bet is to get vaccinated and not get the life threatening disease.
Efficacy data and arguments from it appear to be comically worthless for providing information that matters to people. The question people care about is will you get really sick and be hospitalized or die.
The efficacy numbers for the vaccines are all over the place multiple studies put efficacy of Pfizer below 50% .. others 88% ... some say Moderna and Pfizer are similar others show a massive spread.
The J&J vs Pfizer / Moderna was not even in the same ballpark in terms of efficacy pre-delta.. I don't even think they published data on anything less than symptomatic disease during the trials. Have not bothered to check what it is now.
Yet in the end where it really matters in the area of protection from hospitalization and death all of the vaccines appear to have very similar results.
So this leaves a basic question where if we know with a good level of certainty that efficacy is demonstrated to be disconnected from severe health outcomes ... why do people keep insisting upon invoking it as evidence that their perspective is correct?
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https://pubmed.ncbi.nlm.nih.go... [nlm.nih.go] Shows that immunization acquired by vaccines are less likely to be bypassed by mutation.
That's interesting but the abstract has a "however" clause that ... needs more explanation and study...
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That's a bad link. Correct it to go to https://pubmed.ncbi.nlm.nih.go... [nih.gov] . (This looks like Slashdot code truncating the link.)
And you're correct that that "however" clause is a bit confusing and worrying. The experts *ARE* confused and worried. And are continuing to work on the problem.
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the experimental unapproved gene therapy from Moderna and Pfizer.
It quite possibly is better than the "the experimental unapproved gene therapy", whatever that might be, but how does it stack up against the Pfizer and Moderna vaccines?
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There's nothing about evolution that requires life to operate. Viruses respond to evolutionary pressures just like living organisms do. Even programs can be setup to respond to evolutionary pressures https://www.solver.com/genetic... [solver.com] . Or naked RNA molecules https://www.pnas.org/content/6... [pnas.org] .
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...experimental unapproved gene therapy from Moderna and Pfizer.
Say the same people who have always complained that the FDA approval cycle takes too long.
Having made the same complaint myself about the FDA, I would actually argue in the opposite direction: why not regularize "emergency approval" for any compound as a standard initial approval tier for patients willing to accept the risk of being early adopters? The more cautious can if they wish wait a few years more for "full approval."
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You're not going to find any "pseudoscience" in the FDA pipeline. The risk you run at the emergency-approval stage, where toxicity and efficacy have already been tested, is that you might get side effects that appear only with advanced testing.
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Burzynski’s compound did not pass testing, so any claims his clinic still makes about it being in the pipeline are fraud. The FDA has called them out on this with warnings and, more recently, fines.
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Wait what, how is "natural immunity is just as good as any vaccine". Its the same thing. Vaccines work by giving you natural immunity.
And just so you know, you'll get a better natural immunity if you use an mRNA vaccine, because so far the mRNA vaccines are producing the strongest responses. Although the russian adenovirus based one appears to produce excellent responses too, and I'm not quite sure why sputnik gets the 90% efficacy while oxfords adenovirus on
Re:Benefit? (Score:4, Interesting)
I'm not quite sure why sputnik gets the 90% efficacy while oxfords adenovirus one (AstraZenica) is only around the 70% mark.
Pure speculation here, but...
The adenovirus vaccines are essentially presenting two virus to the immune system at once. The adenovirus it's based on, and the coronavirus we want to train the immune system against. The immune system learns to fight both of those viruses.
AstraZenica gives two identical doses. When you get the second dose, your body is reacting to both viruses it sees and attacks from two angles, quickly eliminating the vaccine from your system as it learns to build antibodies.
The Russian vaccine is a different formula for each dose. They use a different adenovirus base for each one. When you get the second dose, your immune system sees the coronavirus spike and reacts quickly, further establishing its defenses against it. It doesn't recognize the adenovirus side, so it takes longer to react to that portion. Your immune system ends up much more focused on the coronavirus portion of it.
Re:Benefit? (Score:4, Funny)
Although the russian adenovirus based one appears to produce excellent responses too, and I'm not quite sure why sputnik gets the 90% efficacy while oxfords adenovirus one (AstraZenica) is only around the 70% mark.
Russian virus is ordered to be 90% effective by Putin.
