Claim: Pfizer's own data shows that their vaccine "does more harm than good"

deirdre

Senior Member.
I kind of thought that too. But then going by the table:

1641356733092.png

That would mean serious (127) is a subset of severe (262) and then there's another subset of serious called severe serious severe (71).
serious means say you get admitted to the hospital. so 127 of the 262 got admitted to hospital. (assuming they wouldnt know "permanent disability" at 6 months in.)

serious is divided into severe 71 or life threatening 21. and we can maybe assume a not-super-severe but still hospitalized number of like 35. that's how i'm understanding the break down anyway.

you know like after tragedies and victims are in hospital they say they are "critical" or "stable" or ..well im quoting the uk ones in this iffy wiki entry (as the american ones might confuse you more)
Article:
Each National Health Service (NHS) trust has its own guidance for statements to the press. The Department of Health's code of practice has no official definitions of the standard phrases use. Terms typically used by NHS trusts include:[5][6]

Deceased
Brain dead
Critical
Critical but stable
Serious
Stable
Satisfactory
Comfortable
Progressing well
Discharged
 

Itsme

Active Member
Note that "myocardial infarction" (a.k.a. "heart attack") does not imply death though. It can be mild or even when severe the patient can still survive. So this would not change a spreadsheet row labelled "Death by cardiac arrest" unless you verified those myocardial infarctions also caused death.
Well, they were in the 'causes of death' table so I guess these myocardial infarctions also caused death..
 

Itsme

Active Member
Myocardial infarction is basically a heart attack, but cardiac arrest is something different:

Heart Attack and Sudden Cardiac Arrest Differences

People often use these terms interchangeably, but they are not synonyms. A heart attack is when blood flow to the heart is blocked, and sudden cardiac arrest is when the heart malfunctions and suddenly stops beating unexpectedly. A heart attack is a “circulation” problem and sudden cardiac arrest is an “electrical” problem.

https://www.heart.org/en/health-top...-sudden-cardiac-arrest-how-are-they-different
Content from External Source

NB: I fully expect it to be debunked. I just don't think we're quite there yet with the detail.

I'm no expert, but from studying Wikipedia it seems that
An MI [Myocardial Infarction] may cause heart failure, an irregular heartbeat, cardiogenic shock or cardiac arrest.
So myocardial infarction is one of the possible causes of a cardiac arrest. I guess that 'cardiac arrest' is the diagnosis if one does not know exactly what caused it, while 'myocardial infarction' is given as the cause if one knows this was the reason the heart stopped beating.
 

Rory

Senior Member.
So myocardial infarction is one of the possible causes of a cardiac arrest. I guess that 'cardiac arrest' is the diagnosis if one does not know exactly what caused it, while 'myocardial infarction' is given as the cause if one knows this was the reason the heart stopped beating.

That doesn't seem right according to this explanation:

Heart Attack and Sudden Cardiac Arrest Differences

A heart attack is when blood flow to the heart is blocked, and sudden cardiac arrest is when the heart malfunctions and suddenly stops beating unexpectedly. A heart attack is a “circulation” problem and sudden cardiac arrest is an “electrical” problem.

What is a heart attack?

A heart attack occurs when a blocked artery prevents oxygen-rich blood from reaching a section of the heart. If the blocked artery is not reopened quickly, the part of the heart normally nourished by that artery begins to die. The longer a person goes without treatment, the greater the damage.

Symptoms of a heart attack may be immediate and intense. More often, though, symptoms start slowly and persist for hours, days or weeks before a heart attack. Unlike with sudden cardiac arrest, the heart usually does not stop beating during a heart attack. The heart attack symptoms in women can be different than men.

What is cardiac arrest?

Sudden cardiac arrest occurs suddenly and often without warning. It is triggered by an electrical malfunction in the heart that causes an irregular heartbeat (arrhythmia). With its pumping action disrupted, the heart cannot pump blood to the brain, lungs and other organs. Seconds later, a person loses consciousness and has no pulse. Death occurs within minutes if the victim does not receive treatment.

What is the link?

