Monitoring

Vaccine Injuries Part 2: Monitoring the Monitors

A Treatise for our Health Officials Who Appear to be Either Ignorant or Averting Their Eyes

The second in our eight part series on vaccine injuries. See here for the introduction.

Monitoring the Monitors

Medsafe has in place a robust process for monitoring the safety and efficacy of medicines, including vaccines.”

The clinical trial for the Pfizer vaccine is ongoing until 2024 and the vaccine only has provisional approvalMedsafe says: “COVID-19 vaccines have been given provisional approval in New Zealand because data to support the longer-term safety and efficacy of COVID-19 vaccines is not yet available.”  We assert that monitoring during this clinical trial and provisional approval phase should have been, and should still be, very thorough. 

Originally, provisional consent was for medicines that were going to be used on “a restricted basis for the treatment of a limited number of patients”.  When the NZ government wanted to use this consent for rolling out the vaccine to the whole population over the age of 16, it was challenged in court in May 2021.  The court determined that the use of provisional consent in this way was not legal so the government promptly changed the law such that a provisionally consented medicine can now be administered to anyone.

With provisionally consented medications there should be a compulsory reporting and monitoring system and any new medical event or death that occurs in a person at any time post-vaccination should be reported and investigated.  Our own Helen Petoussis-Harris even urged the world to institute robust safety monitoring systems prior to the rollout. “To deploy these new vaccines fast across diverse populations, it is vital that robust pharmacovigilance and active surveillance systems are in place.”

Unfortunately, NZ has only implemented a passive voluntary reporting system which means many events are not being counted or investigated.  In fact, many people report being told by doctors that their medical event is a ‘coincidence’ or is due to ‘anxiety’ and is not related to the vaccine.  Events treated like this are unlikely to have been reported, counted or investigated.

Medsafe in NZ is well aware that with such a voluntary system only a small percentage of adverse events to medications get reported.  “However, it is estimated that only 5% of all reactions are reported so there is still room for improvement.”  Internationally it is expected that between 1 and 10% of events get reported.

What Does/Did the Government Know?

The Govt would have received the information contained in the Pfizer 3 month post marketing surveillance report in May 2021.  This showed that 1223 fatal outcomes post vaccination had been reported to Pfizer in just three months.  The version of this report that was submitted to the US regulatory agencies listed 8.5 pages of adverse events recorded in the following format:

In a document discussing maximising vaccine uptake in border workers dated Feb 2021 released under the OIA (Official Information Act), it appears NZ health officials were expecting up to 1.1% of vaccinees to experience a severe adverse reaction.  These could include medical events such as heart attacks, strokes, myocarditis, Bell’s palsy, Guillain Barre syndrome etc.  We struggle to understand how it is ethical or moral to state publicly that the vaccine is ‘safe and effective’ while behind closed doors acknowledge that it is likely to cause severe adverse effects in up to 1.1% of the population.

Despite the CARM database receiving only voluntary reports of adverse events, the numbers are significant.  One year after the rollout started, there were 58,135 adverse events reports just for the Pfizer vaccine, with 2,842 of those being serious.  That is following 10.6 million doses of vaccine.  Medsafe/CARM would normally receive 3-5 thousand reports per year for all medications combined.  There are over 11 times the usual number of reports to process and investigate.  If it was to be done properly, presumably that would require 11 times as many staff to gather, collate and assess the information.  Presumably an increase in pathologists (who are in short supply) might be needed as well to examine tissue samples and do the post mortems.

How Is the Mass of Data Reported to Medsafe Being Assessed?

It has been difficult, impossible really, even for us as doctors, to understand what happens when an adverse event following Covid vaccination is reported to CARM.  We have had to resort to OIA requests because it has been impossible to get straight and coherent answers to our questions.

As late as December 2021, it still stated on Medsafe’s website: “Medsafe has not yet finalised all of the methods that we will use to monitor Covid-19 vaccine safety.”

