RELEASE OF PFIZER DOCUMENTS

WHAT HAS BEEN REVEALED ABOUT THE COVID-19 VACCINES AND WHERE WE GO FROM HERE.

Readers will be aware that a court ordered release of documents filed by Pfizer with the FDA, further to the granting of the Conditional Use Authorisation and thereafter, has resulted in the release of documents on a phased basis from February 2022, with 10,000 documents released in March 2022, 10,000 in April, 80,000 a piece in May June and July 2022, and 55,000 pages after that until all of the documents have been released. Approximately 400,000 pages of documents are to be released.

The FOI request was made by Public Health and Medical Professionals for Transparency in America. The group is composed of medical and public health professionals and scientists from Harvard, Yale and other institutions.

The FOI request was first made in August 2021. The group looked for 400,000 documents approximately, pertaining to the EUA approval given to Pfizer for their vaccines, the request covering safety and effectiveness, adverse events reports and, significantly, a list of the vaccines ingredients, active and inactive.

The FDA ignored the FOI request, leading to the court application. The court ordered the FDA to release the documents and it was subsequently submitted by the FDA that this could only be done at a rate of 500 pages per month, on the basis of the large amount of relevant documentation involved and the redaction required. Effectively this would have taken a period of 75 years in order to release all of the relevant data. The fact that the FDA were not willing to release this documentation without a court order, regardless of the public interest issues involved, and the fact they then proposed to release court ordered information over a period of 75 years, raises an immediate red flag. The released documents to date are heavily redacted, another red flag. The covid-19 Vaccines use a kind of technology never before administered to a human population on a mass scale, and were rushed out under an EUA authorisation. The vaccines are still in trial. Monitoring of adverse events, full disclosure to the public including both heath professionals and vaccine recipients, is an essential precondition for use of these vaccines on the public. In any event, US Judge Mark Pittman rejected the FDA proposal and ordered the release of documents as outlined above. There are approximately eight more months of document dumps pending. A smaller cache of the Pfizer documents were released by the FDA in November and December 2021, and January 2022.

What do the documents reveal? They are heavily redacted and dense in content and number. It has been a herculean task of analysis as to what is revealed so far, from all accounts.

There is much discussion in internet based independent media just now about the Pfizer Study, (within released documents) covering the period from the 1st December 2021 to the 28th February 2022, as to adverse events reported to the pharmaceutical company. In fact this document was released in a tranche before Christmas and the takeouts from the report are being clarified, essentially, at this stage. The study reveals reported adverse events involving 1223 vaccine related deaths, a subset of 158,893 vaccine injuries reported in this period. These adverse events relate to a caseload of 42, 086 reports to Pfizer, revealing a death rate of one in 35 in the group reporting the adverse events. An issue with the data released is that it does not reveal the total number of vaccinations given, and so it is impossible to establish exactly the overall rate of serious injury and death in the total population vaccinated without this figure. A death rate however of 3% overall has been calculated, extrapolating out from these figures, and giving a generous margin of error in Pfizers favour. Our readers will be aware of the survival rate from covid-19 infections.

It is inarguable also, and acknowledged by Pfizer itself, that the reporting system is a passive one and generally accepted to result in the under-reporting of adverse events. Interestingly enough, Pfizer acknowledge in this report that their reporting system were heavily challenged by the sheer volume of reports from the public over this period. We must also be mindful of the fact that this is a study on injury reports to Pfizer. The rate and nature of reports made on the national reporting systems such as the MHRA, VAERs, our HPRA, and Eudravigilence for the EU may show higher rates of injuries and deaths overall.

The Pfizer Report released in these documents include an Appendix of all injuries as reported to the Pfizer reporting system for the three month period, which is nine pages long. This list has been much discussed, referred to in understandable horror indeed, by the public on various online platforms and in independent media since the March 2022 release. Of course the report was released earlier, but the sheer volume of adverse effects as experienced by the individuals reporting is there for anyone to read. The list is certainly not a part of any insert provided with the vaccine to the public, prior to rolling up their sleeves for the shot. The specified injuries listed, 1300 injuries approx, are not definitively established as being caused by the vaccine, but it both arguable and persuasive that these injuries are being reported by the population who took the vaccine and believed by them to be subsequent to and caused by the vaccine. Causation directly or indirectly in respect of these injuries is not confirmed but Pfizer, in the report, offered more data of concern about injuries in the reporting group which they categorised as adverse effects of ‘special interest’ (AESI). These included 1,403 cardiovascular AESI, 932 hematologic, 3,.000 musculoskeletal, 501 neurologic and 3,674 other serious AESIs, all reported as occurring with an onset of two days from vaccination. A great deal to concern us here then.

