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

[Rory]

A conspiracy theorist friend forwarded me a 'report' apparently put together by some doctors, scientists and health care practitioners who make up a group called the Canadian Covid Care Aliiance:

https://www.canadiancovidcareallian...tions-More-Harm-Than-Good-REV-Dec-16-2021.pdf

He claims that:

"According to the Pfizer reports that they reported themselves the vaccine does more harm than good."

According to the CCCA paper:

PFIZER'S 6 MONTH REPORT showed:

• an Efficacy of 91.3%. (Which means a reduction in positive cases compared to placebo group)
• compared to the placebo group, an increase in illness and death:

• There is no benefit to a reduction in cases if it comes at the cost of increased sickness and death

The original Pfizer report is here:

https://www.nejm.org/doi/pdf/10.1056/NEJMoa2110345

Lots of other claims in the CCCA paper too (it's 51 pages long).

I will look into it when I get a chance.

 

[deirdre]

i dont want to click on their site and boost their ratings, so i'll have to trust reddit info (unless you @Rory shows me its wrong"

Article:

It is an antivaccine site disguised as a Healthcare site. They promote unproven treatments and protocols.

Disclaimer

Disclaimer: Given the speed at which new laws, regulations and policies have been implemented to control the COVID-19 pandemic, it is possible that the responses below will be impacted.

The information contained or presented on this website is presented solely for educational purposes only on matters of interest for the personal use of the reader, who accepts full responsibility for its use. The information is provided with the understanding that the authors and publishers are not herein engaged in rendering medical, pharmaceutical, nutritional, mental health, legal, or any other professional advice or services. As such, it should not be used as a substitute for consultation and advice from a licensed professional in the specific field of interest who will provide recommendations based on your particular situation and factual background. Do not make any decisions based on the information contained or presented on this website without consulting an appropriate professional.

While we have made every attempt to ensure the information contained in this site has been obtained from reliable sources, Canadian Covid Care Alliance (CCCA) is not responsible for any errors or omissions, or for the results obtained from the use of this information. All information in this site is provided "as is," with no guarantee of completeness, accuracy, timeliness or of the results obtained from the use of this information, and without warranty of any kind, express or implied, as to the fitness for any particular purpose. Nothing herein shall to any extent substitute for the independent investigations and judgement of the reader. Information, laws and regulations are continually changing, and can be interpreted only in light of particular factual situations.

Source: https://www.reddit.com/r/CoronavirusUS/comments/rro697/canadian_covid_care_alliance_pfizer_inoculations/

edit add: here's the google cache version, disclaimer is accurate and i dont see any actual doctors listed anywhere. granted ad hominen doest debunk the claims but i dont see any data links, just a "meme" that anyone can make up so... i'll sit back and watch @Rory do the work.

 

[deirdre]

The original Pfizer report is here:

https://www.nejm.org/doi/pdf/10.1056/NEJMoa2110345

you'll also want the supplemental appendix which is here https://www.nejm.org/doi/suppl/10.1056/NEJMoa2110345/suppl_file/nejmoa2110345_appendix.pdf

 

[Rory]

i dont see any actual doctors listed anywhere

True. There are no names in the 'paper', despite this claim:

i dont see any data links, just a "meme" that anyone can make up

They do link to the Pfizer report. But you're right: especially later in the 'paper' it does become quite memey.

 

[Mendel]

The best link to the study "Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months" is https://www.nejm.org/doi/full/10.1056/NEJMoa2110345 , it includes links to all supplementary materials.
Some excerpts:

Vaccine efficacy against severe disease was 96.7% (95% CI, 80.3 to 99.9).

During the blinded, placebo-controlled period, 15 participants in the BNT162b2 group and 14 in the placebo group died; during the open-label period, 3 participants in the BNT162b2 group and 2 in the original placebo group who received BNT162b2 after unblinding died. None of these deaths were considered to be related to BNT162b2 by the investigators. Causes of death were balanced between BNT162b2 and placebo groups (Table S4).

