12 ms·

Study: Chances of serious side effects from coronavirus vaccines

140 points by EGreg 4y ago

t0bia_s 4y ago
So it was a hoax 2 years ago. Now we have studies for that. But media still wont talk about it. Instead our government plans to distribute 4th dose in spring because they already bough 17 milion doses for 10 milion people. From Pfizer with unknown prices and hidden contracts. In time of inflation caused by lockdowns and energy crisis. I'm not surprised that people are on streets, despise the government and do not trust any traditional media.
deleted 4y ago
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hprotagonist 4y ago
Pfizer and Moderna mRNA COVID-19 vaccines were associated with an excess risk of serious adverse events of special interest of 10.1 and 15.1 per 10,000 vaccinated over placebo baselines of 17.6 and 42.2 (95 % CI -0.4 to 20.6 and -3.6 to 33.8), respectively. The placebo groups for the pfizer cohort and moderna cohort differed in baseline rate by the same magnitude (~25/10000) as the observed effect. At best, that’s really noisy data.
- cyanydeez 4y ago
  What's important for the discerning paranoid: _chances_
- shadowgovt 4y ago
  Right. If I'm understanding those stats correctly, they indicate that even if a patient has an adverse reaction after taking the vaccine, the odds are >50% the reaction is caused by something else.
- aix1 4y ago
  Yeah, I do wonder what might have caused such a massive difference between the two placebo groups (17.6 and 42.2 per 10K). Small samples? The confidence intervals look pretty wide.
  - em500 4y ago
    Here's the full paper: https://reader.elsevier.com/reader/sd/pii/S0264410X22010283 https://reader.elsevier.com/reader/sd/pii/S0264410X22010283 As I understand it, these are results from two different trials done separately by Pfizer and Moderna, with slightly different protocols and reporting standards: "Moderna reported SAEs [serious adverse effects] from dose 1 whereas Pfizer limited reporting from dose 1 to 1 month after dose 2." "For reasons that are not documented in the trial protocol, Moderna included efficacy outcomes in its SAE tabulations, while Pfizer excluded them. As a result, Moderna’s SAE table did not present a traditional SAE analysis but rather an all-cause SAE analysis. " Thus, only numerical comparisons between treatment and control within the same trial are valid (assuming proper randomization), not between the two trials.
    - rurban 4y ago
      https://www.sciencedirect.com/science/article/pii/S0264410X22010283?via%3Dihub https://www.sciencedirect.com/science/article/pii/S0264410X2... Pfizer reported serious adverse effects in 127 vaccine and 93 placebo. Moderna reported serious adverse effects in 206 vaccine and 195 placebo. => Headline: "Serious adverse events of special interest following placebo vaccination in randomized trials in adults"
    - LorenPechtel 4y ago
      Normally there aren't competing drugs racing to market, thus the FDA doesn't have any system in place to ensure apples-to-apples comparisons in a case like this. Each company decides it's test protocols and gets FDA approval, they aren't working in cooperation.
  - LorenPechtel 4y ago
    The number of test subjects isn't small, but the number that have something bad happen is small (they're not going to accept test subjects with obvious, serious problems because that makes the data noisier.) Reducing noise means increasing the sample size--to get clean data here you would need a truly huge test group. I wouldn't be surprised if you would have to use the whole nation as your test group--and what's the point??
- PragmaticPulp 4y ago
  > At best, that’s really noisy data. This is the reality of measuring rare events among moderately large groups of people. It’s also possible that any number of unexpected cofounders could have occurred for a small group of people receiving the placebo doses in one segment, such as a small number of placebo doses having an unexpected issue. Impossible to say, which is why large numbers of people are necessary in trials exploring relatively rare events like this. Regardless, there doesn’t appear to be cause for concern among any of their observed serious events during the study period.
  - hprotagonist 4y ago
    indeed.
  - nerdponx 4y ago
    Is it possible that the data was tampered with? We are in the midst of a scientific fraud crisis and there are powerful interests heavily invested in making sure this result comes out negative or inconclusive. For those about to downvote me: my general (but unscientific) opinion is that it doesn't make sense for the covid vaccine to be riskier than covid itself. But as a society we have shown that even "technical" people like researchers and scientists are willing to fudge, ignore, or misinterpret data for various political or personal purposes, not to mention that doing so in domains outside of public health is common practice in academia. So I believe it's only prudent and rational to be extremely skeptical of anything that looks "off".
    - origin_path 4y ago
      Not only possible but proven. There are cases where people who suffered extremely severe adverse effects right after vaccination, were recorded by the trial operators as having minor ailments or even having had COVID despite negative tests, e.g. as in this case: https://dailysceptic.org/2022/05/23/concerns-of-fraud-in-pfizer-vaccine-trial-as-participants-hospitalisation-with-heart-inflammation-is-swept-under-carpet/ https://dailysceptic.org/2022/05/23/concerns-of-fraud-in-pfi... Another similar problem in which a trial participant appears to have died a day or two after taking the shot, but it was ruled unrelated (by Pfizer!): https://igorchudov.substack.com/p/pfizer-study-subject-c4591001-1162 https://igorchudov.substack.com/p/pfizer-study-subject-c4591...