This is backed up by documents 2 to 5 in this OIA response from Feb 2022 in which the coronial service appears to be flying blind regarding what to do with deaths reported to it and to CARM.

In August 2021, six months after the rollout began the Deputy Chief Coroner is asking the MoH for advice about what to do with deaths post vaccination and how long after vaccination a coroner should consider a death as possibly related to vaccination.  This is even though the Chief Coroner (Judge Deborah Marshall) and the Director-General of Health (Dr Ashley Bloomfield) apparently signed a MOU (Memorandum of Understanding) on information sharing in 2020 which was revised in June 2021 to include vaccination related issues.

It appears that pathologists doing post mortems did not initially have access to the immunisation records of the deceased.  In September 2021 it was suggested that all pathologists conducting post mortems at the direction of the coroner should have access to the CIR (Covid Immunisation Register).  That would seem fairly basic if robust pharmacovigilance was indeed taking place.

It seems there is a lot of buck-passing going on between CARM, Medsafe, the Ministry of Health and the Coroners.  Where does the buck actually stop?

Even now, in June 2022, we are still awaiting the coroner’s verdict on whether any deaths following vaccination were due to vaccination. How can they be monitoring the effects of the vaccine?

Summary of Reported Deaths

Up to and including 30 April 2022, a total of 160 deaths were reported to CARM after the administration of the Comirnaty vaccine. Following medical assessments by CARM and Medsafe it has been determined that:

  • 99 of these deaths are unlikely related to the COVID-19 vaccine
  • 48 deaths could not be assessed due to insufficient information
  • 10 cases are still under investigation.
  • 3 deaths were likely due to vaccine induced myocarditis (STILL awaiting Coroner’s determination)

However, in Sept 2021 the Coroner was quick to make a pronouncement about the death of a teenager in relation to the vaccine within a few days of her death, suggesting that it was not linked to the vaccine but at the same time saying that the investigation was likely to take months. 

New Zealand’s Chief Coroner has issued a statement saying the death of an Auckland teenager “does not appear” to be “linked to the Pfizer COVID-19 vaccine”.”

We find it extremely unprofessional.  It is not appropriate for a Coroner to pre-determine the outcome of an investigation. That our PM had told the nation on TV the same thing the day before speaks to obvious political interference. The Narrative must not be undermined. 

We would like to be given a clear explanation of what process would be followed if we reported the death of a previously healthy 32 yr old man 3 days after vaccination who apparently died in his sleep (i.e. found dead in bed in the morning) who said he had felt a bit tired and ‘off’ for the day or two following vaccination.  Would the family be interviewed, would the doctor(s) be interviewed, would the medical records be actively gathered, would a post-mortem be done, what would be looked for, would the tissues be sampled for the presence of spike protein, lipid nanoparticles or synthetic mRNA, would vasculitis in vessels of all sizes be assessed, would the heart be examined for signs of myocarditis, would unusual clotting be looked for, or would a hasty cremation be arranged and funded by the Government? This is not rhetorical but based on fact. 

There is a curious sentence in the OIA documents mentioned above.  “It is important to note that death is an outcome, not an adverse reaction.”  What does that mean?  Does it mean deaths can be hidden in the heart attack or blood clot column of the Safety Reports and not actually be counted as a death?

Another thought-provoking sentence in the same documents: “It would be helpful to establish a closer communication channel between Coronial Services and the Ministry of Health to facilitate and streamline this process.”   Should that not have been set up right at the start and what was the point of the MOU then?

And one more for good measure: “In contrast, death due to progression of cancer after a dose of Comirnaty will not be related to the vaccination.”  Really?  Why would some medical events automatically be off the table without any data?  That’s not scientific.  Scientists overseas are specifically suggesting that the proven down-regulation of some protective mechanisms (toll like receptors, BRCA and p53 genes) by this mRNA technology may lead to new cancers or rapidly progressive previously stable cancers.  We say progression of a previously stable or quiescent cancer or the development of a new cancer should be on the coroner’s list of things requiring further investigation and assessment.