Severe Covid-19, as defined by the Food and Drug Administration, with an onset after receipt of the first dose occurred in 31 participants, of whom 30 were placebo recipients;

cases of Covid-19 were observed in 81 vaccine recipients and in 873 placebo recipients,

Spoiler: Causes of Death (table S4)

Regarding the 5 deaths in this graph:
View attachment 48648
The idea behind a random placebo-controlled trial is that you gather a group of participants, randomly divide them into 2 groups, and then treat one group (treatment arm) and pretend to treat the other group (placebo arm, control), and compare what happens. If you don't do that, you might see that 15 people died after the vaccination, and conclude that the vaccination is very dangerous; but when you notice that 14 people in the control group died, you may realize that if you observe 20000 people of all ages for 6 months, some are going to die (unless your teeatment makes people immortal ), and those 15 deaths weren't actually caused by the treatment.

So where do these extra 5 deaths come from? After the comparison phase, the "pretend treatment" people received actual vaccinations, and then 2 of them died. But we don't know if these deaths matter, because now there's no comparison! Or is there? 3 people, who were actually vaccinated over 6 months ago, also died; since the vaccination was so long ago, it's possible to determine that the vaccination definitely didn't cause these deaths; there's our ad-hoc comparison:

As before, these deaths just happened, unrelated to the vaccination.

Whoever made the original chart does not understand random controlled trials (and thus can't have successfully studied medicine), or is purposely misleading their audience, presumably so they can hawk some snake oil. Don't trust them!

 

[deirdre]

3 people, who were actually vaccinated over 6 months ago, also died; since the vaccination was so long ago, it's possible to determine that the vaccination definitely didn't cause these deaths;

what?

how do you know the vaccination definitely didnt cause the deaths?

 

[Rory]

The best link to the study "Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months" is https://www.nejm.org/doi/full/10.1056/NEJMoa2110345 , it includes links to all supplementary materials.

View attachment 48653

I think with the deaths: a) it seems clear that they were balanced between placebo and vaccine; and b) with regard to the 'extra' deaths after unblinding the numbers are always going to be too small to discern anything anyway.

Is it stated anywhere how many of the 81 vaccinated and 873 unvaccinated who contracted Covid died?

For adverse events, it's clear that there were more among the vaccinated group than the placebo group. The question is "how adverse?" Bearing in mind that something as mundane as a headache or soreness at injection site would be counted as an adverse event ("any").

One thing that interests me is the difference between Severe Adverse Event (262/150), Serious Adverse Event (127/116), and Severe Serious Adverse Event (3/0).

Also why some of the figures are reported as "0.0%" when 2 decimal places would have cost the same as one.

Going by that table above, though, there were actually more life-threatening Adverse Events among the placebo group (26 to 21).

Perhaps it's safe to say that Pfizer's "own data" actually shows:

• Deaths among study and control group were about the same
• Life-threatening adverse events in both groups were also about the same
• Serious adverse events were about the same
• Trivial adverse events were much higher in the study group (approximately 3-4 times)
• Any adverse event (severe) was significantly higher in the study group (1.2% to 0.7%)
• Protection against Covid was significantly lower in the study group

So the question is "what counts as a severe adverse event, and how severe were they"? Plus, "how severe/fatal were the cases of Covid in both groups?"

Answering those answers the claim.

(I would do more digging myself but I'm not online enough right now unfortunately.)

 

[deirdre]

So the question is "what counts as a severe adverse event, and how severe were they"?

didnt we go over that in your other thread about Pfizer? i thought we did.

 

[deirdre]

point to ponder: also there are multiple vaccines from different companies and countries, i am confident that if Pfizer's vaccine was dangerous than Moderna or Russia or China would be more than happy to be pointing that out.. so that their vaccines can make more money.

 

[Rory]

didnt we go over that in your other thread about Pfizer? i thought we did.

