OPINION
New Zealand Doctors Speaking Out with Science
People Involved
For ACC
- ECA doctors: Dr T – pharmacovigilance, Dr W – neurologist
- Medical Advisor: Dr G – GP
- ACC review specialist
- ACC Reviewers x2
For Jessica
- Treating physician, infectious diseases expert
- Consultant neurologist
- GP
- Immunology Specialist
- Neuropsychologists x2
Glossary
ACC Accident Compensation Corporation
AEFI Adverse Event Following Immunisation
AEFI-A Adverse Event Following Immunisation – Assessed
AESI Adverse Event of Special Interest
CARM Centre for Adverse Reactions Monitoring
CSF cerebrospinal fluid
CT computed tomography
ECA External Clinical Advice
EEG electroencephalograph
FDA Food and Drug Administration
GVDN Global Vaccine Data Network
ICU Intensive Care Unit
ISMB Independent Safety Monitoring Board
IVIG Intravenous immunoglobulin
MA Medical Advisor
MOG Myelin oligodendrocyte glycoprotein
???????MRI magnetic resonance imaging
NMDA N-methyl-D-aspartate
PCR polymerase chain reaction
USS Ultrasound Scan
VRBPAC Vaccines and Related Biological Products Advisory Committee
WCC white cell count
WHO World Health Organisation
Part 1 of Jessica’s story outlined the medical details of the encephalitis she developed post Pfizer vaccine and covered her experiences with applying for an exemption and attempting to understand the CARM adverse reactions monitoring process. It briefly discussed her ACC claim. Part 2 goes into detail about the ACC process and demonstrates what those suffering from vaccine injuries have to contend with.
[For international readers, New Zealand has a no-fault compensation scheme to cover medical, rehabilitation and loss of income costs for people suffering from accidental injury, including medical treatment injuries. It is managed by the Accident Compensation Corporation (ACC).]
Introduction
A Treatment Injury claim was filed in Jan 2022 by the hospital specialist who cared for Jessica during Dec 2021. The injury was encephalitis (brain inflammation) and the treatment that was implicated was the Pfizer covid vaccination received 8 days prior to symptom onset.
On 24 March 2022 the ACC claim was declined on the basis of an External Clinical Advice (ECA) report provided by Dr Michael Tatley of CARM 2 days prior (22 March 2022).
He stated that there was no apparent physical injury because the CT and MRI scans were normal. [This is odd as ACC regularly accepts mild traumatic brain injury claims which often have normal imaging.] He noted but discounted the abnormal CSF and EEG findings. He has not considered the ongoing neurological symptoms as an indication that the brain has been injured.
He also cited the absence of ‘well-respected large-scale epidemiological studies’ that would confirm an association between Pfizer vaccination and encephalitis. [It is not clear who he thinks is doing such studies or when they would have been done.] He did not indicate whether a formal causality assessment using recognised criteria had been undertaken. He did not mention that extensive testing had excluded other known causes of encephalitis.
By providing an opinion denying a connection between covid vaccination and life-threatening encephalitis 8 days later, Dr Michael Tatley ignored one of the first principles of pharmacovigilance (his specialty) which is that the medication in question is the cause of the adverse event until proven otherwise.
Jessica was unable to work due to the continuing effects from encephalitis and she had ongoing medical expenses. She had been optimistic ACC would help and did not accept this decision.
Next Steps – Review Hearing
Jessica then entered into a protracted series of interactions with ACC over the next 18 months to get to a review hearing.
The review hearing initially got delayed due to Jessica’s ongoing symptoms (difficulty concentrating, headache, fatigue) and difficulty with understanding how the ACC process worked. Later delays were due to the ACC Reviewer being on prolonged leave.
The Case – as per ACC
An ACC Medical Advisor (Dr G) provided a report on 14 Jun 2022 which concluded:
“In this case a cause was not found. This does not make the Pfizer Covid vaccination more likely (or less likely) to be the cause. However, it does not make the Pfizer Covid vaccination the probable cause which is the test in this case.
In summary: There is not enough medical evidence to support that the Pfizer Covid vaccination is the probable cause of the autoimmune encephalitis.”