These two distinct heart conditions are linked. Sudden cardiac arrest can occur after a heart attack, or during recovery. Heart attacks increase the risk for sudden cardiac arrest. Most heart attacks do not lead to sudden cardiac arrest. But when sudden cardiac arrest occurs, heart attack is a common cause. Other heart conditions may also disrupt the heart’s rhythm and lead to sudden cardiac arrest. These include a thickened heart muscle (cardiomyopathy), heart failure, arrhythmias, particularly ventricular fibrillation, and long Q-T syndrome.

https://www.heart.org/en/health-top...-sudden-cardiac-arrest-how-are-they-different
Content from External Source
 

Itsme

Active Member
I think the explanation you quoted basically states the same:
Unlike with sudden cardiac arrest, the heart usually does not stop beating during a heart attack.
But when sudden cardiac arrest occurs, heart attack is a common cause.
So, a heart attack can lead to the 'electrical problem' that causes a cardiac arrest, and this is a common cause of cardiac arrest.
 

econ41

Senior Member
I think the explanation you quoted basically states the same:


So, a heart attack can lead to the 'electrical problem' that causes a cardiac arrest, and this is a common cause of cardiac arrest.
My engineer's explanation - the heart is a pump comprising pipes, electrical controls. If the pipes block OR the electrical system fails the pump won't work properly. If the failure is in either critical pipes blocking or key electrical circuits going open-circuit - the pump stops.

And which failed first makes little difference to the outcome.
 

Rory

Senior Member.
All right, I finally got around to filling in that table (still work in progress, open to modification) and this is how it looks:

1642370236578.png

Top table are the study results slightly reorganised and with Covid hospitalisations and deaths added based on what appeared to be somewhere near the average rates in a few places I looked (rates can be changed).

Second table are the Pfizer study figures extrapolated out to a million people.

Obviously the figures don't align with reality. For example, here we have an average mortality rate of 10/100,000 in unvaccinated people, yet only 4 fatal cases in 1,000,000 based on the study data.

I would guess this is to do with timeframe - ie, the 873 Covid cases among the placebo group (and estimated 0.09 deaths) was a measurement taken after (iirc) just a few months.

I know there will be other reasons, explanations and objections about this data. But remember the original claim: that Pfizer's own data shows the vaccine does more harm than good. And if we're only looking at Pfizer's own data what does it tell us?

To me it says:

- There's no massive advantage to taking the vaccine
- There's about the same risk of hospitalisation and death
- It works in helping to prevent Covid-19
- Trivial reactions are much worse but serious ones aren't
- Deaths by cardiac arrest are worryingly higher and merit further investigation

More harm than good? I guess the jury's out on that one. Some would argue the claim in the OP is valid, some will go the other way.

Personally, those cardiac arrest deaths are scary and tip me over into "probably about the same but I'd want more data before I take the chance."

And, again, of course we now know that the vaccine massively helps against Covid; that the chance of catching it (and being hospitalised and dying) is much higher among the unvaccinated than the data from the placebo group shows; and that there isn't a 4x greater chance of cardiac arrest among vaccinated people - but this is purely about what their study data shows. And if that's all we're going by then I think the claimant in the OP has a bit of a point.

Discuss?
 

deirdre

Senior Member.
Personally, those cardiac arrest deaths are scary and tip me over into "probably about the same but I'd want more data before I take the chance."

4 is not a "small sample" as you say. it is a miniscule sample. cpr.org says there are 475,000 deaths from cardiac arrest in U.S every year.

to rule out if it is a data anomaly, i would look at other Pfizer covid vaccine studies and see if the same anomaly repeats.

you are also looking at data for a full range population. even if (big IF) the vaccine causes more cardiac arrests in those 75 and older, the risk is still probably worth it as covid wipes out that population pretty good. I'm saying you know nothing about those 4. were they over 60? over 75? were they obese? did they have hypertension? did they have heart disease? did they have diabetes?

if so you cant make the claim that the vaccine does more harm than good, because those populations dont fare well with covid.
 

Rory

Senior Member.
if so you cant make the claim that the vaccine does more harm than good, because those populations dont fare well with covid.

It's not really about the vaccine "as a whole" though, it's about "Pfizer's own [study] data".

Also, it's definitely not my claim. :p

I suppose the response to the claim might be "you're not totally wrong - but there's a bigger picture to consider."
 

