Claim: adverse reactions in Covid vaccine trials are not being recorded

Rory

Senior Member.
I'm looking for a solution to the liability issue.

Do you mean an explanation of how liability works?

From what I've read it probably varies from trial to trial. To know what Pfizer offered/required we'd have to see one of their consent forms.

My guess - based on reading about other trials - is that they would be liable if they had done something wrong but probably, outside of providing basic treatment in the immediate event, they don't need to do anything.

This is from an FAQ talking about Covid-19 vaccine trials:


Also:


And:


To be honest, I did some drug studies when I lived in New York in my early-twenties - as an illegal alien! - and I know I didn't read the consent form, didn't think for one second that something might go wrong, and had no idea about healthcare. All I thought about was the nice bed, the unlimited sorbets, and the check at the end of it. I'm sure there are still people like that today. :)
 

econ41

Senior Member
totally agree. but i'm going to assume clinical trials (esp this big) do cover that up front. the patient can release a copy of what they signed to us if this is not the case. now.. whether the patient actually understands what they are reading is another issue. but in U.S i bet the courts would side with the manufacturer in that case unless the language was excessively ambiguous.
Agreed all points. ESp "...whether the patient actually understands..." which is that foggy situation I hinted at when Isaid " informed consent >>a topic of some complexity for possible discussion at another time." It is a can of worms. ;)
now, for people in the UK.. with National Health, i dont know. my above link says
Article:
Federal law also does not require states to cover routine patient care costs in clinical trials through their Medicaid plans.


medicaid is like our "national health" for poor people.
Yes, understood. There is wide diversity between countries. In AU Govt coverage of medical costs is Federal, not state - only 25million population. And a different approach to Fed/State relations to USA. Also AU has a "two tier" arrangement - basic Government coverage plus optional private insurance on top. I'm not sure If I would be covered for trials. Haven't checked and the issue has never arisen.
 

econ41

Senior Member
Do you mean an explanation of how liability works?
No - I comprehend the generic legal principles. My concern is about what specifically applies to the case under discussion. Was it:

a) Liability was accepted upfront by one side or the other >> then does the claim align with that pre-determined allocation of liability.
OR
b) Was liability NOT pre-defined or agreed >> then it should have been but that doesn't help sort out this instance.

AND - I'm betting it is very much as you describe:
.... and I know I didn't read the consent form, didn't think for one second that something might go wrong, and had no idea about healthcare. All I thought about was the nice bed, the unlimited sorbets, and the check at the end of it. I'm sure there are still people like that today. :)
AKA sort of a "caveat emptor" situation.

Hence my several references to "informed consent" which often isn't as "informed" as it should've because people rush to sign the paper and get things moving.
 

Rory

Senior Member.
Gotcha.

Is there a relationship between the issue of liability and the claim of the thread though? Or are we going in a new direction?
 

econ41

Senior Member
Gotcha.

Is there a relationship between the issue of liability and the claim of the thread though? Or are we going in a new direction?
Your thread so mostly your call. But the topic is essentially a claim about "damages" from the side effects illness. i.e. meeting of medical costs and any associated tortious claims. The specific issue of "failure to report" as part of the trial MAY be a red herring. It depends on the status of the contract. The medical condition and associated compensation is a valid concern but at this stage we do not know where it should be addressed. i.e. within the contract for participation in that trial OR has it already been explicitly identified as outside the scope of trial management. Does it explicitly belong a different context? So we cannot discuss the claim without knowing where it fits in the agreement between the parties. And if it does not belong in trial management the non-reporting in detail will be perfectly valid.
 

deirdre

Senior Member.
But the topic is essentially a claim about "damages" from the side effects illness. i.e. meeting of medical costs and any associated tortious claims.
the OP topic, if you read the full link he originally quoted is mostly about them wanting to be sure the FDA has the numbers of long term adverse effects so they can weight that into the "safety" determination of the vaccines.

which also maybe Rory can make a chart of each claimant he knows of and what the pool was. Because IS it a safety issue really? and how does it relate to long-haul covid [funky "abnormal" immune system responses] numbers (which is alot of the same type symptoms and seriously buggers people financially and emotionally as well)

Like Dressen was the astra zeneca trial which was something like 20,000 people who received the vaccine. so we know of 1 case in 20,000.
Maddie was i think Pfizer. how big was that trial? so her case would be 1 in x number.

the uk woman in the other thread was not in a trial , she was general population of vaccinated.
 