- gus_massa 4y ago
  >> (95 % CI -0.4 to 20.6 and -3.6 to 33.8) > At best, that’s really noisy data. Yes. That's exactly why each of the confidence intervals have a negative and a positive extreme. If there is a real effect, it's below the noise level.
  - ponow 4y ago
    The fact that the confidence intervals for the excess risks aren't roughly symmetric around zero, but rather biased to mostly positive, is worrying. Most of the probability is for positive excess risk. If it were just noise, wouldn't we expect the excess risk CI's to be roughly centered around zero?
    - benjaminwootton 4y ago
      The fact that benefits are not an absolute slam dunk over risks is also worrying given the coercion that was used to get people to take these vaccines.
      - hprotagonist 4y ago
        that metric is not quantified here.
      - cortesoft 4y ago
        This study doesn't talk about benefits at all.
        josephcsible 4y ago
        Isn't "the risk reduction for COVID-19 hospitalization" a benefit?
        Arnt 4y ago
        "A" benefit? I'd say no. It's a wide range of benefits ranging from "not spending a night in hospital" to "surviving". If you know that the benefits and risks result in similar distributions of the risks, then you can just compare the numbers. If not, you have to check the distribution first.
jdsleppy 4y ago
It looks like the largest effect found (from reading only the summary) is how many more adverse effects the Moderna placebo causes compared to the Pfizer placebo. Given that, I won't regret my vaccinations just yet.
- shadowgovt 4y ago
  Clearly, we really need to improve quality control on the Moderna placebo. /s
- smt88 4y ago
  There has been decent research showing that a lot of Covid vaccine side effects appear when subjects are given placebo, which indicates that the subjects expected the side effects. So we may someday discover that vaccine misinformation causes people to experience imaginary negative effects from vaccines or placebo.
  - ceejayoz 4y ago
    I'm not sure why this is downvoted; it's almost certainly the case. Many of the folks who fainted shortly after vaccine administration were probably in this category.
  - goda90 4y ago
    I read too much FUD about the vaccines before my Moderna booster, particularly the myocarditis in younger men results. Started feeling tight chested and a lump in my throat later that day after the vaccine. Finally went to urgent care after a day or two and got an x-ray and EKG and it showed nothing of concern. Doctor suggested it was probably anxiety, suggested taking an NSAID and relaxing and I was better pretty soon after.
  - Terretta 4y ago
    There was considerable chatter among the “vaccine hesitant” about Pfizer being “better” than Moderna, which could play into your point.
    - 4y ago
Havoc 4y ago
> adverse events of special interest. This feels like we’re looking at some sort of subset rather than overall risk profile? Don’t think anyone was expecting vaccines to be entirely risk free.
- aaa_aaa 4y ago
  Yet they (Government, CDC and media) downplayed it blatantly. They certainly made people believe forcing it to young people (<40), especially teenagers and kids was ok. Risks were higher than benefit and it was obvious from the data.
  - Bud 4y ago
    - aaa_aaa 4y ago
      Universities or government institutions (including Army) did not allow working or studying without a vaccine. This is forcing. Also numbers are out there. It is laughable people comes with "alternative was dying" argument for young people.
      - ceejayoz 4y ago
        Joining the army and complaining you’re being forced to do something seems… odd.
        jonnycomputer 4y ago
        Fair, re military. But at my government job as a programmer at a university I was "forced" to vaccinate as well (unless I wanted to change jobs). I didn't mind, personally. But the descriptor of "forced" is pretty accurate. And not just jobs. Heck, I went to a concert and had to prove vaccination status. I think that requiring vaccination was justified at the height of the pandemic. It is unfortunate that the vaccines were not more neutralizing/preventing. I've had three doses and got the virus twice. I ended up being okay; my unvaccinated brother-in-law very much not okay. Like most people do, I have relatives who either died or were severely disabled by covid.
_448 4y ago
One more thing that bothered me was that lot of medical staffs world over were not informed about aspiration for intramuscular injection.
- Bud 4y ago
  But they're certainly aware of the general issue. Also, there does not appear to have been conclusive evidence that aspiration was warranted, especially not in 2020. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8783631/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8783631/
- core-utility 4y ago
  Additionally, many doctors have said that 2 weeks between shots was too quick and would not be enough time for the first shot to "primer". 2 weeks acted more like a single larger dose than 2 spread out doses. Edit: My memory failed me, the spacing was 3 weeks and 4 weeks (Pfizer and Moderna respectively). Point still stands though. Ref: https://www.medpagetoday.com/opinion/marty-makary/94315 https://www.medpagetoday.com/opinion/marty-makary/94315
  - belltaco 4y ago
    What vaccine was given with 2 weeks between shots?
    - core-utility 4y ago