Mendel

Senior Member.
you're completely disregarding the error bars of your data

using made-up numbers, if you have a value that is 182 (but could really be 60-400) and one thst is 48 (but could really be 20-200), can you really be certain that one is lower than the other, and by how much?
 

deirdre

Senior Member.
Also, it's definitely not my claim. :p
i meant the claimants. a universal "you". sorry.

I suppose the response to the claim might be "you're not totally wrong - but there's a bigger picture to consider."
i'd say "you aren't privy to all the data. you are basing conclusions on an incomplete picture"

the question is: "does more harm than good"
but they are calculating "good" by using all age groups and health statuses.
and calculating "harm" possibly by using only 75+ obese people with hypertension.

(i might have those two sentences backwards, hopefully you get my jist. )

comparing apples and oranges.

It's not really about the vaccine "as a whole" though, it's about "Pfizer's own [study] data".
Pfizers ONE study data, shows an anomaly between vaxxed and unvaxxed cardiac arrests.
Science is about replicating the results.
Pfizer did studies in other countries. if the same 'anomaly' shows up in those Pfizer studies, it still wouldnt prove anything, but would be more reason for concern.
One data blip, is not concerning. it could just be coincidence.
 

Rory

Senior Member.
i'd say "you aren't privy to all the data. you are basing conclusions on an incomplete picture"

the question is: "does more harm than good"
but they are calculating "good" by using all age groups and health statuses.
and calculating "harm" possibly by using only 75+ obese people with hypertension.

(i might have those two sentences backwards, hopefully you get my jist. )

comparing apples and oranges.

I think those are all great points. But didn't Pfizer look at the self-same data and come to the conclusion that "it does more good than harm"? So I would think there'd be some validity in saying the same things to them (if we were looking only at the study data).

Perhaps the key is in more accurate Covid figures. If, for example, these numbers:

1642386000518.png

were based more on reality than the study results it would tip greatly in the direction of "much more good than harm".

you're disregarding the error bars of their data

That's a good point. I suppose Pfizer did too. So perhaps the study data taken in isolation is kind of meaningless - other than to show administering the vaccine didn't massively kill people or blow up heads or something.
 

deirdre

Senior Member.
But didn't Pfizer look at the self-same data and come to the conclusion that "it does more good than harm"?
Pfizer has the personal data on who specifically died of cardiac arrest and what the circumstances were. We don't.
 

deirdre

Senior Member.
Remember how scientists were (are) upset that China didnt share "the raw data"?

what you are looking at in this thread is 13 pages of summaries. I imagine the raw data file is a bit bigger.

Article:
According to the documents filed (PDF) in a U.S. District Court for the Northern District of Texas, the FDA asked a federal judge for 55 years to complete a FOIA request for data and information on the approval of Pfizer-BioNTech's COVID-19 vaccine, Comirnaty.
 

Mendel

Senior Member.
That's a good point. I suppose Pfizer did too. So perhaps the study data taken in isolation is kind of meaningless - other than to show administering the vaccine didn't massively kill people or blow up heads or something.
No, it's not meaningless.

Your table has a "much worse" for the cardiac arrests, that Pfizer looked at to see if they're resulting from the vaccination, and that are basically a randomly singled-out cause of death, while deaths overall rate a "similar".
It also has a "much worse" for the trivial reactions that people might complain about for a day, but that aren't really dangerous.
All of the other side effects are "about the same". From this data, I'd say we can already be certain that if there's a bad risk, it's got to be under 1:1000, and maybe there isn't even one.
The "massively kill people" is already ruled out in the stage 1 and stage 2 trials (I think stage 1 trials are closely supervised, with subjects kept in medical care?).
This stage 3 trial rules out "sometimes kills people", and leaves open "rarely kills people". That risk is handled via pharmacovigilance aka the reporting system and followup studies.

It also shows the efficacy of the vaccine, those are your "much better" rows, that show the vaccine actually has the intended effect. (This is the bar alternative medicine often has trouble clearing.) It also gives us an idea how big that effect is.

So, we know from this stage 3 trial
• reasonably small risk
• reasonably good effect
It's possible to weigh both mathematically, and come to conclusion that it'd be morally worse to not authorize the vaccine than to authorize it.
 

