Pfizer, BioNTech Vaccine Gets Full Approval From US Regulators (bloomberg.com) 407
The Covid-19 vaccine made by Pfizer and BioNTech was granted a full approval by U.S. regulators, a move that is expected to help bolster the immunization drive amid a surge in infections caused by the delta variant. From a report:
The Food and Drug Administration said in a statement on Monday that it had cleared the vaccine for the prevention of Covid-19 in individuals 16 years of age and older. It will be marketed under the name Comirnaty. The vaccine continues to be available to people age 12 to 15 under an emergency-use authorization, the agency said. The approval is expected to boost confidence in the shot and is likely to open the door to more vaccine mandates among employers and businesses. It is also likely to solidify its future as a blockbuster for its makers.
Well, finally (Score:5, Funny)
Finally all those who claimed they won't vaccinate until FDA gives it the full approval will be joining in to get vaccinated, right?
Re:Well, finally (Score:5, Insightful)
Expect the goalposts to be moved shortly. There will always be some excuse.
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Missouri or one of those other backwards states already did something similar saying the vaccine had to be approved for two years. Politicians that don't know an iPhone from a calculator are legislating medical advice now.
Re:Well, finally (Score:4, Insightful)
Politicians that don't know an iPhone from a calculator are legislating medical advice now.
The same can be said for most of what they legislate. Politicians that don't know the difference between an AR15 and a SuperSoaker are legislating for or against gun laws. There are some for and others against minimum wage laws, even though none will likely never have to worry about money for the rest of their lives. And internet and copyright laws...
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What is the difference?
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Translation into US terms: the Taliban is a political party, like the Republican Party; al Qaeda is a terrorist organization that the Taliban sheltered while in power, like the Proud Boys; ISIS are religious fundamentalist revolutionaries, like those nut jobs you see on TV who have lots of guns and think they're going to overthrow the government.
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https://www.businessinsider.co... [businessinsider.com]
Re:Well, finally (Score:4, Insightful)
It was Trump who negotiated a complete surrender with the Taliban. Nothing anyone could do about it after that. Tho the whole retreat with tail between legs should have been much better organized. It's not like America hasn't had plenty of practice over the years.
Considering that most things Trump has done, Biden has undone (pipeline, paris accord, possibly Iran deal), why was this different?
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We were still there and Biden had 7 months to do what you just wrote.
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From someone who "wrote" The Art of the Deal, he's never made good one...except to convince people to buy the book. Hell, even the real author pissed all over that book.
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Gonna need the citation for "has killed thousands". Because the number actually killed is zero. [cdc.gov]
Reports of adverse events to VAERS following vaccination, including deaths, do not necessarily mean that a vaccine caused a health problem. A review of available clinical information, including death certificates, autopsy, and medical records, has not established a causal link to COVID-19 vaccines.
Deaths after vaccination must be reported to VERS, no matter the cause. Get the vaccine, and then die when you get hit by a bus, and your death is reported to VERS.
They are investigating two deaths where someone died of TTS after the shot, but they're not sure yet that the TTS was caused by the shot.
2 deaths vs ~800,000 deaths is not a difficult decision. And if you think it is, you're not getting paid enough
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Ok, let's do that.
It's still 2 (maybe, not determined yet) vs about 800,000.
which included things like bullets and motorcycles
Nope, it didn't. But lying about that is helpful when you're trying to sell bullshit.
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It's called cost-benefit analysis. Thousands die from the vaccine, hundred of millions don't die from the virus
Where did you get that number from? Are you honestly thinking that we are going to increase the death rate by 1000% even with all the progress made if the FDA doesn't stamp their approval on this vaccine?
https://www.worldometers.info/... [worldometers.info]
Re:No one dies from the vaccine (Score:4, Interesting)
The Astrazenica vaccine had at least a couple of deaths associated with it, actually. The risk factors are evidently very low, however, and people who are concerned they may be at risk can consult their doctor, because once the risk was discovered, procedures were quickly devised that can determine ahead of time if one has a chance of being susceptible.
Something to do with blood clots, from what I recall. Apparently the chance of it happening is far lower than the chance of dying if you get COVID19, so it's still a net statistical win for the vaccine. Nevertheless, if one is concerned, they should consult with their doctor.
There have been no deaths linked to either the Pfizer or Moderna vaccines, as far as I am aware, however.