Rory

Senior Member.
Your thread so mostly your call. But the topic is essentially a claim about "damages" from the side effects illness. i.e. meeting of medical costs and any associated tortious claims.

Yeah, it's about whether some people who had adverse effects were included in the data - now expanded to whether their effects were "underreported" (eg, "in a wheelchair and feeding through a tube" recorded as "functional abdominal pain"*).

Financial aspects I guess are part of some other conversation really, but I suppose interesting to know.

Maddie was i think Pfizer. how big was that trial?

2,260 12-15 year-olds

(*As Deirdre pointed out earlier, Pfizer were only reporting AEs up to 30 days after the trial, so it's very possible that adverse reactions that came later were legitimately ommitted.)
 

Rory

Senior Member.
Report in the British Medical Journal about a 'whistleblower' who worked at a site testing Pfizer's vaccine and who listed a dozen concerns including:
  • Participants placed in a hallway after injection and not being monitored by clinical staff
  • Lack of timely follow-up of patients who experienced adverse events
  • Protocol deviations not being reported
  • Vaccines not being stored at proper temperatures
  • Mislabelled laboratory specimens, and
  • Targeting of Ventavia staff for reporting these types of problems.
 

econ41

Senior Member
Because IS it a safety issue really? and how does it relate to long-haul covid [funky "abnormal" immune system responses] numbers (which is alot of the same type symptoms and seriously buggers people financially and emotionally as well)
Those are the two real questions about safety rather than compensation and blame for a couple of exceptional cases. And whether or not it is a safety issue is a matter of risk probabilities related to the potential user population. Far too many of these discussions treat "safety" or "good enough" as yes<>no binary matters. "Yes - there has been a death - ban the medication" is the style of the common error of logic. Arguably the foundation error of much anti-vax propaganda. The wrong frame for the logic.

I forget the actual numbers but when I was scheduled - age priority - for Astra-zeneca the news broke about a couple of blood clot issues. In I think a couple of million usages. I didn't hesitate the protection offered still far outweighed the addition of the newly "discovered" risk. Not all people think so objectively and blood clots seemed to cause a significant slow down in Australian vaccinations. But the core issue on the probabilities - "How much do one or two exceptions shift the risk?" "Does the risk become unacceptable?"

Then - separate issue - the evidence being presented seems to indicate some cover-ups may be occurring. This raises two issues:

First - is it plausible, if there are "cover-ups", that the number of cases concealed would, if accounted for, significantly change the risk profile for the vaccine. And, if it is one or two cases in millions it probably won't. If it is one or two cases in a few thousand - it would need a more thorough assessment.

BUT base the decision on valid probability-based risk assessment NOT the emotion of a couple of individual scenarios. One whistle blower, one proven example is a possible warning sign. Not proof of guilt.

Second: If there is sufficient indication of deliberate cover-up then formal investigation is warranted. AND it is totally distinct from questions of vaccine efficacy or safety.
 
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Mendel

Senior Member.
The agency this week told a court that it had found about 329,000 pages of responsive information, but that it would like to release just 500 pages each month — giving it until 2076 to complete the request. The FDA took just more than 10 weeks, by contrast, to review the data before it approved the vaccine. Source: https://www.msn.com/en-us/news/us/critics-outraged-by-fda-request-to-hide-pfizer-vaccine-data-for-55-years/ar-AAQUufd?ocid=msedgntp
Article:
The Phase 3 clinical trial was designed to determine if the Pfizer-BioNTech COVID-19 vaccine is safe and effective in preventing COVID-19 disease. This trial began July 27, 2020, and completed enrollment of 46,331 participants in January 2021.

They have about 7 pages per participant, most of these probably include some kind of personal data which needs to be anonymized before being published. The FDA wouldn't need to review all of that in detail for the EUA; for example, they wouldn't check 46000 consent forms, or verify the age for each participant; if that was my job, I'd do spot checks. But to anonymize the pages, you have to go through and edit each one, which takes a lot more time.

Article:
The FDA proposes releasing 500 pages per month on a rolling basis, noting that the branch that would handle the review has only 10 employees and is currently processing about 400 other FOIA requests.