Who Is Involved in Pharmacovigilance and Monitoring?

There seems to be a large number of people and organisations involved in pharmacovigilance (the monitoring and assessing of medications – vaccination in this case).  It is not obvious whether they are communicating clearly with each other or if they even know who is reporting to whom.  We think a diagram showing the relationship between all these entities would be very helpful.  Maybe there are other entities as well?

It is plain to us that the warning from IMAC’s Dr Pertousis-Harris to ensure robust pharmacovigilance has not been heeded in her own country. She has never mentioned this in her frequent media spots when she front-foots Safe and Effective. 

CARM was never intended to function as an independent safety data monitoring board (ISMB) for a clinical trial. It is to passively survey already-registered medicines that have been through the requisite clinical trials before being approved, not as a proactive early warning system for taking immediate action. In a normal phase 3 trial the ISMB receives the regular clinical assessments of all participants, who are actively followed up. Conversely Medsafe’s CV-ISMB relies on what makes it through the CARM process (we presume, since its members and methods are kept secret), with its choke points, disincentives to report and murky ‘black box’ mechanisms.

Groups/People Involved in Pharmacovigilance and Monitoring

CARM – headed by Dr Michael Tatley

Medsafe – Group Manager is Chris James

Director General of Health – Dr Ashley Bloomfield, soon to be Dr Diana Sarfati

Chief Medical Officer Ministry of Health – initially Dr Andrew Connolly, now replaced by Dr Robyn Carey

Office of the National Director of Covid-19 Vaccination and Immunisation Program – Group Manager is Caroline Greaney

Post Event Group of the Covid-19 Vaccination and Immunisation Program within MoH – GM is Dr Tim Hanlon

Covid-19 Vaccine Technical Advisory Group (CV-TAG)

Clinical Governance Group

Covid Vaccination – Independent Safety Monitoring Board  

Chief Coroner – Judge Deborah Marshall

Deputy Chief Coroner – Anna Tutton

Coronial Services Unit within MoJ (Ministry of Justice)

Can We Really Trust Our Regulators to Undertake Monitoring?

In our view and experience this ‘robust pharmacovigilance’ is shrouded in obfuscation. The system seems designed to make it impossible for the average person, let alone doctor, to understand what process takes place.

The Medsafe website has a lot of words and pages but gives no clear indication of what they actually do.  At what point would Medsafe stay “stop, there are too many dead and injured New Zealanders”?

The following are examples of either incompetence or deliberate evasiveness on the part of our regulators who are meant to be monitoring the vaccine.

1. This is a reply to an OIA request enquiring whether everything that gets reported to CARM gets to the Medsafe Safety Reports or whether filtering occurs.

“April 08, 2022

Kia ora X,

Thank you for your request under the Official Information Act 1982 (the Act) to the Ministry of Health (the Ministry) on 25 March 2022 for information regarding the COVID-19 vaccine. The Ministry will respond to each part of your request in turn.  

1. In total, how many Covid vaccine adverse reaction reports have been received by CARM?
2. In total, how many Covid vaccine adverse reaction reports have been sent by CARM to the MoH? 
3. If there is a difference between the numbers given in Questions 1 and 2, please explain why there is a difference.  

This information is publicly available on the Medsafe website and can be found within Medsafe’s Safety Reports at: www.medsafe.govt.nz/COVID-19/vaccine-report-overview.asp

4. Does the MoH publish the data exactly as received from CARM? 
5. If the MoH does not publish the data exactly as received from CARM, please explain why.
6. If some of the data from CARM is removed, what criteria are used to decide what is removed?
7. If some of the data from CARM is removed, what is the process for removing some Covid vaccine adverse reaction reports?
8. If some of the data from CARM is removed, who makes the decision to remove the data?  

The Ministry and Medsafe work very closely with the Centre for Adverse Reactions Monitoring (CARM) at the University of Otago. The data published on the Medsafe website comes from the database in which the reports sent to CARM are stored. Published data does not impact individual’s privacy and information included in a CARM report can change as a result of further information being submitted.  