Itsme

Active Member
All right, I finally got around to filling in that table (still work in progress, open to modification) and this is how it looks:

1642370236578.png

Top table are the study results slightly reorganised and with Covid hospitalisations and deaths added based on what appeared to be somewhere near the average rates in a few places I looked (rates can be changed).

Second table are the Pfizer study figures extrapolated out to a million people.

Obviously the figures don't align with reality. For example, here we have an average mortality rate of 10/100,000 in unvaccinated people, yet only 4 fatal cases in 1,000,000 based on the study data.

I would guess this is to do with timeframe - ie, the 873 Covid cases among the placebo group (and estimated 0.09 deaths) was a measurement taken after (iirc) just a few months.

I know there will be other reasons, explanations and objections about this data. But remember the original claim: that Pfizer's own data shows the vaccine does more harm than good. And if we're only looking at Pfizer's own data what does it tell us?

To me it says:

- There's no massive advantage to taking the vaccine
- There's about the same risk of hospitalisation and death
- It works in helping to prevent Covid-19
- Trivial reactions are much worse but serious ones aren't
- Deaths by cardiac arrest are worryingly higher and merit further investigation

More harm than good? I guess the jury's out on that one. Some would argue the claim in the OP is valid, some will go the other way.

Personally, those cardiac arrest deaths are scary and tip me over into "probably about the same but I'd want more data before I take the chance."

And, again, of course we now know that the vaccine massively helps against Covid; that the chance of catching it (and being hospitalised and dying) is much higher among the unvaccinated than the data from the placebo group shows; and that there isn't a 4x greater chance of cardiac arrest among vaccinated people - but this is purely about what their study data shows. And if that's all we're going by then I think the claimant in the OP has a bit of a point.

Discuss?
The myocardial infarction cases should be added to the cardiac arrest cases, I thought this would be clear by now. This makes the cardiac arrest cases 'about the same' as well, they are NOT 'much worse'.
On top of that you cannot just extrapolate to a million people like that if you only have 3 or 4 incidents in a group of more than 20000 people.
 

Itsme

Active Member
About those "scary" cardiac arrest cases: A Danish study covering almost 5.000.000 individuals who were followed during a 1 year period during which most of them got vaccinated yielded a 50% REDUCED risk of cardiac arrest after vaccination.

The study covered 3.213.951 unvaccinated person-years, and about 1.458.000 vaccinated person-years (a lot of people got vaccinated during the study period, from Oct 2020 to Oct 2021). During their unvaccinated time, the risk for these people to get a cardiac arrest was twice as high.

Source: https://www.bmj.com/content/375/bmj-2021-068665
 

Mendel

Senior Member.
Article:
Sudden cardiac death is the largest cause of natural death in the United States, causing about 325,000 adult deaths in the United States each year. Sudden cardiac death is responsible for half of all heart disease deaths.

Article:
In 2020, the U.S. Census Bureau counted 331.4 million people living in the United States; more than three-quarters (77.9%) or 258.3 million were adults, 18 years or older

Let's add ~8.1 million people aged 16 and 17, because 16 was the minimum age for the Pfizer study. That makes 325000/(331.4+8.1)= 957 cardiac arrest deaths per million per year. For 6 months, the chance to die of cardiac arrest is 0.00048 = 0.048%.
If I randomly appy this chance to 22000 people, the probability that 4 or more will die from this is over 99%. (See e.g. https://stattrek.com/online-calculator/binomial.aspx .)

So maybe the people who sign up for these studies are less at risk for these kinds of deaths.
How likely is it that a 1:4 split could happen by chance?
If the risk was 0.0001, then for n=22000, P(X>3)=18%, P(X<2)=35%, total 0.18×0.35=0.063=6.3%, or around 1 in 16. Table S4 lists 24 different causes of death, so a split with a 6.3% chance is probably (P(X>0)=0.79) going to be among them.
Rory in his table cherry-picks that event, which makes it look more significant than it actually is.

I'm going to reiterate that it's pointless to look at a 44000 people study when 100s of millions of people have received this vaccine already.
What we can say is that this stage 3 trial showed clearly that the benefits of this vaccine for adults outweigh its risks, and the record has since confirmed that judgment.
 
