Pfizer Documents Released under court order

[ArcticFox]

The FDA working with Pfizer attempted to have all of Pfizer's Covid vaccine documentation sealed for 55 years.
Public Health and Medical Professionals for Transparency filed a suit against the FDA to have the documents released.
The court ruled in favor of the Public Health and Medical Professionals for Transparency and the Pfizer documents were order to be released to the public.  Copies of Pfizers documents can be found on the Public Health and Medical Professionals for Transparency web site (https://phmpt.org)



Of the documents to be reviewed by independent sources, the live trial data published in the document 5.3.6 CUMULATIVE ANALYSIS OF POST-AUTHORIZATION ADVERSE EVENT REPORTS OF PF-07302048 (BNT162B2) RECEIVED THROUGH 28-FEB-2021 (link: https://phmpt.org/wp-content/uploads/2021/11/5.3.6-postmarketing-experience.pdf)  Section 3 - Results outlined the adverse reactions to the Pfizer vaccinated as Pfizer reported to the FDA.

This is Pfizer's trial data as reported to the FDA.  Read it for yourself. 

For those who don't wish to read it - a summery:
"Cumulatively, through 28 February 2021, there was a total of 42,086 case reports (25,379 medically confirmed and 16,707 non-medically confirmed) containing 158,893 events."
The 'events' are then broken down by age, sex, and types of adverse reaction.

[ArcticFox]

One other item to note in Pfizer's concern of the vaccine's safety is the potential for
Vaccine-Associated Enhance Disease, Including Vaccine-associated Enhanced Respiratory Disease. 

Those terms are defined here: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7901381/

To summarize, the vaccines enhances the ability of 'wild-virus' to infect host cells creating more damage to a vaccinated host than to a host without the vaccine.

The issue here is there are no long term studies of these vaccines.  Which is why the average time it takes to develop a 'safe' vaccine is between 5 to 10 years.  The long-term studies would identify and quantify the risks of Vaccine-Associated Enhance Disease, Including Vaccine-associated Enhanced Respiratory Disease. 

Edited December 8, 2021 by ArcticFox

[Virt]

Or you can jump straight to the end.

 

5. SUMMARY AND CONCLUSION
Review of the available data for this cumulative PM experience, confirms a favorable
benefit: risk balance for BNT162b2.

[ArcticFox]

22 minutes ago, Virt said:

Or you can jump straight to the end.

 

5. SUMMARY AND CONCLUSION
Review of the available data for this cumulative PM experience, confirms a favorable
benefit: risk balance for BNT162b2.

"According to Pfizer, the adverse reactions and deaths confirms a favorable benefit: risk balance for BNT162b2."

Which to date Pfizer states it expects to generate $36 billion dollars in revenue in 2021 alone. They have just a tad bit of a serious conflict of interest. 

This will eventually be analyzed by independent medical experts, organizations, and researchers who have no conflicts of interest or monetary gain.  These metadata will be compared against all other previous vaccine research as vaccine safety profiles are compared.  If the differences in safety profiles are statistically significant - there will be calls for investigations into the FDA's regulatory conduct.  If the comparison between BNT162b2 and historical safety data for most vaccines released for public consumption are the same and not statistically significant, then the independent metadata studies will validate Pfizer and they will be vindicated and can use those studies to market their product safety.
We'll know a lot more within the next 6 months to a year. 

However, the optics for attempting to bury this data for 55 years isn't good.  If there is nothing to see, why attempt to keep it from the public if the data actually shows a great safety profile as we are continually told?

Edited December 8, 2021 by ArcticFox

[Virt]

35 minutes ago, ArcticFox said:

"According to Pfizer, the adverse reactions and deaths confirms a favorable benefit: risk balance for BNT162b2."

Which to date Pfizer states it expects to generate $36 billion dollars in revenue in 2021 alone. They have just a tad bit of a serious conflict of interest. 