The most recently released cache in March 2022 include documents pertaining to animal studies, specific kinds of adverse reaction of initial trial subjects, amendments made to the study protocols in the initial trial, and the original application from Pfizer-Biontech to market the vaccine to the US Department of Health and Human services.

The information released is vast in volume and requires time and careful study to unpack. This is ongoing and there will be analyses and conclusions made public over the next weeks and months.

One area of interest revealed in the March 2022 documents concerns the animal studies carried out on rats, and a report described as ‘The Final Report’ entitled ‘A Tissue Distribution Study of a (3H) Labelled Lipid NanaParticle-mRNA Formulation Containing ALC-0315 and ALC-0159 Following Intramuscular Administration in Wistar Han Rats’. The report concerns the bio-distribution of Lipid NanoParticles, (LNPs) carrying vaccine ingredients active and inactive including mRNA components around the body after vaccination. The public were assured that these LNPs would stay in the arm, bio degrading quickly, and certainly would not travel around the body actively, in the production of spike proteins. This report is currently being analysed, and is the subject of an article by Jessica Rose PH.D. She concludes in the article, dated March 8th 2022, that the Final Report in the Pfizer documents confirm that biodistribution was clearly demonstrated in the liver, spleen, adrenals and ovaries from her reading of the data. She further refers to the Japanese study data which clearly showed biodistribution and accumulation of LNPS around the body. The Pfizer study relates to the period of the study only. It is unknown as far as Pfizer are concerned, and as they present the data, how long the vaccine continues to distribute these LNPs, or how long they remain in these organs. Biodistribution in the adrenals, liver, spleen and ovaries is confirmed then, in Pfizer’s submitted data to the FDA.

The current and ongoing court case brought by whistleblower Brook Jackson relates to issues of concern arising around the conduct of the clinical trials for the Pfizer vaccine. Ms Jackson worked on the trials as a supervisor of the trial process, employed by a company called Ventavia, who were one of the test companies contracted to carry out the Pfizer covid-10 vaccine clinical trials. She became concerned about the poor management of the trials and describes a shambolic process where data was improperly managed, trial participants unblinded during the study, and the incidence of various protocol deviations. She describes poor recording and follow up of serious adverse effects suffered in trial participants. She was sacked within six hours of reporting these issues to the FDA. Her court case is taken against the FDA, Pfizer and Ventavia and is ongoing. Four hundred pages of her complaint evidence was unsealed by the court in January 2022 and is publicly available. Ms Jackson has explained that the details of her claims, as outlined in the proceedings, were sealed by the court from January 2021 when she initiated the lawsuit until January 2022, due to the repeated adjournments sought by the other side. The effect being that she was unable to bring the relevant issues to public notice in any great detail until January 2022, to her great regret. The basis of her case is that Pfizer, Ventavia and ICON withheld crucial information from the United States that challenges the safety and efficacy of the vaccine. Jackson gave a cache of internal company documents to The British Medical Journal and an article based on the documents by journalist Paul Thacker followed, concentrated on the evidence in these documents highlighting Ventavia’s repeated failures.

The March Pfizer documents now released include data relevant to the clinical trials, carried out pre-approval, and will have bearing on the case Brook Jackson is presenting.

It is worth noting that Ventavia continued to run vaccine trials for Pfzier as a subcontractor, in vaccine clinical trials for the roll-out of Pfizer’s covid-19 vaccine to children, young people,. pregnant women and booster doses, despite these serious issues as raised by Jackson.

The pharmaceutical companies have revealed publicly that test subjects in the covid-19 vaccine clinical trial placebo groups were offered the vaccines when the EUA was granted, and reportedly many took up the offer. This was disingenuously presented as a humane action, the reality being that not only were the clinical trials as to safety and efficacy prior to the FDA conditional authorisation hugely compromised (if the case made by Jackson as to the unblinding, fraud, and negligence by Ventavia correct ) but the necessary assessments as between vaccinated and placebo groups post vaccination, as to the medium to long term injuries in an ongoing trial, is not now possible.

