Yesterday, we posted what we thought was a disturbing list of MHRA board members. We pointed out that the press had already exposed this state of affairs with little success. We have already run many posts exposing a long list of problems. We hoped that someone would do something about a public agency that should be on the side of citizens but is manifestly failing to do so.

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Now, one of our subscribers has written to us telling us the story of the months of 2021-22 when the Covid vaccines were first rolled out. He is an eye doctor, and he saw an abnormally high number of cases of Bell’s Palsy. This is a frightening progressive weakness of facial muscles, usually one-sided. Most cases recover, but some do not. How would you like to go around with half your face hanging down and unable to see properly?

Unfortunately, some cases are associated with nasty autoimmune diseases or conditions thought to be so.

So, we did some preliminary checking because the TTE office is small, and our assistants get in the way the whole time. Bear in mind that this is not a systematic review; it is only a preliminary “walkabout”.

First, we found this answer by the MHRA to a 2022 FOI request on the number of Yellow Card reports for Bell’s Palsy over the previous three years (FOI 21-750).

So our reader was not going mad after all. But perhaps we are, as here comes the second bit under the table:

Read again: the number of reports of facial paralysis….is similar to the expected natural rates…… No increased risk. Ah…… phew!!!   We were getting worried.

Then we go and look at whether members of the public were concerned. To do this, we use the FOI web-based facility, WhatDoTheyKnow. 

We found that Michael Tyas, whom we do not know, is on the ball (in our experience, members of the public are far more switched on, perhaps because it’s their skin or their money and they do not work for Microsoft or perhaps they are tired of being regarded as cannon fodder). Mr Tyas managed to get from the NHS Business Services Authority (no idea what that is, by the way) a list of conditions awarded a Vaccine Damage Payment or in which vaccine causation was accepted (yes, you read that right).

The list of nasties is long, but no prizes for guessing what condition is in the second category (disablement less than 60%). To get Damage Payment, you probably have to die as only anaphylaxis gets listed (hence “Condition” and not “Conditions”), and some folks die of this. But it’s okay; your sons and daughters or, even worse, a child’s parents can benefit from the Payment. Not to worry.

Now the question is, how big is the Bell’s Palsy problem? 

We know up to 98% of suspected harms are not reported in Yellow Cards. Step in Anthony Haywood, another member of the public who has just asked a simple question: “Dear Medicines and Healthcare Products Regulatory Agency, would you please supply your estimate of the degree of underreporting to your ‘Yellow Card’ scheme, and subsequently your estimate of the actual number of deaths and adverse events, likely to be related to the covid 19 vaccine, at least in the view of the injured party.”

This FOI request was a few days ago. We recommend registering on the site, as we have, to follow the MHRA answer (towards the bottom of the page, click the blue button). 

While you are there, type in “Bell’s Palsy” in the search box to get a sense of what folks are asking. Either way, do not worry—we are in the safe hands of the MHRA. 

By the way, when you were given your informed consent form to sign before vaccination, did anyone mention Bell’s Palsy? 

The current evidence from systematic reviews 

We found nine systematic reviews (SRs)—a 2022  systematic review of 17 studies examining Bell's Palsy in adults and COVID-19 Vaccination.  However, the review only includes 33 cases diagnosed with Bells’ palsy.  Another updated review included 20 articles that reported vaccination does not increase the risk of developing Bell's palsy.  The review didn’t asses quality, and all the studies were retrospective. Of the 4.54 × 10⁷ individuals receiving vaccines against COVID-19, 1,739 cases developed Bell’s palsy. In the control group, 203 cases out of 1,809,069 were reported. A further 2023 SR of seven studies reported the incidence of Bell's Palsy after vaccination was comparable to that of the general unvaccinated population.

In contrast, a 2022 SR of reported cases of facial palsy of 37 studies, providing data on 58 individuals, reported that  Bell's palsy could be a plausible effect of COVID-19 vaccination. Another review of 25 records reports the rate ratio of Bell's palsy after COVID-19 vaccination was 25.3 per 1,000,000, and was higher after the first dose compared to the second dose and was higher among those who took Oxford/AstraZeneca vaccine compared to other vaccines. A systematic review and meta-analysis, including RCTs, found 50 studies, of which 17 entered the quantitative synthesis, suggesting a higher incidence of Bell’s palsy among SARS-CoV-2-vaccinated vs placebo groups. Finally, a 2022 SR of 88 studies that included a search of the VAERS database reported that venous and arterial thrombotic events, Bell's palsy, and myocarditis/pericarditis were the most common adverse events of special interest. 

We found numerous methodological problems and mistakes in the reviews. The number of studies differs systematically, suggesting none are systematic. All these reviews are subject to large-scale publication and reporting bias. Because of the substantial problems with all of these reviews, it is impossible to determine anything from the published literature as it currently stands. 

Readings 

Is Ebenezer Scrooge Running UK Pharmacovigilance?

Who is running pharmacovigilance?

Pharmacovigilance escape and evasion

Covid-19 Vaccine Damage Payments Bill Volume 738: debated on Friday 20 October 2023, look at Columns 508-509.

The System for Reporting Adverse Drug Reactions should come with a Warning -1 

The System for Reporting Adverse Drug Reactions should come with a Warning - 2,

Abuse and reason

Why Dame June should stay on at the MHRA

Do you think the MHRA is doing an adequate job?