This will eventually be analyzed by independent medical experts, organizations, and researchers who have no conflicts of interest or monetary gain.  These metadata will be compared against all other previous vaccine research as vaccine safety profiles are compared.  If the differences in safety profiles are statistically significant - there will be calls for investigations into the FDA's regulatory conduct.  If the comparison between BNT162b2 and historical safety data for most vaccines released for public consumption are the same and not statistically significant, then the independent metadata studies will validate Pfizer and they will be vindicated and can use those studies to market their product safety.
We'll know a lot more within the next 6 months to a year. 

However, the optics for attempting to bury this data for 55 years isn't good.  If there is nothing to see, why attempt to keep it from the public if the data actually shows a great safety profile as we are continually told?

I agree they shouldn't try and bury their data.

That's just like asking for trouble.

 

As for their trial data I'm not that worried.

They had one of the largest if not the largest study ever when it comes to a new vaccine.

If something has been hidden it will be revealed, but i highly doubt that.

 

As for them making money on this situation.

 

I'm totally fine with that.

If they had not invested and researched in the mRNA tech just like moderna, they wouldn't be able to deliver the new vaccines so fast as they did.

It's only fair they make some money off that, so they can put some of the profit back into research for new drugs etc.

 

It's not like it's that expensive for a life saving vaccine.

 

But they shouldn't have tried to bury their data in the first place.

Edited December 8, 2021 by Virt
Spelling

[ThLT]

1 hour ago, ArcticFox said:

One other item to note in Pfizer's concern of the vaccine's safety is the potential for
Vaccine-Associated Enhance Disease, Including Vaccine-associated Enhanced Respiratory Disease. 

Where does it say this?

You didn't quote anything.

You just said that "one other item to note in Pfizer's concern" which doesn't mean much.

[Chomper Higgot]

2 hours ago, ArcticFox said:

"According to Pfizer, the adverse reactions and deaths confirms a favorable benefit: risk balance for BNT162b2."

Which to date Pfizer states it expects to generate $36 billion dollars in revenue in 2021 alone. They have just a tad bit of a serious conflict of interest. 

This will eventually be analyzed by independent medical experts, organizations, and researchers who have no conflicts of interest or monetary gain.  These metadata will be compared against all other previous vaccine research as vaccine safety profiles are compared.  If the differences in safety profiles are statistically significant - there will be calls for investigations into the FDA's regulatory conduct.  If the comparison between BNT162b2 and historical safety data for most vaccines released for public consumption are the same and not statistically significant, then the independent metadata studies will validate Pfizer and they will be vindicated and can use those studies to market their product safety.
We'll know a lot more within the next 6 months to a year. 

However, the optics for attempting to bury this data for 55 years isn't good.  If there is nothing to see, why attempt to keep it from the public if the data actually shows a great safety profile as we are continually told?

Confidentiality of industry/business  information is nothing new and without proof of sinister intent your innuendo regarding this information being withheld is just that ‘innuendo’.

 

You’ve taken pains to quote numbers of reported ‘adverse events’, which may be anything between a headache to severe reaction. What is not provided in this report is the total of vaccinations to which these ‘adverse events’ relate.

 

The safety data sheet for the vaccine is published and has been available since the vaccines were released for use.

 

Unless the reactions and incidence of reactions in this report is significantly different from that recorded in the published data sheets there is no scandal, nothing being hidden no conspiracy.

[Chomper Higgot]

3 hours ago, ArcticFox said:

One other item to note in Pfizer's concern of the vaccine's safety is the potential for
Vaccine-Associated Enhance Disease, Including Vaccine-associated Enhanced Respiratory Disease. 

Those terms are defined here: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7901381/

To summarize, the vaccines enhances the ability of 'wild-virus' to infect host cells creating more damage to a vaccinated host than to a host without the vaccine.

The issue here is there are no long term studies of these vaccines.  Which is why the average time it takes to develop a 'safe' vaccine is between 5 to 10 years.  The long-term studies would identify and quantify the risks of Vaccine-Associated Enhance Disease, Including Vaccine-associated Enhanced Respiratory Disease. 

You are misrepresenting a vaccine assessment methodology as being proof of a vaccine risk existing.

 

If you’ll tell us who’s feeding you this utterly ingenious conclusion we’ll know  who to blame.