The current Ukraine Russia conflict has distracted hugely from what is being revealed by the release of the Pfizer documents submitted to the FDA. The takeaways from documents released have profound significance in the matter of informed consent by individuals to the covid-19 vaccinations. The reality is that the information emerging from the documents release is not being reported in mainstream media and the majority of the population are not being made aware of these urgent findings.

The elephant in the room here, in our view, relates to the emergency or conditional authorisations for mass roll outs of Pfizer’s covid-19 vaccines granted by the various regulatory bodies. Based, presumably, on the information contained in these submitted documents. The conditional authorisation granted by the FDA was followed by conditional or emergency use authorisations by the health systems around the globe including the Europe wide EMA, the UK MHRA, our HPRA, and other health systems regulatory bodies. Did all of these bodies access the Pfizer paperwork now being released by the FDA? Were each of these health systems aware of the content of Pfizer’s submitted documents to the FDA? Were the same or similar documents submitted to them? Are they aware of what is to be revealed going forward? It is speculated that the most controversial content will come towards the end of the court ordered discovery period. Have the various systems, the EMA, the HPRA, the MHRA, each national or European regulatory health body issuing or confirming authorisation, accessed this information or similar information? Or has this been a rubber stamping exercise without due diligence? If so the granting of authorisations by each of these health systems and entities have been criminally negligent. If, on the other hand each of these bodies have examined and are currently privy to all such documents submitted by Pfizer to the FDA they have a number of urgent questions to answer, including our own HPRA.

The covid-19 inoculations of the public continue apace, against this background of red flags, of emerging data casting serious doubts on the safety and efficacy of the vaccines.

We have drafted a letter raising the relevant matters with our own HPRA in this country, and with the EMA (being decisive in the EUA authorisation of the vaccine across the EU) which our readers might wish to forward, requiring immediate clarifications as to the due diligence carried out prior to the authorisations , and requiring a full response from these regulatory bodies as to all matters arising based on what we now know and have learned from the Pfizer documents released to date.

To: Mr Michael Donnelly

Email : info@hpra.ie (email seems to be the only way to correspond with Donnelly or the rest of the 8 members on the HPRA board.)

And to medvigilance@hpra.ie

And to:

The Management Board,

Covid-19 Vaccine Authorisations,

Domenico Scarlattilaan 6,

1083 HS Amsterdam,

The Netherlands,

Further to the ongoing release of the Pfizer documents, submitted to the FDA in furtherance of the condimental approval granted for the covid-19 vaccines, court ordered in February 2022, I, an Irish citizen and a citizen of the European Union, require your response to the following issues as matters of urgent public interest:

Did the EMA and the HPRA familiarise themselves with the contents of these documents, submitted by Pfizer to the FDA as part of their application process for authorisation, before authorising the current EUA authorisation for this vaccine in Europe and in Ireland? Was the said or similar documentation not also submitted to you?

.

If so, why were the public not made aware of the death and injuries reported post vaccination, up to the 28th February 2022, as revealed in these documents. Why were the public not made aware of the nine page appendix of approximately 1300 injuries in total, reported to the pharmaceutical company itself from the period of the 1st December 2021 to the 28th February 2022?

Can the EMA and the HPRA clarify as to how informed consent was possible where the public were not made aware of these matters, in the context of an Emergency Use Authorisation for a vaccine still in trial?

Can the EMA and the HPRA confirm why it was not made clear to each vaccine recipient, post authorisation, that the vaccine trial was ongoing?

Has the EMA and the HPRA established the severity of these adverse effects, as listed in the appendix to the Pfizer study submitted with the said documents? Have your members made themselves aware of how many vaccinations were involved in total over that period?.

Is it the case that the EMA and the HPRA have not and are not accessing this documented evidence of safety and efficacy in the case of Pfizer’s vaccine? If so, how are the EMA and the HPRA managing and monitoring reporting of injuries as reported to Pfizer? How have the EMA and the HPRA deemed the vaccine to be safe and effective? Have the EMA and the HPRA effectively rubber stamped the FDA approval as originally given? Or have you based your authorisations for use of the covid-19 vaccine on different or contrasting submitted data from Pfizer?