The Medical Advisor agreed with Dr Tatley that there was no evidence of a physical injury.
“There is not enough medical evidence that the inflammation has led to a physical injury.”
A neurologist (Dr W) provided an ECA report on behalf of ACC on 20 Dec 2022. He thought the markers of brain inflammation in the CSF likely did indicate a level of brain damage but not to such a degree that would be visible on imaging. However, he concluded there was no proof the Pfizer injection caused Jessica’s encephalitis.
“Despite the results of the brain imaging failing to show tissue damage, it is likely that there was brain tissue damage but at a level not visible on the resolution of the brain imaging.
On the balance of probability, however, it is unlikely or at least not proven that the Pfizer vaccination caused the encephalitis.”
The ACC review specialist provided her report for the hearing based on the advice of the two ECA doctors (Dr Tatley and Dr W) and the Medical Advisor (Dr G) in June 2023. She concluded that ACC had been correct to decline the claim in 2022 . The hearing was scheduled for later in June 2023.
Obstacles
Jessica had been unable to get legal assistance to help her through the ACC process despite attempting to connect with multiple lawyers. The lawyers either did not reply to her at all, or, when they learnt about the case, would stop communicating. No one in ACC had confirmed that Jessica fully understood the process and her rights, or what sort of evidence could and should be submitted.
During the initial review hearing on 16 June 2023, Jessica began to appreciate what sort of evidence she could provide. She asked for a pause so she could go and gather the relevant information. She had seen several health care professionals over the months who had agreed with her that the vaccine could well be implicated. ACC expected her to collect and submit that information on her own.
When ACC assesses a Treatment Injury claim, it needs to establish that a physical injury occurred and that the balance of probability falls on the side of the treatment causing the injury. These are onerous requirements particularly when the Pfizer injection uses novel technologies and was still in a clinical trial when administered to Jessica. The published medical literature on adverse events (which is what ACC expects to see) is in its infancy.
The Case – as per Jessica
On 26 June 2023, the treating physician, an infectious diseases expert, provided a report for Jessica with her medical opinion that the encephalitis suffered was likely due to the Pfizer injection.
She had previously documented this on her discharge summary in Dec 2021 where she wrote:
“Primary diagnosis
– Encephalitis of uncertain etiology. Presumed viral. other
Secondary Diagnoses
– vaccine-related autoimmune encephalitis“
With regards to causality, she noted that WHO (criteria supposedly used by CARM) has a systematic process to determine causality and that a case is considered consistent with causal association if –
- there is no alternative aetiology and
- previous evidence suggests association with the vaccination.
This latter point is problematic in the case of covid injections as the technology used (mRNA and lipid nanoparticles) is new and there is a paucity of literature while the data is being gathered.
ACC considers causation on the balance of probability, so the physician provided a chart from a recent journal article discussing causality assessment of neurological complications with covid vaccines. This chart divides adverse events into three categories which are in line with ACC’s requirements – probable, possible and unlikely.
Using this guideline – Jessica’s case did occur within 6 weeks from vaccination. She had no risk factors and the alternative aetiologies (causes) had all been excluded. In the treating physician’s opinion, and according to these criteria, it was probable that the encephalitis was caused by the vaccination 8 days earlier.
Her conclusion:
“What I would like to submit, is that Jessica’s acute encephalitis was indeed likely due to vaccination, specifically Pfizer BioNtech COVID19 vaccine.”
In addition to this doctor’s report, Jessica also had earlier evidence or commentary from 5 other health professionals.
1) The consultant neurologist who had followed her up on 2 March 2022 had considered whether the covid vaccination has caused the presumed autoimmune encephalitis.
‘We discussed the question of whether the Covid vaccine could have caused her illness. Unfortunately it is difficult to say for sure but this seems possible given the timing, other options would include a mild infection (though testing at the time was negative) or non-vaccine related autoimmune (antibody negative) process.’
