The MHRA Papers - Part 8

Facilitating Bell’s palsy and vaccination in pregnancy with wrong or non-existent data

SUMMARY: The EWG reaches conclusions on incomplete or no data. But it was all secret anyway.

We continue our review of the minutes of the meeting of the MHRA’s ​​Commission On Human Medicines (CHM) COVID-19 Vaccines Benefit Risk Expert Working Group, which took place on 22 December 2020

This was the day after the EMA met and gave conditional market authorisations to PfizerBioNTech’s Comirnaty vaccine.

The first topic discussed by the EWG was the risk of anaphylactic reaction after exposure to BNT162b2.

There appeared to be a lot of roundabouts and circumlocutions, and here is some of the text:

“The EWG heard about two cases of anaphylaxis reaction on the first day of the UK vaccination campaign. 

The EWG recalled that polyethylene glycol (PEG) was previously considered a potential causative agent of the two allergic reactions seen in the vaccination campaign”.

However, we do not really know much about exposure to PEG in humans, so with a lot of warnings, the discussions petered out with a final appeal to the Yellow Card system and the statement: 

“The EWG was reassured that the signal of anaphylaxis does not appear to be strong”.

Next, EWG considered Bell’s palsy: 

The EWG heard about four reports of facial paralysis in the vaccine arm of BNT162b2, with zero cases in the placebo arm and one report of facial paresis in the placebo arm, with none in the vaccine arm. 

The EWG heard that the Yellow Card data includes one report of facial paralysis submitted by a healthcare professional and one report of facial weakness submitted by a patient”. 

These facial paralysis events were considered to be within the range of the background incidence rate—nothing to see here, then.

However, this statement contradicts the experience of our ophthalmologist reader, whose comment on the high incidence of Bell’s Palsy following immunisation triggered our Comirnaty series.

It also wrongly predicted what happened once the vaccine was rolled out. As with the Pandemrix story, one thing is immunising a few thousand people and another is immunising millions.  

Why would mortality data by vaccine exposure be withheld from Parliament and Jane/Joe Public?

Once again, we would like to see the case report forms for the Comirnaty registration trial as they contradict what actually unfolded. Will the New York Times or the BBC launch a campaign for the final full disclosure? 

We cannot see from the minutes what data the EWG used when they made such a statement.

Next, the EWG considered vaccine exposure in pregnancy and lactation and stated on page 11 of the minute:

It is limited in rats and non-existent in humans, as we have reported:

Even the rat data was open to different interpretations between the EMA and the MHRA.

However, as per usual at the EWG, all is well

This was on the basis of rat data, which indicated two months as the clearance time for the lipid nanoparticles. Yet, we now know that they do not stay around the vaccination site and that repeated administration of LNPs is likely to be highly toxic. 

It assumes  animal models are good predictors of human toxicity - they are not. The lack of correlation between animal models and humans is well documented. While they may be an adjunct to understanding mechanisms, they are no substitute for human trials - under no circumstances should animal models provide reassurance that all is well. 

The disconnect between animal and human predictors of effect is not new. A thousand years ago, the Persian physician Ibn Sina wrote, “Experiments should be carried out on the human body. If the experiment is carried out on the bodies of [other animals], it is possible that it might fail…” (See the James Lind Library). Clearly, the EWG were not students of history or willing to delve into the evidence of what is known about the use of animal studies and their limitations in ensuring safety.  

The basis on which the EWG was reassured is hard to fathom as there is no mention of the RNA clearance. What is the half-life of mmRNA in the elimination phase in different organs, and what happens to the mmRNA in humans in different organs was one of our fifteen questions that remain unanswered.

Exploring regulatory data sets of the Comirnaty vaccine - 9e

The last nine pages of the minutes are devoted to discussions of the Oxford Astra Zeneca and Moderna vaccines.

This post was written by two old geezers who were horrified that women who were pregnant or in the reproductive age group were pressurised into being vaccinated on the basis of XXXXXXXXXX [censored by secret squirrel ltd] data. 

Postscript 

The two old geezers are still waiting for the publication of the RCT on pregnant women

Exploring regulatory data sets of the Comirnaty vaccine - 7