https://news.ycombinator.com/item?id=28275509&p=2
https://news.ycombinator.com/item?id=28275509&p=3
(Comments like this will eventually go away. Sorry for the annoyance.)
Basically it is manufacturing, funding and red tape being the difference, nothing about safety or clinical trials differs.
In software terms, EUA is parallel tracked sprints for clinical trials and manufacturing at same time vs. regular approval is Waterfall where manufacturing occurs after approval.
[0] https://healthtalk.unchealthcare.org/whats-the-difference-be...
> The EUA process is different than an FDA approval or clearance. Under an EUA, in an emergency, the FDA makes a product available to the public based on the best available evidence, without waiting for all the evidence that would be needed for FDA approval or clearance.
I don't post this to spread doubt about the EUA and am fully confident in the safety and efficacy of these vaccines. But as written, this website would seem to suggest that the only difference is when production happens - which is not accurate.
[0] https://www.fda.gov/consumers/consumer-updates/understanding...
I think the major talking point is covered by this info, which is meant for the general public. I'll make an assumption that the general public is also less educated on average than the users on HN on average. A flowchart that would satisfy a bunch of nerdy engineers (us HN users) with all possible paths would confuse the heck out of everyone else.
https://www.cnbc.com/2020/12/16/covid-vaccine-side-effects-c...
Claims can only go by "vaccine court" (yes that's a thing according to Wikipedia)...
https://en.wikipedia.org/wiki/National_Vaccine_Injury_Compen...
> "NCLA is pleased that GMU granted Professor Zywicki’s medical exemption, which we believe it only did because he filed this lawsuit. According to GMU, with the medical exemption, Prof. Zywicki may continue serving the GMU community, as he has for more than two decades, without receiving a medically unnecessary vaccine and without undue burden. Nevertheless, NCLA remains dismayed by GMU’s refusal—along with many other public and private universities and other employers—to recognize that the science establishes beyond any doubt that natural immunity is as robust or more so than vaccine immunity.”
https://www.federalregister.gov/documents/2020/03/17/2020-05...
The Secretary must also state that liability protections available under the PREP Act are in effect with respect to the Recommended Activities. These liability protections provide that, “[s]ubject to other provisions of [the PREP Act], a covered person shall be immune from suit and liability under federal and state law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or use by an individual of a covered countermeasure if a Declaration has been issued with respect to such countermeasure.”
...
The PREP Act states that a “Covered Countermeasure” must be a “qualified pandemic or epidemic product,” or a “security countermeasure,” as described immediately below; or a drug, biological product or device authorized for emergency use in accordance with Sections 564, 564A, or 564B of the FD&C Act.
Edit: also why is there such a large lag between EUA and full FDA approval? That flow chart seems misleading.
The EUA rules for each category is different in how they differ from the categories baseline. For vaccines the gulf between EUA and full process was relatively small - the clinical dataset was basically equivalent.
I found this article to be a better summary of the differences between EUA and BLA (https://blog.petrieflom.law.harvard.edu/2021/06/15/whats-the...). I think you are right - the diagram from the OP is somewhat misleading.
There is absolutely nothing stopping a company from manufacturing whatever they want before they get a BLA - they just can't market it.
In real terms, it looks like the two big time savers was reducing long-term effects follow up from 6 months to 2 months, and well as probably an abbreviated review of manufacturing processes.
That's plausible. Thanks!
Said another way, what was the extra steps that needed to happen between EUA & full approval?
Current Covid vaccines are non-sterilizing. They do not provide immunity that is equivalent to the MMR vaccine.
A future (nasal) Covid vaccine may offer long-term mucosal and blood/serum immunity.
https://twitter.com/ksorbs/status/1417538663018344448
Remember to get vaccinated or a vaccinated person might get sick from the virus that they were vaccinated against because you’re not vaccinated.
I'm really interested a rebuttal to this.
The statement is true. If you're not vaccinated, and you get COVID, there's a non-zero chance that you'll be the source of someone else's breakthrough case.
This statement is also true: If you're vaccinated, and you get COVID, there's a non-zero chance that you'll be the source of someone else's breakthrough case.
So, the quote is kind of useless. The unvaccinated probably do spread COVID faster and with more frequency. So, the directionality of the quote is fine. But it reads like a boolean statement, which is incorrect. COVID is almost certainly endemic at this point. Vaccines clearly help, but it's incorrect to blame all of the mutations and spread on the unvaccinated.
I'm pro vaccine, but even if everyone in the US got vaccinated in the next month we would still have to worry about vaccine-resistant variants coming in via other places.
Additionally, some people can't get vaccinated, or vaccines only work more weakly for them.
Also also, pandemics have knock on effects beyond just the people who get sick, in terms of economic impact, as well as societal rules and restrictions, e.g. schools closing down because of too many sick people, medical procedures getting delayed because the ICU is overwhelmed, etc.
No person is an island; even someone who hypothetically somehow had magical superimmunity from the start of the pandemic would still be facing its effects.
The goal is to reduce the load on the healthcare system. Expanding ICU capacity to always support COVID peak would be expensive, both from the infrastructure and staffing perspectives.
Since the Delta variant is making kids sick, and we don't have a vaccine for kids who are 12 and under yet, we're going to see more kids end up in the ICU.
Also, the Delta variant is 2-3x as transmissible as the COVID strains we've seen before.
The claims that vaccines put evolutionary pressure on the virus to create more virulent strains don't seem that credible when you consider India is seeing new strains develop with a 6% vaccination rate.
A rebuttal would be that we should get vaccinated so we don't die while taking up scarce resources for no real reason.
Covid has an animal host vector. Unless we start vaccinating deer, it's here to stay regardless.
https://en.wikipedia.org/wiki/National_Childhood_Vaccine_Inj...
https://www.govinfo.gov/content/pkg/FR-2020-03-17/pdf/2020-0...
Without this, all we really have to go on is the public information that was release a year ago.
That means that it may be prescribed to individuals <18 in some circumstances, and that it's legal to do so (explicit emergency authorization notwithstanding).
They would say “it’s not FDA approved!” not as the core of their hesitancy, but because they were trying to be appeal to pro-vax peoples decision making framework.
I don’t think we should be able to require them to.
To many of you here: imagine the Trump admin trying to require you to take the vaccine in November of last year. Cities would have burned over it.
And honestly: I was one of the first to take it, but the desire to almost force me to take a booster, and the weird, Orwellian ways that the government talks about it, has turned me against the booster.
It ends up feeling less like the decisions are guided by science and more like they’re guided by petty tyrants wanting to control what others do.
Anybody who has ever lived under an HOA will recognize this.
Public schools, colleges, and the military have been requiring vaccines for decades.
>It ends up feeling less like the decisions are guided by science and more like they’re guided by petty tyrants wanting to control what others do.
This sounds like a result of reading about what health care and government officials are saying instead of actually reading what they are saying.
"The voluntary phase is over" - Bill de Blasio
https://www.forbes.com/sites/jackkelly/2021/08/03/new-york-c...
NBC News: https://www.youtube.com/watch?v=sBMCXkjaMxQ&t=778s
I'm under the impression that the vast majority of mandates have exceptions for existing immunity, no?
My HOA telling me to take Christmas decorations down in January doesn't really equate to the government trying to keep me and my community alive and out of the hospital. Don't like the HOA covenants? Move. Don't want the vaccine? Stay away from places that will now be allowed to require vaccination.
We have made up a huge number of arbitrary rules, some at a very broad scale (for instance, that you must shoes and shirts to go into most businesses), others idiosyncratic and basically between one person and another (no cats in this apartment). They all restrict our choices and our freedom and our actions.
We have also set specific limits on what sort of rules we can make up. You can say "no cats" in an apartment, fine, but you can't say "no pregnant women". You can fire someone for showing up at work one day with a face tattoo but not for changing their religion.
