Covid winter spike starting

Investment Analysis Clubs Macro Economic Trends and Risks
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The data are derived from the studies used to gain approval of the RNA vaccines. Groups were either given the vaccine or a placebo and the number who developed Serious Adverse Events (SAEs) were counted. The data was normalized to 10,000 for ease of comparisons. To explain the Pfizer results:

"“The Pfizer trial exhibited a 36 % higher risk of serious adverse events in the vaccine group; risk difference 18.0 per 10,000 vaccinated (95 % CI 1.2 to 34.9); risk ratio 1.36 (95 % CI 1.02 to 1.83)."

With the Pfizer vaccine more developed SAEs compared to the placebo group. As in any study there is variation in the results, which when quantified showed that the number of additional SAEs could range from 1.2 to 34.9 with 95% statistical confidence, with 18 the most probable. The 36% higher risk put in numbers means that 50 out of 10,000 from the placebo group showed SAEs compared to 68 out 10,000 for the Pfizer vaccine—(68-50)/50 = 0.36. The risk ratio is Pfizer/placebo (68/50) = 1.36. Again, when taking into account observed variability, this ratio ranges from 1.02 to 1.82 at 95% confidence. The same goes for the Moderna data.

Note that the statement: " Combined, there was a 16 % higher risk of serious adverse events in mRNA vaccine recipients" does NOT mean 16% of vaccinated get SAEs. It means there is a 16% higher risk compared to those vaccinated with no RNA. The frequency of SAEs was relatively low, <100 per 10,000.

Also worth noting one conclusion of these authors who made a quick and superficial risk assessment just to provide some context to the data (AESI means adverse events of special interest which simply means bad stuff that from their biology are likely to be a direct result of the specific vaccine):

In the Moderna trial, the excess risk of serious AESIs (15.1 per 10,000 participants) was higher than the risk reduction for COVID-19 hospitalization relative to the placebo group (6.4 per 10,000 participants). In the Pfizer trial, the excess risk of serious AESIs (10.1 per 10,000) was higher than the risk reduction for COVID-19 hospitalization relative to the placebo group (2.3 per 10,000 participants)….[this data is summarized in the Discussion as:] Rational policy formation should consider potential harms alongside potential benefits. To illustrate this need in the present context, we conducted a simple harm-benefit comparison using the trial data comparing excess risk of serious AESI against reductions in COVID-19 hospitalization. We found excess risk of serious AESIs to exceed the reduction in COVID-19 hospitalizations in both Pfizer and Moderna trials.". Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults - PMC

So they cautioned that for most healthy individuals using hospitalization as the metric, the data shows a possible greater risk from the vaccines than from Covid at the time of the analysis.

I want to emphasize that this is only one study of what will likely be many that are analyzing the data coming out of the pandemic. No doubt there will be some that disagree. Just keep in mind that the development and deployment of the Covid RNA vaccines were unprecedented in their speed so there is much less data on secondary effects than typical for vaccines. I am not saying the vaccines are dangerous, I’ve had three jabs of Moderna. But it may be prudent to consider the possible risks of future boosters to a Covid disease that appears to be becoming increasingly more mild.

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Also good to keep in mind that it would be a mistake for anyone to infer from this statement that development of the specific Covid RNA vaccine didn’t begin totally cold from a “standing start” when * we * first got to hear of this novel virus early 2020 (I’m sure it wasn’t the poster’s intent to imply this but a lot of folk have glommed onto that notion already and it’s dead easy for the unwary to jump to erroneous conclusions from throwaway remarks.

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That is likely because it is mostly the elderly dying of COVID
that appears to be the situation within the USA.

Deaths are concentrated in the 50+ year olds.
50-64-194146–~18.4%
65-74-240399–~22.7%
75-84-273371–~25.9%
85±276783–~26.2%
US total deaths 1,056,002

for the State of New Mexico
50-59-12.94%
60-69-18.21%
70-79-19.97%
80-34.55%

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Just to clarify, it is not the RNA technology that is concerning. It is the lipid nanotech delivery system and the resulting possibility of overexpression of the Spike protein in certain tissues, both of which are complications specific to the Covid RNA vaccines. The evidence is conflicting though some recent studies (linked above) indicate reasons for concern.

It is also because European regulators are concerned that too many Covid boosters are exhausting the immune system.

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Let me start with a sincere thank you. Understanding statistics-speak is well out of my wheel house. My couple of classes in statistics were a very long time ago.

How can one have a Severe Adverse Event from a placebo? Ok - I suppose things related to the injection itself are possible. Like soreness at the injection site or some infection. Is there any indication of what they actually counted as a SAE?

That seems like a pretty wide interval to get to 95% confidence. There might be two additional SAEs, there might be 34. That would be a wide and flat curve. Any idea how that compares to other common vaccines, like the flu or shingles or others?

Let’s see if I’m getting this right. The difference of 18 is the central estimate from the previous snippet. The actual number of additional adverse events is between 1.2 and 34.9 per 10,000 vaccinations, with 95% confidence. And just the act of poking you with a needle and injecting a similar amount of salt water is estimated at causing problems for 50 people per 10,000.

