The nocebo effect will result in lost of complaints and in all likelihood some actual harm. Just as a placebo effect can have a strong positive impact, the nocebo effect can result in strong negative consequences.
"A nocebo effect is said to occur when negative expectations of the patient regarding a treatment cause the treatment to have a more negative effect than it otherwise would have.[1][2] For example, when a patient anticipates a side effect of a medication, they can suffer that effect even if the "medication" is actually an inert substance."
This can even manifest as a "communicated disease", a disease you only get after someone tells you about it. The classic is "Wind Turbine Syndrome". If people are told that a vaccine will do them harm, the combination of these two physiological forces can result in very real negative symptoms.
What I really want to know is, what happens if I think the vaccine will only do me good and I continue to think so while hearing about negative effects that are being reported. That is, is there a chance that my subconscious will subject me to nocebo because of that, even though my conscious thoughts have a positive attitude?
And furthermore, could thinking about the possibility of nocebo cause my body to experience it?
I'm less worried about the nocebo effect than I am the campaign of lies and misinformation anti-vaxxers and COVID denialists are going to wage against this.
No matter what actual effects occur, social media is going to be flooded with fabricated stories of people being poisoned or killed outright by it.
My daughter was injured by a vaccine. Taking her to the western doctors proved useless. They were unable to even acknowledge that the vaccine she had taken might have any connection what so ever to her symptoms.
You might what to open yourself up to the people that have been injured and stop dismissing them.
Not to get too deep into your daughter's medical history, but what facts could possibly demonstrate that the vaccine was the cause of the harm to the degree of certainty that you seem to show? It's my layman's understanding that there is a small but non-zero population of people who do not tolerate vaccines well, but they are heavily outnumbered by people who wrongly believe vaccines have caused them harm.
My daughter went from speaking to not speaking, crying and rocking and pissing herself. We had to put her into speech therapy for years. All this happened directly following the vaccine. Nothing else new was introduced into her diet or system
then you should also be appalled at the lack of understanding that media and politicians have exhibited in the way the pandemic has generally been covered and combatted. it's all been about what might possibly happen, in infinitely many variations, not how likely, with probabilities and uncertainty bounds, couched among comparable ailments, and more importantly where, when, and why. it's been non-stop what-ifs and paranoia, narrative-making and politics, not science and reason.
covid-lockdowners, pro-maskers, and anti-vaxxers have much in common, of being fear-driven, not rational.
> "Specifically, if you take 10 million people and just wave your hand back and forth over their upper arms, in the next two months you would expect to see about 4,000 heart attacks. About 4,000 strokes. Over 9,000 new diagnoses of cancer. And about 14,000 of that ten million will die"
My God, this hand-waving needs to be stopped immediately!
All phase 3 clinical trials should include odds ratios of side effects of drug versus placebo (should be usually found in the drug instructions for use). These side effects will be reported.
Check out the article, he's talking about the fact that when you distribute so many vaccines, you're almost guaranteed to have a coincidence like a massive heart attack (to give a stark example) that appears correlated. So he's not saying you should ignore people saying there are side effects (in fact the whole point of clinical trials is to listen REALLY REALLY CLOSELY to what people say about side effects), he's saying be prepared for these correlations to be blown out of proportion.
It’s not about some ONE reporting diarrhoea it’s about enough people reporting diarrhoea immediately after receiving a vaccine. The reports go via VAERS
Nobody is "ignoring" anything. The process for approval includes three rounds of trials with tens of thousands volunteers being closely monitored in a standard, double-blind protocol.
Some side effects are expected. A needle hurts, for example. So the very first act does, indeed, harm. If you consider that needles have been a standard feature of medicine for a while, you may want to rethink your interpretation of that "first, do no harm" principle.
Before needles it was leeches and bloodletting and mercury, by the way. So I don't think harm avoidance was ever as paramount as Paramount may make it seem.
Anyway, and I'm not entirely sure why this needs spelling out, but treatment decisions are always trade-offs involving uncertainties.