Are the EMA and the HPRA aware that clinical trial subjects in the placebo group have been offered and have largely taken up covid-19 vaccinations in the period immediately following on the clinical trial, after EUA or conditional approval? Are you aware that, if this is the case, there is effectively no control group to measure medium to long term adverse effects arising in the vaccinated?.

Are the EMA and the HPRA aware of the allegations made by whistleblower Brook Jackson as to the unblinding of trial subjects in the pre-authorisation trials? Are you as a regulatory body aware, or have you made yourself aware, of the protocol deviations the whistleblower describes and documents? Have you investigated these claims?

Are you aware that Ventavia, the company employing the whistleblower, was again contracted by Pfizer to carry out clinical trials for the roll-out of the covid-19 vaccine to children, young people, pregnant women and in respect of booster shots?

Do the EMA and the HPRA members see an active role for themselves as a body in monitoring ongoing adverse events in any meaningful way, and if so are you not concerned about the obstacles to carrying out any meaningful monitoring of vaccine injuries without a placebo group?

Are the EMA or the HPRA members aware of the contents of the Pfizer documents yet to released? If not, why have you not required sight of the submitted information by Pfizer further to that company’s approval application?

If the EMA and the HPRA members are aware of the contents in the Pfizer documents yet to be released over the next six to 8 months, are you satisfied as to safety and efficacy in continuing with the Pfizer covid-19 vaccinations, based on the evidence of these said documents?

Are the EMA and the HPRA members aware of the constituent active and inactive ingredients of the vaccines, and if so are you prepared to make these details available to the public? if not, can the EMA and the HPRA explain how they have deemed the vaccines to be safe and effective for public roll-out?

I await your urgent response.

You may follow up and question any response received. Whether you receive a response or not it is an exercise worth doing. It flags to these entities that we are watching, we are aware, and these issues are being challenged, we will not go away.

You can send this draft in letter form to the EMA if you choose. The EMA provides a postal address on its website, unlike the HPRA.

You can use the draft to contact the EMA and the HPRA separately. in the alternative.

Pm us if required.

Readers will be aware that a court ordered release of documents filed by Pfizer with the FDA, further to the granting of the Conditional Use Authorisation and thereafter, has resulted in the release of documents on a phased basis from February 2022, with 10,000 documents released in March 2022, 10,000 in April, 80,000 a piece in May June and July 2022, and 55,000 pages after that until all of the documents have been released. Approximately 400,000 pages of documents are to be released.

The FOI request was made by Public Health and Medical Professionals for Transparency in America. The group is composed of medical and public health professionals and scientists from Harvard, Yale and other institutions.

The FOI request was first made in August 2021. The group looked for 400,000 documents approximately, pertaining to the EUA approval given to Pfizer for their vaccines, the request covering safety and effectiveness, adverse events reports and, significantly, a list of the vaccines ingredients, active and inactive.

The FDA ignored the FOI request, leading to the court application. The court ordered the FDA to release the documents and it was subsequently submitted by the FDA that this could only be done at a rate of 500 pages per month, on the basis of the large amount of relevant documentation involved and the redaction required. Effectively this would have taken a period of 75 years in order to release all of the relevant data. The fact that the FDA were not willing to release this documentation without a court order, regardless of the public interest issues involved, and the fact they then proposed to release court ordered information over a period of 75 years, raises an immediate red flag. The released documents to date are heavily redacted, another red flag. The covid-19 Vaccines use a kind of technology never before administered to a human population on a mass scale, and were rushed out under an EUA authorisation. The vaccines are still in trial. Monitoring of adverse events, full disclosure to the public including both heath professionals and vaccine recipients, is an essential precondition for use of these vaccines on the public. In any event, US Judge Mark Pittman rejected the FDA proposal and ordered the release of documents as outlined above. There are approximately eight more months of document dumps pending. A smaller cache of the Pfizer documents were released by the FDA in November and December 2021, and January 2022.

What do the documents reveal? They are heavily redacted and dense in content and number. It has been a herculean task of analysis as to what is revealed so far, from all accounts.