That seems to be saying that risk of SAEs from just having an injection is higher than the risk added by actually injecting the vaccine. Running the math, that would mean that 50/10,000 or 0.5% of people are expected to have a bad reaction to being poked with a needle. And if you actually inject a vaccine with that needle poke, an additional 18/10,000 or 0.18% of people will also have a bad reaction.

That sounds like the vaccine is pretty safe to me. The main risk isn’t in the vaccine, it’s in the delivery mechanism.

–Peter

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So you would be OK driving without a seat belt because you have a car with air bags?

Mike

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This should be the headline of any article trying to explain the stats to the public
Well said, Peter.

I came to the same conclusion when reading btresist’s post before I got to your reply. But the problem is that when people hear that getting any shot, even a placebo has “some” risk it might turn them off to getting any vaccine as a shot. Maybe the industry needs to work on the oral and nasal delivery mechanisms more.

Mike

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Which probably have their own risks … :grinning:

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That sounds startlingly like something the anti-vaxxers repeat ad nauseum WRT childhood vaccines…“too many, too soon” weakening the immune system etc. Hopefully something gone wrong in the translation there…sounds a bit anti-science otherwise.

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That’s not so much a blanket statement - more like a statement of my understanding of the statistics to see if I actually understand at least a portion of the statistics.

I’m still questioning how you can have a significant adverse effect from a placebo. I assume the placebo would be basically salt water, which should be inert. Problems with the placebo would have to boil down to issues like sterilization. Was the needle properly sterile? Was the saline properly sterile? Was the skin properly sterilized before the injection? Any of those could introduce some pathogen through the skin (which is a pretty good defense from pathogens on it’s own).

Does the person have some allergy to something in the saline? An allergy to something in the needle or syringe or something the medical professional was using to touch the person? Is it just plain old human error and they got the vaccine instead of the placebo? Or human error in keeping things properly sterile? Keeping sterile is hard. And it’s never really perfect, at least not once a living human enters the room.

And then there’s the placebo effects. If you think you got a vaccine, can your mind convince your body to react as if it did get a vaccine? Or at least to demonstrate some common side effects? Can you confuse soreness from bumping into a doorway with soreness from the injection?

It would be interesting to know how adverse effects happen in the placebo side of the control group.

–Peter

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It is the power of the mind. The “placebo effect” is well-studied phenomenon where a patient feels better if they think they are being treated even if the treatment is a sham. There is also negative placebo effect called the “nocebo” where a patient will feel the side effects of a drug even if given a sugar pill.

This is biology. Living things are highly variable. Think about this for a bit. The vaccine effect is being compared to the nocebo frequency. The likelihood of a nocebo probably depends on how aware the patient is of possible negative side-effects and their susceptibility to the power of suggestion. High variability isn’t surprising. What is important is that despite this high variation, they were able to get a statistically significant difference.

The Covid RNA vaccines ARE safe. They are just not without risks. All vaccines have some risk. In fact, all medical treatments have some risk. This is why one should avoid needless medical treatments. It is a personal decision as to whether a medical treatment is necessary. And while the risk of an individual shot is small, how many boosters are you planning on taking over the next few months/years? The risks add up after a while.

Just keep in mind that the Covid RNA vaccines are new technology and that the current program of boosters every few months is unusual. It is also the case that all Covid vaccines tested have other odd impacts such as temporarily increasing the length of the menstrual cycle. The effect is minor and not anything to worry about, but it suggests that we don’t fully understand the biology of what happens with the Covid vaccinations. That adds a bit of uncertainty to the risk assessments.

It is not anti-science. It rather reflects what some feel is the lack of science demonstrating the effectiveness of frequent boosting for those not at high risk of Covid, and the possibility of negative consequences of frequent boosting. From the Harvard School of Public Health:

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I can well accept that the law of diminishing returns kicks in with a virus that appears to be evolving to a less aggressive form… along with a consequent change in risk:benefit ratio… but “because it weakens the immune system” should not factor into the discussion. Anyone attempting communicate scientific rationale to the public … along with anyone using their utterances in a Gish Gallop of link dumping … should be a little more accurate in their choice of words.

On the subject of Placebo/Nocebo effects…yes, they are very real. However if these are being included in a seemingly official looking list of reported adverse events and such a list is being used to inform public health policy then there’s very poor oversight of said list.

Anti vaxxers quote heavily from the VAERS list of adverse events…

This sounds like an eerily similar situation.

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I suspect that the database is complied from self reported events as well as medically documented much like the VAERS reporting.

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Additionally. I’ll point out that a publication that been quotedtwice…

…has a among its authors two folk who have a strong history of uttering anti vaxx sentiments (not just Covid) on public media sites along with more august journals.

