NZDSOS Dissect Medsafe’s Deceptive Response to an OIA Request

It is interesting to look at the quality (or perhaps inadequacy) of OIA request responses that people receive.  This recently received one has the Group Manager at Medsafe, Chris James, avoiding answering questions as best he can. The casual and evasive responses are highly suspicious, and do not meet the standard expected of public officials under the Act.

NZDSOS Dissection of Medsafe’s OIA Response

Below is the response in blue from Chris James, and our replies to each point in green.

Response to your request for official information: Thank you for your request under the Official Information Act 1982 (the Act) to Manatū Hauora (the Ministry of Health) on 6 November 2022. Please find a response to each part of your request below.

Question 1: Seeing as the Pfizer Phase 3 clinical trial was still in progress when NZ was subjected to mandates, and that the whole world is now in the phase 4 trial of postmarking and surveillance, how is Medsafe participating in this phase?

Chris James: Pfizer has consent to distribute the COVID-19 Comirnaty vaccine and it is administered in the same way as other medicines in New Zealand. It is incorrect to suggest that the vaccine rollout in New Zealand was a clinical trial.

NZDSOS: The writer did not suggest that the vaccine rollout in NZ was a clinical trial but rather that the vaccine was still in a clinical trial when it was rolled out, which is in fact the case.  The original phase 3 trial is not due for completion until 2023, which is still short for a vaccine trial.  Chris James warped the question.

He also didn’t address the second part about the fact that the whole world is supposedly gathering the post marketing data, which is phase 4 of a clinical trial.  The phase 3 trial no longer has a functional control group which means gathering and examining the phase 4 data is even more important than usual.  We know that our NZ CARM data shows up in VAERS (the US Vaccine Adverse Events Reporting System), so we are contributing to a global vigilance program, albeit one which is ignoring the strident safety signals it is producing. 

Question 2: What procedures and protocols have been set up in NZ to report accurately on this phase?

Chris James: This part of your request is refused under section 18(e) of the Act, as the information requested does not exist. New Zealand is not conducting a clinical trial for the COVID-19 Comirnaty vaccine. Medsafe’s processes for monitoring the safety of all medicines and vaccines in use in New Zealand are publicly available on the Medsafe website: COVID-19 Vaccine Safety Monitoring (medsafe.govt.nz).

NZDSOS: Chris James has obfuscated the issues here too, saying NZ is not conducting a clinical trial.  No, but NZ is gathering data that we understand feeds into the Global Vaccine Data Network via Dr Helen Petousis-Harris (and without us being able to see it) for the post marketing surveillance.

Medsafe seems to be gathering large amounts of data but no-one is acting on it.  It just says “Continue to monitor”.  How many serious adverse effects are acceptable before someone will say STOP?  Already 3,550 people have reported serious adverse events (many of which will be life-altering) and that is likely to be a significant underestimate. We have reported frequently on the growing toll of children and young people who are dying suddenly.

Question 3: In NZ, are the number of injections being recorded against the onset of a new disease e.g. cancers or autoimmune conditions, worsening of a disease, or death of a person who received the injection? If not, why not?

Chris James: We have interpreted this part of your request as asking whether Medsafe or Manatū Hauora engages in a comparative exercise between COVID-19 vaccinations and new diseases or medical conditions in a general sense. Medsafe and Manatū Hauora do not report in this way and doing so would be of no value without establishing a causal link between COVID-19 vaccinations and other conditions. Therefore, this part of your request is refused under section 18(g) of the Act, as the information requested is not held by Manatū Hauora or any other agency subject to the Act.

Adverse events following an immunisation with any vaccine can be reported to the Centre for Adverse Reactions Monitoring (CARM) by anyone. For COVID-19 vaccines, a summary of these reports is published here: www.medsafe.govt.nz/COVID-19/vaccine-report-overview.asp. 22 November 2022

NZDSOS: “…doing so would be of no value without establishing a causal link between COVID-19 vaccinations and other conditions.“

This is a circular and disingenuous answer.   Effectively he is saying “We’re not counting them because we’d have to establish a causal link” (and no-one seems to be trying to do that – in fact Medsafe seems to be actively trying to avoid establishing a causal link).

This is the problem we face trying to understand what exactly they are looking at.  If proper post-marketing surveillance was being done, every new medical condition and every death in a vaccinated person would be counted and thoroughly investigated.  Medsafe seems to be fobbing off most of the problems by saying they are not related, but our question is, how do they know they are not related if they are not looking and counting?

We have learned through other OIA requests that Medsafe’s Independent Safety Monitoring Board, tasked with assessing the few deaths after vaccination that actually get through the opaque triage process to the CARM database, treats them in the same dismissive way.  All truth seems to fall at the altar of discouraging vaccine hesitancy.

Question 4: As we’re in the phase 4 trials, any death of a person who took the injection should be investigated. Are all deaths, whether 1, 2, 3, or any number of weeks, following the injection being investigated? If not, why not?

Chris James: New Zealand is not conducting a clinical trial for the COVID-19 Comirnaty vaccine; therefore this part of your request is also refused under section 18(e) of the Act, as the information requested does not exist. As stated above, Medsafe’s safety monitoring processes are published on the Medsafe website and a summary of reports to CARM regarding COVID-19 vaccines are also published on the Medsafe website.