Vaccines seem to specifically elicit fear in some people who, as far as I can tell, have a surprisingly large overlap with the group that was chucking aquarium cleaners like a goldfish with OCD just a few months back. (My bafflement here is not rhetorical. If you have an explanation that doesn't involve autism, I'm eager to hear it)
No one talks about "ignoring side effects". The article nicely lays out how many diseases, which would be expected in any sizable part of the population, would get wrongly categorized as side effects of the vaccination.
> Non-maleficence, which is derived from the maxim, is one of the principal precepts of bioethics that all students in healthcare are taught in school and is a fundamental principle throughout the world.
I think I understand what you mean. In med ethics you weigh: autonomy, justice, nonmaleficence (do no harm) and beneficence (do good). You're right, no harm is not blindly followed, but it is relevant to bring it up in this discussion.
There are far more dangerous vaccines than this one. The classic smallpox vaccine (the first vaccine ever) kills 1-2 people per million vaccinated for the first time. 14 to 52 people per million experience lift-threatening reactions. About 1000 people per million experience a serious but not life-threatening reaction.[1]
Until 1972, smallpox vaccination was routine in the US. Killing 1-2 people per million was considered better than having a smallpox epidemic.
The classic smallpox vaccine is a live-virus vaccine. It gives you a disease similar to smallpox but far less dangerous, and triggers the immune system into a reaction that eliminates the disease it induces, and thereafter blocks both it and smallpox. There's a newer vaccine, a killed-virus vaccine, against smallpox. It has fewer side effects, but it's never been widely used, since there hasn't been a smallpox epidemic in a while. The U.S. Army has a stockpile, just in case.[2]
The first Western coronavirus vaccines are RNA vaccines. They have a molecule similar to part of the virus, just enough to trick the immune system into creating antibodies. They don't have a complete virus, so they can't reproduce and cause an infectious disease on their own. This is supposed to be safer than the older live-virus and killed-virus vaccines. But the RNA molecule is fragile, hence the need for freezing in storage and transit.
First get it working, then go for ease of use. Merck has a pill version in development.
We also don't know what the adverse reactions to this one are likely to be. mRNA vaccines are very new, and they've never been approved for human use before. If there are long-term adverse side effects, we don't know what they are.
> Given the novel nature of the mechanism of action of RNA vaccines, and their drug delivery vehicles, little is known about the medium and longer-term side effects.
> Up until December 2020, no mRNA vaccine, drug, or technology platform, had ever been approved for use in humans, and before 2020, mRNA was only considered a theoretical or experimental candidate for use in humans.
Can confirm in software, at least, we get about a bazillion angry emails any time our customers upgrade, containing actual issues as well as a number of issues that no reasonable person would conclude is related.
"Support, our batch jobs are taking twice as long to run after our last upgrade." (Fair)
"Support, our server hard-drive filled up after we did the upgrade." (Well, it would be unlikely, but it's certainly possible that an upgrade caused a log file to explode somewhere.)
"Support, we did an upgrade on Saturday and on Sunday we lost power." (That would certainly be an exceptional bug if our software could knock out your power grid!)
"Support, our internet is slow. Do you think it's related to the upgrade?" (Come on, really?)
To be fair, its stupidly hard to work out what is to blame for issues with complex devices. I regularly have issues with things and I have no idea if I'm seeing problems with the hardware, drivers, os, or some specific plugin/software that is installed. All I see is the end result is broken.
This is really the point of the linked article. People are going to be unreasonable. They're going to take out their feelings on the people trying to help because so much of this situation is totally beyond their control.
> Specifically, if you take 10 million people and just wave your hand back and forth over their upper arms, in the next two months you would expect to see about 4,000 heart attacks. About 4,000 strokes. Over 9,000 new diagnoses of cancer. And about 14,000 of that ten million will die, out of usual all-causes mortality. No one would notice. That’s now many people die and get sick anyway.
