5 ms·

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 vaccinat

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.

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.