There is much discussion in internet based independent media just now about the Pfizer Study, (within released documents) covering the period from the 1st December 2021 to the 28th February 2022, as to adverse events reported to the pharmaceutical company. In fact this document was released in a tranche before Christmas and the takeouts from the report are being clarified, essentially, at this stage. The study reveals reported adverse events involving 1223 vaccine related deaths, a subset of 158,893 vaccine injuries reported in this period. These adverse events relate to a caseload of 42, 086 reports to Pfizer, revealing a death rate of one in 35 in the group reporting the adverse events. An issue with the data released is that it does not reveal the total number of vaccinations given, and so it is impossible to establish exactly the overall rate of serious injury and death in the total population vaccinated without this figure. A death rate however of 3% overall has been calculated, extrapolating out from these figures, and giving a generous margin of error in Pfizers favour. Our readers will be aware of the survival rate from covid-19 infections.

It is inarguable also, and acknowledged by Pfizer itself, that the reporting system is a passive one and generally accepted to result in the under-reporting of adverse events. Interestingly enough, Pfizer acknowledge in this report that their reporting system were heavily challenged by the sheer volume of reports from the public over this period. We must also be mindful of the fact that this is a study on injury reports to Pfizer. The rate and nature of reports made on the national reporting systems such as the MHRA, VAERs, our HPRA, and Eudravigilence for the EU may show higher rates of injuries and deaths overall.

The Pfizer Report released in these documents include an Appendix of all injuries as reported to the Pfizer reporting system for the three month period, which is nine pages long. This list has been much discussed, referred to in understandable horror indeed, by the public on various online platforms and in independent media since the March 2022 release. Of course the report was released earlier, but the sheer volume of adverse effects as experienced by the individuals reporting is there for anyone to read. The list is certainly not a part of any insert provided with the vaccine to the public, prior to rolling up their sleeves for the shot. The specified injuries listed, 1300 injuries approx, are not definitively established as being caused by the vaccine, but it both arguable and persuasive that these injuries are being reported by the population who took the vaccine and believed by them to be subsequent to and caused by the vaccine. Causation directly or indirectly in respect of these injuries is not confirmed but Pfizer, in the report, offered more data of concern about injuries in the reporting group which they categorised as adverse effects of ‘special interest’ (AESI). These included 1,403 cardiovascular AESI, 932 hematologic, 3,.000 musculoskeletal, 501 neurologic and 3,674 other serious AESIs, all reported as occurring with an onset of two days from vaccination. A great deal to concern us here then.

The most recently released cache in March 2022 include documents pertaining to animal studies, specific kinds of adverse reaction of initial trial subjects, amendments made to the study protocols in the initial trial, and the original application from Pfizer-Biontech to market the vaccine to the US Department of Health and Human services.

The information released is vast in volume and requires time and careful study to unpack. This is ongoing and there will be analyses and conclusions made public over the next weeks and months.

One area of interest revealed in the March 2022 documents concerns the animal studies carried out on rats, and a report described as ‘The Final Report’ entitled ‘A Tissue Distribution Study of a (3H) Labelled Lipid NanaParticle-mRNA Formulation Containing ALC-0315 and ALC-0159 Following Intramuscular Administration in Wistar Han Rats’. The report concerns the bio-distribution of Lipid NanoParticles, (LNPs) carrying vaccine ingredients active and inactive including mRNA components around the body after vaccination. The public were assured that these LNPs would stay in the arm, bio degrading quickly, and certainly would not travel around the body actively, in the production of spike proteins. This report is currently being analysed, and is the subject of an article by Jessica Rose PH.D. She concludes in the article, dated March 8th 2022, that the Final Report in the Pfizer documents confirm that biodistribution was clearly demonstrated in the liver, spleen, adrenals and ovaries from her reading of the data. She further refers to the Japanese study data which clearly showed biodistribution and accumulation of LNPS around the body. The Pfizer study relates to the period of the study only. It is unknown as far as Pfizer are concerned, and as they present the data, how long the vaccine continues to distribute these LNPs, or how long they remain in these organs. Biodistribution in the adrenals, liver, spleen and ovaries is confirmed then, in Pfizer’s submitted data to the FDA.