It will arguably be much worse than this initially because the the second group to get the vaccine, after health care workers, are likely going to be folks in nursing homes who would be expected to have much higher incidences of serious medical issues or death normally.
Credibility is important if the goal is getting widespread buy-in for a particular action. Playing games with the truth is destructive to credibility. It might work in the short term but works against your goals in the long term. This won't be the last pandemic and odds are that future pandemics will be worse. Destroying credibility to expediate the end of this pandemic ultimately will make the response to future pandemics less effective due to credibility destruction.
Simply tell the truth, the whole truth, and nothing but the truth. Word games, spin, and manipulation is ultimately self defeating. Stop doing it.
I have to complain for a little bit about the infantilism happening right now in America, especially with regards to vaccines. Likely I'll have two choices for a vaccine type, an adenovirus type from astrazeneca, or one of the mRNA choices. Well, time to do some research and find the one that's best for me and my family, right?
I tried googling a little bit about the various side effects for these vaccines to make an informed decision, and it's extremely hard to find any real documentation about short term and long term risks with these vaccines. They're basically scrubbed from the internet.
For example, the CDC page[1] for mRNA vaccines talk only of the benefits and not at all of any risks. The CDC page titled "Different Covid 19 vaccines" has pretty much no information at all[2].
One of the only places I can find good information is the University of Cambridge PHG foundation[3]. They list "benefits" and then "important challenges", as if even muttering the word "risks" will scare people away.
It seems everyone is in a panic that people are too stupid to act in their own self interest and get a vaccine, and therefore we have to coddle them or (worse) mind-hack them into acting differently. It's all so tiresome.
I'm struggling to the find the primary source for the statistics, but they've basically been the same short-term side-effects as you might get from a flu shot, but at slightly higher rates and and severity:
> The independent board that conducted the interim analysis of Moderna’s huge trial found that severe side effects included fatigue in 9.7% of participants, muscle pain in 8.9%, joint pain in 5.2%, and headache in 4.5%. For the Pfizer/BioNTech vaccine, the numbers were lower: Severe side effects included fatigue (3.8%) and headache (2%).
Typically these will be included on the official government sites once the vaccine is approved, so we should see it shortly.
As for long-term side-effects, none have been found. Long-term side effects (so things that may occur within a month or two of the vaccine, but last a long time) are extremely rare. You can really only say there have likely they've occurred in two different vaccines in the last 50 years, and even those were a tiny, tiny percentage (Like 0.001%) of the people vaccinated. Keep in mind billions of vaccines are given annually.
Long-term effects the are delayed in occurring past two months have never been found in the entire history of vaccines, so you won't find any data on it.
Thing is, you're leaving out the fact that mRNA vaccines are very different from vaccines we've used in the past. From wikipedia:
> Given the novel nature of the mechanism of action of RNA vaccines, and their drug delivery vehicles, little is known about the medium and longer-term side effects.
A large part of the issue with understanding the risks of mRNA vaccines is that they have literally never been done before.
On the other hand, some of the potential risks can be partially analyzed in terms of general principles.
mRNA vaccines consist of messenger RNA combined with some form of carrier (vector) to allow it to enter cells (most cells do not normally let external RNA enter them).
One in a cell, the mRNA will occasionally get picked up by a ribosome and used to make the protein it specifies. For mRNA viruses, this is usually a small portion of the viral shell that is distinct enough for the body to use to target the virus (antigen).
mRNA has relative short half-lives inside cells on the order of a few minutes to a day or so. (Larger sequences appear to generally have shorter half lives.) Thus it is not considered likely that the mRNA itself will be able to have any long term negative effects, since it will fairly rapidly get broken down in the body. Once the mRNA is gone, the cells will cease producing the protein in question.
Some Predictable Risks:
1. Unwanted effects of the carrier module.
2. the mRNA directly interacts with things in an undesirable way. (Either by binding to some other important RNA causing said other RNA to not function, or by the mRNA folding itself into some functional shape that harms things).