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The Astrazenica vaccine had at least a couple of deaths associated with it, actually. [...] There have been no deaths linked to either the Pfizer or Moderna vaccines, as far as I am aware, however.
My guess is that rsilvergun was only referring to the vaccines available in the US, and was unaware of complications for the 21 vaccinations approved throughout the world or the 92 other vaccinations in some level of trials worldwide.
Re: No one dies from the vaccine (Score:2)
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You can find a list of people who have died after being vaccinated. In ever case when investigated there has been another cause.
Mainstream news is packed full of stories of "breakthrough infections" and "waning immunity" and other things that when reported without context are bullshit. Its no wonder there are people who won't take the vaccine. Media needs to tone the hype and clickbaiting and exercise some moral responsibility.
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It's the logic of this quarter's numbers. Corporate America no longer does 5 year plans. They don't even do 5 month plans. All that matters is the quarterly report and today's stock price, to hell with tomorrow.
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To what benefit does killing off your viewer/listeners serve?
First, you start with the assumption that "it's just the flu", and you're not going to actually kill many of your viewers/listeners.
Then, you want to deny the Democrats a "win" by having the pandemic end quickly while they are in power, with the associated economic boom while they are in power.
Then you also want to reinforce the anti-government rhetoric you've been using to rile up the rubes for decades. Because the only reason people will tolerate watching your low-production-value pile of bullshit that c
Re:Well, finally (Score:5, Informative)
Expect the goalposts to be moved shortly. There will always be some excuse.
Of course.
People saying they won't get the Covid-19 vaccine because it wasn't fully approved by the FDA was a B.S. excuse when people throughout Texas, Florida, Louisiana, etc [npr.org] had no problem getting the Regeneron monoclonal antibodies even though it only had an emergency use authorization from the FDA [fda.gov] just like the vaccine.
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Maybe conditioned by the anti-GMO crowd to believe anything, gene, is bad.
Not exactly (Score:2)
They're confused. There's too much misinformation and they're not equipped to parse it. So like a deer caught in the headlights they freeze.
This'll be enough to get a lot of them unfrozen.
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They're confused. There's too much misinformation and they're not equipped to parse it. So like a deer caught in the headlights they freeze.
Agreed. There's should have been a much more cohesive response from every institution in a leadership role. Also there's another phenomenon that makes it harder. No one wants to be perceived as wrong.
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This is very true. There is another word for that phenomenon -- it is called "pride". As in, too proud to admit being wrong or needing help. IMHO it is actually a mental illness -- the proud cannot learn, nor can the easily tell the truth. It is essentially ball-less. It is also addictive.
Humility and faith are the opposite -- it takes a great deal of courage and strength to be honest with oneself and everyone el
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As it became a sure thing that the vaccine would be approved it magically changed from an issue of safety to an issue of freedom. There is a group that does not want to rid the US of Covid and they are spending a lot of money to spread FUD.
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As it became a sure thing that the vaccine would be approved it magically changed from an issue of safety to an issue of freedom. There is a group that does not want to rid the US of Covid and they are spending a lot of money to spread FUD.
There is a group that doesn't want to rid anyplace of covid ... but it's those who "never let a crisis go to waste".
(obDisclaimer: I"m vaccinated, I mask, blah blah)
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The "my body my choice" argument is the most hypocritical of them all. So you're fine with a woman's right to have an abortion? Oh no we really don't mean that...
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A woman who gets an abortion can't spread abortion to other people.
A fucking moron who doesn't get the COVID vaccine can spread COVID to many more people.
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Let me know when abortions are contagious.
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Extinguishing covid was never on the table. Your faith in the vaccines is a touch misguided.
It is incorrect to say extinguishing Covid-19 was never on the table. But experts have been saying for quite some time they expect Covid-19 to become endemic and not completely eradicated. It is still something that is on the table, but it isn't something experts find realistic. It certainly isn't the primary driver of vaccinations.
Re:Well, finally (Score:4, Insightful)
Better doesn't mean perfect.
So out of the Hospitalized patients for Covid with the Delta Mutation about 10-20% have been fully vaccinated. So if caching a serious case requiring hospitalization Covid unvaccinated is 1 out of a hundred chance, you have now been moved to 1-2 out of a thousand chance.