"Not wanting to get a vaccine" or "not wanting to wear a face mask" is not currently a recognized protected class (although not being able to because of a medical condition probably is, but hey, of the many many things I am not, I am not a lawyer). There's nothing saying it couldn't be -- we didn't used to have a concept of "protected class", we just had to make it up at some point -- but that's one way to frame this discussion.
The power to exclude is the power to coerce.
Society is coercing people into taking the vaccine by requiring it for any activities outside the home. Want to go to the grocery store? Get a vaccine or wear a mask. Want to go to Disneyland? Get a vaccine or wear a mask. Want to attend a conference? Get a vaccine or take a test and wear a mask. The mask and testing mandates are an effort to wear down anti-vaccine people instead of letting them be.
Compare: "You can murder someone, but then freedoms will be taken from you, because you could hurt someone with these freedoms. You won't get brainwashed out of it, but if you do commit murder, your freedoms are taken away."
Not arguing against the policy, but it in practice, it _is_ the same.
It's not your personal choice when it can harm other people (e.g. immunocompromised people who can't get the vaccine themselves, other people who need ICU beds).
You don't get to dictate the health choices of others. And if we're going down that road (which you seem to embrace) a vaccine against a disease with such a low death rate hardly seems a logical place to start. But that's presuming logic is the starting point, a conclusion lacking evidence.
Putting lives of other people at risk is not your "health choice".
Preventing obesity is *very* hard, or we wouldn't have obese people. Who actually WANTS to be obese?
Preventing your ICU trip due to covid is as easy as driving to the pharmacy once or twice and spending 20minutes there.
It's easier than grocery shopping.
Also: I did take the vaccine.
I don't like "Imagine x doing y" arguments because it makes us insert our own biases on a hypothetical scenario that isn't the current reality.
Is that happening? I cannot find any federal law of any kind (let alone stemming from the oval office) requiring individuals to get the vaccine.
It's very political. There's a bunch of screenshots and videos floating around of left-wing people who didn't trust the vaccine because they perceived it as coming from the Trump administration when it was in place. Now that we've swapped presidents, the side of that have flipped - now a bunch of right-wing people don't trust it because they don't trust the Biden administration.
Oddly, it doesn't seem to bother anyone in either of these camps that it was both developed and pushed through initial testing under the Trump administration, and ramped up to full production and usage and edging towards mandates under the Biden administration.
You can probably find exceptions, but the widely spread examples I am aware of all then went on to talk about believing it when it came from the CDC and other authorities.
I would argue that there has been little flipping. Those who were not going to get the vaccine under President Trump are also not going to get it under President Biden. The recent "boo"ing of former President Trump at his recent rally when he recommended people get vaccines is just the latest evidence of that.
You desperately need to take a step back and look at yourself and how you evaluate things.
You decided to go against the booster because of your feelings, not because of science. You want government decisions to be guided by science, and yet you are very clearly anti-science with your decision making.
> To many of you here: imagine the Trump admin trying to require you to take the vaccine in November of last year.
What vaccine? There wasn't a vaccine available until Dec 14th 2020.
Are you trying to say if Trump actually cut corners and made the vaccine available earlier than we should have, then people would be mad? Well... duh. The difference is that the left generally follows what the leaders in the scientific community have to say, not the POTUS. The scientific community would have been against cutting corners.
For the unaware, there are multitudes of highly acclaimed scientists and academics around the world from top institutions including Nobel prize winners that are advising caution against the vaccine. You don't just get to choose which "science" you listen to. These voices are massively censored so the public doesn't really get to hear both sides of the argument. The whole "don't talk bad about the vaccine lest `vaccine hesitancy`" is evil and plain anti-science.
From a cursory search ~25% of Americans are a part of one.
https://www.youtube.com/watch?v=-dAjCeMuXR0
The same thing was broadly expressed on twitter at the time too, she was far from alone in that sentiment.
Commentator: If the Trump administration approves a vaccine before or after the election should Americans take it? And would you take it?
Harris: If the public health professionals, if Dr. Fauci, if the Doctors, tell us we should take it, I'll be the first in line to take it, absolutely. But if Donald Trump tells us that we should take it I'm not taking it.
Harris is alluding to the fact that we should listen to people who actually have medical experience and know what they're talking about. You have to remember this was only a few months after Trump had tried to play doctor on TV by saying:
"So I asked Bill a question some of you are thinking of if you're into that world, which I find to be pretty interesting. So, supposing we hit the body with a tremendous, whether its ultraviolet or just very powerful light, and I think you said, that hasn't been checked but you're gonna test it. And then I said, supposing it brought the light inside the body, which you can either do either through the skin or some other way, and I think you said you're gonna test that too, sounds interesting. And I then I see the disinfectant, where it knocks it out in one minute, and is there a way you can do something like that by injection inside, or almost a cleaning. Because you see it gets in the lungs, and it does a tremendous number on the lungs. So it'd be interesting to check that. So you're going to have to use medical doctors, but it sounds interesting to me, so we'll see. But the whole concept of the light, the way it goes in one minute, that's pretty powerful."
I think this is a reasonable message of caution when talking about someone pushing HCQ and drinking bleach on the daily.
“If the public health professionals, if Dr. Fauci, if the Doctors, tell us we should take it, I'll be the first in line to take it, absolutely. But if Donald Trump tells us that we should take it I'm not taking it.“
Note “But if…”. That programmers aren’t able to parse this if else statement is concerning.
Kamala was saying that if the only person telling her she should get vaccinated was Donald Trump, then no, she would not take it.
The (very clear) implication is that she would prefer that people who actually know what they are talking about (i.e. virologists, doctors, nurses, scientists, the FDA, the CDC, NIH...etc) recommends getting the vaccine, then she would get it enthusiastically.
Is this really too hard to understand or are you really trying to use this extremely flimsy argument to accuse her of hypocrisy?
You have to remember at the time trump was recommending hydroxychloroquine as a preventative and miracle treatment for COVID-19. Sadly some of his followers still believe it (and now are looking at ivermectin as well).
I don't believe that attending public school while unvaccinated is an essential Liberty.
In addition like previous precedents, public schools would not allow the unvaccinated in the future. These things all combined would mean individuals would be having to change their lifestyle since they’re choosing not to participate in a way that’s safe for others.
The problem is New York will fine any businesses not checking vaccine passes and are forcing them to turn away unvaccinated.
Ok - so can the unvaccinated start their own restaurants of only unvaccinated? Can we open up our own hospitals with the nurses that were fired from mandates? Can we setup our own public transportation? Why not?
Is it because of the scare mongering about variants? Well people who took the vaccine are also causing variants, actually their supposedly super-high levels of vaccine antibodies are not stopping breakthroughs that much - so they are putting evolutionary pressure on the virus to mutate and evade those antibodies. It makes no sense to blame the unvaccinated for that. So why take away unvaccinated freedoms to setup their own restaurants, services etc? That's not liberty for a business or anyone really, that's fascism.
Seriously: what's the hold-up? Why is the US still blocking this vaccine?
Other countries are entirely free to approve it for their citizens.
Which is really strange. Unclear why they would do that.
https://www.hindustantimes.com/india-news/why-was-bharat-bio...
Nobody knows when under 12 will get an EUA: they need more data before they can apply. Rumor is they will have the data soon and so the EUA will happen by the end of September. This is just a rumor: it seems likely, but could be wishful thinking.
DTaP-IPV-Hib: Diphtheria, Tetanus, Pertussis (Whooping Cough), Polio, Haemophilus Influenzae type B (Hib)
Pneu-C-13: Pneumococcal
Rota: Rotavirus
People are so strange about this vaccine...
I don't know what to make of it. Is this a rhetorical strategy that really works? A tic of people experiencing cognitive dissonance?
Based on Israel's vaccine data, we would need to see 2/100k 20-29 year olds or 6/100k 30-39 year olds die or experience side affects worse than severe covid for it to make sense to avoid the vaccine.
[1]: though 'include' carries a _lot_ of potential interpretations there :)
Political matter: What is the extent to which we want to allow people to make their own decisions when these decisions have an impact on the well-being of others?