Peter Doshi has a track record dating back to the mid aughts of attempting to show the the Pharma industry is in cahoots with the CDC and other agencies to inflate flu related death rates to increase demand for vaccines. I’ve read something similar from the first author (he’s on Twitter a lot apparently)

Doesn’t mean that this article is a result of the sort of cherry picked data that has been used to power their argument in the past but, with such a strong track record, it’s good to be aware that such might very well be the case here.

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The same way people have an “adverse effect” from something they think they got–but actually do not. It is psychosomatic.

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Not sure what you mean here. This is from the linked paper: "

> The definition of a serious adverse event (SAE) was provided in each trial’s study protocol and included in the supplemental material of the trial’s publication. Pfizer and Moderna used nearly identical definitions, consistent with regulatory expectations. An SAE was defined as an adverse event that results in any of the following conditions: death; life-threatening at the time of the event; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; a congenital anomaly/birth defect; medically important event, based on medical judgment." https://www.sciencedirect.com/science/article/pii/S0264410X22010283?via%3Dihub

He has strong opinions, but do you have any evidence that he is acting unethically or that the data in his paper are inaccurate?

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No, but if the data include adverse events that could be due to a nocebo response … and you were the one who introduced this as a explanation to a question upstream … this would be misleading to the casual reader who possibly doesn’t read further than the headlines, wouldn’t it.

Your response prompted me to look for some examples of Doshi’s covert anti vaccine writing for any other readers to judge whether this article was more of the same. I found this Snopes-like article instead.

Something I hadn’t thought about but pointed out by folk with a more analytical view than I have was that the length of the time frame for data collection was a short period after the 2 nd dose of both vaccines (a median of 2 months). A time frame which is when most of the adverse events would occur … especially those that prompt self reporting. The measurable benefits of vaccination … reduction in frequency and severity of covid infections, hospitalizations etc … obviously manifest themselves over a much longer time frame. This produces a big discrepancy in the apparent risk:benefit ratio. A disingenuous oversight by the authors, if ever there was one.

Edit: as much as I find Gish Gallop/link dumping tedious to read through I’ll do the same with a more extensive peer review type analysis of Doshi’s paper. From a link within the above link and by someone with better critical thinking skills than I…

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A little more on the credibility of Peter Doshi and his pretensions to expertise in virology, epidemiology etc. I had no idea that Doshi’s paper had been as widely circulated as it has (another reason the Pandemic board shouldn’t have been axed).

Of course, we’ve had Real World evidence since the preprint was first circulated that mortality/morbidity from Covid in the unvaccinated is much worse than in the paper.

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Good, at least now you critiquing the content of the research rather than attacking the politics and character of the people doing the research. That at least provides some perception of objectivity, though I think it very unlikely that you are in fact objective.

Keep in mind certain obvious facts. First, the trials testing the vaccines prior to approval occurred abnormally fast. That doesn’t mean they are inaccurate, I think they are valid. But the possibility has to be considered that they may not have been as comprehensive as standard clinical trials for vaccines that often take several years to complete. Second, the more recent Covid boosters were released without human trials. Third, serious adverse events are known to occur after vaccination at frequencies higher than controls and while these are rare relative to the general public it remains uncertain whether different groups may be more at risk than others. Fourth, asking people to take multiple vaccinations for the same disease over such a short period of time is unprecedented, so it isn’t known how the immune system will respond to such stimulations.

I don’t necessarily agree with Doshi. To be honest I don’t follow him much. But from what I have read I think he is asking worthwhile questions, including how frequently do serious adverse events occur after vaccination for different demographic groups.

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I think you’re venturing into Straw Man territory a bit here. Pointing out that authors’ tendencies to indulge in using social media to promote anti vaccine sentiments is hardly attacking their politics and character. Well, not their politics at least.

To the point that the pre approval studies were abnormally fast…the explanation for that is given in the more specific critique of the article. A cut off point for numbers in the placebo arm who contracted Covid (because they were unvaccinated, obviously) was predetermined. That number was reached by the 2 month mark and the studies terminated. That isn’t at all unusual in clinical trials, BTW…when potential for harm becomes evident or when benefit is undeniable. You can be influenced by Doshi’s argument that the benefits weren’t there (even though such benefits would only materialise…and, I fancy most would argue have done…with the passage of time) However, since the consequences of doing nothing (the placebo arm) showed themselves very quickly in the form of unacceptably high numbers getting infected, that would certainly constitute “harm” in any regulator’s mind.

The fact remains, the pre print for this publication apparently began circulating early last year and gained traction within the anti vaxx community back then (with Doshi’s help, no doubt) That it’s still being promoted my him and the first author as if some malfeasance was afoot back then and, in spite of accumulated evidence that the vaccines are incredibly low risk and the consequences of not vaccinating so dire, they don’t modify their message goes a long way to diminishing their credibility…and anyone who cites their work, come to that.

I can well believe that you haven’t read much by Doshi…including, I suspect this article in full. Why else would you cite it 3 times from 3 different sources… for all the World as if they were 3 independent sources confirming the notion that there was something iffy about the pre approval studies. That hardly smacks if objectivity.

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