Health Experts while they would love the idea of getting rid the virus. Their main hope is to limit it, to rates under what we have for the Flu. So people are going be getting Covid for years or decades to come. However, if they are vaccinated, it won't spread rapidly across the country, also the Vaccine has shown the issues of the vaccinated people to be much less. So it can be managed.
Putting on your seat belt, and having a car with air bags, will not reduce your chances dying in a car accident to 0. Eating healthy foods and getting exercise will not make you immune from getting Cancer, or a Heart Attack.
Shit happens, however if you take steps to reduce it from happening, it will happen less. Vs if you are the guy who just figures well I am going to have bad things happen and don't do anything about it, tend to get bad things much more common.
Re:Well, finally (Score:5, Funny)
Sure, the vaccine is approved, but the tracking chip is still on an emergency use authorization. /s
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Re: Well, finally (Score:2)
Mine bsod'ed and now the gubmint thinks I'm on null island. I want my money back.
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Does this mean that the government has taken away their immunity from lawsuits, such as those from unknown side-affects and long-term affects? If the problem is that they aren't legally liable for long-term side-affects or health issues caused by the vaccine, then approval isn't all that meaningful here. If Pfizer is now liable, then I agree, no more excuse if they were claiming themselves as "test subjects".
I cannot find any mention of the government removing their immunity and the article does not mention
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Why would it be different than other vaccines? If you are injured by a vaccine (and can prove it) you file a claim with the government.
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Huh? It's different because the government has given them immunity from liability over side-affects and long-term affects. Did you not know this???
You can file a government claim, but the vaccine companies are not liable. The government has set up limited funds, and beyond that you're screwed. Ask those who suffered a stroke how much having their droopy face and permanent brain damage is valued by the government? That is, if their claim ever gets approved. Hardly anything.
To give a perspective on likeliness
Comment removed (Score:5, Informative)
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The vaccine makers might have immunity, but we need to prepare a lawsuit against those bats who created this covid mess in the first place.
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The government assumed liability for all vaccines in the 1980s. If you are actually injured by a vaccine, you get paid by the government. The COVID vaccines are no different.
But lying about this sure does sound truthy!
Re:Well, finally (Score:5, Funny)
I don't want to be a guinea pig. I will only take the vaccine after hundreds of millions of people got it before me. Oh wait...
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Does this mean that we'll soon be seeing drug commercials for this on TV? I can't wait to see the commercials with old people driving away into the sunset with their convertible with the voice-over:
"Ask your doctor if Comirnaty is right for YOU!"
Nothing Will Change (Score:4, Insightful)
They'll just find another reason to not get vaccinated.
They know "the REAL truth" and nothing will convince them otherwise.
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It's too late. Covid-19 in a self-defense maneuver is making the infected stupid [youtu.be] and unable to fight back.
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They'll just find another reason to not get vaccinated.
They know "the REAL truth" and nothing will convince them otherwise.
Hey, those goalposts ain't going to move themselves!
I disagree (Score:5, Insightful)
Well, there's anti-vax and there's vaccine hesitant. The anti-vax are constantly trying to convince the hesitant to become anti-vax, and losing this talking point will hurt them.
A lot of the vaccine hesitant are that way because of confusion. They hear things like "emergency approval" and thing "I'm healthy, I don't need emergency medicine". If you follow the news and read about sick & dying people who didn't get vaxxed that's what they site as a reason over and over again.
Point being, the anti-vaxx don't have to convince you vaccines are *bad*, they just have to put a seed of doubt in your mind. FDA approval makes that much harder.
Studies show the #1 thing that convinces the vaccine hesitant is talking to their doctors, but since America lacks single payer healthcare lots of people don't have doctors. It's why countries like the UK & Canada are gradually pulling ahead of us in vaccinations as supplies stop being an issue there.
If you can't get to a doctor to have your worries taken care of FDA approval is the next best thing.
Re: I disagree (Score:2)
Yeah everything is an excuse for socialism and more government programs.
Does anyone stop to think that maybe we should focus on making our existing government programs more effective at their job.
Selling the vaccine is one great example of the whole-of-government stepping on the rake at the same time. I don't know how many times I've seen Francis Collins or Anthony Fauci or Rochelle Wollensky or Vivek Murthy or Jerome Adams or any of these people go on a nominally-serious news program like NPR or PBS or any
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Studies show the #1 thing that convinces the vaccine hesitant is talking to their doctors, but since America lacks single payer healthcare lots of people don't have doctors. It's why countries like the UK & Canada are gradually pulling ahead of us in vaccinations as supplies stop being an issue there.