 

 

Edited December 8, 2021 by Chomper Higgot

[Airalee]

5 minutes ago, Chomper Higgot said:

Confidentiality of industry/business  information is nothing new and without proof of sinister intent your innuendo regarding this information being withheld is just that ‘innuendo’.

That you support the fact that it will take Pfizer 55 years to release information on their vaccine under the FOIA request when it is in the public’s interest is disgusting.

 

Shameful.

[Chomper Higgot]

6 minutes ago, Airalee said:

That you support the fact that it will take Pfizer 55 years to release information on their vaccine under the FOIA request when it is in the public’s interest is disgusting.

 

Shameful.

I don’t support the ‘fact’.

 

I point out that it is very normal practice.

 

You need to produce evidence of sinister intent that is a bit more substantial than half baked innuendo.

[Airalee]

Just now, Chomper Higgot said:

I don’t support the ‘fact’.

 

I point out that it is very normal practice.

 

You need to produce evidence of sinister intent that is a bit more substantial than half baked innuendo.

No,  55 years is not normal practice at all.

 

Disgusting for you to claim so.

[Chomper Higgot]

13 minutes ago, Airalee said:

No,  55 years is not normal practice at all.

 

Disgusting for you to claim so.

Industrial secrets may be legally kept indefinitely, they are not ‘public property’.

 

I, and I have no doubt many other members here, have personally signed confidentiality agreements that forbid me discussing the information I have regarding the businesses I have worked for or with, these secrecy agreements run indefinitely.

 

I assure you of this, nothing I ever came across is being withheld from anyone for sinister reasons.

 

If you allege sinister reason you need to prove sinister reasons.

 

I suggest you start by trying to find a disparity between this released report and the published safety data.

 

After all, if there is something being hidden that something is in the report.

 

My observation is the only thing not revealed is the number of doses to which the reported ‘adverse events’ relate.

 

References (b) (4) are missing from the OP.

Edited December 8, 2021 by Chomper Higgot

[KC 71]

55 yrs is way too long a time withhold information.

It makes them look quite deceitful really.

[Chomper Higgot]

1 minute ago, KC 71 said:

55 yrs is way too long a time withhold information.

It makes them look quite deceitful really.

Well the information is released now.

 

Let us know what you think they were trying to keep from us (with quotes from the released report please).

[blackprince]

52 minutes ago, Airalee said:

No,  55 years is not normal practice at all

 

"Ten years of clinical trial data cannot legally be hidden from the public, US court rules"

https://www.bmj.com/content/368/bmj.m832

 

"Typically, the standard use for NDAs ranges from 1 to 5 years. "

 

https://lawpath.com.au/blog/how-long-should-a-non-disclosure-agreement-last

 

I wrote a much longer post, but it got lost...sorry.

[KC 71]

1 hour ago, Chomper Higgot said:

Well the information is released now.

 

Let us know what you think they were trying to keep from us (with quotes from the released report please).

Look for yourself.

I'm not your secretary .

[placeholder]

Actually, the OP has got it badly wrong. The FDA did not attempt to have all the documents sealed for 55 years. This is absolutely false.

ttps://www.fiercepharma.com/pharma/fda-requests-55-years-to-complete-foia-request-pfizer-s-covid-19-vaccine

What's more the judge has not ordered the FDA to release all the documents on the schedule demanded by the plaintiffs. Maybe the next time the OP launches a new thread, it might be a good idea to take the time to check whether or not the claims are actually facts? 

The plaintiffs in this suit requested every single document relating to the approval of the vaccine including stuff like business invoices. That comes to  329,000 documents .The FDA offered to release 500 documents a month to allow for redactions related to privacy and industrial secrets. At that rate it would take 55 years for all the documents to be released.   (If you link to the documents hosted on the website of the anti-vaccine group as of now there are a grand total of 7.).The plaintiffs knew that this request was unreasonable. They could have chose to target certain classes of documents. But this wasn't about making a serious request. It as about making headlines.

So where is the judge's order to release the almost 400,000 documents? Nowhere, because as of now he has made no such order. 

As for the 156,000 adverse events. These would include symptoms like a sore arm, fatigue or a headache after being vaccinated. They would also include any illness or symptoms that arose in the trial subjects for the entire duration of the trial. People in trials are expected to report any symptom, no matter how small.

