As Vaccines Are Rolled Out, Get Ready for False Side Effects

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.

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?

If it did, physicists everywhere would be unable to communicate. Hand-wavy explanations are essential!

> “First, do no harm.” Isn’t it irresponsible to ignore people’s reports of side effects?

The health debate seems to have shifted to mostly politics.

There is no "first, do no harm" principle in medicine. And for good reason, it's a bad principle.

Not when they're in bad faith.

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.

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)

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.

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.

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.

https://en.wikipedia.org/wiki/RNA_vaccines

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.

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.

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.

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:

https://www.sciencemag.org/news/2020/11/fever-aches-pfizer-m...

> 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.

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.

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.

People in the UK can use the Yellow Card scheme run by MHRA: https://yellowcard.mhra.gov.uk/

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.

It's like the trolley problem what would you do as a doctor.

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.

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 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.

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.

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.

We have excess mortality as a metric to help us determine the cause of the bulk of these deaths:

https://ourworldindata.org/excess-mortality-covid

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.

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.