People in Canada definitely do not talk to their doctor about COVID-19 vaccine. Unless they had an appointment for something else. We just don't call our doctor to discuss stuff like that. It's hard enough to get access to our doctor when we need it. And what do you expect the doctor to say anyways? They just know the same thing as we all do: the vaccine is recommended, benefits outweighs the risks.
Canada is ahead in vaccination because Canada doesn't have the republican party. But the part of the country m
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Studies show the #1 thing that convinces the vaccine hesitant is talking to their doctors, but since America lacks single payer healthcare lots of people don't have doctors. It's why countries like the UK & Canada are gradually pulling ahead of us in vaccinations as supplies stop being an issue there.
People in Canada definitely do not talk to their doctor about COVID-19 vaccine. Unless they had an appointment for something else. We just don't call our doctor to discuss stuff like that. It's hard enough to get access to our doctor when we need it. And what do you expect the doctor to say anyways? They just know the same thing as we all do: the vaccine is recommended, benefits outweighs the risks.
Canada is ahead in vaccination because Canada doesn't have the republican party. But the part of the country most aligned with it (Alberta) also have the lowest vaccination rate.
There is also a lot more people in the USA who think climate change is a hoax/not happening/not caused by human activity. I think it's the same anti-science rationale which is fueling vaccine hesitancy.
I'm not going to say one party or the other is stupider. If you were to ask a room full of Democrats "How do you know the Earth is round" you'll get some dumb looks, and at least one smelly idiot that hasn't discovered deodorant might offer his horribly uninformed opinion on the matter while everyone else looks on dumbfounded. One or two people will try to give a reasonably intelligent answer, but totally inappropriate for the level of intelligence that would ask the question, like using orbital mechanics
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Such as still not being able to sue for long-term health side-affects or any other unknown health issue that results from the vaccine. If the government hasn't revoked their immunity then I suppose this approval doesn't really bring anything new to the table, right?
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In the United States all vaccines added to an NIH recommended list are covered by a government-sponsored insurance pool. You cannot sue the maker of your latest dTAP booster directly either.
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The government assumed liability for all vaccines in the 1980s. If you are actually injured by a vaccine, the government pays. COVID vaccines are no different.
Does lying about this on Slashdot actually pay well?
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The hypothetical "long term health side effects" is a red herring. Nothing more.
The "but I can't sue" is equally BS. Did you know it's rather difficult to sue anyone when you're dead?
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Believe it or not, the entire world is not "smart in-group" versus "lol, so dumb out-group." The reasons people are in the unvaccinated camp are myriad and potentially quite complex. In areas where there have been covid surges, vaccination rates have also spiked, meaning people are doing their own risk assessments. Lowering the perceived risk of vaccines approaches that from the other end. Will this convince everyone? No. But the fact 100% vaccination is unreachable doesn't mean you should forego trying
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When 1,995,000 out of 2,000,000 medical professionals in the US strongly recommended getting one of the COVID19 vaccines I'm not sure what research and risk analysis an individual citizen is supposed to be able to do that outweighs that advice.
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Re:Nothing Will Change (Score:4, Insightful)
The real truth is this is a dangerous, deadly vaccine that doesn't even work.
The vaccine is so ineffective and dangerous that they'd rather take the ineffective [slashdot.org] and unsafe [sunherald.com] Ivermectin instead
Demand for it [fox19.com] is so high that farm supply stores can't even keep it in stock.
Re: Nothing Will Change (Score:4, Interesting)
That is what your opinion becomes when you go by the fake experts or out-of-context statements used on Fox or talk radio. I mean, for example Alex Jones keeps saying Dr. Francis Boyle said X about vaccines, Dr. Francis Boyle said Y about the effects of mRNA, etc. except I am sure he is aware that the so called Dr. Francis Boyle has no science degree (political science is not a natural science). His PhD is in LAW !! .. He has zero science qualifications yet Alex Jones keeps referring to him as doctor to make you think the guy has an MD. That is just one example of how people like you are misled.
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The real truth is this is a dangerous, deadly vaccine that doesn't even work.