What makes this belief that something untoward has been exposed even more nonsensical is that now there's a huge database consisting of million of people who have been vaccinated. It's clear that whatever hazards are posed by the vaccines are vastly outweighed by the benefits.

[blackprince]

As a Brit, I've always been impressed with US FOI laws. But this particular case does sound a little odd:

 

"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."

 

ttps://www.fiercepharma.com/pharma/fda-requests-55-years-to-complete-foia-request-pfizer-s-covid-19-vaccine

 

But as for the adverse events referred to by @placeholder above I have to agree with him on this occasion. In fact I posted a fairly detailed post to that effect 2 or 3 weeks ago. It took me quite a long time to do and required me not just to research and link various websites, but also to make statistical calculations based on the raw data.

 

For some reason it got deleted, possibly because there was a spat on either side of it. Shame though. And needless to say I wasn't pleased. Consequently I would advise posters here who demand ever increasing amounts of data that this can turn into a very big waste of time.

[coolcarer]

Typical anti vaxxers OP that takes a couple of google searches and a sprinkle of logic to send it where it belongs

[Chomper Higgot]

1 hour ago, placeholder said:

Actually, the OP has got it badly wrong. The FDA did not attempt to have all the documents sealed for 55 years. This is absolutely false.

ttps://www.fiercepharma.com/pharma/fda-requests-55-years-to-complete-foia-request-pfizer-s-covid-19-vaccine

What's more the judge has not ordered the FDA to release all the documents on the schedule demanded by the plaintiffs. Maybe the next time the OP launches a new thread, it might be a good idea to take the time to check whether or not the claims are actually facts? 

The plaintiffs in this suit requested every single document relating to the approval of the vaccine including stuff like business invoices. That comes to  329,000 documents .The FDA offered to release 500 documents a month to allow for redactions related to privacy and industrial secrets. At that rate it would take 55 years for all the documents to be released.   (If you link to the documents hosted on the website of the anti-vaccine group as of now there are a grand total of 7.).The plaintiffs knew that this request was unreasonable. They could have chose to target certain classes of documents. But this wasn't about making a serious request. It as about making headlines.

So where is the judge's order to release the almost 400,000 documents? Nowhere, because as of now he has made no such order. 

As for the 156,000 adverse events. These would include symptoms like a sore arm, fatigue or a headache after being vaccinated. They would also include any illness or symptoms that arose in the trial subjects for the entire duration of the trial. People in trials are expected to report any symptom, no matter how small.

What makes this belief that something untoward has been exposed even more nonsensical is that now there's a huge database consisting of million of people who have been vaccinated. It's clear that whatever hazards are posed by the vaccines are vastly outweighed by the benefits.

Excellent post, thank you.

[Chomper Higgot]

3 minutes ago, coolcarer said:

Typical anti vaxxers OP that takes a couple of google searches and a sprinkle of logic to send it where it belongs

The misrepresentation of facts, data and reports by anti-vaxxers is a thing.

 

What we never get to see is where the OP found this ‘accusation’, he surely did not happen upon a court judgement by chance then immediately stumble across an obscure risk assessment procedure.

[Scott]

The request to limit the release was made by the FDA, not by Pfizer.  The documents in question are those submitted to the FDA for authorization.  

 

Keep your discussion civil or suspensions will be issued.  

[Atlantis]

Since we're talking about Pfizer and the issue of trust and transparency, I wonder what some of the posters above think of this:

https://theintercept.com/2021/11/29/pfizer-whistleblower-reform-corporate-fraud/
Pfizer is among the Big Pharma companies trying to block legislation strengthening whistleblowers’ ability to report corporate fraud.

[Atlantis]

And we mustn't forget the investigative piece from the British Medical Journal last month:

https://www.bmj.com/content/375/bmj.n2635

Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial
 

Revelations of poor practices at a contract research company helping to carry out Pfizer’s pivotal covid-19 vaccine trial raise questions about data integrity and regulatory oversight. Paul D Thacker reports.