Whatever your answer to the second question is (an exercise which I leave to the reader) is going to have an impact on the degree of inclusion and on the degree of accommodation that should be extended to people who choose not to vaccinate. Respect and love is possible and encouraged in all cases.
As a bonus, for further consideration...
Ethical matter: What is the moral value of an ill-informed decision, and is the moral value of an ill-informed decision sufficient to support the principle of individual autonomy?
Discussion has devolved into two camps largely villainizing each other, so it is an appeal to address the content of their posts opposed to some claim of the 5G/ microchip/ reptilian crowd
The most common presentation is mild anxiety, but in more serious instances, a needle phobic person may pass out or be genuinely convinced they are having a cardiac arrest.
There are alternative delivery methods being tested, such as by Pharmajet.
I suspect that when needle phobia is addressed in a less hostile light, you may find an increase in uptake.
Can we talk about natural immunity and the path forward?
> Please don't post comments saying that HN is turning into Reddit. It's a semi-noob illusion, as old as the hills.
What does that even mean?
Do marketing people just play Flappy Bird all day?
Honestly, one of my life goals is to somehow tap into creating a plausibly excusable place for companies to dump their marketing dollars, I feel like that's one of the secrets to an easy life.
"While many were hopeful that FDA approval would assuage the large amount of vaccine skepticism, it did not seem to change the narrative."
I will continue laughing at their pathetic graves and funerals while being frustrated at their impact on me.
Like... what the hell? Do we not see a problem here?
I think a huge factor will be how many employers, colleges, etc. are now willing and legally able to require vaccination. It’s one thing to say you trust something you read on Facebook more than your doctor and quite another to walk away from a job because of it.
No doubt this will be the case for some. So, you've found a logical flaw in people's stated reasons for not wanting a vaccine. How does that help anything? In these kinds of debates, the actual goals or beliefs of both sides often differ from what they say.
For example, the government being able to tell you what to do, vs. it not.
People end up locking in to trivialities like approval or some study, but they just obscure the real debate. Doing more to get the tradeoffs we are making into the open, and talk plainly about what people are being asked to do, why, and what their rights and options are, is much more valuable IMO than trying to find clever flaws in the reasoning of either side. Flaws are there, and obvious, but generally not central to anyone's core thesis, and almost certainly not going to sway anybody. They just let people score cheap shots against their opponents and pump up their own supporters.
Not that this is a silver bullet that automatically leads to peace and harmony, but it's a step in the right direction.
A lot of things, but just the top two would be enough:
1) Being able to sue. If you can sue J&J for baby powder, should be able to sue Pfizer for vaccines if anything goes wrong.
2) Falsifiability in government actions. Many rights have been taken away (some permanently) by saying "we just need to do this and then it will all be over" like "a few weeks to flatten the curve", "the last lockdown", and "x% vaccinated and we'll be back to normal".
But when they don't work, the people are blamed, more rights are taken and more restrictions imposed. It's never that the actions were wrong.
I expect something like if "70% of people are vaccinated then we expect no more than 5000 cases per day" and if the statement turns out to be false there will be no more vaccine impositions because it clearly will have turned out to be wrong.
If something doesn't work you shouldn't double down.
Sounds like you should take a look at Street Epistemology. It is a modern version of the Socratic method that asks questions similar to that. The goal is not to make your interlocutor change their mind necessarily, but instead to explore the reasons for the beliefs they hold and whether they may be sufficently justified or not.
I hope that this latest change sways some people but I don't think it will be a lot.
For me number one would be: if the CDC starts tracking re-infection rate in the non-vaccinated, and puts that data front and center as key KPIs on all their releases.
The moment you start talking about techniques you've already objectified the person across you to something to be finessed over, and as such less than a full person.
So many of our recent social-media extremized public debates escalate to the point of denying or diminishing the other side's personhood. They are an "obstacle" to overcome for some greater purpose, and thus we "must" manipulate, coerce or the very least impress conclusions down their throats.
The meta-context is that today we are all more psychologically fragile and the breadth of data points we have to reconcile gets wider (in no small part thanks to engagement metrics optimizations). We all turn into fanatics of some sort or other, fueled by this anxiety, including that of self-doubt. At no point we are incentivized to participate in the process of rationality together, we're only incentivized to willfully assert our own conclusions.
I see most of the "resistance" as an acting out as a protest for having been left out of this process, including having been honored in anxieties. Notice I have said nothing about the truth value of conclusions, nor am trying to draw a false equivalency of "all-sides-ism", because the sense of participation, or lack thereof, is orthogonal to the truth of content, but hurts just as much when neglected.
We've forgot how to be a fellowship of people who share similar fates and see each other as such, we've turned into mere proposition debating machines.
I agree, engaging people is a good way to go. I don't know any anti-vaxxers personally, so I have to actively work to remind myself they might not all have the same reasons as the ones I know impersonally (who all happen to be full of misinfo, like Eric Clapton, et al.).
There are no silver bullets that lead to peace and harmony, obviously, but a greater understanding of each other is good for many reasons.
A vaccine that (1) did not use cell lines from aborted fetuses at any point in its discovery, development, testing, or production, and that (2) has been studied for 10 years to determine long-term safety and efficacy like we would do with any other vaccine.
What would it take to change your mind?
In general terms, I would need the society at large to get off the moral high horse and engage in an honest cost/benefit analysis of all covid measures.
Isn't it hypocritical that people accuse the young not taking the vaccine of being selfish, while hoarding the vaccines away from vulnerable people in poorer parts of the world?
This line of thought leads to the sentence immediately following the one you quoted: if there are a large percentage of people who were hesitant due to sincere safety concerns, the mountain of data showing that the vaccines are low-risk will translate into more of them getting vaccinated but if they're motivated by factors which are not affected by scientific data then the primary mechanism for ending the pandemic will be the kinds of requirements which are made possible by full approval. That either gets people vaccinated or removes them from many contexts where they pose risk to everyone else.
Right now there are a lot of concerns raised about vaccine safety on political and social media. Some of those are devout anti-vaccination activists but I believe that they are still a relatively small fraction of the hesitant. When not being vaccinated comes with a direct personal cost we'll see how sincere those beliefs are.
I have a friend in this group. There was no logical reason to not get vaccinated, her parents just kept regurgitating all the blatantly false conspiracy theories they were reading on the internet. The amount of times I heard "I'd get it if Bill Gates weren't involved, he's trying to track us" made my head spin.
Now work is requiring it to stay employed, so she's getting it. I'm both sad that's what it took, and happy that it was enough to overcome irrational fear mongering on the world wide web.
This. One hundred times, this. I realize in many regards they already tell us what to do, and that does not make the next time more palatable.
Is government regulatory authority really the "real debate"? That too seems like an projected excuse, trivially proven by the fact that the same people who are most invested in the libertarian framing are the ones who believe a secret government agent has been working for the last four and a half years to extrajudiciously round up pedophiles and liberals.
I'm not saying that's what you think. Maybe you're a pure libertarian. But a whole ton of people on "your side" of this debate are quite clearly not serious about regulatory overreach.
FWIW, that's not even close to true among the Libertarians I know. And as a Libertarian myself, I know quite a few. The set of people who "believe a secret government agent has been working for the last four and a half years to extrajudiciously round up pedophiles and liberals" may include a few actual Libertarians, but I would posit that most of the so-called "Libertarians" in that group have only the thinnest grasp on what the Libertarian perspective is about, probably haven't read/studied Libertarian ideology extensively (or anything else for that matter), and are merely repeating a few superficial talking points they heard somewhere that may - by happenstance - align with Libertarian perspectives.
But a whole ton of people on "your side" of this debate are quite clearly not serious about regulatory overreach.
Those people sound more like the fringe of the "Tea Party" movement... populist, anti-establishment and perhaps "anti government" only in the sense that they don't like the current government. But these aren't, by and large, people who have rational, well-reasoned, comprehensive arguments for the need to reduce the size and scope of government across the board.