Righ now I’m at a conference, the second of four big trips that I can take this year because I’m vaccinated. Meanwhile, you’re cowering under the bed running out the clock on your worthless little life.
Re:Nothing Will Change (Score:4, Informative)
Re:Nothing Will Change (Score:4, Informative)
Yes he’s fully vaccinated and showing no symptoms thanks to the vaccine. It’s working just as intended.
The FAA can now mandate... (Score:5, Insightful)
...vaccine requirements for flights.
Re: The FAA can now mandate... (Score:2)
Ah...but can they only mandate Pfizer vaccines for flights?
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They can mandate that you are vaccinated, since there is an FDA approved vaccine. FDA approval doesn't imply that the other vaccines do not work.
Time to call my vaccine hesitant buddies (Score:4, Insightful)
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What about the FCC (Score:3)
I refuse to use a non-FCC approved 5G device.
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T-Mobile should run a promo offering improved cell service to everyone who gets their shots.
They can make it a minor change to data caps or something so it's legal and real, but i'd love to see people lose their minds over it.
Goal posts (Score:2)
"Some people" will just move the goal posts.
They wouldn't get a vaccine because "it's not an approved drug" or simply "it's experimental". Never mind the nearly 100 million people vaccinated with it. "They" know better!
Now that it's approved they've moved on to "we don't fully know the long term effects" without any actual amount of time in mind (much less an understanding of pretty much anything related to drug testing)
Then there's the "but it will/might make women infertile" nonsense floating around tha
Ok... riddle me this.... (Score:2)
Is it not still the case that the reason these vaccines could only receive "emergency approval" in the first place was because they weren't in use long enough to do long-term research on possible side effects?
Regardless of your opinion on the vaccine, it seems to me that either the FDA mandates a new drug is "experimental" until the clinical trials are completed, or we just throw the whole idea out and start approving anything as soon as we see some positive benefits?
Clinical trials typically take 6-10 year
Re:Ok... riddle me this.... (Score:4, Informative)
Is it not still the case that the reason these vaccines could only receive "emergency approval" in the first place was because they weren't in use long enough to do long-term research on possible side effects?
It was never the case. Emergency approval versus normal approval is mostly about paperwork. There is more when doing a normal approval.
There has been no vaccine in the history of vaccines where a side effect appeared long after the shot. Side effects, including long-lasting side effects, have always appeared within a month of receiving the shot. This happens because vaccines are out of your system within a week. Most are gone within 2 days.
As a result, it's not typical to delay normal approval for vaccines until patients can be followed for years. 1 year or less is most common. The time it takes to receive full approval is about getting the paperwork in order and reviewed, not actually studying patients.
Approved means "off label" use is possible (Score:2)
Once a drug is approved by the FDA, physicians may prescribe it for uses not listed by the agency (just like h*dr*x*q**n*l*ne was prescribed for COVID).
I don't think docs are likely to use it for things other than COVID, but there could be shortages if
a) Healthy people (non-immune-compromised) demand boosters
b) Doctors administer it to people under age 12 (there's Emergency Use Authorization for 12-15, the new approval is only 16+)
(I'm in favor of (b) so my grandkids can get immunized)
And to those who say i
Slashdot's tone has changed a lot over the years (Score:4, Insightful)
Go ahead and downvote me. I guess based on the numbers... this is your lawn, so I am the one who has to get off? lol
Re:Slashdot's tone has changed a lot over the year (Score:5, Insightful)
Slashdot's tone has changed, but with more of a twist compared to the way you're describing it. What I see now is politics injected into pretty much EVERY topic, with a mostly left-leaning / progressive bent, and typically by the same dozen to twenty or so incredibly active users. It's driven a lot of the more old-school libertarian (small L) leaning users off the site, or at least caused them to visit and post a lot less frequently. This is tracking nicely with the rest of the Internet BTW, and even political polls. But Slashdot was never really a domain of the far right given its focus on technology and anti-religion (or at least agnostic) stance anyway.
Having said that . . . after having watched millions get their shots before me and generally not get COVID or at least not get very sick, versus watching a whole bunch of dummies willfully not get the shot and then have to go on ventilators and / or suffer a stupid and pretty terrible death -- by all means, you can call me a "big pharma bootlicker" and "cheerleader for fascist government," but I'm confident I'm personally a lot safer with the shot than without it, and so is my family. That's all I really care about, though it is getting pretty irritating that we'll have to continue to get booster shots for the foreseeable future because a bunch of people have decided they're smarter than the actual scientists -- using junk info found on social media, no less.