The question the trial is going to answer is whether some people can force the government to spend more money to respond to this kind of request; or if these people should ask for a smaller, more specific set of documents to receive a timely answer.

If the court decides in favor of the plaintiffs, I expect future legislation to either limit the scope of FOIA disclosure for these studies, or limit the amount of information that needs to be submitted.

----

CICP covers Covid vaccine trial damages if you can prove the connection.

Generally speaking, insurance companies like vaccines bevause it lowers their costs, so in countries with a well-regulated health insurance, it covers trials because it encourages people to participate in them.
 

deirdre

Senior Member.
The FDA wouldn't need to review all of that in detail for the EUA; for example, they wouldn't check 46000 consent forms,
i highly doubt the FOIA request included consent forms. you are trying too hard unnecessarily.

you could have just quoted the DOJ lawyer's response
Article:
The records must be reviewed to redact “confidential business and trade secret information of Pfizer or BioNTech and personal privacy information of patients who participated in clinical trials,” wrote DOJ lawyers in a joint status report filed Monday.
.




If the court decides in favor of the plaintiffs, I expect future legislation to either limit the scope of FOIA disclosure for these studies, or limit the amount of information that needs to be submitted.
No. I doubt anything will be done because it's been decades and noone bothered to do this before. But IF anything changes, my guess is that government agencies and/or clinical trials etc will be mandated to keep irrelevant information and "trade secrets" separate from patient safety result information. You know.. common sense changes, not transparency changes.
 

Mendel

Senior Member.
i highly doubt the FOIA request included consent forms. you are trying too hard unnecessarily.
These CT FOIAs are often formulated in broad terms, i.e. something like "any and all documents pertaining to the FDA authorization process for the Pfizer vaccine". There's no way that a request generates over 300.000 pages unless there are patient-specific pages in there.
The records must be reviewed to redact “confidential business and trade secret information of Pfizer or BioNTech and personal privacy information of patients who participated in clinical trials,”
Aka patient data.
 

deirdre

Senior Member.
your Reuters link has the document ie. Complaint, which says specifically what they asked for :
Article:
ll data and information for the Pfizer Vaccine enumerated in 21 C.F.R. § 601.51(e)[see footnote 5] with the exception of publicly available reports on the Vaccine Adverse Events Reporting System. 6 ” (the “FOIA Request”).

....
footnote 5: 5 21 C.F.R. § 601.51(e) provides that after a biological product is licensed, the following information shall be made available for immediate disclosure absent extraordinary circumstances: “(1) All safety and effectiveness data and information. (2) A protocol for a test or study . . . . (3) Adverse reaction reports, product experience reports, consumer complaints, and other similar data and information . . . . (4) A list of all active ingredients and any inactive ingredients . . . . (5) An assay method or other analytical method . . . . (6) All correspondence and written summaries of oral discussions relating to the biological product file . . . . (7) All records showing the manufacturer’s testing of a particular lot . . . . (8) All records showing the testing of and action on a particular lot by the [FDA].”
Source: 6. PHMPT therefore issued a request to the FDA pursuant to the Freedom of Information Act (5 U.S.C. § 552, as amended) (“FOIA”) for “[a

source fix: https://fingfx.thomsonreuters.com/gfx/legaldocs/klvykdlryvg/vaccine foia complaint.pdf

which is this (see section e):
https://www.law.cornell.edu/cfr/text/21/601.51
 
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Mendel

Senior Member.
yeah, I expect the bulk of the pages is going to be this
 

Rory

Senior Member.
Interesting to read that

Seems like it's something to do with the chimpanzee adenovirus they use. In summary:

1638572837677.png

Interesting that point 2 seems to indicate that the issue is caused/compounded by the vaccine entering into the bloodstream. Perhaps it may turn out that the lack of aspiration, as some have been suggesting for months, really is to do with the problems people have experienced.

So not quite as safe as AstraZeneca assured us. But, as they're keen to stress, probably better than catching Covid.
 

FatPhil

Active Member
Are you sure? Because these blood clot issues are still very rare.

Indeed, and in terms of error bars, these cases may even reduce the upper end of the confidence interval.
Their initial not-very-sure assurance could have been 0-4 arbitrary badness units, and now they have more data it might be 1-3.
Looking at it another way - were they really "assurances" when the drug was new? As one old teacher used to say: "everything has error bars - even pi, historically" (doesn't need debunking, it's just an aphorism, a handy warning that I notice a lot of people don't seem to grasp).
 