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I would take CoronaVac instead of an mRNA or DNA based vaccine
The fun thing is that you have other options: both AstraZeneca's 2-dose vaccine and the Johnson&Johnson single-does vaccine are vector-based vaccines (neither mRNA, nor DNA, nor inactivated virus), similar to many other vaccines that have been around for ages.
so my natural immunity is just as good as any vaccine
If you had the virus here in Germany you are only considered to be "immune" for 6 months, after that you are required to get a single vaccine dose (but not 2), because the experts in the field are not confident enough that having had the virus in t
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I've tried to find any sources for this claim from Switzerland but cannot find it. What I did find was this: https://sciencetaskforce.ch/en... [sciencetaskforce.ch] which is from the Swiss covid-19 science task force and they do not agree with your statement:
After natural infection, neutralizing antibodies decay to a protective level of 50% against re-infection with mild to moderate symptoms within 8 months and to 50% protection against severe re-infection within 16 months in individuals below 65 years of age. In individuals >65 years, duration of protection is likely to be shorter: 3-6 months for 50% protection against mild infection and 10-12 months for 50% protection against severe infection.
After mRNA vaccination, individuals below 65 years of age likely maintain >50% protection against mild infection for 16 months or longer and >80% protection against severe infection for more than three years, whereas individuals above 70-75 years of age likely maintain >50% protection against mild infection for 7-10 months and >70% protection against severe infection for 15-24 months.
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The hospitalization and death rate prevention percentage are higher.
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Call it version 1. It still has major advantages in the storage and transport chain and in the amount of disposable equipment per dose, vs. something that'd require 2 billion individually packaged disposable syringes for giving every Indian a jab of the high-tech mRNA vaccine.
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Here's [ajpmonline.org] a simulation which says this is close to what's needed...
> Results: Simulation experiments revealed that to prevent an epidemic (reduce the peak by >99%),
the vaccine efficacy has to be at least 60% when vaccination coverage is 100% (reproduction number=2.53.5)...
> Conclusions: This study found that the vaccine has to have an efficacy of at least 70% to prevent
an epidemic and of at least 80% to largely extinguish an epidemic without any other measures (e.g.,
social distancing).
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That's enough to offer both significant protection and significant reduction in transmission. I'm guessing one of the advantages may be storage, which would be a big thing when you're vaccinating a billion people, some two hundred million are below the poverty line.
mRNA is supposed to be an ephemeral molecule; it is produced when a protein is needed and degrades almost immediately. That's why you need cryogenic storage. DNA is supposed to be stable for decades. Samples of DNA are stable at ambient tempe
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Bullshit story from a bullshit 'expert'.
Why hasn't this doom scenario happen with other diseases that we vaccinate for?
Evolution is gonna evolve, but where is the evidence that being tough on one variant will increase the survival of a more infectious variant?
I mean, that more infectious variant is already more infectious, so why didn't it surface before and become the main stream variant? Are these viruses battling it out for who gets to infect the next person and the more infectious variants loses out all
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Yeah, that guy from the linked video is very wrong about a number of things. He sounds reasonable but he makes (deliberate or not) some bad assumptions about evolutionary pressures.
It's sad to see so-called experts having it so wrong at the basis.
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Well, before the current vaccines were finished, there was hope that they'd be at least 50% effective. We were lucky and they ended up with over 90% effectiveness but the goal was only over 50% which is still a lot better then 0%
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After it's made and tested, if it's better than nothing, and cheaper or more available than more effective alternatives, then it's still worth using. Even if it's not the most effective solution out there. "Better" is not solely a function of effectiveness. It's a function of effectiveness, cost, ease of production, ease of distribution, number of shots needed, peop
Their problem is YOUR problem (Score:2, Interesting)
Only 66%? And what about Typhoid Marys? (Score:1)
66%? Is that a joke?
We already have vaccines with over 90% effectiveness.
And they aren't even preventing "asymptomatic disease", which is code for the Typhoid^WCovid Marys still being possible, aka the disease still being able to freely spread, aka "we made sure we will make a fuckton of money because it doesn't actually stop the pandemic from spreading to unvaccinated people who haven't given us protection money yet, mwahahahahaha!"
Granted, I don't think that is how they actually talkeds, or even that it w
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BTW many of the vaccines we take like Flu vaccine are only about 50% effective. The FDA bar for approving vaccines is 50%. 90% effectiveness is very rare.
BTW India is approving any vaccine with mo
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India does have Covaxin which is 90% effective against the original strain. This 66% is for effectiveness against Delta strain as the tests were done when India was going through Delta. Pfizer and Moderna are only around 50-70% effective against Delta a per various data sets being shared. Delta is a new beast.
