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The Vaccine Thread


JennyD

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2 hours ago, Lucy the Valiant said:

I found Dr. Steve Kirsh's testimony quite concerning. He is not on the FDA panel but was invited to testify. According to his data, one in 317 boys (16-17) will get myocarditis from the Pfizer vaccine. This rate could increase to 1 in 25 after those patients have received the booster. He also discussed concerning heart attack incidence in adult trial participants.

Interesting. Where is he getting that data, do you know? 

 

2 hours ago, Lucy the Valiant said:

And Dr. Joseph Fraiman spoke after him, frustrated that Pfizer did not have clinical evidence to disprove the claim that covid vaccines are harming more people than they save. (He is not claiming the vaccines do injure people, just lamenting that science can't prove that.)

Well, I don't know how Pfizer would even collect that data. I think it's a very good idea to follow vaccinated vs. unvaccinated people for a few years to see what happens, but I don't see how Pfizer would be able to do that right this instance. And of course, the trade-offs really depend on how many people wind up getting COVID! Like, if there was no COVID, a COVID vaccine would almost do more harm than good, lol. 

These sounds like slightly strange concerns. Does anyone know anything about those doctors? 

 

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I wish they would put people working in schools on the list along with healthcare. They are working with kids who are unvaccinated and unable to be vaccinated. The ONLY people who are as a group working with 100 percent unvaccinated people for hours all day, in a small room. (other than say, pediatricians, but even they see people one at a time, not 20 plus in a room, and pediatricians would be covered under health care workers anyway)

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Just now, ktgrok said:

I wish they would put people working in schools on the list along with healthcare. They are working with kids who are unvaccinated and unable to be vaccinated. The ONLY people who are as a group working with 100 percent unvaccinated people for hours all day, in a small room. (other than say, pediatricians, but even they see people one at a time, not 20 plus in a room, and pediatricians would be covered under health care workers anyway)

Child care providers also do this.

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1 hour ago, Not_a_Number said:

Interesting. Where is he getting that data, do you know? 

 

Well, I don't know how Pfizer would even collect that data. I think it's a very good idea to follow vaccinated vs. unvaccinated people for a few years to see what happens, but I don't see how Pfizer would be able to do that right this instance. And of course, the trade-offs really depend on how many people wind up getting COVID! Like, if there was no COVID, a COVID vaccine would almost do more harm than good, lol. 

These sounds like slightly strange concerns. Does anyone know anything about those doctors? 

 

Pfizer had just over 300 people TOTAL in their clinical trial.  They had no one under the age of 19.  Of course Pfizer cannot provide data at this point for what happens several years after vaccine, but they could include more people in their original trial.  You cannot conclude anything about the incidence of an adverse event after a third booster in 16-18 yearl old males when you had none in the group.  If an adverse event will happen in 1 in 500 shots, you are unlikely to pick that up when you have such a small sample size.  

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3 hours ago, Lucy the Valiant said:

I found Dr. Steve Kirsh's testimony quite concerning. He is not on the FDA panel but was invited to testify. According to his data, one in 317 boys (16-17) will get myocarditis from the Pfizer vaccine. This rate could increase to 1 in 25 after those patients have received the booster. He also discussed concerning heart attack incidence in adult trial participants.

So I've been googling this guy, and he is an antivax activist who claims the vaccine has killed more than 150,000 people in the US, that more people die from the vaccine than covid, that it causes infertility, and that the spike proteins are "cytotoxic." He also believes that ivermectin cures covid. He seems to be an engineer, with no medical expertise.

Anyway, in trying to find where that 1-in-317 statistic came from, I found the tweet below, and read the paper he linked. That study doesn't even include 16-17 year olds, and 25 of the 32 cases of myocarditis they found were from Moderna, not Pfizer! The overall rate for Pfizer was 1 in 2500, and for Moderna it was 1 in 625. All the cases resolved quickly, with no long term effects. Also, this study simply says "this many people were vaccinated and this many had myocarditis" — there is no control and no comparison to the normal background rate in the population, so they are not expressing the increase in risk of myocarditis after vaccination. Here is the study: https://www.medrxiv.org/content/10.1101/2021.09.13.21262182v1

Screen Shot 2021-09-22 at 7.44.16 AM.png

Edited by Corraleno
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3 minutes ago, Corraleno said:

So I've been googling this guy, and he is an antivax activist who claims the vaccine has killed more than 150,000 people in the US, that more people die from the vaccine than covid, that it causes infertility, and that the spike proteins are "cytotoxic." He also believes that ivermectin cures covid. He seems to be an engineer, with no medical expertise.