I think that was more to do with AstraZeneca; the other Pfizer one was the CNN/Joe Rogan/Ivermection argument. Unless I'm forgetting one.

 

[NoParty]

"According to the Pfizer reports that they reported themselves the vaccine does more harm than good."

Aside from the horrible sentence structure...it feels like they're trying to make people
believe that Pfizer is making some kind of admission here, which is clearly not true.

I generally believe in giving folks a long leash, re. interpreting data differently than others...
up until you are dishonestly representing the views of those who did the original report.
I've always said that if you often feel a need to lie to defend your positions,
you're probably way overdue to reconsider how great those opinions really are.

Also, the "Trust us: We're 500+ great, competent professionals...and you're just going to have
to take our word for that...not one will put their name to this" angle is almost always a red flag.

They clearly have an axe to grind. And a media page. And a donations page.
And zero proof that they are who they claim to be.
From an understanding-the-issue perspective...I find them worthless...or worse: Counterproductive.

 

[deirdre]

Also, the "Trust us: We're 500+ great, competent professionals...and you're just going to have
to take our word for that...not one will put their name to this" angle is almost always a red flag.

plus if they already have 500+doctors, scientists and other professionals, why would they be actively seeking more? 500 is an awful lot.

Article:

While CCCA is actively seeking more medical doctors, scientists, healthcare and other professionals to advance its work...

Source: https://webcache.googleusercontent.com/search?q=cache:-oFDWlI6AsYJ:https://www.canadiancovidcarealliance.org/join-support-us/+&cd=22&hl=en&ct=clnk&gl=us

 

[Mendel]

Is it stated anywhere how many of the 81 vaccinated and 873 unvaccinated who contracted Covid died?

No, but I quoted above that there were 1 and 30 cases of severe Covid-19 (basically ICU cases); possibly some of the 30 died, but I don't know. The "cause of death" table lists 1:2 Covid deaths explicitly.

Confirmed severe COVID-19 required confirmation of COVID-19 and the presence of ≥1 of the following: clinical signs at rest indicative of severe systemic illness (respiratory rate ≥30 breaths per minute, heart rate ≥125 beats per minute, SpO2 ≤93% on room air at sea level, or PaO2/FiO2 <300 mmHg); respiratory failure (defined as needing high-flow oxygen, non-invasive ventilation, mechanical ventilation, or extracorporeal membrane oxygenation); evide nce of shock (systolic blood pressure <90 mmHg, diastolic blood pressure <60 mmHg, or requiring vasopressors); significant acute renal, hepatic, or neurologic dysfunction; intensive care unit admission; and/or death

So the question is "what counts as a severe adverse event, and how severe were they"? Plus, "how severe/fatal were the cases of Covid in both groups?"

There's another table with injection side effects that lists "severe" criteria; for example, with a severe headache you might be out of commission for a day, but it'd be more of a nuisance than an actual danger.

Running a fever or feeling fatigued for a day or two would be types of events that could be called severe but not serious, I believe? It disturbs your daily life, but doesn't really require treatment, so it's not "serious".

I haven't seen the paper answer these questions in detail, though.

 

[Mendel]

how do you know the vaccination definitely didnt cause the deaths?

for one, the paper explicitly states it

 

[Mendel]

plus if they already have 500+doctors, scientists and other professionals, why would they be actively seeking more? 500 is an awful lot.

Article:

While CCCA is actively seeking more medical doctors, scientists, healthcare and other professionals to advance its work...

Source: https://webcache.googleusercontent.com/search?q=cache:-oFDWlI6AsYJ:https://www.canadiancovidcarealliance.org/join-support-us/+&cd=22&hl=en&ct=clnk&gl=us

You've left out the damning bit:

While CCCA is actively seeking more medical doctors, scientists, healthcare and other professionals to advance its work, membership is open to all Canadians who support our objectives and want to see our work go forward.

Their members don't even need to work in health care.