Mendel

Senior Member.
Conclusion: AZD1222 was safe, with low incidences of serious and medically attended adverse events and adverse events of special interest;
That's still valid.
Going by their reports quoted in posts 2 and 10.
The language in the #10 quotes is "showed no evidence" or "found no increased risk", which technically doesn't say there isn't any, just that it's hard to find: like Bigfoot, we don't know if it's really rare or if it doesn't exist, until we find it. It's still safe to go hiking, though, because we know that even if Bigfoot exists, we're more likely to get hit by a falling branch than to meet the guy.

I haven't looked at the studies that "found no evidence", but what sometimes happens is that you can see some small effect, but you're not sure if it's just random sampling error: that's when the effect doesn't pass the significance test. That's kind of like the fuzzy bigfoot picture that could be Bigfoot or just a strangely shaped bush: you can't really say "we found evidence for bigfoot". You're still in that gray area where you know nothing except that it's very rare if it exists. And at that point, it comes down to the error you'd rather risk committing.
 

Rory

Senior Member.
#2 in full:

Conclusion: AZD1222 was safe, with low incidences of serious and medically attended adverse events and adverse events of special interest; the incidences were similar to those observed in the placebo group.

And #10:

A careful review of all available safety data of more than 17 million people [...] has shown no evidence of an increased risk.
 

Mendel

Senior Member.
#2 in full:
There were 20,000 people in the treatment group, and the thrombosis risk was so low it didn't show up.

The incidence was 37/17 million = 0.2 per 100 000, and it randomly differed downward from the expected average, possibly because thrombosis in older people wasn't thought to be linked to the vaccine, and not all events had been reported.

Article:
So far, most of the cases reported have occurred in women under 60 years of age within 2 weeks of vaccination.

The Committee carried out an in-depth review of 62 cases of cerebral venous sinus thrombosis and 24 cases of splanchnic vein thrombosis reported in the EU drug safety database (EudraVigilance) as of 22 March 2021, 18 of which were fatal.

As of 4 April 2021, a total of 169 cases of CVST and 53 cases of splanchnic vein thrombosis were reported to
EudraVigilance. Around 34 million people had been vaccinated in the EEA and UK by this date

(62+24)/17 million = 0.5 per 100 000
(169+53)/34 million= 0.65 per 100 000
The number is likely rising because old people got vaccinated first.

In June, with more people vaccinated, Australia saw higher numbers, possibly because their thrombosis surveillance is better (they detected more mild cases). Or maybe Australians are just more susceptible to it.
Article:
Based on available international data at that time, the estimated risk of TTS was 4-6 per million cases following a first dose of COVID-19 Vaccine AstraZeneca.

From early April to 16 June 2021,
60 cases of confirmed or probable TTS have been reported in Australia. This includes an additional seven cases reported in the past week in people between 50-59 years, increasing the rate in this age group from 1.9 to 2.7 per 100,000 AstraZeneca vaccine doses. The revised estimates of risk associated with first doses of COVID-19 Vaccine AstraZeneca are listed in the table below.
Age​
Estimated risk of TTS per 100,000
AstraZeneca vaccine doses (first dose)​
<50 years3.1
50-59 years2.7
60-69 years1.4
70-79 years1.8
80+ years1.9

TTS is a serious condition in a proportion of individuals who develop it. The overall case fatality rate in Australia (3%; 2 deaths among 60 cases) is lower than has been reported internationally. This is likely to reflect increased detection due to heightened awareness, as well as early diagnosis and treatment.

BBC now:
Article:
These clots, known as vaccine-induced immune thrombotic thrombocytopenia, have been linked to 73 deaths out of nearly 50 million doses of AstraZeneca given in the UK.

That amounts to 0.15 deaths per 100 000.
For comparison, the unvaccinated Covid case fatality rate for people under 40 is ~0.2% = 200 deaths per 100 000. (With a 7-day incidence of 50 per 100 000, the vaccine risk is offset in two weeks.)

If you have a choice between 2 vaccines with an otherwise similar safety profile, you obviously choose the one that doesn't have that thrombosis risk.