Anyway, in trying to find where that 1-in-317 statistic came from, I found the tweet below, and read the paper he linked. That study doesn't even include 16-17 year olds, and 25 of the 32 cases of myocarditis they found were from Moderna, not Pfizer! The overall rate for Pfizer was 1 in 2500, and for Moderna it was 1 in 625. All the cases resolved quickly, with no long term effects. Also, this study simply says "this many people were vaccinated and this many had myocarditis" — there is no control and no comparison to the normal background rate in the population, so they are not expressing the increase in risk of myocarditis after vaccination. Here is the study: https://www.medrxiv.org/content/10.1101/2021.09.13.21262182v1

Screen Shot 2021-09-22 at 7.44.16 AM.png

How the heck did this guy get invited to talk at the panel?  How many people are going to assume he's legitimate just because he spoke there?

We are so friggin screwed.  

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7 minutes ago, Wheres Toto said:

How the heck did this guy get invited to talk at the panel?  How many people are going to assume he's legitimate just because he spoke there?

We are so friggin screwed.  

I don't think he was invited — members of the public were allowed to speak at the hearing, just like they are at school board meetings or town council meetings or whatever.

ETA: he said in a tweet that he had to talk fast because he only had 3 minutes, which suggests that he was just some random member of the public, not a specialist who was invited to speak

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3 minutes ago, Corraleno said:

He's also not a doctor, in any discipline. He has a masters in engineering and computer science and has started several tech companies. He has no background or experience whatsoever in medicine, virology, epidemiology, or any science other than computer science.

Thanks. Fixed my post.

I wonder how I will be "targeted" now by the Google algorithm? Ended up on some seriously scary websites by following search results for his name.

The disinformation load in this country is staggering.

Bill

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How is the VAERS data handled? I understand that it is self-reported, which leads to a LOT of questions of validitiy / cause-effect, etc. Is there a better database for adverse vaccine reactions meta-analyzed from clinical trials? 

I don't want to read "quacks", but I want to better understand adverse reactions, especially in minors and in immunocompromised young people. 

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1 hour ago, ktgrok said:

I wish they would put people working in schools on the list along with healthcare. They are working with kids who are unvaccinated and unable to be vaccinated. The ONLY people who are as a group working with 100 percent unvaccinated people for hours all day, in a small room. (other than say, pediatricians, but even they see people one at a time, not 20 plus in a room, and pediatricians would be covered under health care workers anyway)

The advisory panel did vote that  people with high occupational exposure, such as teachers and healthcare professionals, should be eligible.

18 minutes ago, Lucy the Valiant said:

How is the VAERS data handled? I understand that it is self-reported, which leads to a LOT of questions of validitiy / cause-effect, etc. Is there a better database for adverse vaccine reactions meta-analyzed from clinical trials? 

I don't want to read "quacks", but I want to better understand adverse reactions, especially in minors and in immunocompromised young people. 

I don’t know of a database for that, but most of that is best covered with some of the large population studies that have been done since the vaccine was released. V Safe data is also something to look at, though I have been disappointed to find out how many people either didn’t know about or didn’t bother to sign up for V safe when they got their vaccine. That makes quite a bit toward people who had stronger reactions, because those people may have been more likely to go looking for somewhere to report it. Still, the V safe data looks a lot closer to what has shown up in studies versus VAERS, whose Data is wildly wacky and unreliable for this purpose. The guy who said more people have been harmed by the vaccine than saved by the vaccine is definitely from way out in Quacky land. That is clear from even the most cursory look at the data.