YMMV, of course.
Obviously there are exceptions. Some people can objectively look at the situation and come to the conclusion that there are good reasons to start on both sides, and it really depends on your priorities. But those people are not part of the noise, it is the people who are desperate to feel part of a group who are the loudest.
For me the major issue with the vaccine is the extremely fast track from inventing it to getting it out the door.
An FDA approval will not change my mind on the safety of the vaccine, only time can do that.
By that i mean that we need more time to assess the long-term effects, something that many pro-vaccine people seem unwilling to accept. That is unfortunate.
You seem to be saying that the only issue is a question of time. Be specific: how much time? Will you say a specific number? “I will accept an mRNA-based vaccine if it has been around, and proven safe, for x years.”
We are way past the time frame for long-term effects to manifest themselves for a corona-like vaccine.
https://www.uab.edu/reporter/resources/be-healthy/item/9544-...
"This is particularly true of the mRNA vaccines. mRNA degrades incredibly rapidly. You wouldn't expect any of these vaccines to have any long-term side effects. And in fact, this has never occurred with any vaccine."
- Phase 3 trials for Pfizer not complete until May 2023: (https://clinicaltrials.gov/ct2/show/NCT04368728) - Control group(s) were given vaccines after 14 days: (https://www.npr.org/sections/health-shots/2021/02/19/9691430...) - Pfizer generates 1.9bn in revenue off of 100m doses, just in the USA alone, creating a massive revenue loop for them that governments cannot get out of due to predatory contracts (https://www.fiercepharma.com/pharma/pfizer-eyes-higher-covid...) - Pfizer's incredibly predatory, leaked, contract (https://www.documentcloud.org/documents/20616251-albanian-pf...)
It has been clear for a while now that the Pfizer vaccine works and is safe. Just because Pfizer has chosen to keep collecting data doesn't make that there is any doubt about that. This is also why control groups have been given the option to get vaccinated too. It would be highly questionable to prevent them from getting vaccinated when we know that some of them might die without the vaccine.
And Pfizer doesn't "make" 1.9b of 100m doses. They might have 1.9b in revenue but producing the vaccines isn't free. And 1.9b is a tiny drop in the bucket compared to the savings we have already seen thanks to the vaccine.
Moderna was approved on December 18, 2020.[0]
Moderna phase 3 trial started on July 27, 2020.[1]
IE, the control group was offered the vaccine more than five months after the trial began. This is before completion of the trial (Oct 2022 for Moderna, IIRC), which is an issue, but this "14 day" as written seems to be suggesting that it was 14 days after the trial began, when it's actually five month.
Additionally, when a treatment proves to be highly effective, it's normal and appropriate to start providing that treatment to the control group early, because leaving them to die or otherwise suffer an illness is considered unethical. This isn't something unique to the COVID vaccines.
[0] https://www.fda.gov/coronavirus-disease-2019-covid-19/modern...
[1] https://www.cidrap.umn.edu/news-perspective/2020/07/phase-3-...
20 bucks? Cheep! Hopefully this drives up vaccine investment.
From a quick Google, it seems that Phase III trials are about comparing a new treatment to existing alternatives, rather than monitoring side-effects. Perhaps the testing simply can't be complete before 2023, since it involves checking long-term immunity? In this case, the FDA may have approved the vaccine because they are confident that the risk of negative side-effects is sufficiently small, and that the vaccine gives some benefit - even if testing hasn't established exactly how much.
[0]: https://www.theguardian.com/commentisfree/2021/jun/28/alzhei...
Also to be fair it's not like they just rushed it out the door. There are probably very few things on the market (short of fully approved pharmaceuticals) that have been through more testing than these "rushed" vaccines.
edit: https://www.fda.gov/vaccines-blood-biologics/vaccines/emerge...
A drug should be approved once it is very likely causing more good than harm. But obviously that doesn't mean you should stop researching that drug.
What's happening here makes perfect sense. We have more than enough information to conclude that it is extremely likely that the vaccine helps a lot and causes little harm. However if there are any rare side effects then we'd still like to know that, therefore it is a good thing that the patients in the trials are still being observed for anything unusual.
The biggest reason is: J&J's biggest advantage early on was how much cheaper it is. One shot, simpler manufacturing process (which they've screwed up several times anyway, granted), it would be the one to get widely distributed because the cost-per-fully-vaccinated individual is far lower.
The issue is, the government is paying for all this, and they write blank checks. CVS administers a Pfizer/Moderna; insurance or the government refunds (I'm told) $50. They administer a J&J, they get (again, hearsay) $10. Vaccination clinics are actively incentivized to stock the most expensive vaccines, because the profit per vaccine is higher. So, some have stopped stocking J&J (which, coincidentally, is the one vaccine I've heard many anti-vax people say they'd actually consider, as its kinda-sorta-not-really-but-good-enough more traditional. at least one person i've talked to has said 'well, i'd get the J&J, but the closest clinic that has it is 30 minutes away, so i just haven't gotten around to it').
May I ask why? I've had two shots without much hesitation but this whole booster thing came out of nowhere and gives me "fool me twice" vibes. I understand getting a flu shot every year to target new strains but this would be the exact same shot as 8 months ago.
Second, Pfizer’s vaccines in terms of value produced are worth trillions. Even making $10 billion is completely worth it.
In terms of what we as a society should value and pay for, I would rather us pay a lot of money to Pfizer to develop life saving vaccines than 100’s of billions for ads or weapons.
I actually would like for Pfizer to have made even more money than they are making now.
I saw some conspiracy theory that said this weeks ago and just shook my head at how ridiculous that would be. At least it seemed like a conspiracy theory because my view of control group was apparently something else.
Emergency use authorization, for a vaccine that was never tested on humans, and both Pfizer and Moderna eliminated the control groups?
What the hell!? There must be… other or new control groups right? You can’t really have phase3 trials and reference nothing for control can you? What will they reference?
"Information is not yet available about potential long-term health outcomes."
2 Shots of vaccine to end covid -> Most Americans will have to take booster shots -> Booster shots may not be one time thing
Meanwhile in Japan: people living freely their lives with no lockdowns, no forced vaccination, no vaccine pass. Another model is possible but the Western governments are addicted to their power trip.
We have all known people who will double down on their arguments after being proven wrong because they've gone too far. This could give them an out.
https://blogs.sciencemag.org/pipeline/archives/2021/06/08/th...
Just like reducing cholesterol does not lower heart attacks.
Read more about that here: https://medium.com/@petilon/cholesterol-and-statins-e7d9d8ee...
This should be posted to the front page of the site. I get so tired of seeing comments pointing out some flaw in an institution and concluding that the institution is therefore useless. It really is lazy thinking.
So it’s not 20%. It’s a third.
I think it was a big mistake not to keep that as some kind of trial but my primary reason for that is because it encourages faulty conflations like yours. The message we should take from this is that the problem was NOT following the standard process rather than drawing any conclusions about the process which wasn’t followed.
That story was all over the headlines not because it was normal. It was in headlines, and in the front of your mind, because it was the exception that proves the rule. That’s not typical.
Regardless, the FDA approval was mostly about assessing safety of the drug in controlled trials and follow-ups. Likewise, the vaccine studies were rigorous examinations of safety and an in-depth search for warning signs that might indicate problems in small populations. The correct interpretation of this approval is to see that it has been thoroughly examined for safety in the field.
Finally, we already have mountains of evidence that the vaccine is effective. That much is not in question after administering an incredible number of doses globally and observing the outcomes. Proving efficacy was the least of the FDA’s concerns at this point.
It was in the headlines because it is normal, and some people were trying to improve the system but they failed. There are tons of existing drugs that have been approved based on surrogate endpoints, e.g. iirc the entire class of statin drugs.
Looks like NYC Public Schools are going to mandate all staff be vaccinated (https://www.nytimes.com/2021/08/23/nyregion/nyc-schools-empl...). I would expect most hospitals/health care organizations to pretty quickly mandate it as well.