      Updated my original comment, I thought it was 2 and 3 weeks, not 3 and 4 weeks.
cpcallen 4y ago
Am I correct in reading this that the Pfizer vaccine was associated with fewer serious side effects (as defined) than the Moderna _placebo_? It seems plausible that both vaccines cause slightly more serious side effects than their corresponding placebos (30–60% more if I understand correctly), but it's hard to know how meaningful this result is when one of the placebos is 2.5x more 'dangerous' than the other placebo.
- deleted 4y ago
  [deleted]
- PragmaticPulp 4y ago
  > Am I correct in reading this that the Pfizer vaccine was associated with fewer serious side effects (as defined) than the Moderna _placebo_? Given the small differences and wide confidence intervals, the correct interpretation is that the incidence of side effects isn’t really significantly different than placebo. Or you could look at the numbers and decide that given the noise of the data that a massively larger study (10-100X more people) would be necessary to discover any practical differences, should they exist.
- vannevar 4y ago
  Not according to this part of the result: "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). The Moderna trial exhibited a 6 % higher risk of serious adverse events in the vaccine group: risk difference 7.1 per 10,000 (95 % CI -23.2 to 37.4); risk ratio 1.06 (95 % CI 0.84 to 1.33)." This seems to contradict the first sentence, which implies Moderna is worse: "Pfizer and Moderna mRNA COVID-19 vaccines were associated with an excess risk of serious adverse events of special interest of 10.1 and 15.1 per 10,000 vaccinated over placebo baselines of 17.6 and 42.2 (95 % CI -0.4 to 20.6 and -3.6 to 33.8), respectively." I'm not sure how to reconcile the apparent contradiction, perhaps others understand what's being said?
  - EGreg 4y ago
    What it’s saying is that in both cases the unvaccinated group had less risk from not taking the vaccine than taking it. The placebo isn’t relevant, just the fact they didn’t take the vaccine. Since it’s randomized, it’s unsurprising that both groups of unvaccinated people had diff risk outcomes. What IS surprising is that the vaccine performed worse than both random groups of unvaccinated people.
aix1 4y ago
> Combined, there was a 16 % higher risk of serious adverse events in mRNA vaccine recipients: risk difference 13.2 (95 % CI -3.2 to 29.6); risk ratio 1.16 (95 % CI 0.97 to 1.39). I am not a statistician, but isn't this saying that there's not enough data to reject the null hypothesis (that the risk difference is 0 and the risk ratio is 1.0) with 95% confidence?
- LorenPechtel 4y ago
  Not a statistician, either, but that's my understanding also. If your CI includes 0 you take the null hypothesis.
aceazzameen 4y ago
What kind of serious adverse events are they?
- somenameforme 4y ago
  In the paper [1] they're all listed. The most common, by far, were "coagulation disorder" or "other forms of acute cardiac injury". The give examples of the former as including pulmonary embolism, acute myocardial infarction, immune thrombocytopenia, and disseminated intravascular coagulation. [1] - https://www.sciencedirect.com/science/article/pii/S0264410X22010283 https://www.sciencedirect.com/science/article/pii/S0264410X2...
  - Madmallard 4y ago
    So basically life threatening severe problems, nice.
jonnycomputer 4y ago
Assuming (for the sake of argument) that covid vaccines were more harmful than typical vaccines, I have a few questions [based entirely on my ignorance]: 1. Were the doses too high? or ... 2. It is something about what was being vaccinating against, or ... 3. the mRNA technology mRNA vaccine technology seems to be really exciting; what might be done to make them safer? or is there really not special risk to that technology at all?
- m348e912 4y ago
  Here's an interesting theory to consider. The covid-19 vaccines are intended to administered intramuscularly. The resulting immune reaction is intended to be localized to that area and generally the expected result is some localized discomfort (and the creation of antibodies) -- so far so good, right? Medical professionals are recommended to perform a technique called intramuscular aspiration. It helps ensure the vaccine is delivered to a localized area. The technique involves injecting the needle, sucking back on the syringe slightly and looking for blood. If there is no blood, push the contents of the syringe into the muscle and complete the vaccine administration. If during aspiration there IS blood, it means the needle may have hit a vein or artery in or near the muscle. At that point, administration should be stopped and the medical professional should re-administer the vaccine in a different location. Here is the theory: Intramuscular aspiration has not been consistently practiced. A certain percentage of covid-19 vaccinations have not been administered locally, but into the circulatory system via a vein or artery. This is not how the vaccine was designed to be administered, and it's not fully clear on what (if any) negative affects may result.
  - jonnycomputer 4y ago
    Interesting. Given how many people were giving out shots, wouldn't surprise me at all if best practices were not adhered to.
    - LorenPechtel 4y ago
      And my first two were definitely by people that weren't exactly routine injectors and I think one of my wife's shots was placed too high.
somenameforme 4y ago