 

[NoParty]

...membership is open to all Canadians who support our objectives and want to see our work go forward.
[/ex]
Their members don't even need to work in health care.

Their next press release will surely include that they "now have 3,529 Architects & Engineers"
supporting their shadowy enterprise...

 

[JMartJr]

plus if they already have 500+doctors, scientists and other professionals, why would they be actively seeking more? 500 is an awful lot

As Mr. Einstein is said to have remarked in response to "100 Authors Against Einstein:"

"If I were wrong, one would have been enough."

 

[econ41]

Their next press release will surely include that they "now have 3,529 Architects & Engineers"
supporting their shadowy enterprise...

I've been resisting the temptation to draw the analogy and comparisons of recruiting "style".

 

[porkpie]

This is from the causes of death table:

Death by death it shall be.

 

[Rory]

for one, the paper explicitly states it

I wonder how they know that for sure? Or how we can be certain that they identified them correctly?

4 cardiac arrests in study group vs 1 in placebo seems not so good. Though with such tiny numbers it could very easily be down to chance.

 

[Mendel]

I wonder how they know that for sure? Or how we can be certain that they identified them correctly?

Why do you have doubts?

 

[Rory]

Why do you have doubts?

Well, as we've seen with AstraZeneca, stating something like "we found no evidence of x" doesn't mean x doesn't exist.

 

[Mendel]

Well, as we've seen with AstraZeneca, stating something like "we found no evidence of x" doesn't mean x doesn't exist.

so, nothing that actually has any bearing on whether a M.D. can assess a cause of death correctly, as pertains its link to an old vaccination

 

[deirdre]

I wonder how they know that for sure?

could have been something like the cardiac arrests happened months after the vaccines. Don't forget its not just the pfzifer investigators looking a t the data.. every county's health authorities (like FDA in America) would have access to the raw data before emergency approval.

 

[Rory]

Yep, could be something like that. Would be good to know for sure though - especially given the vaccines' connections to heart problems.

I suppose what I'm thinking, in order to answer the question/claim, is that we could complete a table such as this one:

and then see whether there's any merit in the claim. I mean, obviously the vaccine prevents Covid itself - but I still don't think we've fully answered the question of whether it's done more good than harm based on Pfizer's data.

Personally I don't quite get how they've broken up the different categories of adverse reactions. Also, without the bad/fatal covid figures it doesn't seem quite possible to tell. Though maybe this data doesn't exist.

 

[deirdre]

4 cardiac arrests in study group vs 1 in placebo seems not so good.

and dont forget the placebo group was eventually given the vaccine. and they didnt have 4 additional cardiac arrest deaths after their vaccine. no?

 

[Mendel]

we could complete a table such as this one:

you could also make a list of foods served at British Rail stations and determine if they're better or worse than Covid, because they're all unrelated to the vaccination as well

there is no evidence of a link
and your table is meaningless

 

[Rory]

your table is meaningless

Could you post a meaningful one that addresses the claim?

 

[Mendel]

Could you post a meaningful one that addresses the claim?

The claim only exists because the authors created a skewed comparison, adding 5 deaths to the treatment arm when there weren't any controls to compare them to.
I explained that when I adressed the claim.

I won't "adress the claim" by pretending the adverse events are related to the vaccination, when there is no evidence that they are.
Something that happens to people in the treatment arm can be unrelated to the treatment.
Because the study is diligent and transparent, it gets listed anyway.

If you're interested in the actual harm, look for a much bigger study.

 

[deirdre]

Personally I don't quite get how they've broken up the different categories of adverse reactions.

this likely depends on which country the study was done in... so this is American (dont remember which study the OP is about)

Article:

The intensity of these reactions may range from mild to moderate to severe. They often resolve on their own, and may or may not require medical intervention. Depending on severity, an adverse reaction may also be considered a serious adverse event.
........