The current and ongoing court case brought by whistleblower Brook Jackson relates to issues of concern arising around the conduct of the clinical trials for the Pfizer vaccine. Ms Jackson worked on the trials as a supervisor of the trial process, employed by a company called Ventavia, who were one of the test companies contracted to carry out the Pfizer covid-10 vaccine clinical trials. She became concerned about the poor management of the trials and describes a shambolic process where data was improperly managed, trial participants unblinded during the study, and the incidence of various protocol deviations. She describes poor recording and follow up of serious adverse effects suffered in trial participants. She was sacked within six hours of reporting these issues to the FDA. Her court case is taken against the FDA, Pfizer and Ventavia and is ongoing. Four hundred pages of her complaint evidence was unsealed by the court in January 2022 and is publicly available. Ms Jackson has explained that the details of her claims, as outlined in the proceedings, were sealed by the court from January 2021 when she initiated the lawsuit until January 2022, due to the repeated adjournments sought by the other side. The effect being that she was unable to bring the relevant issues to public notice in any great detail until January 2022, to her great regret. The basis of her case is that Pfizer, Ventavia and ICON withheld crucial information from the United States that challenges the safety and efficacy of the vaccine. Jackson gave a cache of internal company documents to The British Medical Journal and an article based on the documents by journalist Paul Thacker followed, concentrated on the evidence in these documents highlighting Ventavia’s repeated failures.

The March Pfizer documents now released include data relevant to the clinical trials, carried out pre-approval, and will have bearing on the case Brook Jackson is presenting.

It is worth noting that Ventavia continued to run vaccine trials for Pfzier as a subcontractor, in vaccine clinical trials for the roll-out of Pfizer’s covid-19 vaccine to children, young people,. pregnant women and booster doses, despite these serious issues as raised by Jackson.

The pharmaceutical companies have revealed publicly that test subjects in the covid-19 vaccine clinical trial placebo groups were offered the vaccines when the EUA was granted, and reportedly many took up the offer. This was disingenuously presented as a humane action, the reality being that not only were the clinical trials as to safety and efficacy prior to the FDA conditional authorisation hugely compromised (if the case made by Jackson as to the unblinding, fraud, and negligence by Ventavia correct) but the necessary assessments as between vaccinated and placebo groups post vaccination, as to the medium to long term injuries in an ongoing trial, is not now possible.

The current Ukraine Russia conflict has distracted hugely from what is being revealed by the release of the Pfizer documents submitted to the FDA. The takeaways from documents released have profound significance in the matter of informed consent by individuals to the covid-19 vaccinations. The reality is that the information emerging from the documents release is not being reported in mainstream media and the majority of the population are not being made aware of these urgent findings.

The elephant in the room here, in our view, relates to the emergency or conditional authorisations for mass roll outs of Pfizer’s covid-19 vaccines granted by the various regulatory bodies. Based, presumably, on the information contained in these submitted documents. The conditional authorisation granted by the FDA was followed by conditional or emergency use authorisations by the health systems around the globe including the Europe wide EMA, the UK MHRA, our HPRA, and other health systems regulatory bodies. Did all of these bodies access the Pfizer paperwork now being released by the FDA? Were each of these health systems aware of the content of Pfizer’s submitted documents to the FDA? Were the same or similar documents submitted to them? Are they aware of what is to be revealed going forward? It is speculated that the most controversial content will come towards the end of the court ordered discovery period. Have the various systems, the EMA, the HPRA, the MHRA, each national or European regulatory health body issuing or confirming authorisation, accessed this information or similar information? Or has this been a rubber stamping exercise without due diligence? If so the granting of authorisations by each of these health systems and entities have been criminally negligent. If, on the other hand each of these bodies have examined and are currently privy to all such documents submitted by Pfizer to the FDA they have a number of urgent questions to answer, including our own HPRA.

The covid-19 inoculations of the public continue apace, against this background of red flags, of emerging data casting serious doubts on the safety and efficacy of the vaccines.

We have drafted a letter raising the relevant matters with our own HPRA in this country, and with the EMA (being decisive in the EUA authorisation of the vaccine across the EU) which our readers might wish to forward, requiring immediate clarifications as to the due diligence carried out prior to the authorisations , and requiring a full response from these regulatory bodies as to all matters arising based on what we now know and have learned from the Pfizer documents released to date.