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Mendel

Senior Member.
A Danish study covering almost 5.000.000 individuals who were followed during a 1 year period during which most of them got vaccinated yielded a 50% REDUCED risk of cardiac arrest after vaccination.
I've analysed this study in another thread.
The table also indicates that vaccinees are less likely to die, which is probably due to "healthy person bias": people on the brink of death don't get vaccinated, which causes more deaths in the unvaccinated group.
I don't expect that the vaccination causes the risk reduction (how?).
And it's not a controlled trial, so biases like these can occur.

It may indicate that doctors don't recommend the vaccine to patients who might have a cardiac arrest, or that those people have lifestyles that encompass vaccine aversion.
 

Itsme

Active Member
I've analysed this study in another thread.

I don't expect that the vaccination causes the risk reduction (how?).
And it's not a controlled trial, so biases like these can occur.

It may indicate that doctors don't recommend the vaccine to patients who might have a cardiac arrest, or that those people have lifestyles that encompass vaccine aversion.
If you look at the table in the study, you'll see that the mean age in the unvaccinated person-years is actually lower and the overall health is higher.

My guess is that the vaccines prevent cardiac arrest caused by the Corona virus. After all, the study period was from Oct 2020 to Oct 2021, in the midst of the Corona pandemic.
 

Mendel

Senior Member.
My guess is that the vaccines prevent cardiac arrest caused by the Corona virus.
On one hand, people who had a SARS-CoV-2 infection were excluded from the analysis.
On the other hand, who tests people that just died from cardiac arrest?

I'd just be very careful because the study wasn't really designed to support your conclusion, and there may be confounding factors we're not aware of. The SCCS analysis addressed that source of error for the study objective.
Because of that, I'd consider "vaccination reduces risk" a plausible idea that lacks confirmation.

(Ab-)using studies in this way gets you down the rabbit hole quickly.
 
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Itsme

Active Member
On one hand, people who had a SARS-CoV-2 infection were excluded from the analysis.
On the other hand, who tests people that just died from cardiac arrest?

I'd just be very careful because the study wasn't really designed to support your conclusion, and there may be confounding factors we're not aware of. The SCCS analysis addressed that source of error for the study objective.
Because of that, I'd consider "vaccination reduces risk" a plausible idea that lacks confirmation.

(Ab-)using studies in this way gets you down the rabbit hole quickly.
Agree, and I misinterpreted the results a bit: The 50% risk reduction for cardiac arrest is only measured during the 28 day follow-up after vaccination. Overall, there does not seem to be a significant difference in risk. Look at the numbers in the figure below:
F1.large.jpg
25933 cardiac arrests in 3213951 unvaccinated person-years = 0.807%
4438+298=4736 cardiac arrests in 509609+74461=584070 person-years = 0.811%
Same ratio, which at least shows that the cardiac arrest risk is NOT 'much worse' when vaccinated.

The 50% risk reduction only during the 28 days after vaccination is discussed in the article:
the fact that SARS-CoV-2 vaccines are rarely given to people with an acute or terminal illness is a likely explanation for the low 28 day risk of cardiac arrest or death in our study.

They also remark:
SARS-CoV-2 infection was associated with a 14-fold increased risk of cardiac arrest or death in the 28 days after a positive SARS-CoV-2 test compared with uninfected follow-up.
But they excluded infected people from their analysis of the relation between myocarditis and vaccination, like you said.
 

Itsme

Active Member
Since editing does not seem to work: Please skip my remark that 'overall, there does not seem to be a significant difference in risk'.
Reason: the numbers next to the graph probably are the numbers during the 28 day follow-up and the reduced risk ratio is based on the fact that young and healthy people are much more represented in the unvaccinated person-years (see table 1 in the article) so you would expect much less cardiac arrests there.
 

deirdre

Senior Member.
I'm going to reiterate that it's pointless to look at a 44000 people study when 100s of millions of people have received this vaccine already.

it's not pointless, if the Trump administration approved a vaccine whose data said it was dangerous then the media can make millions off the headlines (and the chances the Dems can hold one of the chambers in the midterms increases a bit.)
 