But compared to the incidence rates we've seen in Europe, the harm the AZ vaccine causes is still less than the harm it protects you from.

Australia has had fewer cases overall, and Covid is less severe in younger people, so for Australia with low incidence, AZ vaccine risk can actually balance with Covid risk, but if they get a big wave again, AZ would still have benefits.

So in most situations, the AZ vaccine is still safe (as in: clearly better than no vaccination), it's just worse than the mRNA vaccines, which are recommended instead.
 

Rory

Senior Member.
I mean, we can agree to disagree on this, that's fine. But I think you're chasing red herrings by persisting in saying that "safe" equates to "it's better than no vaccination".

"Safe" to me means "it doesn't cause serious adverse effects". That a vaccine is better than no vaccine isn't argued, nor is it the issue. The issue is whether it causes SAEs or not.

In the beginning, AZ said it didn't; now they're saying it does. That's all I was saying when I wrote:

So not quite as safe as AstraZeneca assured us.
 

Mendel

Senior Member.
"Safe" to me means "it doesn't cause serious adverse effects". That a vaccine is better than no vaccine isn't argued, nor is it the issue. The issue is whether it causes SAEs or not.

In the beginning, AZ said it didn't; now they're saying it does. That's all I was saying when I wrote:
Yes. In my opinion, AZ never said that; what they said is that they hadn't found any.
 

econ41

Senior Member
I mean, we can agree to disagree on this, that's fine. But I think you're chasing red herrings by persisting in saying that "safe" equates to "it's better than no vaccination".

"Safe" to me means "it doesn't cause serious adverse effects". That a vaccine is better than no vaccine isn't argued, nor is it the issue. The issue is whether it causes SAEs or not.
Therein is one of the fundamental problems in these COVID or similar epidemiological debates. The assumption that the situation has binary outcomes. "True or False" "Safe or Not Safe".

The whole topic is probability-based. The criterion is not "is it safe" it should be "is it safe enough". And the topic is not just about one aspect of probability. It is several and they're conflicting and interacting in various layers. Decisions are inherently a matter of risk management and selecting the best bets.

Probably the two most significant probability factors are:
(a) The over-riding position that the benefits far outweigh the downside risks.
(b) The downside risks which are typically order\s of magnitude lower than the
benefits.

So taking the AZ blood clots issue. It was not identified in the trials process but emerged once full-scale vaccination programs were underway.
In my case at age 70+ I was eligible for age-based priority under the Australian Federal program. My wife and I were scheduled for vax at the time the blood clot risk was discovered. With a couple of AU cases. We didn't hesitate - a chance of the order on one in a million is not much different than zero chance though that factor did seem to cause many older Aussies to hesitate.

In the beginning, AZ said it didn't; now they're saying it does. That's all I was saying when I wrote:
Both could be true if the argument is assumed to be "binary" - with no-one defining "safe enough". Most anti-vax "argument" relies on presumption of "binary" OR making the wrong choice for those who do recognise "probabilty" based.-
 

Mendel

Senior Member.
The criterion is not "is it safe" it should be "is it safe enough".

Sure. Let's say I ask the question "will it put me in a wheelchair or kill me?"

"No" = safe
Rory's definition of "safe" is pretty radical, though I expect it is shared by many.

However, if we're evaluating what AZ means when they say that their vaccine is safe, we ought to use their definition (unless it is uncommon and misleading).

And that probably means not taking "safe" as an absolute, but considering "safe" in the context of feasible alternatives (e.g. remaining unvaccinated).

"Safe" is often not absolute, but relative: when we hear "safe", we need to ask, "compared to what?"
 

econ41

Senior Member
"Safe" is often not absolute, but relative: when we hear "safe", we need to ask, "compared to what?"
Which is nearly the same point I am making about "Binary" expectations on a system that is determined by probabilities.
Rory's definition of "safe" is pretty radical, though I expect it is shared by many.
It is implicitly a "global" expectation of absolute guarantees of perfection - the implied assumption that "safe" means there will NEVER be a single example of "not safe". Wrong paradigm. Wrong frame of reference.
And that probably means not taking "safe" as an absolute, but considering "safe" in the context of feasible alternatives (e.g. remaining unvaccinated).
Which is not the same emphasis I made in my comment but an equally important issue in the overall selection of risk-managed options or alternatives.
 
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