To: Mr Michael Donnelly

Email : info@hpra.ie (email seems to be the only way to correspond with Donnelly or the rest of the 8 members on the HPRA board.)

And to medvigilance@hpra.ie

And to:

The Management Board,

Covid-19 Vaccine Authorisations,

Domenico Scarlattilaan 6,

1083 HS Amsterdam,

The Netherlands,

Further to the ongoing release of the Pfizer documents, submitted to the FDA in furtherance of the condimental approval granted for the covid-19 vaccines, court ordered in February 2022, I, an Irish citizen and a citizen of the European Union, require your response to the following issues as matters of urgent public interest:

Did the EMA and the HPRA familiarise themselves with the contents of these documents, submitted by Pfizer to the FDA as part of their application process for authorisation, before authorising the current EUA authorisation for this vaccine in Europe and in Ireland? Was the said or similar documentation not also submitted to you?

.

If so, why were the public not made aware of the death and injuries reported post vaccination, up to the 28th February 2022, as revealed in these documents. Why were the public not made aware of the nine page appendix of approximately 1300 injuries in total, reported to the pharmaceutical company itself from the period of the 1st December 2021 to the 28th February 2022?

Can the EMA and the HPRA clarify as to how informed consent was possible where the public were not made aware of these matters, in the context of an Emergency Use Authorisation for a vaccine still in trial?

Can the EMA and the HPRA confirm why it was not made clear to each vaccine recipient, post authorisation, that the vaccine trial was ongoing?

Has the EMA and the HPRA established the severity of these adverse effects, as listed in the appendix to the Pfizer study submitted with the said documents? Have your members made themselves aware of how many vaccinations were involved in total over that period?.

Is it the case that the EMA and the HPRA have not and are not accessing this documented evidence of safety and efficacy in the case of Pfizer’s vaccine? If so, how are the EMA and the HPRA managing and monitoring reporting of injuries as reported to Pfizer? How have the EMA and the HPRA deemed the vaccine to be safe and effective? Have the EMA and the HPRA effectively rubber stamped the FDA approval as originally given? Or have you based your authorisations for use of the covid-19 vaccine on different or contrasting submitted data from Pfizer?

Are the EMA and the HPRA aware that clinical trial subjects in the placebo group have been offered and have largely taken up covid-19 vaccinations in the period immediately following on the clinical trial, after EUA or conditional approval? Are you aware that, if this is the case, there is effectively no control group to measure medium to long term adverse effects arising in the vaccinated?.

Are the EMA and the HPRA aware of the allegations made by whistleblower Brook Jackson as to the unblinding of trial subjects in the pre-authorisation trials? Are you as a regulatory body aware, or have you made yourself aware, of the protocol deviations the whistleblower describes and documents? Have you investigated these claims?

Are you aware that Ventavia, the company employing the whistleblower, was again contracted by Pfizer to carry out clinical trials for the roll-out of the covid-19 vaccine to children, young people, pregnant women and in respect of booster shots?

Do the EMA and the HPRA members see an active role for themselves as a body in monitoring ongoing adverse events in any meaningful way, and if so are you not concerned about the obstacles to carrying out any meaningful monitoring of vaccine injuries without a placebo group?

Are the EMA or the HPRA members aware of the contents of the Pfizer documents yet to released? If not, why have you not required sight of the submitted information by Pfizer further to that company’s approval application?

If the EMA and the HPRA members are aware of the contents in the Pfizer documents yet to be released over the next six to 8 months, are you satisfied as to safety and efficacy in continuing with the Pfizer covid-19 vaccinations, based on the evidence of these said documents?

Are the EMA and the HPRA members aware of the constituent active and inactive ingredients of the vaccines, and if so are you prepared to make these details available to the public? if not, can the EMA and the HPRA explain how they have deemed the vaccines to be safe and effective for public roll-out?

I await your urgent response.

You may follow up and question any response received. Whether you receive a response or not it is an exercise worth doing. It flags to these entities that we are watching, we are aware, and these issues are being challenged, we will not go away.

You can send this draft in letter form to the EMA if you choose. The EMA provides a postal address on its website, unlike the HPRA.

You can use the draft to contact the EMA and the HPRA separately. in the alternative.

Pm us if required.