The most critical section from the paper [1]. AESI = Adverse Event of Special Interest: --- 3.4. Harm-benefit considerations 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). --- [1] - https://www.sciencedirect.com/science/article/pii/S0264410X22010283 https://www.sciencedirect.com/science/article/pii/S0264410X2...
- TechBro8615 4y ago
  Now stratify it by age and gender and see where everyone fits. Does it lead to the conclusion that a course of multiple injections reduces the risk of hospitalization for the average individual in each band? Personally, I only followed the data for my own band, which was generally stratified as “Male 18 - 40.” I did not see any data that convinced me to begin a course of mRNA injections.
  - gnarbarian 4y ago
    I got j&j because I would have lost my job otherwise. it was the only non mrna option available. also there was extreme social pressure from my immediate family. They refused to see me for over a year until I was vaccinated. I still caught coronavirus about 2 months later.
    - joeman1000 4y ago
      I got all the same shit basically. Barred from all establishments except grocery shops, barred from taking exams & visiting my university campus, excluded from my cousins wedding, couldn’t board a plane… I just never gave in because I knew it wasn’t the right thing for me. I’m 25 now and never got the shot. My wife had it, and when we both got the virus she was sicker than me for a longer time.
- lamontcg 4y ago
qwertyuiop_ 4y ago
- ttpphd 4y ago
  Anyone can go on vaers and lie. You aren't proving the point you think you are. https://hillreporter.com/dont-be-fooled-antivaxxers-misrepresent-vaers-data-to-keep-you-scared-heres-what-you-should-know-110069 https://hillreporter.com/dont-be-fooled-antivaxxers-misrepre...
  - mw888 4y ago
    So the best indicator of harm from vaccines allowed its well to be poisoned from the start? Certainly smells bad.
    - ttpphd 4y ago
      You mean worst indicator
  - dapf 4y ago
    They could have in the past too. Is there a conspiracy going on now?
    - deleted 4y ago
      [deleted]
    - ttpphd 4y ago
      The psychological and political incentives for people to manipulate an unverifiable public database are obvious. Antivaxxers are a well known group of troublemakers.
      - dapf 4y ago
        "The others" you mean.
roenxi 4y ago
Without the actual study to read I'm going to actively assert there is nothing here for a general audience. We know vaccines have adverse effects. And the rate they occur is useless info. We really need cost-benefits of adverse effects v. COVID outcomes stratified by ages, and it takes more than one study to build the picture.
- core-utility 4y ago
  > We really need cost-benefits of adverse effects v. COVID outcomes stratified by ages, and it takes more than one study to build the picture. Also when taking this into account, one must take note that many who have had the vaccine still end up getting COVID at some point, so the additional adverse effects that COVID brings may add onto any risks the vaccine brought.
- junofan 4y ago
  I disagree. Classic trolley problem. You don’t get to decide for other people how they’d like to approach the intervention ethical dilemma.
themantalope 4y ago
It's an interesting publication, and a necessary one. However, there are a couple of thoughts to keep in mind: 1. The confidence intervals for the risk differences are wide, and some categories include negative numbers. This means that perhaps the vaccines were protective (?) against these other outcomes, but overall the trend based on this analysis is the vaccines were associated with increased risk of these other bad outcomes. 2. Capturing and reporting SAEs in the study designs are sensitive but not specific (i.e. they try to capture everything and aren't particularly concerned with verifying the cause of the SAE). For example, in the Pfizer study, they captured data related to any SAE from the start of consent to 6 months after the last dose of trial vaccine [1]. That is a long time for typical medical problems to crop up. I would like to know a comparison between the intervention group and the estimated rates of such illnesses for an age-matched population. 3. In this study they looked at all SAEs as compared to any SAE (which is what the FDA did). I don't want to discredit they study in any way and it is a valid analysis. However, it is important to keep in mind that when someone becomes ill, injury to one organ system can cause downstream injury to a second (for example a heart attack reduces cardiac output, which causes kidney injury). One way to explain the findings here is that the vaccine triggered more secondary, unintended, bad outcomes. Another way to explain the data is that a small number of people became very ill in the peri-vaccination period and had a lot of bad stuff happen. Also keep in mind from point 2 that the time period for collecting SAEs was from consent to 6 months after the last dose of vaccine. The data presented here is interesting, and it's possible that the vaccines could be more harmful than initially thought. Overall, I am skeptical. The numbers here are still very low compared to the total number of people in the trial. If patient level data is released and there is more meat to the findings here it might change how I think about vaccination, but at this point I wouldn't change. [1] https://www.nejm.org/doi/suppl/10.1056/NEJMoa2034577/suppl_file/nejmoa2034577_protocol.pdf https://www.nejm.org/doi/suppl/10.1056/NEJMoa2034577/suppl_f...
elforce002 4y ago
Oh boy, this comment section is going to be lit.
joemazerino 4y ago
Anyone remember how this data was treated 2 years ago? Bannings, Doctors losing their licenses/being fired etc.

