When deciding whether to allow a new medicine to be available for doctors to prescribe, Medsafe must assess its potential benefits and its potential harms and weigh them up.
They Knew and They Lied
On 28 January, 2021 Medsafe referred the Pfizer application for consent to distribute Comirnaty to the Medicines Assessment Advisory Committee (MAAC) and asked them to assess:
Whether the benefit risk balance of Comirnaty vaccine for active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2, in individuals 16 years of age and older is positive.
This sort of risk-benefit assessment is also mentioned on Medsafe’s website at https://www.medsafe.govt.nz/profs/PUArticles/June2021/Spotlight-on-Comirnaty-vaccine.html
“Comirnaty vaccine has provisional approval for use in individuals aged 16 years and older, based on a favourable benefit risk profile.”
At paragraph 18 in his affidavit dated 16 February 2022 for the NZDSOS and NZTSOS court case challenging the vaccine mandates, Ian Town writes:
“In granting provisional approval, data from clinical trials was considered in a risk-benefit matrix, and it was recommended that the benefits the vaccines provide from covid-19 outweigh any risks.”
When asked for the risk-benefit balance/profile/matrix that was done prior to the granting of provisional consent for the Pfizer Comirnaty injection, Derek Fitzgerald of Medsafe provided the following: Document 10 (of which 62 out of 80 pages are redacted), on p 94/162.
h202106950 – response Download
They Knew and They Lied
They knew that the Absolute Risk Reduction (ARR) was only 0.84 per cent. They knew that ARR was the number that should have been used and that Relative Risk Reduction (RRR) is a deceptive number used by pharmaceutical companies to inflate the benefits of their products. How many New Zealanders would have taken a jab if they had been told the TRUTH? That it was 0.84 per cent effective, not 95 per cent effective?
They knew that severe adverse effects occurred at twice the rate in the vaccinated group v the placebo group (1.2% v 0.6%).
They presumably knew that more people died in the vaccinated group than the placebo group, including twice as many sudden cardiac events. (The section on ‘Serious Adverse Events and Deaths’ is redacted in the official document.)
They knew they only had two months of efficacy and safety data and could not know how long any immunity would last.
They knew there was no information on transmission, nor could there be as the trial was explicitly designed now to show it.
They knew there was no information on use in pregnancy, the elderly, those with autoimmune conditions, or those with complex medical needs.
They knew there was no data regarding the effect of vaccinating those already immune from natural infection.
When you get to the nitty gritty this is what the summary actually says:
Summary
The benefit risk balance of Comirnaty (COVID-19 mRNA Vaccine) for active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2, in individuals 16 years of age and older, is not clear. At this stage, there is evidence only for short-term protection, and longer-term safety data are lacking. However, experience with the vaccine is accumulating rapidly.
Notwithstanding uncertainties, in the light of high clinical need and the expectation of further data (including regarding duration of protection) around April 2021, a provisional consent under section 23 of the Medicines Act 1981 may be appropriate.
This is the so-called ‘favourable‘ benefit risk profile expounded by Medsafe on its website and that Dr Ian Town reported in his affidavit for the vaccine mandate challenge for health and education workers.
When Chris James of Medsafe sat in a comfy chair having a chat with Dr Ashley Bloomfield in early February 2021 to reassure the public that the approval process was thorough and robust, he was lying.
They Knew and They Lied
This article was originally published by New Zealand Doctors Speaking Out with Science.