3. The resulting protein has some undesirable interactions with the body.
4. The resulting protein could misfold in a way such that it has undesirable interactions with the body. Even here, the effects are likely short term, although there exist ways it could become a long term effect. One theoretical way that could manifest is that it triggers misfolding in some unrelated protein into a prion configuration, thereby triggering a prion disease.
5. The normal risks associated with the activation of the bodies immune system. These are pretty much all possible with any vaccine, but specific attributes of a specific vaccine could make certain immune system risks more or less likely.
6. Other typical risks like contaminants in the vaccine.
All told, I personally suspect that in general the risks from mRNA vaccines will be lower than live or deactivated virus vaccines, including the adenovirus vaccine approach of putting the +ssRNA for the antigen in an unrelated virus that has been made unable to replicate. But obviously the risks of any specific vaccine can vary versus other vaccines of the same basic type.
With the exception of the UK, none of the vaccines are officially approved yet. So the official information on potential side effects simply does not exist yet. The known side effects should be listed in the instructions once the vaccine is approved.
General question to the community here. I have zero background in medicine or biology after high school. I barely understand the difference between virus and bacteria.
I read a lot of articles which dismiss anti-vaxxers as morons and anti-science, I have first hand seen the immense benefits a vaccine like polio vaccine has brought to India so I am all for more vaccines.
But what is the standard of evidence that X vaccine won't cause some harm to me ? Is is more formal proof but looking at the molecular structure of he virus, vaccines human biology and proving that only possible effect is on new anti-bodies and it won't bring any harm ? Or this is more about just ensuring vaccine meets FDA's guidance ?
I have lot more faith in science but next to no faith in FDA, CDC and other government bodies.
The standard is a phase III trial, in this case the trials were with around ~40,000 people each for the current vaccine candidates. Then you look at the observed efficacy and the observed side effects and decide whether the benefits are worth the side effects.
There is nothing even close to a formal proof here, that is simply far outside of what science can do today. In the end we always have to run trials and observe.
The other trouble is that these excellent trials will only be able to observe relatively immediate side effects. If there's other long-term side effects, they won't be detected for years or more.
While this is true, the Pfizer vaccine was created by essentially reverse engineering the SARS-COV-2 virus and copying a small section of mRNA from it in order to stimulate the body into creating antibodies. Unlike older methods of creating vaccines this has a much lower risk of side effects because only a harmless portion of the virus's genetic code that allows it to infect people is being injected, rather than deactivated virus cells. Pretty interesting stuff:
https://www.forbes.com/sites/alexknapp/2020/11/10/what-you-n...
There are a number of vaccines based on the older methods of creating a vaccine, including the J&J vaccine, but most are not as far along in the trial process.
> Unlike older methods of creating vaccines this has a much lower risk of side effects because only a harmless portion of the virus's genetic code that allows it to infect people is being injected, rather than deactivated virus cells.
That's exactly what I have a problem with: mRNA vaccines have never been approved for use in humans, and they're only getting an emergency approval this time. https://en.wikipedia.org/wiki/RNA_vaccines
Don't tell me it's 'pretty interesting stuff': tell me that we're not using an experimental drug that's not using a novel type of vaccine that's never been used in humans prior to this year, for which long-term side effects are pretty much unknown.
The mechanism for how these vaccines work is pretty straightforward, well understood, and quick acting. They trigger your immune system to be aware of a threat and train it to defeat that threat. This is something your body does fairly constantly with natural pathogens without any known delayed long-term effects.
This idea that there is some sort of known risk of a significant issue popping up out of nowhere months or years down the road has no historical precedent. The two modern (last 50 years) incidences where a vaccine may have caused a serious side effect in a statistically significant way [0][1] may have taken a little bit of time to be noticed, but it was because they were so statistically rare, not because the actual problem was delayed in occurring. Interestingly, both those incidents involved auto-immune illnesses which would have likely been much more likely to occur if the vaccinated folks caught the virus itself.