140 points by EGreg 4y ago

So it was a hoax 2 years ago. Now we have studies for that. But media still wont talk about it. Instead our government plans to distribute 4th dose in spring because they already bough 17 milion doses for 10 milion people. From Pfizer with unknown prices and hidden contracts. In time of inflation caused by lockdowns and energy crisis. I'm not surprised that people are on streets, despise the government and do not trust any traditional media.

deleted 4y ago

[deleted]

hprotagonist 4y ago

Pfizer and Moderna mRNA COVID-19 vaccines were associated with an excess risk of serious adverse events of special interest of 10.1 and 15.1 per 10,000 vaccinated over placebo baselines of 17.6 and 42.2 (95 % CI -0.4 to 20.6 and -3.6 to 33.8), respectively. The placebo groups for the pfizer cohort and moderna cohort differed in baseline rate by the same magnitude (~25/10000) as the observed effect. At best, that’s really noisy data.

cyanydeez 4y ago
What's important for the discerning paranoid: _chances_
shadowgovt 4y ago
Right. If I'm understanding those stats correctly, they indicate that even if a patient has an adverse reaction after taking the vaccine, the odds are >50% the reaction is caused by something else.
aix1 4y ago
Yeah, I do wonder what might have caused such a massive difference between the two placebo groups (17.6 and 42.2 per 10K). Small samples? The confidence intervals look pretty wide.
- em500 4y ago
  Here's the full paper: https://reader.elsevier.com/reader/sd/pii/S0264410X22010283 https://reader.elsevier.com/reader/sd/pii/S0264410X22010283 As I understand it, these are results from two different trials done separately by Pfizer and Moderna, with slightly different protocols and reporting standards: "Moderna reported SAEs [serious adverse effects] from dose 1 whereas Pfizer limited reporting from dose 1 to 1 month after dose 2." "For reasons that are not documented in the trial protocol, Moderna included efficacy outcomes in its SAE tabulations, while Pfizer excluded them. As a result, Moderna’s SAE table did not present a traditional SAE analysis but rather an all-cause SAE analysis. " Thus, only numerical comparisons between treatment and control within the same trial are valid (assuming proper randomization), not between the two trials.
  - rurban 4y ago
    https://www.sciencedirect.com/science/article/pii/S0264410X22010283?via%3Dihub https://www.sciencedirect.com/science/article/pii/S0264410X2... Pfizer reported serious adverse effects in 127 vaccine and 93 placebo. Moderna reported serious adverse effects in 206 vaccine and 195 placebo. => Headline: "Serious adverse events of special interest following placebo vaccination in randomized trials in adults"
  - LorenPechtel 4y ago
    Normally there aren't competing drugs racing to market, thus the FDA doesn't have any system in place to ensure apples-to-apples comparisons in a case like this. Each company decides it's test protocols and gets FDA approval, they aren't working in cooperation.
- LorenPechtel 4y ago
  The number of test subjects isn't small, but the number that have something bad happen is small (they're not going to accept test subjects with obvious, serious problems because that makes the data noisier.) Reducing noise means increasing the sample size--to get clean data here you would need a truly huge test group. I wouldn't be surprised if you would have to use the whole nation as your test group--and what's the point??
PragmaticPulp 4y ago
> At best, that’s really noisy data. This is the reality of measuring rare events among moderately large groups of people. It’s also possible that any number of unexpected cofounders could have occurred for a small group of people receiving the placebo doses in one segment, such as a small number of placebo doses having an unexpected issue. Impossible to say, which is why large numbers of people are necessary in trials exploring relatively rare events like this. Regardless, there doesn’t appear to be cause for concern among any of their observed serious events during the study period.
- hprotagonist 4y ago
  indeed.
- nerdponx 4y ago
  Is it possible that the data was tampered with? We are in the midst of a scientific fraud crisis and there are powerful interests heavily invested in making sure this result comes out negative or inconclusive. For those about to downvote me: my general (but unscientific) opinion is that it doesn't make sense for the covid vaccine to be riskier than covid itself. But as a society we have shown that even "technical" people like researchers and scientists are willing to fudge, ignore, or misinterpret data for various political or personal purposes, not to mention that doing so in domains outside of public health is common practice in academia. So I believe it's only prudent and rational to be extremely skeptical of anything that looks "off".
  - origin_path 4y ago
    Not only possible but proven. There are cases where people who suffered extremely severe adverse effects right after vaccination, were recorded by the trial operators as having minor ailments or even having had COVID despite negative tests, e.g. as in this case: https://dailysceptic.org/2022/05/23/concerns-of-fraud-in-pfizer-vaccine-trial-as-participants-hospitalisation-with-heart-inflammation-is-swept-under-carpet/ https://dailysceptic.org/2022/05/23/concerns-of-fraud-in-pfi... Another similar problem in which a trial participant appears to have died a day or two after taking the shot, but it was ruled unrelated (by Pfizer!): https://igorchudov.substack.com/p/pfizer-study-subject-c4591001-1162 https://igorchudov.substack.com/p/pfizer-study-subject-c4591...
gus_massa 4y ago
>> (95 % CI -0.4 to 20.6 and -3.6 to 33.8) > At best, that’s really noisy data. Yes. That's exactly why each of the confidence intervals have a negative and a positive extreme. If there is a real effect, it's below the noise level.
- ponow 4y ago
  The fact that the confidence intervals for the excess risks aren't roughly symmetric around zero, but rather biased to mostly positive, is worrying. Most of the probability is for positive excess risk. If it were just noise, wouldn't we expect the excess risk CI's to be roughly centered around zero?
  - benjaminwootton 4y ago
    The fact that benefits are not an absolute slam dunk over risks is also worrying given the coercion that was used to get people to take these vaccines.
    - hprotagonist 4y ago
      that metric is not quantified here.
    - cortesoft 4y ago
      This study doesn't talk about benefits at all.
      - josephcsible 4y ago
        Isn't "the risk reduction for COVID-19 hospitalization" a benefit?
        Arnt 4y ago
        "A" benefit? I'd say no. It's a wide range of benefits ranging from "not spending a night in hospital" to "surviving". If you know that the benefits and risks result in similar distributions of the risks, then you can just compare the numbers. If not, you have to check the distribution first.