Mendel

Senior Member.
Agree, and I misinterpreted the results a bit: The 50% risk reduction for cardiac arrest is only measured during the 28 day follow-up after vaccination. Overall, there does not seem to be a significant difference in risk. Look at the numbers in the figure below:
F1.large.jpg
25933 cardiac arrests in 3213951 unvaccinated person-years = 0.807%
4438+298=4736 cardiac arrests in 509609+74461=584070 person-years = 0.811%
Same ratio, which at least shows that the cardiac arrest risk is NOT 'much worse' when vaccinated.
Here's the same table for longer intervals than 28 days. The adjusted ratios go a little towards 1, which means the bias gets better. And the raw, unadjusted ratios look worse now, presumably because of the better vaccine uptake among older people.
SmartSelect_20220117-163256_Samsung Notes.jpg
The person-years go up rather slowly because for 28 days, about half of that number is first-dose recipients, but few of these remain in that group for longer as they receive their second shot. That's why the increase isn't linear. Moderna has a relatively large number of people who drop out after the first shot as their second shot is Pfizer, which makes that increase even slower.
 

deirdre

Senior Member.
Here's the same table for longer intervals than 28 days. The adjusted ratios go a little towards 1, which means the bias gets better. And the raw, unadjusted ratios look worse now, presumably because of the better vaccine uptake among older people.
SmartSelect_20220117-163256_Samsung Notes.jpg
The person-years go up rather slowly because for 28 days, about half of that number is first-dose recipients, but few of these remain in that group for longer as they receive their second shot. That's why the increase isn't linear. Moderna has a relatively large number of people who drop out after the first shot as their second shot is Pfizer, which makes that increase even slower.

this off topic discussion will likely confuse outside readers. If you already discussed this study in another thread, why didn't you just link it and move the discussion over there?
 

Itsme

Active Member
this off topic discussion will likely confuse outside readers. If you already discussed this study in another thread, why didn't you just link it and move the discussion over there?
I think it's very much on topic, because it presents data collected in a scientific study that falsifies the claim that Pfizer vaccination increases the risk of cardiac arrest.
 

Rory

Senior Member.
So, we know from this stage 3 trial:

• reasonably small risk
• reasonably good effect

It's possible to weigh both mathematically and come to conclusion that it'd be morally worse to not authorize the vaccine than to authorize it.

Yep, I agree. Just as it's also possible to weigh the study results mathematically and come to a different conclusion.

The myocardial infarction cases should be added to the cardiac arrest cases

Myocardial infarction =/= cardiac arrest. See posts 37 and 44 for an explanation of the differences.

About those "scary" cardiac arrest cases: A Danish study covering almost 5.000.000 individuals who were followed during a 1 year period during which most of them got vaccinated yielded a 50% REDUCED risk of cardiac arrest after vaccination.

The study covered 3.213.951 unvaccinated person-years, and about 1.458.000 vaccinated person-years (a lot of people got vaccinated during the study period, from Oct 2020 to Oct 2021). During their unvaccinated time, the risk for these people to get a cardiac arrest was twice as high.

Exactly. The conclusion on the "scary cardiac arrest" figures in Pfizer's study should be: "more data required because the sample size is too small."

More data shows there's nothing to be worried about in that regard. :)

Rory in his table cherry-picks [the cardiac arrests] which makes it look more significant than it actually is.

Not cherry-picking, just reporting what Pfizer reported.

It may look significant to you (and others) but it doesn't look significant to me. It looks like something that would happen by chance.

It's pointless to look at a 44,000 person study when 100s of millions of people have received this vaccine already.

If we don't look at the study then how can the claim be debunked?

I think it's very much on topic, because it presents data collected in a scientific study that falsifies the claim that Pfizer vaccination increases the risk of cardiac arrest.

That's not the claim in question (and I'm not aware of anyone who has made it).

The claim is: Pfizer's study data shows their vaccine does more harm than good.

Which I think we can all agree has been pretty much debunked.
 

Itsme

Active Member
@Mendel: Thanks for the additional info in post #65.