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"trump's own supporters booed him when he said to get vaccinated"
They're now conditioned to do that at the mere utterance of words derived from "vaccine."
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Well why would you need a vaccine if the whole thing is a hoax by the democrats?
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Nothing gives me a bigger laugh than seeing nurses anti vaxxing themselves out of a job.
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Unfortunately that means burnout [youtu.be] for the remainder.
Re: Get ready. (Score:2)
All the more reason to not discount the importance of maintaining trust and social cohesion peacetime so that they're there during an emergency when you need it.
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Nothing gives me a bigger laugh than seeing nurses anti vaxxing themselves out of a job.
I don't know about a laugh, but *educated* medical professionals (excluding those who change bedpans that are still in the medical field) should truly know better. If they really think vaccines are harmful they are likely spouting tons of other nonsense in the course of their jobs as well. They should go and, labor shortages aside, the medical field will be better off without them.
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Re:I wish people would just let this go... (Score:4, Insightful)
People are not going to get vaccinated because their alt-right news feeds tell them it is dangerous and it is the act of a true patriot to say no way to the government's vaccine.
Well Slashdot regularly tells it's audience not to trust any institutions. And as noted a lot of vaccine hesitancy is rooted in distrust of institutions. [motherjones.com] So who's left that the public should trust after years of being told you can't trust anyone?
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Does it? I think that is a kind of a vague statement. Slashdot.org doesn't particularly tell anyone anything, they mostly post articles written by other sites. I don't recall those articles being anti-medical establishment.
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Some of us have children under 12, and are actually rather fond of them.
Some of us are aware that immunocompromised people still have trouble with COVID even after vaccination.
Some of us think death is bad.
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Go ahead and cite which part of that post is trusting "the government".
And keep in mind the data we're talking about is not from a single government.
Re:I am sadly amused. (Score:5, Informative)
I'm sadly amused by all the "all anti-vaxxers are killing people" - why?
Even if 100% of people were vaccinated this is not going away PERIOD. Think I'm wrong?
Yes, it will. If R0 artificially drops below 1 because the population is sufficiently vaccinated, the number of cases drops to zero fairly quickly. If it can't infect more people faster than it gets killed off by their immune system, it's done. There are no persistent reservoirs of note. People don't get it from pets easily enough to be relevant, and if everyone around the pet is vaccinated, no one gets it at all.
This is how vaccination works. This is how it has always worked. My mother remembers when polio was a persistent childhood nightmare. There was always a kid in your neighborhood who was going to get it and be crippled for life because of it. Then everyone got vaccinated for it and now it's a distant memory of your grandparents and you have no idea what it was like.
Comprehensive vaccination campaigns for viruses work. It's only things like tetanus, which is a bacteria that can live in soil, that we can never eliminate. Viruses require a host. No hosts, no virus. Stop being a willing host and get your damn shots.
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Israel has only ~60% vaccinated. If you understood R0, you'd know that it's not enough to get heard immunity.
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It's not because it's not going away that we should give up on vaccination.
How do you suggest we reach the hesitant? Vaccine passport is one way. It could be mandatory vaccination as well. I agree that I'd prefer not to show papers, but it's a minor nuisance compared to being stuck with 15-20% of 12 years old+ who refuse the vaccine and enjoy the same rights and privileges as I do.
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Why not just admit that vaccines dramatically reduce the infection rate and therefore means less contamination hence less people dying from Covid? How is that hard to understand?
We don't know whether the vaccine can completely eradicate the disease (but we have a good guess given vaccines have eradicated many, many diseases before), but what's sure is that if people don't get vaccinated, it won't go away, and remain strong, and kill many.
So for the likely reasons of telling people need to get vaccinated,
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Reading through your comments, I'd have to suggest that you find yourself a nice little cabin deep in the woods.
Move there, stay off the grid, and enjoy your freedom.
Bring plenty of ammunition, and shoot at anything that comes near you.
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Well, I go to google and type in "covid natural immunity vs vaccine study"
And the first hit is: New CDC Study: Vaccination Offers Higher Protection than Previous COVID-19 Infection [cdc.gov]
Boy...that was hard to find.