There is very little incentive for a large organization to take on the added costs of allowing a large percent of their staff/members to remain unvaccinated now.
And despite all the stories/articles about the desperate, angry anti-vax people, they are really just a small minority who are good at being noisy, and the rest of us are becoming increasingly impatient with them.
Maybe you are not talking about "me" but I guess I couldn't tell from your comment.
There is of course also the issue that mandates come with legal liability for consequences that manufacturers are seemingly not liable for. However, when you mandate or pressure your employees, you are violating several laws, let alone fundamental human rights, and you are also not just taking responsibility for the effects/impacts but you are unnecessarily grabbing hold of that liability when it is not at all necessary. It is kind of mind boggling that we are facing a situation where people, companies, and organizations are increasing their legal risks by purposefully taking on legal liabilities they would not have by doing nothing.
I know someone with a totally inexplicable, debilitating, possibly neurological issue (but no one can tell her after ~5 months) that started with the injection. She chose to submit herself to the experimental treatment and is therefore personally liable even if it kills her. The manufacturers have been given immunity, but that liability will be taken on by employers that choose to mandated/coerce the injections.
I don't think people, organizations, and corporations are taking that into account adequately and are rather mindlessly rushing to grab the legal liability bag that the manufacturers were exempt from.
It's rather irrational and actually quite insane. I cannot make sense of why it is happening. One guess is that it is the effects of moral hazard after decades of nearly zero consequences for the administrative and ruling class. There are never consequences, so why not jump in head long that has never produced meaningful consequences and also in most casts has been quite profitable. Of course you would sycophantically rush to be the most obsequious to the system.
Nothing else makes any sober sense to me.
I'm vaccinated and everyone I know is, but I cringe a bit at the tolerance of what seems authoritarian to me. If I were to wager, things get better once antiviral treatments improve and when data analysis gets better, not when "full compliance" happens. To me it's clear that there is a seasonal nature, but it varies based on latitude/climate/time of year. For whatever reason it seems taboo to mention this. Anyone wanting to prove a point about masks/vaccines working or not working often compares one region/climate to another.
nice use of the oxford comma btw.
This is not new: only the most libertarian fringes reject the idea that living in a society comes with obligations. We avoided millions of life-altering diseases with vaccination and politicizing medical care is going to go down in history as the worst move since the CIA decided to use public health workers as a cover story.
So they're not even all that good at providing the one thing companies may argue is necessary to go back-to-work; stopping spread. Similar with cruise lines and airplanes requiring it. Yes, the vaccines are very good at saving peoples' lives, but industry doesn't care about that, and it alone is not a good enough reason to mandate it.
You say everyone needs to get vaccinated so we can protect the people who can't get the vaccine or for whom it doesn't work. I have very bad news for you; the vaccine won't help. You can still get COVID, and you can still spread it to your four year old. I can still get it and spread it to my immunocompromised sister. It sucks. That's the reality we live in.
There are a lot of assumptions in that counterargument that people will hope you don't examine, for example, the assumption that the probability of a covid transmission ending in harm crosses the same probability threshold if, say, drunk driving ending in harm. I say it doesn't. And since the stakes are so high with what we're talking about allowing the government to do, the burden of proof is on needing to prove the individual's likelihood for serious harm being high.
You do realize that drunk driving is illegal, right? Do you think drunk driving should be legal because it's "unlikely" to cause harm to others?
> I say it doesn't.
628k confirmed deaths in the US from COVID. 37.8M confirmed infections. That's a death rate of 1.66%.
In 2016, 10,497 people died from drunk driving. 1 million people were arrested in 2016 for drunk driving. That's a rate of 1.0497%. So COVID is literally more dangerous than drunk driving.
Drunk driving stats: https://www.cdc.gov/transportationsafety/impaired_driving/im...
Also vaccine requirements aren’t anything new, so is the concern here that they’re mandating vaccines or this specific vaccine due to how new it is? If the latter, then what’s your bar for acceptance?
See for example https://fivethirtyeight.com/features/unvaccinated-america-in...
There’s a pretty stable “never” population at 14%, and you see that as time goes on the hesitants have been gradually been getting won over.
I’m sure some in the “never” camp are using “it’s not been approved” as their current first-line given reason. But I think you need to break down the groups a bit more. There are genuinely people who are not fundamentally anti-vax that are just nervous about how fast the vaccines were developed or scared about what having “RNA” in the vaccine means (I don’t share these concerns but I understand where they come from). Some of these people will at the margin be persuaded by things like full approval.
Maybe some. But, while I don't really like governments and big employers wielding sticks in this case, you'll probably see even more people decide that they're not hesitant enough about vaccines to lose their jobs or be excluded from a lot of activities.
And while those sort of requirements could be implemented before full approval, a lot of organizations apparently wanted the additional air cover.
What is it, day 600 something of "just two weeks" to stop the spread? Oh wait, that's just the _other side's_ fault for not following the rules as well as you did.
From where I sit, it seems like a lot of people are having a hard time admitting that shutting down the world's economy may have been the wrong choice, hindsight.
> Some experts have estimated that full approval might convince just five percent of those who are unvaccinated to get shots.
And there's zero evidence supporting that premise. The US has historically been superior to Europe when it comes to vaccinations for example (look at Europe's long history of bad measles outbreaks). It's the difference between garbage propaganda slung at the US and reality. In reality the US has a tremendous long-term track record of making and utilizing vaccines, which is also why the US didn't disregard developing and distributing vaccines for this pandemic, and in fact was one of the world leaders in both categories.
I don't think this is a decision they made lightly.
Several small startups I’ve talked to are already requiring proof of vaccination. But it’s legal and insurance demanding it, not their team. And these are for _fully remote_ positions. I suspect FAANG is finding itself in a similar position.
Tin foil hat: I’m starting to suspect someone (gov? Pharma?) is leaning on insurance companies to in turn pressure the industry to mandate vaccination.
> Walk away from a job because of it
It’s starting to seem like you’ll be free to not vaccinate in the U.S., but it’s more than walking away from a job. If insurance requires it, you’ll have to find a company that has an insurance company willing to float you an exemption for non-protected class reasons; it’s not clear how much the market is going to allow for that.
BTW: I’m vaccinated. I left my job not to avoid vaccination, but because they thought they could remove my agency.
I want to know when insurance companies will start adjusting rates.
Note that they're NOT mandating/requiring vaccination (which may turn out to violate constitutional rights here) -- it's still the customer's choice -- but you're gonna pay more, just like if you smoke tobacco.
As mandates increase, I anticipate a wave of fake vax cards, as the ones in the USA are simple and trivially easy to forge.
Regarding your comment. I know several people who have already quit, many looking for new jobs and many who have shored up their finances. Many who have had the vaccine have explicitly stated they would never get their kids vaccinated. So there's also that...
I also know probably 10 families who have up and moved to Texas and Florida in 2021.