2) Her GP had written on 3 March 2022
‘This is to confirm that Jessica was granted a medical exemption following her first vaccine dose (Comirnaty Covid-19 vaccine) because of a severe adverse reaction. Unfortunately following the vaccination she developed encephalitis (infection/inflammation of the brain). This reaction resulted in a stay in Intensive Care at X Hospital. After discussion with relevant specialists, it was decided she should not receive any further doses of the vaccination.’
3) An Immunology Specialist in Australia on 10 August 2022 wrote that
‘while encephalopathy has not been seen as an mRNA specific reaction, the temporal events and lack of an alternative cause for the encephalopathy would keep a vaccine reaction as a primary suspect.’
4) Australian Government Medicare Services on 26 August 2022 recorded that she had a medical contraindication to Pfizer Comirnaty which would expire on 10 August 2023. [A temporary exemption following a life-threatening adverse event is not usual medical practice. If there is a contraindication to a vaccine it would previously have been life-long.]
5) Jessica also had neuropsychological follow up in January and December 2022. Both the professionals that assessed her concluded that her brain function had been affected by the encephalitis. She was not able to process things as fast and suffered from neurogenic fatigue when trying to concentrate for longer periods of time. Further follow up has been recommended.
ACC Medical Advisor report
The Medical Advisor (Dr G) looked at the additional evidence Jessica submitted as well as the two ECA reports and provided her second report on 9 July 2023.
Her conclusion and advice to ACC was not to cover the claim as there was no evidence of a physical injury and not enough evidence of a causal link between vaccination and encephalitis.
In her report, Dr G incompletely quoted the treating physician (‘To date, the entity of vaccine induced encephalitis post COVID vaccination has not been acknowledged by either the WHO or the FDA.’) which changed the meaning of what the treating physician had said. The full sentence was “To date, the entity of vaccine induce encephalitis post COVID vaccination has not been acknowledged by either the WHO or the FDA as a common complication of vaccination like myocarditis/thrombosis.” This implies that the WHO and FDA do recognise vaccine induced encephalitis as an adverse effect but not a common one.
Dr G has also selectively quoted the immunologist from Australia with her comment: “An Immunologist based in Australia also stated that encephalopathy has not been seen as an mRNA specific reaction, supporting the lack of a proven link.”
The full sentence actually said “While encephalopathy has not been seen as an mRNA specific reaction, the temporal events and lack of an alternative cause for the encephalopathy would keep a vaccine reaction as a primary suspect.” Her incomplete quote has once again changed the meaning of the expert.
Dr G has not provided a logical assessment process or documented which criteria she has used for determining causality with a new medication.
The treating physician, on the other hand, has provided a clear, concise, common-sense approach to the question of causality and referenced the scientific literature in doing so.
Hearing
Jessica had to attend the hearing and provide evidence on her own behalf in a quasi-court situation. She was on a Zoom meeting with an ACC Reviewer (lawyer), and the ACC Review Specialist who had provided two reports recommending not accepting the claim. Jessica had not been informed in advance about how the review would proceed. The ACC Review Specialist was unable to appear by video so there was no ability for Jessica to see her to read facial expressions or body language. It was an intimidating, biased and unbalanced experience, made worse by the ongoing symptoms including difficulty concentrating and fatigue.
The following information/evidence backs up Jessica’s assertion that the vaccine was the most likely or probable cause of her auto-immune encephalitis. She provided much of this at the ACC review hearing. However, because she had to represent herself and was not a doctor or medical expert, it was discounted.
The ACC Reviewer stated:
- “While I acknowledge [Jessica] has provided a response in her submissions to the report of Dr G, her opinion cannot carry much weight. This is because she is not medically qualified to give an opinion on causation, which must be determined with reference to the medical evidence.“
- “Furthermore, although I appreciate the effort [Jessica] has made to source relevant articles, information from the internet or from journals (however reputable) in support of her claim, these are of little probative value without interpretation by a suitable specialist.”
Evidence in support of Pfizer Vaccine Causing Encephalitis
1) The hospital discharge diagnosis written by a consultant physician was “encephalitis of uncertain aetiology, presumed viral, other vaccine related autoimmune encephalitis”.