jdsleppy 4y ago

It looks like the largest effect found (from reading only the summary) is how many more adverse effects the Moderna placebo causes compared to the Pfizer placebo. Given that, I won't regret my vaccinations just yet.

shadowgovt 4y ago
Clearly, we really need to improve quality control on the Moderna placebo. /s
smt88 4y ago
There has been decent research showing that a lot of Covid vaccine side effects appear when subjects are given placebo, which indicates that the subjects expected the side effects. So we may someday discover that vaccine misinformation causes people to experience imaginary negative effects from vaccines or placebo.
- ceejayoz 4y ago
  I'm not sure why this is downvoted; it's almost certainly the case. Many of the folks who fainted shortly after vaccine administration were probably in this category.
- goda90 4y ago
  I read too much FUD about the vaccines before my Moderna booster, particularly the myocarditis in younger men results. Started feeling tight chested and a lump in my throat later that day after the vaccine. Finally went to urgent care after a day or two and got an x-ray and EKG and it showed nothing of concern. Doctor suggested it was probably anxiety, suggested taking an NSAID and relaxing and I was better pretty soon after.
- Terretta 4y ago
  There was considerable chatter among the “vaccine hesitant” about Pfizer being “better” than Moderna, which could play into your point.
  - 4y ago

Havoc 4y ago

> adverse events of special interest. This feels like we’re looking at some sort of subset rather than overall risk profile? Don’t think anyone was expecting vaccines to be entirely risk free.

aaa_aaa 4y ago
Yet they (Government, CDC and media) downplayed it blatantly. They certainly made people believe forcing it to young people (<40), especially teenagers and kids was ok. Risks were higher than benefit and it was obvious from the data.
- Bud 4y ago
  - aaa_aaa 4y ago
    Universities or government institutions (including Army) did not allow working or studying without a vaccine. This is forcing. Also numbers are out there. It is laughable people comes with "alternative was dying" argument for young people.
    - ceejayoz 4y ago
      Joining the army and complaining you’re being forced to do something seems… odd.
      - jonnycomputer 4y ago
        Fair, re military. But at my government job as a programmer at a university I was "forced" to vaccinate as well (unless I wanted to change jobs). I didn't mind, personally. But the descriptor of "forced" is pretty accurate. And not just jobs. Heck, I went to a concert and had to prove vaccination status. I think that requiring vaccination was justified at the height of the pandemic. It is unfortunate that the vaccines were not more neutralizing/preventing. I've had three doses and got the virus twice. I ended up being okay; my unvaccinated brother-in-law very much not okay. Like most people do, I have relatives who either died or were severely disabled by covid.

_448 4y ago

One more thing that bothered me was that lot of medical staffs world over were not informed about aspiration for intramuscular injection.