For a direct comparison, Covaxin is 65% effective against the delta variant, assuming current dosing (two doses four weeks apart). So this is about as effective as Covaxin. This may be an indication that they need to update it for the new strains, or it may just be an indication that two doses aren't enough.
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RNA (Score:2)
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See my previous comment. It's 66% effective against the delta strain, which is comparable to the effectiveness of Covaxin against the delta strain. AFAIK, only the Moderna vaccine is definitively doing better than that at two doses. Pfizer *might* be, according to some studies, though other studies show it being much less effective.
Plasmids (Score:3)
Would you kindly get vaccinated?
Hypospray?? (Score:4)
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Almost as good as a nasal spray. [youtu.be]
DNA? The wet dream of antivaxxers (Score:2)
We will vaccinate you with a gene-manipulated DNA vaccine, much better than last year's RNA model vaccine, you just have to get 3 doses because the tiny chips to be injected are so many, Bill Gates can't do them smaller yet.
PS. 'Made in India' as additional bonus.
I can already imagine their enthusiasm.
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Manipulate your DNA by a lab in a third-world country. What could go wrong?
Really, how does it work? (Score:2)
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no tree bark.
Aspirin was derived from tree bark. But I agree, alternative medicine is almost entirely a scam. If it turns out to work, it's called "medicine".
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But I agree, alternative medicine is almost entirely a scam. If it turns out to work, it's called "medicine".
I think this (beat poetry) video [youtube.com], an oldy but a goody, is still one of the best 'rants' I've ever seen on the subject. Given the recent debates over 'big pharma' it's also rather topical.
Other than the "Do you know what they call alternative medicine that's been proved to work? Medicine" line, I always laugh at "Water has memory, and whilst its memory of a long lost drop of onion juice seems infinite it somehow forgets all the poo it's had in it."
If you haven't previously seen it, I heartily recommend it. I
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I prefer to say that if water has memory, we should be grateful it doesn't hold a grudge after being used to flush all that shit.
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People watching TV without critical thinking are the dumbest. Could you explain how the immune system works?
At a high level? To the best of my understanding, it's something like this:
First, a virus infects the epithelial cells that line your lungs, nose, etc. When it does, they release signaling proteins called cytokines (e.g. interleukins). In response to this, the immune system begins producing more white blood cells.
Next come the neutrophils, which release antigens intended to destroy the microorganisms, then try to ingest those microorganisms. Later, you get other innate immune cells, such as monocytes, w
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... training the immune system on only the parts of a virus that don't change is inherently more effective...
The spike protein is not an invariant part of covid virus;
The tip of the spike protein is changing quite a bit. The protein as a whole is not, as I understand it.
This is the reason the natural immunity is more effective, in the long run (more than 6 months), in this specific case.
Nope. With the possible exception of severe COVID cases, natural immunity falls off faster than vaccine-derived immunity [jhu.edu] because of the way the second dose boosts your immunity.
Re:Targeting the Spike protein is a mistake! (Score:4, Informative)
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I was thinking of this video when I made my post.
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Re:Alternative Health (Score:4, Funny)
>> No folks, eastern "medicine" won't help you hear.
I disagree, from this study [nih.gov]:
> Results: This review shows that approximately 25 herbal species and 40 active compounds prescribed in TOM [Traditional Oriental Medicine] for hearing loss and tinnitus have shown in vitro or in vivo beneficial effects for acquired sensorineural hearing loss produced by noise, aging, ototoxic drugs or diabetes. The inner ear is highly vulnerable to ischemia and oxidative damage, where several TOM agents have revealed a direct effect on the auditory system by normalizing the blood supply to the cochlea and increasing the antioxidant defense in sensory hair cells. These strategies have shown a positive impact on maintaining the inner ear potential, sustaining the production of endolymph, reducing the accumulation of toxic and inflammatory substances, preventing sensory cell death and preserving sensory transmission...
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You are both right and wrong.
The most drugs you can get prescribed, are merely some compound found in something in nature. My blood pressure medication, for example, in literally (based on) snake poison.
To plants (and animals) *definitely* can and do have verified effects and are medicine.
BUT: The drugs you actually buy, have been 1. highly purified, and 2. modified a bit.
Because the first problem is, that the amount of a compound in a plant can vary *a lot*. That's fine, if you can just take more, and slow