Here's follow up studies in specified in the letter:
4. Study C4591009, entitled “A Non-Interventional Post-Approval Safety Study of the Pfizer-BioNTech COVID-19 mRNA Vaccine in the United States,” to evaluate the occurrence of myocarditis and pericarditis following administration of COMIRNATY. We acknowledge the timetable you submitted on August 21, 2021, which states that you will conduct this study according to the following schedule:
- Final Protocol Submission: August 31, 2021
- Monitoring Report Submission: October 31, 2022
- Interim Report Submission: October 31, 2023
- Study Completion: June 30, 2025
- Final Report Submission: October 31, 2025
5. Study C4591021, entitled “Post Conditional Approval Active Surveillance Study Among Individuals in Europe Receiving the Pfizer-BioNTech Coronavirus Disease 2019 (COVID-19) Vaccine,” to evaluate the occurrence of myocarditis and pericarditis following administration of COMIRNATY. We acknowledge the timetable you submitted on August 21, 2021, which states that you will conduct this study according to the following schedule:
- Final Protocol Submission: August 11, 2021
- Progress Report Submission: September 30, 2021
- Interim Report 1 Submission: March 31, 2022
- Interim Report 2 Submission: September 30, 2022
- Interim Report 3 Submission: March 31, 2023
- Interim Report 4 Submission: September 30, 2023
- Interim Report 5 Submission: March 31, 2024
- Study Completion: March 31, 2024
- Final Report Submission: September 30, 2024
6. Study C4591021 substudy to describe the natural history of myocarditis and pericarditis following administration of COMIRNATY. We acknowledge the timetable you submitted on August 21, 2021, which states that you will conduct this study according to the following schedule:
- Final Protocol Submission: January 31, 2022
- Study Completion: March 31, 2024
- Final Report Submission: September 30, 2024
7. Study C4591036, a prospective cohort study with at least 5 years of follow-up for potential long-term sequelae of myocarditis after vaccination (in collaboration with Pediatric Heart Network). We acknowledge the timetable you submitted on August 21, 2021, which states that you will conduct this study according to the following schedule:
- Final Protocol Submission: November 30, 2021
- Study Completion: December 31, 2026
- Final Report Submission: May 31, 2027
8. Study C4591007 substudy to prospectively assess the incidence of subclinical myocarditis following administration of the second dose of COMIRNATY in a subset of participants 5 through 15 years of age. We acknowledge the timetable you submitted on August 21, 2021, which states that you will conduct this assessment according to the following schedule:
- Final Protocol Submission: September 30, 2021
- Study Completion: November 30, 2023
- Final Report Submission: May 31, 2024
9. Study C4591031 substudy to prospectively assess the incidence of subclinical myocarditis following administration of a third dose of COMIRNATY in a subset of participants 16 to 30 years of age. We acknowledge the timetable you submitted on August 21, 2021, which states that you will conduct this study according to the following schedule:
- Final Protocol Submission: November 30, 2021
- Study Completion: June 30, 2022
- Final Report Submission: December 31, 2022
10. Study C4591022, entitled “Pfizer-BioNTech COVID-19 Vaccine Exposure during Pregnancy: A Non-Interventional Post-Approval Safety Study of Pregnancy and Infant Outcomes in the Organization of Teratology Information Specialists (OTIS)/MotherToBaby Pregnancy Registry.”
- Final Protocol Submission: July 1, 2021
- Study Completion: June 30, 2025
- Final Report Submission: December 31, 2025
11. Study C4591007 substudy to evaluate the immunogenicity and safety of lower dose levels of COMIRNATY in individuals 12 through <30 years of age.
- Final Protocol Submission: September 30, 2021
- Study Completion: November 30, 2023
- Final Report Submission: May 31, 2024
12. Study C4591012, entitled “Post-emergency Use Authorization Active Safety Surveillance Study Among Individuals in the Veteran’s Affairs Health System Receiving Pfizer-BioNTech Coronavirus Disease 2019 (COVID-19) Vaccine.”
- Final Protocol Submission: January 29, 2021
- Study Completion: June 30, 2023
- Final Report Submission: December 31, 2023
13. Study C4591014, entitled “Pfizer-BioNTech COVID-19 BNT162b2 Vaccine Effectiveness Study - Kaiser Permanente Southern California.”
- Final Protocol Submission: March 22, 2021
- Study Completion: December 31, 2022
- Final Report Submission: June 30, 2023
https://www.fda.gov/drugs/postmarket-drug-safety-information...
Or point out that the 737 MAX had approval from another federal agency.
We simple can't be sure, it is personal risk management. Requiring the vaccine is silly because vaccinated people can still spread it (especially Delta), perhaps even spread it more since their symptoms aren't as severe and they are far more willing to mix with large crowds.
"In addition, a growing body of evidence suggests that mRNA COVID-19 vaccines also reduce asymptomatic infection and transmission."
https://www.cdc.gov/coronavirus/2019-ncov/science/science-br...
"FDA set to grant full approval to Pfizer vaccine without public discussion of data": https://www.bmj.com/content/374/bmj.n2086?s=09
Expecting the public to have confidence in these vaccines is demanding a level of subservience and blind faith that most reasonable people are unwilling to provide.
>Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.
https://www.fda.gov/advisory-committees/advisory-committee-c...
Or maybe just stick with the fact that it isn't very effective. [1]
[1] https://www.medrxiv.org/content/10.1101/2021.08.06.21261707v...
> Both vaccines were highly effective during this study period against SARS-CoV-2 infection (mRNA-1273: 86%, 95%CI: 81-90.6%; BNT162b2: 76%, 95%CI: 69-81%) and COVID-19 associated hospitalization (mRNA-1273: 91.6%, 95% CI: 81-97%; BNT162b2: 85%, 95% CI: 73-93%). However, in July, the effectiveness against infection was considerably lower for mRNA-1273 (76%, 95% CI: 58-87%) with an even more pronounced reduction in effectiveness for BNT162b2 (42%, 95% CI: 13-62%). Notably, the Delta variant prevalence in Minnesota increased from 0.7% in May to over 70% in July whereas the Alpha variant prevalence decreased from 85% to 13% over the same time period.
2. You linked to an old version that says "However, in July, the effectiveness against infection was considerably lower", in the current version the same sentence reads "In July, vaccine effectiveness against hospitalization has remained high"
That's generally how the media describes the papers that respectively go against, or with the narrative they're trying to push.
It also does seem like the approval process may be influenced by political pressure to remove barriers to hesitancy or to support vaccine mandates. My understanding is that the approval timeline here is faster than any previous one. Did the FDA really review the over 300,000 pages submitted for this approval and scrutinize it to the extent necessary? Maybe. But from the outside it seems suspiciously quick based on relative terms.
By looking at other vaccines historically and seeing that side effects tend to happen in the first few weeks.
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/expect/af...
> Vaccine monitoring has historically shown that side effects generally happen within six weeks of receiving a vaccine dose.
But I do not believe that this is valid at all, being that this is the very first mRNA vaccine.
>By looking at other vaccines historically and seeing that side effects tend to happen in the first few weeks.
I feel like what you are saying is basically like someone asking "How do we know that self driving cars will be safe on the road" and you responding with, "well obviously by looking at the history of cars, we have been doing them for a century!"
"Other vaccines historically" work on fundamentally different principles. We can not use that data to assume that mRNA vaccines are going to work the same way.
People who avoid the vaccine are akin to people who don't wear seat belts because they might drown if their car falls into the water.
Because of e and f, I think the risk of a vaccine is much lower. By now, we see very small risks for serious short and mid term effects. We know how long the mRNA survives in the body (I don't think we know that from the COVID virus, that could potentially hide for a very long time, as other viruses demonstrate), virtually eliminating direct long-term effects. What remains are the unkown unknowns. Can it trigger something? Sure, we have observed that in other vaccines. But it is very, very rare, not only that vaccine can cause it, but also that if the vaccine can cause it, one is affected. Additionally: It is very likely that a COVID infected person would have a similar risk -- much of the immuno-response is the similar to a vaccination (but maybe broader). Since I assume a close to 100% prob to get infected at some point if unvaccinated, it's not an additional risk.
To explain the last point a little: A way you can construct a long term effect goes like this: If the presented spike protein is close enough to a natural,i.e. normally expressed, protein, the antibodies could affect both, and potentially destroy an important body function. That risk, I think, is actually higher with a full infection, since the antibodies learn not only the spike protein, but potentially more of the virus, so there is more chance of similarity with something else. In any case, as far as we know, the chance for something is remote.
RE approval process: What calms my mind there is that all countries for which I normally trust the approval process gave their OK, including those which went with a different strategy, or where it was less of a political issue. While it's possible that they all got corrupted by political pressure, that's less likely.
If a doctor is recommending you don't take it based on their experience and expertise, it carries a bit more weight than "something you read on facebook". And if you can't trust doctors now, who may even be your own doctor, why would you trust anyone else, or "some other doctor"?
This is not something that can be resolved by bullying or mandates. It can only be resolved by open dialogue and debate between the two sides, which thus far, has been prevented.