Bud 4y ago
But they're certainly aware of the general issue. Also, there does not appear to have been conclusive evidence that aspiration was warranted, especially not in 2020. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8783631/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8783631/
core-utility 4y ago
Additionally, many doctors have said that 2 weeks between shots was too quick and would not be enough time for the first shot to "primer". 2 weeks acted more like a single larger dose than 2 spread out doses. Edit: My memory failed me, the spacing was 3 weeks and 4 weeks (Pfizer and Moderna respectively). Point still stands though. Ref: https://www.medpagetoday.com/opinion/marty-makary/94315 https://www.medpagetoday.com/opinion/marty-makary/94315
- belltaco 4y ago
  What vaccine was given with 2 weeks between shots?
  - core-utility 4y ago
    Updated my original comment, I thought it was 2 and 3 weeks, not 3 and 4 weeks.

cpcallen 4y ago

Am I correct in reading this that the Pfizer vaccine was associated with fewer serious side effects (as defined) than the Moderna _placebo_? It seems plausible that both vaccines cause slightly more serious side effects than their corresponding placebos (30–60% more if I understand correctly), but it's hard to know how meaningful this result is when one of the placebos is 2.5x more 'dangerous' than the other placebo.

deleted 4y ago
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PragmaticPulp 4y ago
> Am I correct in reading this that the Pfizer vaccine was associated with fewer serious side effects (as defined) than the Moderna _placebo_? Given the small differences and wide confidence intervals, the correct interpretation is that the incidence of side effects isn’t really significantly different than placebo. Or you could look at the numbers and decide that given the noise of the data that a massively larger study (10-100X more people) would be necessary to discover any practical differences, should they exist.
vannevar 4y ago
Not according to this part of the result: "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). The Moderna trial exhibited a 6 % higher risk of serious adverse events in the vaccine group: risk difference 7.1 per 10,000 (95 % CI -23.2 to 37.4); risk ratio 1.06 (95 % CI 0.84 to 1.33)." This seems to contradict the first sentence, which implies Moderna is worse: "Pfizer and Moderna mRNA COVID-19 vaccines were associated with an excess risk of serious adverse events of special interest of 10.1 and 15.1 per 10,000 vaccinated over placebo baselines of 17.6 and 42.2 (95 % CI -0.4 to 20.6 and -3.6 to 33.8), respectively." I'm not sure how to reconcile the apparent contradiction, perhaps others understand what's being said?
- EGreg 4y ago
  What it’s saying is that in both cases the unvaccinated group had less risk from not taking the vaccine than taking it. The placebo isn’t relevant, just the fact they didn’t take the vaccine. Since it’s randomized, it’s unsurprising that both groups of unvaccinated people had diff risk outcomes. What IS surprising is that the vaccine performed worse than both random groups of unvaccinated people.

aix1 4y ago

> Combined, there was a 16 % higher risk of serious adverse events in mRNA vaccine recipients: risk difference 13.2 (95 % CI -3.2 to 29.6); risk ratio 1.16 (95 % CI 0.97 to 1.39). I am not a statistician, but isn't this saying that there's not enough data to reject the null hypothesis (that the risk difference is 0 and the risk ratio is 1.0) with 95% confidence?

LorenPechtel 4y ago
Not a statistician, either, but that's my understanding also. If your CI includes 0 you take the null hypothesis.

aceazzameen 4y ago

What kind of serious adverse events are they?

somenameforme 4y ago
In the paper [1] they're all listed. The most common, by far, were "coagulation disorder" or "other forms of acute cardiac injury". The give examples of the former as including pulmonary embolism, acute myocardial infarction, immune thrombocytopenia, and disseminated intravascular coagulation. [1] - https://www.sciencedirect.com/science/article/pii/S0264410X22010283 https://www.sciencedirect.com/science/article/pii/S0264410X2...
- Madmallard 4y ago
  So basically life threatening severe problems, nice.

jonnycomputer 4y ago

Assuming (for the sake of argument) that covid vaccines were more harmful than typical vaccines, I have a few questions [based entirely on my ignorance]: 1. Were the doses too high? or ... 2. It is something about what was being vaccinating against, or ... 3. the mRNA technology mRNA vaccine technology seems to be really exciting; what might be done to make them safer? or is there really not special risk to that technology at all?

m348e912 4y ago
Here's an interesting theory to consider. The covid-19 vaccines are intended to administered intramuscularly. The resulting immune reaction is intended to be localized to that area and generally the expected result is some localized discomfort (and the creation of antibodies) -- so far so good, right? Medical professionals are recommended to perform a technique called intramuscular aspiration. It helps ensure the vaccine is delivered to a localized area. The technique involves injecting the needle, sucking back on the syringe slightly and looking for blood. If there is no blood, push the contents of the syringe into the muscle and complete the vaccine administration. If during aspiration there IS blood, it means the needle may have hit a vein or artery in or near the muscle. At that point, administration should be stopped and the medical professional should re-administer the vaccine in a different location. Here is the theory: Intramuscular aspiration has not been consistently practiced. A certain percentage of covid-19 vaccinations have not been administered locally, but into the circulatory system via a vein or artery. This is not how the vaccine was designed to be administered, and it's not fully clear on what (if any) negative affects may result.
- jonnycomputer 4y ago
  Interesting. Given how many people were giving out shots, wouldn't surprise me at all if best practices were not adhered to.
  - LorenPechtel 4y ago
    And my first two were definitely by people that weren't exactly routine injectors and I think one of my wife's shots was placed too high.

somenameforme 4y ago

The most critical section from the paper [1]. AESI = Adverse Event of Special Interest: --- 3.4. Harm-benefit considerations 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). --- [1] - https://www.sciencedirect.com/science/article/pii/S0264410X22010283 https://www.sciencedirect.com/science/article/pii/S0264410X2...