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1 hour ago, Corraleno said:

So I've been googling this guy, and he is an antivax activist who claims the vaccine has killed more than 150,000 people in the US, that more people die from the vaccine than covid, that it causes infertility, and that the spike proteins are "cytotoxic." He also believes that ivermectin cures covid. He seems to be an engineer, with no medical expertise.

Anyway, in trying to find where that 1-in-317 statistic came from, I found the tweet below, and read the paper he linked. That study doesn't even include 16-17 year olds, and 25 of the 32 cases of myocarditis they found were from Moderna, not Pfizer! The overall rate for Pfizer was 1 in 2500, and for Moderna it was 1 in 625. All the cases resolved quickly, with no long term effects. Also, this study simply says "this many people were vaccinated and this many had myocarditis" — there is no control and no comparison to the normal background rate in the population, so they are not expressing the increase in risk of myocarditis after vaccination. Here is the study: https://www.medrxiv.org/content/10.1101/2021.09.13.21262182v1

Screen Shot 2021-09-22 at 7.44.16 AM.png

Thanks for doing the Googling. I kind of didn't even want to go there. 

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Did Pfizer's data show that a booster would increase efficacy against Delta or just that it increased antibodies? That's not exactly the same thing. No one has yet (to my knowledge) determined that Pfizer's decreased efficacy is due to waning immunity rather than simply being less effective against Delta.

I understand all the arguments in favor of boosters. I want them for my parents, in-laws and high risk brother-in-law. But I think a some of the pressure for boosters is simply frustration that mRNA shots are no longer 95% effective. It'd be great if boosters could create that again. But I'm skeptical they would and, honestly, I don't see that Pfizer is providing evidence to that effect. In the last month, the number of people I know who've had break-through Covid19 cases has jumped exponentially. Some got their vaccines as long ago as February; some as early as June; most in April. Does that show waning immunity or is it just the Delta wildfire in my area?

At this point I think the FDA is right to wait on boosters for everyone. I don't see that they've completely rejected it. The panel just didn't receive the evidence they needed to convince them that the risks outweigh the benefits. Perhaps in the next few months the data will show that boosters are needed. Since vaccines do seem to be protecting against severe Covid19 and hospitalizations, waiting strikes me as a good thing.

Here's an article from The Atlantic that gives compelling evidence for a wait and see approach to boosters:

https://www.theatlantic.com/health/archive/2021/09/when-you-should-get-your-covid-booster-shot/620123/

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1 hour ago, Lucy the Valiant said:

How is the VAERS data handled? I understand that it is self-reported, which leads to a LOT of questions of validitiy / cause-effect, etc. Is there a better database for adverse vaccine reactions meta-analyzed from clinical trials? 

I don't want to read "quacks", but I want to better understand adverse reactions, especially in minors and in immunocompromised young people. 

I agree with you on the poor quality of the US data, and it seems purposeful to me that they pump the boys into groups like "under 40" to dilute the true risk for the adolescents and teens.  Israel has done a much better job keeping track of myocarditis.  I used their numbers in determining if and when to vaccinate my 12yo son.

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14 minutes ago, Ilera25 said:

Did Pfizer's data show that a booster would increase efficacy against Delta or just that it increased antibodies? That's not exactly the same thing. No one has yet (to my knowledge) determined that Pfizer's decreased efficacy is due to waning immunity rather than simply being less effective against Delta.

 

Define "efficacy." The panel seemed to accept that the only way to stop infections was by raising antibodies, which the boosters clearly do.

So is this "efficacy" against infections (and infectiousness) or "efficacy" against severe illness, hospitalization, and death?

Most of the panel seems willing to allow infections/infectiousness to rise, with no consideration of Long Covid among those with mild and moderate disease or without taking into account the very high transmissibility of the Delta variant.

Bill

 

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22 minutes ago, Ilera25 said:

Did Pfizer's data show that a booster would increase efficacy against Delta or just that it increased antibodies? That's not exactly the same thing. No one has yet (to my knowledge) determined that Pfizer's decreased efficacy is due to waning immunity rather than simply being less effective against Delta.

Yes, they have. That's exactly what the Israeli data shows -- that there's waning immunity. And there's also data that boosters increase immunity back to the normal effectiveness. 