Under section 28(3) of the Act, you have the right to ask the Ombudsman to review any decisions made under this request. The Ombudsman may be contacted by email or by calling 0800 802 602. 

Ngâ mihi

OIA Services Team”

This sort of response to a reasonable request for information makes us wonder what they are trying to hide.  They haven’t actually answered a single one of the 8 questions asked.

2. Unable to provide studies to back statements.

We’ve heard from “experts” such as Dr Nikki Turner and Helen Petoussis-Harris that the mRNA from the vaccine stays in the deltoid muscle and is quickly broken down.  However, as the Comirnaty data sheet says “Pharmacokinetic properties: Not Applicable” we were curious how they knew the mRNA was quickly broken down and didn’t leave the arm.  Neither Medsafe nor IMAC responded to an initial email questioning this.  When pushed repeatedly Medsafe did eventually reply and provided ever more obscure references that didn’t actually answer the question.  We are still left wondering why they think the mRNA stays where it is injected and disappears quickly when this is not what scientists around the world are demonstrating. Anyway, medicines have been injected into muscles for over a century precisely for rapid dissemination into the blood stream and round the body. 

3. Unable to provide studies to back up recommendations.

When asked to provide the scientific evidence on which the recommendations for vaccinations and/or boosters post Covid infection were based, IMAC was unable to provide any scientific studies.  It resorted to saying “We’re the experts.  Trust us.”  The actual words were: “We are the experts who read the research, our advice is not based on nothing… we can get you references. But our experts are at the top of their fields and research and discuss these issues before we give advice.”

They did eventually provide some studies but these did not answer the question adequately.

4. The following is an example of a non-answer from the Medsafe website:

“What is an acceptable number of side effects?

We encourage healthcare professionals and consumers to report any suspected side effect to a COVID-19 vaccine. For this reason, and because so many people will be receiving a vaccine, we expect many side effects to be reported. Reports describing significant events are reviewed by medicine safety experts to identify any previously unrecognised adverse drug reactions or changes in the patterns of adverse drug reactions.

Receiving large numbers of reports also indicates that the reporting system is working and easy to use.”

Now we want to know how many Kiwis are considered acceptable collateral damage.

5. Conflicting information provided by Government departments.

A communication from Dr Bloomfield’s office on 12 Feb 2021 to health care leaders included the sentence: “On arrival the vaccine will be independently tested for quality assurance, which is another important safety check.”

A recent query to the Ministry of Health about this independent testing received the following reply: “The capability to conduct independent testing of the vaccine does not currently exist in New Zealand, however Medsafe’s robust assessment process assures that all ingredients in all medicines approved for use in New Zealand meet international standards which include identity verification.  In addition, a condition of the provisional consent for Comirnaty requires that Pfizer provide the results of batch testing from an independent laboratory to Medsafe upon request.”

This sort of contrary answer raises even more questions.  So why did Dr Bloomfield advise us that the vaccine would be tested on arrival if that capability doesn’t exist, did Medsafe actually request results of independent batch testing from Pfizer and did Pfizer provide them?

6. No reply to questions about the possibility of contamination or graphene oxide in the vaccine vials.

On several occasions, we have alerted health officials and the police to our concerns of possible contamination in the vaccine vials, noted both here in NZ and by overseas investigators.  We have asked for an explanation and reassurance that there is nothing untoward.  Our requests for explanations and reassurance have been ignored.  If there is a simple explanation and nothing to hide, why the silence?

In Conclusion, Who Is Monitoring The Monitors?

In our view, there does not appear to be any intention on the part of the government, health officials or the police to evaluate evidence of harm we suggest is caused by the vaccine. There does not appear to be any intention to pause or halt the vaccine program to allow an investigation to occur. There appears to be inadequate monitoring.

In the next section the Pfizer vaccine itself is discussed.

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