NZDSOS: Again obfuscating the answer.  There is no phase 3 clinical trial in NZ but the question asked about the ‘phase 4 clinical trial’ (i.e. post marketing surveillance) and asked whether post-inoculation deaths and illnesses were being investigated as would occur in normal times.  Chris James has just fobbed the writer off to the usual Medsafe protocols page which says nothing of substance. If Pfizer’s phase 3 pre-approval trial is ongoing (with all it’s flaws and suppressed bad news), then the experiment continues. Period.

Question 5: Are autopsies for the spike-protein being carried out in all persons who have died at any time after uptake of the injection? If not, why not?

Chris James: Referrals for autopsies are not made by Medsafe or Manatū Hauora. This decision is made by the family of the deceased person with support from the healthcare workers involved in the patient’s care. When autopsy results are available, Manatū Hauora requests the findings of the post mortem which are then used to review the relationship between vaccination and the cause of death as determined from the post-mortem. Manatū Hauora does not determine the cause of death. For more information, you may wish to contact the Coronial Services team at Ministry of Justice by email at: [email protected] or by calling 04 466 2789 or 04 466 2786.

NZDSOS: Another unhelpful response.  No Medsafe and MoH don’t refer for autopsies so they can’t respond.  The MoH doesn’t determine the cause of death but it does request ‘the findings of the post mortem which are then used to review the relationship between vaccination and the cause of death.’  We’re not clear what that means.  It seems everyone passes the buck to someone else, and no-one is ultimately responsible.  It appears to be a bit of a circus.

The families of the deceased do not appear to be making decisions.  A number have been denied post-mortems despite requesting them. Several have claimed they were told one thing to their faces but written findings were different. 

It is our understanding that pathologists (doctors doing the autopsies) don’t have access to the stains needed to detect spike protein in the tissues.  It is not clear if they are looking for inflammation in blood vessels of all sizes as has been found overseas, or commenting on the ‘clots’ being seen by embalmers.  It is not clear whether coroners are considering autoimmune conditions as possibly related to vaccination as they should be since condition 5 of the original provisional consent specifically mentioned this possibility. We do know the coroners were advised to discount cancers (document 4, page 9/11).

Previous contact with the coronial services has been unhelpful. The chief coroner has ignored our letter of concern.

Question 6: Why haven’t ALL the side effects of the injection ever been reported in the media?

Chris James: Information concerning the known side-effects of the Pfizer COVID-19 vaccine can be found here: www.medsafe.govt.nz/profs/Datasheet/c/comirnatyinj.pdf.

Manatū Hauora cannot comment on what media outlets choose to report about COVID-19 vaccinations, as they are separate entities that are responsible for the material they produce. If you have concerns about a media entity, we suggest you contact the New Zealand Media Council. You can find more information about the New Zealand Media Council’s complaint procedure here: www.mediacouncil.org.nz/complaints/.

NZDSOS: “Information concerning the known side-effects of the Pfizer COVID-19 vaccine can be found here.”  Well, that list on the Medsafe Datasheet (tabulated below) is woefully inadequate and deliberately leaves out all the major possible adverse effects that Pfizer knew to be concerned about and were interested in during vaccine development – blood clots, heart attacks, strokes, menstrual changes, still births, sudden death, auto-immune conditions, cancers.

What about all the other unknown ones that they’re supposed to be monitoring for?  Every new medical condition in a vaccinated person should be reported.

Events Medsafe IS looking for:

Events Medsafe SHOULD BE looking for:

Helpful advice re Media Council complaint’s procedure!  Yeah right.  As if they’ll listen when they are in the pay of the Single Source of Truth. James implies an independence amongst different players who are all pushing the same narrative. That speaks for itself, and our experience is of lockstep denial of any problem without producing any quality evidence to support their positions. Truly disgusting, in view of the lives lost and wrecked so far.

Question 7: Clause 57 of the document of “Provisional Consent to the distribution of a new medicine”, dated 3 Feb 2021, stated that Medsafe would provide monthly reports as well as safety reviews that are conducted or they become aware of. Where have these monthly reports and safety reviews been posted for public awareness?

Chris James: The New Zealand Gazette lists the obligations placed on the sponsor (Pfizer) by Medsafe. It does not create an obligation for Medsafe to produce monthly safety reports. As stated earlier in this response, you can find the safety reports created by Medsafe here: www.medsafe.govt.nz/COVID-19/vaccine-report-overview.asp.

NZDSOS: Again unhelpful. So, Pfizer is supposed to produce the reports but how is the public to know that they actually do, or what the reports say, if they are not publicly available?

Medsafe are posting their own Safety Reports only every 3 months now! It took a year from Rory Nairn’s death until the public were informed of his cause of death, and the coroner has still not released her recommendations. In the meantime we contend other people have died in the same manner, from post vaccine myocarditis, including a 14 year old boy just this month, we understand. This casual and underhand approach to their duties to the public surely makes government agencies completely responsible for every death following the vaccine. 

​This one example from Mr James of Medsafe reflects the government’s dismissive and deceptive attitude, and they will go down badly in history.