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23 minutes ago, Ilera25 said:

Some got their vaccines as long ago as February; some as early as June; most in April. Does that show waning immunity or is it just the Delta wildfire in my area?

April would be enough for serious waning immunity, since it's 5 months ago. 

Do I wish the darn vaccines would last longer? Yes. Do I also want to be protected during the Delta wave, especially while the kids are unvaxxed? Also yes. 

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2 hours ago, RootAnn said:

Child care providers also do this.

Oh, absolutely

1 hour ago, KSera said:

The advisory panel did vote that  people with high occupational exposure, such as teachers and healthcare professionals, should be eligible.

 

Thank you, the quick thing I read didn't mention teachers, or I missed it somehow. 

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1 hour ago, ktgrok said:

Oh, absolutely

Thank you, the quick thing I read didn't mention teachers, or I missed it somehow. 

https://www.reuters.com/world/us/us-covid-19-booster-debate-moves-fda-vaccine-advisory-committee-2021-09-17/

Quote

Advisers to the U.S. Food and Drug Administration voted on Friday to recommend COVID-19 vaccine booster shots for Americans 65 and older and those at high risk of severe illness, after overwhelmingly rejecting a call for broader approval.

The panel also recommended that the FDA include healthcare workers and others at high risk of occupational exposure to the virus that causes COVID-19, such as teachers.

Despite the narrowed scope of the proposed authorization, the panel's recommendation would cover most Americans who got their shots in the earliest stages of the U.S. vaccination campaign.

 

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3 hours ago, Spy Car said:

Thanks. Fixed my post.

I wonder how I will be "targeted" now by the Google algorithm? Ended up on some seriously scary websites by following search results for his name.

The disinformation load in this country is staggering.

Bill

I don't know if it helps or if I've been lucky to have relatively little backlash from my searches, but when I want to know about someone questionable, I search "who is x" vs. just their name (or "what is x" for a questionable organization). My top results often bring up an article about them vs. their crazy site. 

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5 hours ago, Corraleno said:

I don't think he was invited — members of the public were allowed to speak at the hearing, just like they are at school board meetings or town council meetings or whatever.

ETA: he said in a tweet that he had to talk fast because he only had 3 minutes, which suggests that he was just some random member of the public, not a specialist who was invited to speak

Well that's a relief.  I thought he was the one someone mentioned before was invited.  

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6 minutes ago, Wheres Toto said:

Well that's a relief.  I thought he was the one someone mentioned before was invited.  

That poster misunderstood and thought he was a speaker invited by the FDA. Maybe the FDA needs to make more clear that not everyone speaking there was invited by or speaking for them.

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https://www.nejm.org/doi/full/10.1056/NEJMoa2113017
 

Efficacy data for Moderna at the end of the Blinded Phase

The efficacy in preventing severe disease was 98.2% (95% CI, 92.8 to 99.6), with 2 cases in the mRNA-1273 group and 106 in the placebo group, and the efficacy in preventing asymptomatic infection starting 14 days after the second injection was 63.0% (95% CI, 56.6 to 68.5), with 214 cases in the mRNA-1273 group and 498 in the placebo group. Vaccine efficacy was consistent across ethnic and racial groups, age groups, and participants with coexisting conditions. No safety concerns were identified.

 

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25 minutes ago, Ausmumof3 said:

https://www.nejm.org/doi/full/10.1056/NEJMoa2113017
 

Efficacy data for Moderna at the end of the Blinded Phase

The efficacy in preventing severe disease was 98.2% (95% CI, 92.8 to 99.6), with 2 cases in the mRNA-1273 group and 106 in the placebo group, and the efficacy in preventing asymptomatic infection starting 14 days after the second injection was 63.0% (95% CI, 56.6 to 68.5), with 214 cases in the mRNA-1273 group and 498 in the placebo group. Vaccine efficacy was consistent across ethnic and racial groups, age groups, and participants with coexisting conditions. No safety concerns were identified.

 

Super interesting. Very good for severe disease, but not great for asymptomatic stuff. What was it at earlier points? I remember better numbers for that, but I don't remember how many months in that was. 