2) Other causes of encephalitis were excluded by comprehensive assessment – infective (extensive PCR and blood testing for viral, bacterial and fungal causes), toxic, para-neoplastic, known auto-immune.
3) The follow up neurologist’s letter from March 2022 stated “encephalitis autoimmune, related to vaccination” as the diagnosis. Neither the discharging consultant physician nor the follow up neurologist provided a proven alternative diagnosis, and both considered vaccine-induced autoimmune encephalitis a likelihood. The ‘presumed viral’ cause was excluded by extensive testing.
4) The treating consultant physician stated that dramatic improvement with IV methylprednisolone and IVIG is consistent with other similar cases of post-vaccine autoimmune encephalitis when she applied for an exemption for Jessica.
5) An immunology specialist in Australia stated that “While encephalopathy has not been seen as an mRNA specific reaction, the temporal events and lack of an alternative cause for her encephalopathy would keep a vaccine reaction as a primary suspect.” He then went on to say that Jessica should avoid further mRNA vaccination and that he would support a temporary vaccine exemption at least until symptoms resolved.
6) During development of the covid vaccines in 2020 a meeting was held between the FDA (Food and Drug Administration) and the VRBPAC (Vaccines and Related Biological Products Advisory Committee) to discuss plans for monitoring covid vaccine safety and effectiveness. At this meeting it was noted that both encephalitis and autoimmune disease could be expected following vaccination, and they were listed on a presentation slide as a potential adverse effects.
7) The Pfizer vaccine in NZ had only provisional consent until 15 November 2023. Pfizer applied for consent to distribute their Comirnaty vaccine in New Zealand in November 2020. Under the Medicines Act 1981, before a medicine can be distributed in New Zealand the Minister of Health must grant either ‘Consent’ or ‘Provisional Consent’. These are not the same and have quite different standards.
The legal requirement to gain ‘Provisional Consent’ under Section 23 is a very much lower bar than that required for full ‘consent’. The minister may grant provisional consent if he “is of the opinion that it is desirable that the medicine be sold, supplied, or used.”
Unlike full consent, provisional consent under Section 23 of the Medicines Act, does not require the applicant to submit any reports that establish the safety of the medicine, or any reports that relate to the efficacy of the medicine, prior to the medicine being available to the NZ population.
The safety profile therefore had not been fully defined and collection of information about adverse effects was ongoing in December 2021. Gathering of safety data continues to this day.
The provisional consent was granted with 58 conditions that needed to be fulfilled and was valid until 3 November 2021. When this expired, again only provisional consent, not full consent, was granted valid until 3 November 2023. The provisional consent was recently renewed for a further two years and shortly afterwards Comirnaty was granted full approval. Until very recently Medsafe did not have enough data (including safety data) to be able to grant full consent.
Provisional consent meant that robust information about the incidence, severity and clinical course etc. of vaccine-induced encephalitis post vaccine was missing. Jessica is part of the evidence that is still being gathered.
8) One of the 58 conditions of the initial provisional consent related to Medsafe’s specific concern about the possibility of autoimmune conditions. Condition 5 stipulated that Pfizer needed to:
“Provide data to further characterise the truncated and modified mRNA species present in the finished product. Data are expected to cover batches used in clinical trials (for which the characterisation data could be available earlier) and the PPQ batches. These data should address results from ion pairing RP-HPLC addressing 5’cap levels and presence of the poly(A) tail. These data should also address the potential for translation into truncated S1S2 proteins/peptides or other proteins/peptides. Relevant protein/peptide characterisation data for predominant species should be provided. Any homology between translated proteins (other than the intended spike protein) and human proteins that may, due to molecular mimicry, potentially cause an autoimmune process should be evaluated. Due date: 9 August 2021.”
This means that it is quite possible that the vaccine induced the production of peptides or proteins that had the ability to cross-react with brain proteins to cause the encephalitis. It is unlikely that these proteins or peptides have been sufficiently characterised to allow tests to be developed for the diagnosis of conditions caused by them.