Serious adverse event report ― These reports meet the definition of "serious" specified by the Code of Federal Regulations because one of the following is reported: death, life-threatening illness, hospitalization or prolongation of hospitalization, permanent disability, congenital anomaly, or birth defect.

Source: https://www.cdc.gov/vaccinesafety/ensuringsafety/sideeffects/index.html

Also, without the bad/fatal covid figures it doesn't seem quite possible to tell. Though maybe this data doesn't exist.

i have seen this is some Moderna studies... which look formatted almost identical to Pfizr, so mayeb the Pfizer is available somewhere. it must be of they wouldnt be able to give numbers on how well the vaccine prevents severe disease (which they do always give a number for)

moderna ex: (not a 6 month follow up, just grabbed first one i saw)

https://www.nejm.org/doi/full/10.1056/nejmoa2035389

 

[deirdre]

Article:

Pfizer's initial Phase 3 clinical data presented in December showed its vaccine to have 95% efficacy. In April, the company announced the vaccine had 91.3% efficacy against COVID-19, based on measuring how well it prevented symptomatic COVID-19 infection seven days through up to six months after the second dose. It also found it to be 100% effective in preventing severe disease as defined by the CDC, and 95.3% effective in preventing severe disease as defined by the FDA.

Another study, not yet peer-reviewed, provided more new data that brought the efficacy number down to 84% after 6 months, although efficacy against severe disease was 97%.

Source: https://www.yalemedicine.org/news/covid-19-vaccine-comparison

 

[FatPhil]

View attachment 48676

43847 participants is not a "small sample size."

How long was the study period? I'd expect dozens of cardiac arrests per year from that number across an unskewed sample from the US, to put those numbers into perspective. (I could jokingly now say "so it looks like the covid vaccine helps lower risk of CA!" but I will resist.)

 

[Mendel]

43847 participants is not a "small sample size."

We have administered millions of doses now, and that's how the AZ blood clotting issues were found. Some studies use health system data, so I expect there ought to be something bigger than this phase 3 clinical trial. It's a sufficient trial size to demonstrate safety.

How long was the study period? I'd expect dozens of cardiac arrests per year from that number across an unskewed sample from the US, to put those numbers into perspective.

6 months. Mortality is around 1%, but these were the winter months, so slightly more (and nl children!).

Those "dozens of cardiac arrests" aren't all deadly, I think?

 

[FatPhil]

6 months. Mortality is around 1%, but these were the winter months, so slightly more (and nl children!).

Those "dozens of cardiac arrests" aren't all deadly, I think?

That is indeed an important factor. I had done a very quick websearch which found numbers ranging from (what would scale down to) 40 CAs from 90% fatality, through 60 CA fatalities, to 100 CAs with no fatality ratio, so I got cowardly and decided to be very fuzzy with my number and aim on what seemed to be the low side.

Repeating the search (with the Startpage search engine, and search term "death by cardiac arrest USA") yields:
40: "There are more than 356,000 out-of-hospital cardiac arrests (OHCA) annually in the U.S., nearly 90% of them fatal" -- https://www.sca-aware.org/about-sudden-cardiac-arrest/latest-statistics
60: "In one year alone, 475,000 Americans die from a cardiac arrest." -- https://cpr.heart.org/en/resources/cpr-facts-and-stats
100: unable to get that same hit from the search, clearly I didn't use the same search term previously.
None of the sites were vetted for reliability, or even much context, I was just scanning down the snippets.

[edited for silly typo/braino, but no change in meaning]

 

[Itsme]

Yep, could be something like that. Would be good to know for sure though - especially given the vaccines' connections to heart problems.

I suppose what I'm thinking, in order to answer the question/claim, is that we could complete a table such as this one:

View attachment 48676

and then see whether there's any merit in the claim. I mean, obviously the vaccine prevents Covid itself - but I still don't think we've fully answered the question of whether it's done more good than harm based on Pfizer's data.