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1 minute ago, Not_a_Number said:

Super interesting. Very good for severe disease, but not great for asymptomatic stuff. What was it at earlier points? I remember better numbers for that, but I don't remember how many months in that was. 

I mean it’s still 60pc and I remember a point where 60pc protection was all we were going for.  I think 60pc is also the minimum for approval but I think that’s for disease not infection.  I must admit it doesn’t allay my worries about being an asymptomatic spreader though.

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Just now, Ausmumof3 said:

I mean it’s still 60pc and I remember a point where 60pc protection was all we were going for.  I think 60pc is also the minimum for approval but I think that’s for disease not infection.  I must admit it doesn’t allay my worries about being an asymptomatic spreader though.

That's the kind of thing that has me reaching for boosters, lol. 

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1 hour ago, Martha in GA said:

I don't know if this has been posted, but this kind of data fascinates me (about a prison outbreak in TX):

https://www.macon.com/news/coronavirus/article254435113.html?ac_cid=DM535667&ac_bid=1839955727

3 out of 4 hospitalized prisoners were unvaccinated and this is significant as there were only 42 unvaccinated prisoners vs 185 who had vaccines.

The only prisoner to die was unvaccinated. One death out of 42 unvaccinated prisoners. None among the 185 vaccinated prisoners.

The infection rate was significantly lower for vaccinated prisoners 70% vs 93%. 

A pretty compelling case for vaccinations.

Bill

 

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39 minutes ago, Spy Car said:

3 out of 4 hospitalized prisoners were unvaccinated and this is significant as there were only 42 unvaccinated prisoners vs 185 who had vaccines.

The only prisoner to die was unvaccinated. One death out of 42 unvaccinated prisoners. None among the 185 vaccinated prisoners.

The infection rate was significantly lower for vaccinated prisoners 70% vs 93%. 

A pretty compelling case for vaccinations.

Bill

 

But, the infection rate was even lower for partially vaccinated prisoners than for fully vaccinated prisoners. 

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Hoping that the local places will start giving boosters by this weekend. If I could get an appointment Friday after work, that would be ideal. 

 

I'm averaging 10% of my students  out sick every week, and we're only a month in. Last year I didn't have 10% get sick the entire school year put together. Schools were in person, with masks last year, and theoretically are the same this fall. 

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Just now, Dmmetler said:

Hoping that the local places will start giving boosters by this weekend. If I could get an appointment Friday after work, that would be ideal. 

 

I'm averaging 10% of my students  out sick every week, and we're only a month in. Last year I didn't have 10% get sick the entire school year put together. Schools were in person, with masks last year, and theoretically are the same this fall. 

Ugh. But you have much higher rates of community transmission, too, right? 

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8 minutes ago, Bootsie said:

But, the infection rate was even lower for partially vaccinated prisoners than for fully vaccinated prisoners. 

Could that be caused by requiring masks until people are fully vaccinated, but not after full vaccination, so that the half-vaxed were masked?

There are so many possible moving parts and confounding factors on these things. 

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Just now, Not_a_Number said:

Ugh. But you have much higher rates of community transmission, too, right? 

Yes. TN is "Covid? What's that?" Country and we have community events, football, etc happening at pre-pandemic levels, and while we have a county mask mandate apparently that doesn't include noses :(. 

 

 

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6 minutes ago, elroisees said:

Could that be caused by requiring masks until people are fully vaccinated, but not after full vaccination, so that the half-vaxed were masked?

There are so many possible moving parts and confounding factors on these things. 

It is my understanding that masks were required for all.  There were two housing units and I don't know how infections and vaccinations were dispersed among those two units.  So, there are many possible explanations.  And the fact that one died who was not vaccinated and none in the unvaccinated population is not statistically signivicant.

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3 minutes ago, Bootsie said:

It is my understanding that masks were required for all.  There were two housing units and I don't know how infections and vaccinations were dispersed among those two units.  So, there are many possible explanations.  And the fact that one died who was not vaccinated and none in the unvaccinated population is not statistically signivicant.

The highly desperate hospitalization rate is statistically significant. The death is significant in that it fits with all other data on deaths from Covid between vaccinated and unvaccinated people, even if as a one-off it isn't conclusive.