Isn't the last column, tagged 'aHR' the adjusted Hazard Ratio? What surprises me is that the numbers stay below 0.6, even after 112 days. But then again, these are cases of 'cardiac arrest or death' - is this 'or death by cardiac arrest' or 'death in general' I wonder?

Anyhow, the vaccinated group seems to be much better off.
 

Mendel

Senior Member.
Just as it's also possible to weigh the study results mathematically and come to a different conclusion.
yeah, but that analysis would be flawed
The conclusion on the "scary cardiac arrest" figures in Pfizer's study should be: "more data required because the sample size is too small."
In a situation where thousands are dying daily, waiting for more data is not an option for responsible public health authorities (they collect more data anyway)
it may be reasonable for individuals
If we don't look at the study then how can the claim be debunked?
by telling people looking for light that they're fumbling in the dark
the claim can have different motivations:
• "I want to know how good the vaccine is" -> go look at a bigger study
• "I want to know whether the FDA authorization was justified" -> go look at a bigger study
• "I want to know if the FDA decision was responsible at the time" -> let's look at this (but then we'd best also cite some FDA documents)
• "I'm afraid of the vaccine and need an excuse not to take it" -> no debunk will help with that

I've been trying to address #3 within the limitations of arguing only from that paper
Isn't the last column, tagged 'aHR' the adjusted Hazard Ratio?
compare footnotes * and ** in my screenshot
 

deirdre

Senior Member.
I think it's very much on topic, because it presents data collected in a scientific study that falsifies the claim that Pfizer vaccination increases the risk of cardiac arrest.
that is not the topic of this thread.
 

deirdre

Senior Member.
waiting for more data is not an option for responsible public health authorities (they collect more data anyway)
they didn't have to wait for more data, because they already had a ton more data then we the public are privileged too. including actual health data on the 4 people who died of cardiac arrest.

In a situation where thousands are dying daily
that is irrelevant to science.
 

Mendel

Senior Member.
that is irrelevant to science.
not irrelevant to public health

the weighing is between three courses of action:
1) start vaccinating now
2) defer decision
3) reject vaccine

Decision 1) had clear, foreseeable benefits in terms of fatalities and severe illness. Any other decision let people suffer and die needlessly.
 

deirdre

Senior Member.
not irrelevant to public health

the weighing is between three courses of action:
1) start vaccinating now
2) defer decision
3) reject vaccine

Decision 1) had clear, foreseeable benefits in terms of fatalities and severe illness. Any other decision let people suffer and die needlessly.

that may be how science and "FDA" approval works in Germany, but not in the U.S.

THe FDA do not approve medications if they are, or studies indicate, the medications are unsafe.
 

Mendel

Senior Member.
THe FDA do not approve medications if they are, or studies indicate, the medications are unsafe.
We've already had the discussion over the meaning of "unsafe".
Article:
FDA makes its decisions based on its analysis of the benefits and risks for the intended population who will receive the vaccine, as well as the disease(s) to be prevented.

Benefits, risks, disease. What I said.
 

Mendel

Senior Member.
What figures from the study are you using to back that up?
Show me your analysis and I'll show you where it's flawed.

Very roughly: In the second half of 2020, at least 0.06% of the US population died of Covid.
The study shows 99% of these could have been saved with a vaccination (and many more hospitalisations averted). The study also had 1 more death in 22000, which is 0.005%; so even if that death is vaccine-related (which it wasn't), that saves 9 out of 10 lives., with a comfortable margin for error.
 

deirdre

Senior Member.
What I said.
I dont know what you think you said, but i am responding to what my AMerican ear heard.

The FDA is not going to approve a vaccine that will give 60,000 people fatal cardiac arrests. Covid is not smallpox or ebola. and there were other vaccines available for approval.

Safety is important.
Article:
AstraZeneca’s large, late-stage U.S. trial has remained on hold since Sept. 6, after a study participant in Britain fell ill with what was believed to be a rare spinal inflammatory disorder called transverse myelitis.

The widened scope of the FDA probe raises the likelihood of additional delays for what has been one of the most advanced COVID-19 vaccine candidates in development. The requested data was expected to arrive this week, after which the FDA would need time to analyze it, two of the sources said.

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“It just shows that the FDA is being thorough,” said one of the sources.
 
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