 

[Virt]

34 minutes ago, Atlantis said:

And we mustn't forget the investigative piece from the British Medical Journal last month:

https://www.bmj.com/content/375/bmj.n2635

Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial
 

Revelations of poor practices at a contract research company helping to carry out Pfizer’s pivotal covid-19 vaccine trial raise questions about data integrity and regulatory oversight. Paul D Thacker reports.

 

Another aspect from this story.

 

https://www.medpagetoday.com/special-reports/exclusives/95484

[sirineou]

Everyone should be able to find something to confirm their bias in this report. 

[Atlantis]

7 minutes ago, Virt said:

Another aspect from this story.

 

https://www.medpagetoday.com/special-reports/exclusives/95484

I just read this article three times. I applaud Cheryl Clark for her ability to say almost nothing and it took her over 700 words to do so. Did you miss the pointless padding she added from her 'expert interviews'?

It barely addresses any of the points made in the original BMJ article - this is not hard to see. All you need to do is read the original piece by Thacker, and this piece by Clark. She probably let it slip a little with "Vague kind of handwaving". Vague, vacuous, bland, nothing-burger is quite a suitable description of her piece.

Do you have anything better? (<< Serious question / request).

[Virt]

12 minutes ago, Atlantis said:

I just read this article three times. I applaud Cheryl Clark for her ability to say almost nothing and it took her over 700 words to do so. Did you miss the pointless padding she added from her 'expert interviews'?

It barely addresses any of the points made in the original BMJ article - this is not hard to see. All you need to do is read the original piece by Thacker, and this piece by Clark. She probably let it slip a little with "Vague kind of handwaving". Vague, vacuous, bland, nothing-burger is quite a suitable description of her piece.

Do you have anything better? (<< Serious question / request).

I'm familiar with the many articles that describes this case,

and yeah it does sound like there are certain things to criticize.

I'm not denying that.

The most worrying thing might be that some of vaccines were not all stored at correct temperatures.

It sounds like a sloppy job at the facility in Texas but not necessarily tampering with the results. 

It was headlines here in Denmark as well.

 

As far as i know FDA were notified about this by Jackson, and they didn't take any action.

Why is that?

Wouldn't you think FDA would have taken actions if they were worried at that time?

 

Also we have to remember this was from the trials last year and involved 1000 people of 44000 in total, and since then in the US more than 275 millions doses has been given, and i don't know how many millions in the rest of the world.

 

So should we really worry about the quality of the vaccine?

Not in my opinion, but that does mean it's ok to do a sloppy job in a small part of the trials.

 

Sorry for my english but trying as best as i can to explain how i feel about this case.

 

[Chomper Higgot]

10 hours ago, Scott said:

The request to limit the release was made by the FDA, not by Pfizer.  The documents in question are those submitted to the FDA for authorization.  

 

Keep your discussion civil or suspensions will be issued.  

The FDA have a very practical reason to seek protection of the confidentiality of documents submitted to them during drug trials and drug authorizations.

 

The task of review and authorization requires full and candid disclosure of findings, which will inevitably include data useful to competitors of the applicant, without assured confidentiality of data submitted there is a commercial risk to applicants and therefore a commercial imperative to be less candid in their submissions.

[placeholder]

6 hours ago, Atlantis said:

I just read this article three times. I applaud Cheryl Clark for her ability to say almost nothing and it took her over 700 words to do so. Did you miss the pointless padding she added from her 'expert interviews'?

It barely addresses any of the points made in the original BMJ article - this is not hard to see. All you need to do is read the original piece by Thacker, and this piece by Clark. She probably let it slip a little with "Vague kind of handwaving". Vague, vacuous, bland, nothing-burger is quite a suitable description of her piece.

Do you have anything better? (<< Serious question / request).

I read the article. For one thing, both Pfizer and Ventavia claim that they weren't contacted by the author. That's a pretty serious and specific charge. For another Medpage tried to reach the author and was unsuccessful. The article also notes that Ventavia claimed it notified the appropriate parties. Did the author of the BMJ article try to fact check to see if this was true? Why do you think it's incumbent upon the Medpage article author to reinvestigate Jackson's charges? Apparently, they did what the BMJ article failed to do: get the other side of the story.