Bill

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3 minutes ago, Bootsie said:

I don't see any information about length of time of incarceration for any of the population

Correct. Without that data one must suspect anything that appears to show that one vaccination is superior to two doses, as that does not fit the known data generally.

Bill

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2 minutes ago, Spy Car said:

Correct. Without that data one must suspect anything that appears to show that one vaccination is superior to two doses, as that does not fit the known data generally.

Bill

This is a small sample size; any conclusions about the data have to be carefully drawn, whether they are consistent with or contrary to our initial bias.   P values of less than 0.05 were considered statistically significant; the P-value for the death rate was 0.23

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13 minutes ago, Bootsie said:

This is a small sample size; any conclusions about the data have to be carefully drawn, whether they are consistent with or contrary to our initial bias.   P values of less than 0.05 were considered statistically significant; the P-value for the death rate was 0.23

I don't disagree on the small sample sizes reducing the statistical value.

That said, the numbers are pretty strongly in line with larger models. People are much more likely to get seriously ill and require hospitalization and are more likely to die if they are not vaccinated. This is one more case that part of a much larger picture.

Bill

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7 minutes ago, Spy Car said:

I don't disagree on the small sample sizes reducing the statistical value.

That said, the numbers are pretty strongly in line with larger models. People are much more likely to get seriously ill and require hospitalization and are more likely to die if they are not vaccinated. This is one more case that part of a much larger picture.

Bill

But I would argue that it isn't the statistical value of the study that is in question--it is the statistical significance of the variables.  The statistics here do not support a claim that the death incidence is any different in one group than the other.  Thus, these numbers are NOT in line with other models that suggest there is a difference between the vaccinated and unvaccinated.  

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39 minutes ago, Bootsie said:

But I would argue that it isn't the statistical value of the study that is in question--it is the statistical significance of the variables.  The statistics here do not support a claim that the death incidence is any different in one group than the other.  Thus, these numbers are NOT in line with other models that suggest there is a difference between the vaccinated and unvaccinated.  

I think that is quite a stretch. Broad models show a significant difference in death between the vaccinated and the unvaccinated. We agree on that, correct?

The prison results are in line with what might be expected given the broader statistics. I agree that without the broader statistics that one could not give such a small number a lot of weight as a matter of statistics, but there was a death in the unvaccinated group which is unsurprising and no deaths in the much larger vaccinated cohort, which is also unsurprising.

Bill

 

 

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52 minutes ago, Bootsie said:

But I would argue that it isn't the statistical value of the study that is in question--it is the statistical significance of the variables.  The statistics here do not support a claim that the death incidence is any different in one group than the other.  Thus, these numbers are NOT in line with other models that suggest there is a difference between the vaccinated and unvaccinated.  

Not being statistically significant means absolutely nothing here, yeesh. It just means the numbers are too small. 

If we followed 10 vaccinated and 10 unvaccinated people, probably we'd have 0 deaths in either group. Then what, would you argue that the numbers were not in line with other models because the numbers didn't provide sufficient power to conclude anything?? That's completely ridiculous. 

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18 minutes ago, Spy Car said:

I think that is quite a stretch. Broad models show a significant difference in death between the vaccinated and the unvaccinated. We agree on that, correct?

The prison results are in line with what might be expected given the broader statistics. I agree that without the broader statistics that one could not give such a small number a lot of weight as a matter of statistics, but there was a death in the unvaccinated group which is unsurprising and no deaths in the much larger vaccinated cohort, which is also unsurprising.

Bill

 

 

Then what do you do with the data that is not in line--such as a lower incidence rate among the partially vaccinated?  

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9 minutes ago, Not_a_Number said:

Not being statistically significant means absolutely nothing here, yeesh. It just means the numbers are too small. 

If we followed 10 vaccinated and 10 unvaccinated people, probably we'd have 0 deaths in either group. Then what, would you argue that the numbers were not in line with other models because the numbers didn't provide sufficient power to conclude anything?? That's completely ridiculous. 

Because I can't conclude anything, I can not conclude that they are in line with previous studies.  I can't conclude that they are opposite of previous studies.  I can't conclude anything means I can't conclude anything.  

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