> The mechanism for how these vaccines work is pretty straightforward, well understood, and quick acting.
Before 2020, mRNA was only considered a theoretical or experimental candidate for use in humans. Sure, we have a theory behind the mechanism, but that's it. Your implication that we know all about what these novel, unfamiliar mRNA vaccines will do is flat out wrong.
> This idea that there is some sort of known risk of a significant issue popping up out of nowhere months or years down the road has no historical precedent.
That's because there's almost no precedent at all.
> This idea that there is some sort of known risk of a significant issue popping up out of nowhere months or years down the road has no historical precedent.
RotaShield [0] was a vaccine for the rotavirus that was released in 1998 and taken off the market in 1999 because of intussusception (bowel folding on itself). 5 cases of this issue occurred during during trials of 10,054 participants, which was deemed "not statistically significant". After the vaccine was licensed and widely distributed, the CDC determined the risk of this complication from the vaccine was 20 to 30 times over the expected risk and the vaccine was pulled off the market.
If you ever feel the need, remember that US patients can report any adverse event using the HHS Vaccine Adverse Event Reporting System. That way you can ensure your reaction is counted in all statistics, reporting, etc.. But to be clear, filling in a VAERS report does not substitute talking to your doctor if you feel sick.
I'm also in the "why don't you take it first" group personally because I'm not at very high risk personally. But my 80-something mother is bucking the vaccine and she should absolutely take it ASAP because of her age and comorbidities, but here we are.
Yeah, also get ready for real side effects that will simply be dismissed by doctors. And I say this as someone who will go get vaccinated as soon as it's available.
You're being downvoted without comment, the implication being that calling the safety into question is heresy and that all vaccines are 100% free of side effects.
I am NOT an anti-vaxxer by any means so hold your fire, you who downvote.
When we don't admit of nuance it makes us just as dogmatically blind as the anti-vaxxers. I think the framing here is really: "who cares what the side effects are, anything in service of a cure". That's fine and all things considered I agree with it. But that's what it is. There very well could be some long-term ill effects. To deny it is ignorant at best, dishonest at worst.
There's a reason why https://vaers.hhs.gov exists for example. Have some intellectual honesty and we'll make greater strides in getting more people vaccinated in the long run.
The article reads more like "brace yourselves, morons are coming".
And I understand where this is coming from. But having had absolutely terrible experience with doctors first hand, I just don't like how people's concerns are dismissed. Take an ibuprofen, you'll be fine.
And I get it, they have to deal with a lot of people, all with their own opinions, many of which are indeed wrong.
But that results in a rather sizeable minority of people who aren't getting the care they need. And worse, they can't just go and do something about it on their own, even if they take full responsibility, everything is tightly controlled.
Billions of people will receive the vaccine. I am quite sure there will be real side effects in a sizeable number of people (I hope I'm wrong, really). And I have no doubt that in many parts of the world, they'll be dismissed, ridiculed and laughed at.
These otherwise normal people are marginalized and then join the more radical movements as they try to make sense of everything.
I've been saying we need public funded PSA's against conspiracy theories, and not just dry science talk. Address all the points the conspiracists make, it may not change the minds of the hardcore believers, but it will help the "moderates" not fall deeper into the hole.
"And I get it, they have to deal with a lot of people, all with their own opinions, many of which are indeed wrong."
This is a great point, but it's important to keep in mind that many medical professionals INSIST that you get your healthcare from them.
If you're going to force people to obtain their healthcare through the system you run, then you are obligated to address all their concerns.
But this is impossible. That is why medical freedom is so important. Medical freedom as in the ability to choose your own insurance, decline medical treatments, or pay out of pocket for whatever test or treatment you desire.
That's exactly what I meant with "And worse, they can't just go and do something about it on their own, even if they take full responsibility, everything is tightly controlled."
You're right, there will always be a minority who will suffer in anything at this scale. But like LGBT+ rights, for example, perhaps there's something that can be done about it.