Censorship and stifling of debate only hardens the opinions of either side.
It also makes no sense - many areas have massive resistance, no matter what has been thrown at them - proving the fear of "if we let them talk freely they'll influence others and go off and do whatever they want!" isn't founded. Basic human psychology, along with experience, shows the reverse has proven true.
If you stop people who are suspicious of something from being able to talk about what they're suspicious of, they get even more suspicious of it.
Certainly, there is no other time in history widespread censorship has resulted in anything other than widespread division, suspicion and ultimately, violence.
If employers mandate based on this approval, it will likely just result in mass walk-outs.
Minds are not won by force.
Your second claim is massively untrue: all of the information is public and actual medical doctors overwhelmingly support vaccination and bend over backwards trying to help patients understand it (note that most of the high profile objectors either aren't real MDs and/or are speaking far outside of their area of expertise). The problem is that many people are defining “open dialogue” as meaning that untrue statements they make need to be taken as seriously as the consensus of the scientific community.
The first is rather debatable: mandates have been highly effective everywhere they've been tried because they shift the cost calculation to “do I feel strongly enough about this that I'm willing to give up something I like?”.
It's not possible to have anything remotely resembling a "debate" in such a climate.
Mandates have not been effective. Nothing that's been done can be said to have been "effective". We are apparently in an even worse place now, even with vaccines, than we were last year.
In reality though, we aren't.
The pathology of the virus is well-understood, as are the mechanisms to defeat it. But we're not allowed to talk about it.
It'd all be over in weeks if we were - as we saw in India recently, in all provinces but the one that stuck with the dogma.
I highly doubt it.
"Minds are not won by force."
How is it by force? They still have agency in their decision: Job or jab.
So with that in mind, I'm much more keen on seeing how employers will decide on vaccination mandates now that at least one vaccine is fully approved. Any news yet on whether any more employers are likely implementing mandates (if they haven't already this morning) based on the news? Guessing a few probably had their policies and news pre-written in anticipation.
Or continue an existing reason:
"Information is not yet available about potential long-term health outcomes."
There is uncertainty about long-term effects of both. There is no uncertainty about the short-term effects of COVID, which are magnitudes worse than the short-term effects of a vaccine. COVID for me was a multi-week flu that scared the shit out of me because I didn't know how bad it would get or if I'd live through it. I took months to get my smell/taste back, three months to get back to previous fitness levels, hair loss, and significant mental fog and memory problems. The jab was one day of tiredness and I ran a marathon two days after no problem.
I really can't fathom how anyone could put themselves and those around them at such great risk, rather than taking a vaccine.
Vaccine or not, you can still get covid and suffer the consequences depending on your body. So I dont see the point in getting a vaccine and suffer its long term consequences when it basically does nothing.
If you are saying it prevents covid death - you are wrong. Check England's data. More unvaccinated people are getting covid but they are dying less. Vaccinated people are getting covid less but the ones who died after getting covid are more. The math isn't adding up for the vaccines.
As a 30-odd year old knowledge worker (vaccinated), that's the thing that affects my personal risk assessment the most right now.
I have a lot of trouble arguing with these people (friends, family) because I read daily about how bad covid is and they are simply ignorant. For some of them it's basically "he said, she said" (so like: who should I trust?) as if anti-vaxxers and science are on the same level of trustworthiness. And also when you talk about data they say something like "I don't trust the data" and rather trust some stupid people in their social circle. Also it appears like they feel like "vaccination can be bad", "covid can be bad (but not necessarily, my daughter had it and it was like the flu!)", so they rather try to avoid both. Yeah, logic...
It's like worrying about the long-term impact of breathing fire extinguisher powder while being engulfed by flames.
But the local fire department isn't doing anything about it. Nobody around here is installing sprinklers as a precaution. They act like there is no fire at all.
Covid is a serious thing. But "engulfed by flames" is the exact overstatement that causes people to question the motivation of fear-mongers.
I'm vaccinated. I wear a mask. I think too many people are whipping up a frenzy for profit. Why don't we lockdown our highways when there are 600,000 deaths from auto accidents? Why not lockdown breweries when there are 2 million drunk-driving incidents? Why isn't there a frenzy over influenza?
Covid frenzy has a better marketing campaign. It's the kind of thing that has people claiming we are "engulfed by flames" when things get smoky.
1) Risk of potential negative long-term health outcomes from COVID-19 vaccine.
2) Risk of potential negative health outcomes (long and short term) from COVID-19 infection.
As well as
3) Risk of potential negative non-health outcomes from COVID-19 infection (social and economic, risk of infecting others, risk of overrunning ICUs)
With a proper risk analysis vaccine 100% wins for the vast majority of people and it's not even close.
(Referenced studies are linked in the article).
Why should people who already have antibodies take marginal unnecessary risk for no gain?
https://www.cdc.gov/mmwr/volumes/70/wr/mm7032e1.htm
“Among Kentucky residents infected with SARS-CoV-2 in 2020, vaccination status of those reinfected during May–June 2021 was compared with that of residents who were not reinfected. In this case-control study, being unvaccinated was associated with 2.34 times the odds of reinfection compared with being fully vaccinated.”
> Prof. Zywicki’s immunologist, Dr. Hooman Noorchashm, has advised him that, based on his personal health and immunity status, it is medically unnecessary to get a Covid-19 vaccine — and that it violates medical ethics to order unnecessary procedures.
> the Policy is unmistakably coercive and cannot reasonably be considered anything other than an unlawful mandate. And even if the Policy is not deemed coercive, it still represents an unconstitutional condition being applied to Professor Zywicki’s constitutional rights to bodily integrity and informed medical choice, respectively.
> GMU’s Policy infringes upon Professor Zywicki’s rights under the Ninth and Fourteenth Amendments to the United States Constitution
https://www.cidrap.umn.edu/news-perspective/2003/12/judge-or...
I think the focus on a small minority of people who don't want to take a vaccine is unhealthy.
It's not this simple. Not taking a vaccine during a pandemic has negative externalities, since you're increasing the risk of infection and death of those you interact with, you increase the likelihood of consuming scarce resources (such as ICU beds), etc.
I largely agree with you, but framing it as a simple "individual choice" issue is reductive at best.
2. Some vaccinated people have been found to carry the same levels of the virus as unvaccinated people, so stating that unvaccinated people could be increasing risk to others is also a moot point
3. Once the so called "R" rate is below one, the virus is on a path to fizzling out
It's not as though unvaccinated people will be dying in their thousands for centuries to come. Herd immunity just needs to kick in which many countries have already achieved.
Are you saying it would be legal to ban cars for those reasons?
Israel would like a word with you.
https://www.npr.org/sections/goatsandsoda/2021/08/20/1029628...
The focus is just, these folks are robbing everyone else of their freedom and happiness.
>The same people that don't understand vaccines are also likely to think masks don't work
I don't see how this is relevant. It just seems like a strawman argument to dismiss people who might have legitimate reasons for not having the vaccine or otherwise just want to exercise their right not to have it.
Who are they killing? Others that didn't get the vaccine?
I hope you didn't know it or didn't think it through, otherwise mention of Fox News seems to me a blatant hypocrisy. Either way it was an unnecessary ad hominem attack.
What about people with immune dysfunction? Are you going to dismiss them as Fox News viewers too because aren't having the vaccine?
They can just pass on the cost onto the consumer and raise their profits.
Sorry for not wanting to inject myself with unproven technology with unknown long term effects. Why politicians and certain pharma companies keep pushing these vaccines instead offering conventional inactivated virus vaccines? Heck maybe I'd go even for protein based one (Novavax).
As healthy non-obese non-smoking relatively young person I'm not afraid of COVID, but I'd be willing to take safe vaccine with technology proven by decades of track record to make some people happy (though ideally everyone should have same rights vaxxed or unvaxxed and this should be entirely voluntary same as influenza, hepatitis and other vaccines nobody requires when you travel to neighboring country or visit restaurant).