Personally I don't quite get how they've broken up the different categories of adverse reactions. Also, without the bad/fatal covid figures it doesn't seem quite possible to tell. Though maybe this data doesn't exist.

Concerning the "much worse" heart attack occurences: Note that "myocardial infarction" is basically also a heart attack. There were two of these in the placebo group and none in the control group. If we add those to the heart attack occurences, that makes 4 vs 3, so about the same.

 

[Beaker]

Thank you deidre for posting the supplemental appendix above, which is very helpful.

Concerning the "much worse" heart attack occurences: Note that "myocardial infarction" is basically also a heart attack. There were two of these in the placebo group and none in the control group. If we add those to the heart attack occurences, that makes 4 vs 3, so about the same.

Good point Itsme. I just verified with my brother who was head PA in cardiac surgery unit (is now an administrator at same hospital) that "myocardial infarction" is indeed the formal name for a common type of heart attack. 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.

 

[Rory]

The claim only exists because the authors created a skewed comparison, adding 5 deaths to the treatment arm when there weren't any controls to compare them to.

Not really. We've already discarded that aspect of it. The claim (as it stands now) is more based on serious/severe adverse reactions.

I won't "address the claim" by pretending the adverse events are related to the vaccination

Well, clearly there are adverse reactions related to the vaccine, but maybe not a significant number of serious/severe ones.

Serious adverse event report ― These reports meet the definition of "serious" specified by the Code of Federal Regulations because one of the following is reported: death, life-threatening illness, hospitalization or prolongation of hospitalization, permanent disability, congenital anomaly, or birth defect.

Thanks for that, that's helpful. I wonder if there's also a way to tell the difference between "severe (any event)" and "severe (serious events)"?

43847 participants is not a "small sample size."

It's true that 43,847 isn't a small sample size in most regards - but when looking for things that happen say 100 times in a million it is. That's why it's not possible to say something like: gee, it looks like the vaccine increases the risk of cardiac arrest by 300% even though this is what the data appears to show. Same way tossing a coin 100 times and getting 75 heads doesn't mean the coin is biased towards heads.

Concerning the "much worse" heart attack occurences: Note that "myocardial infarction" is basically also a heart attack.

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

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

 

[deirdre]

Thanks for that, that's helpful. I wonder if there's also a way to tell the difference between "severe (any event)" and "severe (serious events)"?

it actually sounds to me that "serious" events are a subset of all severe events. it sounds to me like "serious" only means those severe reactions that also met the criteria of:

death, life-threatening illness, hospitalization or prolongation of hospitalization, permanent disability, congenital anomaly, or birth defect.

edit add: note: this definition likely applies to ALL medications, not covid vaccine specific. also note: hospitalization would mean being admitted, i believe. Most people go to the ER (emergency room) get some tests or a prescription, maybe get a iv drip to help dehydration and are sent home without being admitted into the hospital.


add2: like a severe allergic reaction may be designated as life threatening? but likely not admitted into the hospital.
a moderate allergic reaction may not be designated as life threatening. and also not admitted into the hospital.

 

[Rory]

it actually sounds to me that "serious" events are a subset of all severe events.

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

That would mean serious (127) is a subset of severe (262) and then there's another subset of serious called severe serious severe (71).

 

[econ41]

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

View attachment 48730

That would mean serious (127) is a subset of severe (262) and then there's another subset of serious called severe serious severe (71).

That is not the taxonomy of the table as quoted. As the Table is presented together with its indented identification of sub-setting "Any serious adverse effect (127)" is implicitly a subset of "Any event (6617). And "implicitly" because the taxonomy is indicated by the standard protocols of indented formatting.

Why not simply accept the taxonomy as written? For the set of "Adverse Events" there are three what appear to be nested sub-sets. "Any event" which implicitly is the full set. "Any serious adverse event" appears to be a subset of "Any event" then "Any adverse event leading to withdrawal" which is, in turn, a sub-set of "Any serious adverse event". Whilst each of those three subsets is itself subdivided.