The MHRA Papers - Part 24
Do you want answers to the 36 questions? Buzz off!
In January 2025, we published the second post of our series on minutes of the MHRA’s Commission On Human Medicines (CHM) COVID-19 Vaccines Benefit Risk Expert Working Group (EWG) meetings. We now refer to the session of 18 November 2020 and its fallout from the MHRA stonewalling of Parliament and the public.
During the 18th of November meeting, the EWG made the usual contradictory and troubling statements such as:
The EWG heard there would be a lower degree of risk associated with the ‘clinical trial product’ due to the availability of safety data.
The EWG noted the sparse data and information on flow, batch testing, protocols, and full roll-out details.
The EWG asked if the vaccine's lipid nanoparticle element possesses any adjuvant properties other than innate adjuvant activity.
The EWG also noted that the duration of available follow-up data could be insufficient to capture the development of adverse events.
The EWG asked about the death in the vaccine group. The EWG heard the subject was a 60-year-old male, obese and taking two concomitant medicines for depression. The EWG heard that specific cardiovascular events are usually recorded as a cause of death rather than arteriosclerosis.
The EWG noted that lymphopenia was reported using the vaccine in the phase I trial.
Last but not least we found the surprising statement: The EWG asked if the company are required to respond to the 36 questions posed by the MHRA.
We only managed 15 on the pharmacokinetics of Comirnaty.
However, the MHRA confirmed that there is no formal obligation to reply.
What happened afterwards? None of the following minutes (either in the first publication batch or in the second) provided answers to the 36 questions. We do not know what the questions were, there is no mention of anyone in the EWG being tasked with following them up.
Naively we thought a senior Member of Parliament might get an answer.
We next suggested that a FOI request from a taxpayer might discover what happened to the 36 secret squirrel questions. The MHRA replied that ‘on balance we are satisfied that, in this instance, the public interest in applying the exemption therefore outweighs the public interest in disclosure.'‘
You can read the letter here:
We have no doubt that all of you can think of lots of highly beneficial new medicines approved recently by the reputation-conscious enabler. However here we are, or were, dealing with an experimental biologic of which we know little, used on populations on which it had not been tested in near coercitive situations by governments. In addition the strenuous efforts of the MHRA to cover their tracks by two lots of redacted minutes should not be acceptable to any member of the public.
This post was written by two old geezers who have difficulty believing what they have been reading.
This is a really good point, Alan. I think history will regard all this as madness and the imposition of experimental products on misinformed and terrorised populace.
An old geezer
Yes, the best body swerves in the business.
An old geezer