9) New Zealand and the world are currently in the phase 4 clinical trial or post-marketing surveillance for Pfizer’s Comirnaty. This is the period after initial (provisional) approval of a new medicine when further information is collected to augment information gathered in the clinical trial. During this time, the usual principle of pharmacovigilance is to assume the new medication caused the adverse effect until proven otherwise. This means it should be assumed that vaccine caused the encephalitis since all other causes have been excluded. The onus should be on ACC to prove an alternative cause of encephalitis and should not be on the injured recipient to prove that it was the vaccine.
10) Pfizer’s own early post marketing document 5.3.6 lists many different forms of encephalitis appearing within the first 3 months of general use of the vaccine from 1 December 2020 to 28 February 2021. The following types of encephalitis are all listed in Appendix 1 of the document titled “LIST OF ADVERSE EVENTS OF SPECIAL INTEREST”
- Encephalitis,
- Encephalitis allergic,
- Encephalitis autoimmune,
- Encephalitis postimmunisation,
- Immune-mediated encephalitis,
- Limbic encephalitis,
- Noninfective encephalitis,
- Panencephalitis
By April 2022, an Appendix listing Pfizer’s Cumulative Number of Case Reports had the following number of reports of various forms of encephalitis.
| Encephalitis | 323 |
| Acute disseminated encephalomyelitis | 140 |
| Autoimmune encephalitis | 58 |
| Non infective encephalitis | 55 |
| Leukoencephalitis | 49 |
| Hypoxic ischaemic encephalitis | 46 |
| Meningoencephalitis | 43 |
| Viral encephalitis | 27 |
A report does not mean a definitive cause is proven, but these are highly concerning numbers.
11) The references provided by Dr Tatley and Dr W do indeed confirm that cases of autoimmune encephalitis have occurred following immunisation with novel genetic covid-19 vaccines. Case reports are often the first indication of a problem and suggest that further investigation is needed. They can guide the direction of the research.
12) The Medical Advisor Report of 14 June 2022 states: “In this case a cause was not found. This does not make the Pfizer Covid vaccination more likely (or less likely) to be the cause. However, it does not make the Pfizer Covid vaccination the probable cause which is the test in this case.
In summary: There is not enough medical evidence to support that the Pfizer Covid vaccination is the probable cause of the autoimmune encephalitis.”
This statement is incorrect. Excluding all the other possible and likely causes of encephalitis in someone with no risk factors or underlying health conditions makes the Pfizer vaccine the probable cause. As explained above encephalitis was an anticipated adverse effect, there is biological plausibility for how an autoimmune reaction could occur, there have been other similar cases and there is clearly a temporal association. These are all important features when determining causality.
13) The GVDN (Global Vaccine Data Network) in NZ is monitoring vaccine safety. One of the Adverse Events of Special Interest (AESI) it is monitoring is encephalitis. See Appendix 2 (p45/48) of this document.
The reason it is an AESI is because researchers are expecting to see it and intend to monitor its frequency and severity etc.
14) At least 13 other cases of encephalitis post vaccine have been recorded in New Zealand.
New Zealand Cases of Encephalitis Post Covid Vaccine
15) Common sense would suggest that a recent immunisation could affect the immune system and possibly cause an auto-immune condition. In the absence of any other cause of encephalitis having been demonstrated, that is the most likely cause.
Outcome of Review Hearing
Jessica was provided with the outcome of the Review Hearing on 2 October 2023. The ACC Reviewer dismissed the application for review.
Her opinion was that she was unable to substantiate that there was a physical injury and she was unable to conclude that there was a causal link between the Pfizer injection and the encephalitis.
In her decision she outlined the details of the case and said she preferred the totality of evidence from ACC on causation.
Conclusion
The ACC process appears not fit for purpose when it comes to injury caused by covid vaccines. It places the requirement to provide an impossible burden of proof on the injured person and it seems set up to fail the patient.
In our opinion, the default setting for previously healthy people with no underlying conditions, should be that the injury is caused by the vaccine until there is proof that there was some other cause.
In Jessica’s case, there was clearly an injury to the brain and she has ongoing symptoms from this. Following extensive testing there is no other plausible cause, and as demonstrated, there are multiple reasons to suspect the covid injection.