TechBro8615 4y ago
Now stratify it by age and gender and see where everyone fits. Does it lead to the conclusion that a course of multiple injections reduces the risk of hospitalization for the average individual in each band? Personally, I only followed the data for my own band, which was generally stratified as “Male 18 - 40.” I did not see any data that convinced me to begin a course of mRNA injections.
- gnarbarian 4y ago
  I got j&j because I would have lost my job otherwise. it was the only non mrna option available. also there was extreme social pressure from my immediate family. They refused to see me for over a year until I was vaccinated. I still caught coronavirus about 2 months later.
  - joeman1000 4y ago
    I got all the same shit basically. Barred from all establishments except grocery shops, barred from taking exams & visiting my university campus, excluded from my cousins wedding, couldn’t board a plane… I just never gave in because I knew it wasn’t the right thing for me. I’m 25 now and never got the shot. My wife had it, and when we both got the virus she was sicker than me for a longer time.
lamontcg 4y ago

qwertyuiop_ 4y ago

ttpphd 4y ago
Anyone can go on vaers and lie. You aren't proving the point you think you are. https://hillreporter.com/dont-be-fooled-antivaxxers-misrepresent-vaers-data-to-keep-you-scared-heres-what-you-should-know-110069 https://hillreporter.com/dont-be-fooled-antivaxxers-misrepre...
- mw888 4y ago
  So the best indicator of harm from vaccines allowed its well to be poisoned from the start? Certainly smells bad.
  - ttpphd 4y ago
    You mean worst indicator
- dapf 4y ago
  They could have in the past too. Is there a conspiracy going on now?
  - deleted 4y ago
    [deleted]
  - ttpphd 4y ago
    The psychological and political incentives for people to manipulate an unverifiable public database are obvious. Antivaxxers are a well known group of troublemakers.
    - dapf 4y ago
      "The others" you mean.

roenxi 4y ago

Without the actual study to read I'm going to actively assert there is nothing here for a general audience. We know vaccines have adverse effects. And the rate they occur is useless info. We really need cost-benefits of adverse effects v. COVID outcomes stratified by ages, and it takes more than one study to build the picture.

core-utility 4y ago
> We really need cost-benefits of adverse effects v. COVID outcomes stratified by ages, and it takes more than one study to build the picture. Also when taking this into account, one must take note that many who have had the vaccine still end up getting COVID at some point, so the additional adverse effects that COVID brings may add onto any risks the vaccine brought.
junofan 4y ago
I disagree. Classic trolley problem. You don’t get to decide for other people how they’d like to approach the intervention ethical dilemma.

themantalope 4y ago

It's an interesting publication, and a necessary one. However, there are a couple of thoughts to keep in mind: 1. The confidence intervals for the risk differences are wide, and some categories include negative numbers. This means that perhaps the vaccines were protective (?) against these other outcomes, but overall the trend based on this analysis is the vaccines were associated with increased risk of these other bad outcomes. 2. Capturing and reporting SAEs in the study designs are sensitive but not specific (i.e. they try to capture everything and aren't particularly concerned with verifying the cause of the SAE). For example, in the Pfizer study, they captured data related to any SAE from the start of consent to 6 months after the last dose of trial vaccine [1]. That is a long time for typical medical problems to crop up. I would like to know a comparison between the intervention group and the estimated rates of such illnesses for an age-matched population. 3. In this study they looked at all SAEs as compared to any SAE (which is what the FDA did). I don't want to discredit they study in any way and it is a valid analysis. However, it is important to keep in mind that when someone becomes ill, injury to one organ system can cause downstream injury to a second (for example a heart attack reduces cardiac output, which causes kidney injury). One way to explain the findings here is that the vaccine triggered more secondary, unintended, bad outcomes. Another way to explain the data is that a small number of people became very ill in the peri-vaccination period and had a lot of bad stuff happen. Also keep in mind from point 2 that the time period for collecting SAEs was from consent to 6 months after the last dose of vaccine. The data presented here is interesting, and it's possible that the vaccines could be more harmful than initially thought. Overall, I am skeptical. The numbers here are still very low compared to the total number of people in the trial. If patient level data is released and there is more meat to the findings here it might change how I think about vaccination, but at this point I wouldn't change. [1] https://www.nejm.org/doi/suppl/10.1056/NEJMoa2034577/suppl_file/nejmoa2034577_protocol.pdf https://www.nejm.org/doi/suppl/10.1056/NEJMoa2034577/suppl_f...

elforce002 4y ago

Oh boy, this comment section is going to be lit.

joemazerino 4y ago

Anyone remember how this data was treated 2 years ago? Bannings, Doctors losing their licenses/being fired etc.