For instance these are currently my options in EU, if I want conventional vaccine against COVID approved by EMA or any COVID vaccine using any technology approved more than 2 years ago:
EDIT: I wonder if all those people defending these new technoloy vaccines also use all their software running Alpha/Beta versions and don't wait for Stable version. But it seems when it comes to one's own health it's less important than software for most.
You're refusing the "beta" (installed by billions of users) version of something that can save your life because you (mistakenly) believe the choice is between that, and staying as you were before.
It's not. That's no longer true with the Delta variant. Now it's really a choice between "carefully designed, just officially declared stable" vaccine with billions of users vs getting the "totally unstable, totally doesn't care about your health, completely unknown long term effects" SARS-CoV-2 virus forcefully installed on you.
You will get antibodies one way or another, and there is orders of magnitude more risk and uncertainty associated with getting them through infection rather than controlled vaccination.
Furthermore, there has never been in history any vaccine side effect that occurred later than a few weeks after administration at most.
There is just no theoretical basis for why anything wrong would happen here.
Are you demanding 100% certainty ? Sure, you won't get it here but you also didn't get it with anything else you ever did in medicine and you can live with that.
With Delta, ICUs (and even more so long covid clinics) are full of unvaccinated "healthy non obese non smoking relatively young" guys like you.
If you're not afraid of Covid, rationally you should be even less afraid of getting a vaccine.
To put things in perspective, here are the odds in young males for the most talked about vaccine side effect (myocarditis, which usually resolves in a few days), vs the odds of getting severe Covid at your age :
I can't figure out what these vaccines do that could even have long term effects beyond getting your immune system to recognize the protein.
There is one example of this actually happening. Have a look at what happened with the pandermix vaccine:
narcolepsy.org.uk/blog/important-ruling-pandemrix-case
https://www.theguardian.com/world/2019/nov/20/swine-flu-vacc...
So what you need is not longer trials, but trials with more people. Which is what is done in so called phase 4 trials after approval.
I'm in a low-risk group and see no use in getting vaccinated, especially since herd immunity is off the table and nearby ICUs are not overflowing. The media/pharma/politicians/bigtech are all passing out the same message: get the vaccine. Non of them highlight that there are good reasons not to. So much for informed consent?
Why all the hate against people being cautious?
My wife is a pediatric ER doctor (but because the adult ER is so swamped with COVID patients they're now seeing all patients up to 25), during the first few waves of COVID, she saw almost no severe cases in children and young adults. There were plenty of kids who came in with COVID, but she didn't admit a single otherwise healthy kid or young adult because of COVID.
In the last week, she's admitted 3 17 year olds to the PICU, and they've admitted many more than that to the floor for treatment.
>It's stories like this --gov't makes out of court settlements and vaccine retracted-- that give a lot of credibility to those against/ hesitant towards vaccination.
We have now administered billions of doses of MRNA vaccines. The safety profiles are more well known than a large percentage of drugs on the market that most people would take without a moment's hesitation.
Historically vaccines have been taken off the market b/c of issues that were too uncommon to show up in trials, which consist of only a few thousand or tens of thousands of people. The side effects were so rare that they only showed up once millions of people started taking them.
There has never been a vaccine that was pulled off the market for a side effect that took a year to show up.
I also think you underestimate how ANGRY people are that they spent 18 months in lockdown, only to have some anti-vaxers mess things up at the end. By this point, we shouldn't be talking about which areas do/don't have overflowing ICUs, we should be talking about which areas have hit milestones for number of days without a positive case!
Now where we are: long lockdowns, talks of vax passports everywhere, no herd immunity, covid is here to stay with us (due to animal reservoirs), no overflowing ICUs but still gov'ts reigning with wartime-like superpowers.
The fearful/obedient have their vaccine, those who did not will not. Some died, most live. This is no spanish flu. So what was the problem again?
I'm just interested in how common this is after vaccination, and perhaps when may this end, so I again spent a few hours yesterday to try to find some significant (N > 5000, preferably more) independent prospective studies of "mild" side effects like these of this vaccine.
So much vaccination going on, so why not just give every 5th person vaccinated in some large center a link and a code to enter observed side effects after 1 day, 3 days, week, and a month, and then maybe 3 months after into some website. Maybe ask for a phone number and call them to ask, if they don't fill the form in time. Even such a stupid study design would satisfy me.
No such thing on google scholar.
There are barely any studies that track side effects over time. It's almost all just binary X,Y,Z side effects after vaccine - yes/no. All studies I could find are < 1000 people or in that range.
The small amount of studies that actually tracked side effects over time, just track for 7 days and end with 4% people still having side effects after a week. One Czech study I found tracked side effects for a month! With 2% having still issues after a month. Well, good! No, not really, N<1000 again, and a biased survey style study.
Also the fucking irony of search returning about 5-10x more so called "hesitancy" studies per a side effect survey, despite me not search for it.
I'm fully vaccinated, and there's no shortage of studies about efficacy, so no problem there. But people that proclaim how well the side effects are studied, because of how many millions of people were already vaccinated just sound ridiculous to me now. Where are all the actual studies?
From what can be found it just seems that very little fuck is given about serious study of so called "mild" side effects, and some guidance given on how to mitigate them, based on results.
("no compensation for from anyone" is because my country actually passed a law that allows for compensation for covid vaccine gone wrong; but with no proof of some statistical relationship, this was just another bullshit anti-hesitancy stunt from the government, and will be of no real help to the affected)
However one problem we have is that for mere side effects ("My arm aches a bit", "My period was a week late", "I feel kinda sleepy in the morning") we don't have good baseline data to compare with. I'd quite like to see someone study, e.g. if we change the Facebook blue colour slightly, and ask a study cohort, what medical "side effects" do they report for that? Clearly someone in a large survey population will report that their right thumb hurts now, and we can reason (but not prove) that's not going to be a direct result of the CSS change, but measuring what this noise looks like would provide a baseline for low risk vaccinations.
That means that at the moment there's just no reasonable way to decide whether it's safe to get a second dose or not. If there were studies that would show that almost nobody has a lasting head pain post vaccination, then one could conclude it's probably just a super weird coincidence, and take a risk with a second dose, to at least get the full protection against covid-19.
Without data the most prudent thing is to do no further harm to oneself, and live with increased risk of infection and all the restrictions and increased costs that are put on unvaccinated.
Maybe add a self-reported intensity scale for the symptoms.
Anyway, I can see why studies like these can be hard.
Can we create an open-source tool that supplements the much-criticized VAERS, which is at least government (i.e. taxpayer) funded, regulated and provides open data for developers? Use standard analytics to extract the most common side effects, then start collecting crowdsourced data not only on side effects, but most importantly, on TREATMENTS and MITIGATIONS for those, especially the mild-but-life-affecting ones that don't justify R&D with future billion-dollar revenue streams.
If you go to the gp/doctor and you tell them you are suffering issues after a vaccine they have to (by law) pass that on to the regulator and to the vaccine manufacturer. In Israel and in the UK reports to doctors about longer term side effects of the vaccine are within and below the expected ranges.
Reports on twitter may be high, reports to doctors remain low. You can draw your own conclusions.
https://ourworldindata.org/covid-vaccinations?country=OWID_W...
The CDC ran such a study. IDK about results, or how many people participated.
Would be nice to see the results.
From societal perspective, why would you do it if you can transmit it in the same amount as if you are not vaccinated?
Doesn't makes sense to me, but well..
I do think that it's a good thing for people that have disease that can complicate covid recovery and older generations.
The graph shows about a .1% chance of death at age 50 if you catch COVID-19. The chance of hospitalization and potential long-term symptoms is a multiple of that.
Vaccinated folks have a lower chance of catching COVID, so as a whole, they have a lower chance of spreading it.
1. https://pubmed.ncbi.nlm.nih.gov/33289900/#&gid=article-figur...
So age and associated diseases should be deciding factor for every person. Or are you proposing something else?:)