Oh, I'm not afraid of reports of heart attacks a week after being vaccinated. I'm afraid of developing cancer 2 years later, which another 2 years later will be confirmed to be side effect of the vaccine. That's why normally clinical testing any drug takes years - to give long-term adverse effect the time to show.
Totally agree. Coming from a family with a medical background, I'm fully aware this is a major consideration. It'll be interesting to see if you remain downvoted.
We know some degree of them will be false because there is already a widespread political movement against vaccines in general, and COVID-19 procedures specifically.
We know that all reports of side-effects will be false because the emotional and political implications if any of them were to be true are just too much to bear.
e can say with 95% certainty that this 5% of symptoms are caused by the vaccine...
I'm sure the stupid is going to be on full display as this thing rolls out. Beyond requiring doctors, teachers, public school children, etc to take the vaccine if they want to keep their jobs or stay in school, what else can we do to encourage those who are bad at math to take it?
Be less condescending. People don’t learn from people they dislike.
Edit:FWIW - I upvoted your comment to keep it visible. We should try to be aware when our own behavior reinforces the very behaviors in others we seek to change.
Interesting how this vaccine's side effect (which are real as per studies, most people have headaches, myalgia, etc...) are already dismissed as "false" but any "long term COVID" symptom which can 100% be explained by anxiety due to the constant fear mongering and propaganda is 100% real
>Specifically, if you take 10 million people and just wave your hand back and forth over their upper arms, in the next two months you would expect to see about 4,000 heart attacks. About 4,000 strokes. Over 9,000 new diagnoses of cancer. And about 14,000 of that ten million will die, out of usual all-causes mortality. No one would notice. That’s how many people die and get sick anyway.
So why is it all year long the world has been operating the complete opposite to this?
Why is it every covid death with a comorbidity was classed solely as a covid death and why is it every couple hundred deaths in places with populations of millions was treated as such a big deal if now we shouldn't be so worried about 14000 deaths in 10 million and shouldn't be in a rush to attribute side effects to the vaccine?
All year long there's been a rush to attribute everything to covid. All year long every death has been a massive deal.
Now it's the entire opposite to everything everyone's been saying all year because...vaccine?
If you knew how comorbidity worked then you would know why. All potential health issues are listed, but that doesn't mean they're all viable. Also if you die from lung complications, that will also be listed on there even if it was brought on by covid.
At the end of the day there's still only one cause of death. If it's covid then that counts as a covid death.
I believe you've got it backwards. Many deaths that were probably attributable to COVID-19 were not recorded as caused by it. Excess mortality is much higher than reported deaths due to the disease. In the US some of this was caused by the fact that many COVID victims were just found already dead at their homes in places like New York.
Yeah...and the article in the op is saying we shouldn't rush to attribute excess deaths to the new vaccine.
Yet all year it's been the opposite with covid. Why have we been attributing every excess death to covid but we shouldn't be in a rush to do the same with the vaccine?
The deaths the OP references are specifically NOT excess. An effective vaccine would reduce the number of excess deaths. No one is saying we start ignoring those when the vaccine rolls out, if anything we should watch the number even more closely to make sure it is working.
> Yeah...and the article in the op is saying we shouldn't rush to attribute excess deaths to the new vaccine.
That's NOT what the article is saying. Excess deaths are those beyond what are to be expected. The article specifically is saying not to attribute the many, many usually expected deaths to the vaccine.
The article's own words:
> And about 14,000 of that ten million will die, out of usual all-causes mortality.
"A nocebo effect is said to occur when negative expectations of the patient regarding a treatment cause the treatment to have a more negative effect than it otherwise would have.[1][2] For example, when a patient anticipates a side effect of a medication, they can suffer that effect even if the "medication" is actually an inert substance."
https://en.wikipedia.org/wiki/Nocebo
This can even manifest as a "communicated disease", a disease you only get after someone tells you about it. The classic is "Wind Turbine Syndrome". If people are told that a vaccine will do them harm, the combination of these two physiological forces can result in very real negative symptoms.