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As Side-Effects of Covid Vaccines Piled Up, the MHRA Expanded its Advice Lists But Took No Action

by Nick Hunt
15 December 2023 11:25 AM

I wrote here about the fact that MHRA’s definition of ‘safe’ is relative – “the benefits outweigh the risks” – whereas all other safety sectors define ‘safe’ in absolute terms – one in a million probability of death, one in a thousand probability of serious injury, etc. Other sectors define these up front and then investigate all safety incidents and take appropriate action to limit, modify or suspend the product if those absolute safety risks are breached in practice.

MHRA would doubtless argue that manufacturers have to put absolute safety risks in the Patient Information Leaflets which you find in the box. That’s true, there are probabilities (‘common’, ‘rare’, ‘very rare’, or one in 100, one in 1,000 etc.) However, there’s a big problem: those aren’t thresholds which, if breached, trigger MHRA to take action to limit, modify or withdraw the medicine. Instead, MHRA just seems to list all the emerging side-effects in the Patient Information Leaflets and carries on.

To illustrate this, I’ve had a poke around the evolving versions of the Patient Information Leaflets for the Covid vaccines since rollout started. It’s terrifying. I’ll show you them in a moment, but what it’s been doing as Yellow Card reports rapidly accumulated is to:

1. Move already known adverse events between frequency categories if they turn out to be more common than they thought based on the (much shorter than normal) clinical trials.

2. Add new adverse events which only emerged during rollout (i.e., they weren’t identified in the clinical trials).

Worse still, months after rollout started, MHRA:

3. Added a new category (‘1 in 10,000’).

4. Added some words on the risk of death (which wasn’t previously mentioned at all).

You can see this in all its glory by using the Wayback Machine for Pfizer/BioNTech, AstraZeneca and Moderna. Go to the version of that webpage archived on the various dates shown and then find the corresponding Patient Information Leaflet.

Space doesn’t permit showing you them all, but just spot the differences between the first AstraZeneca PIL (December 30th 2020) and the most recent (November 2023).

AstraZeneca Covid vaccine Patient Information Leaflet, December 30th 2020
AstraZeneca Covid vaccine Patient Information Leaflet, November 2023

I mentioned that the original PILs didn’t include the risk of death. This was only added later to the AstraZeneca PIL (on April 18th 2021) and the Moderna PIL (on September 15th 2023).  But it wasn’t actually quantified: it was just introduced as “fatal cases have been seen” or “some cases had a fatal outcome”. It is still not mentioned in the Pfizer PIL despite at least one coroner citing that vaccine as the cause of death. This is the antithesis of informed consent.

I found something else. The Human Medicines Regulations state that: “The licensing authority may establish a list of medicinal products that are subject to additional monitoring” and “the summary of product characteristics and the package leaflet must include a symbol and statement as follows: “▼ This medicinal product is subject to additional monitoring.”  Using the Wayback Machine, I found that the COVID-19 vaccines were not designated as such until months after Temporary Authorisation: Moderna on April 1st 2021, AstraZeneca on July 7th 2021 and Pfizer on July 14th 2021. It is not clear why the COVID-19 vaccines were not designated as worthy of additional monitoring from the start, or, if they were, why the Black Triangle was not included in the Patient Information Leaflet (which would be seem to be a breach of the Human Medicines Regulations).

Finally, let’s go back to MHRA’s relative definition of safety: “benefits outweigh the risks”. That might even have been fine if the benefits from the Covid vaccines got better as the risks got worse but, as we all know, the benefits got worse, too. Effectiveness turned out to be less than the manufacturers originally claimed and it waned within months – hence booster after booster. And the vaccine effect on transmission turned out to be illusory. But MHRA doesn’t want you know about the benefit side of the equation. For example, here’s a slide from an internal MHRA presentation just released under an FOI:

I’ve got more like this. Redaction after redaction. MHRA claims it’s hiding the data to protect commercial confidentiality. A suspicious person might think it’s got more to do with the ongoing legal cases against AstraZeneca.

It’s outrageous. MHRA is supposed to be protecting us from pharmaceutical manufacturers, not the other way round.

Until Nick retired a few years ago, he was a Senior Civil Servant in the Ministry of Defence responsible for the safety and effectiveness of ammunition used by the Armed Forces. He is co-author of the Perseus Group report on U.K. medicines regulator the MHRA.

Tags: AstraZenecaCOVID-19MHRAModernaPfizer/BioNTechSafetyVaccine

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17 Comments
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Jon Garvey
Jon Garvey
1 year ago

MHRA claims it’s hiding the data to protect commercial confidentiality.

Think about that – “Whether this drug is effective is a commercial secret.” Carte blanche for snake oil salesmen, then.

131
0
transmissionofflame
transmissionofflame
1 year ago

“I wrote here about the fact that MHRA’s definition of ‘safe’ is relative – “the benefits outweigh the risks” –”

Well, if only there were benefits….

76
0
Free Lemming
Free Lemming
1 year ago

I love these patient information leaflets. I can remember my Dad showing me one years ago for some medication he’d been put on (can’t remember what). Under side effects they’d casually slipped in “death”. May cause death. Yep, that’s definitely an unwanted side effect! Still chuckle about that now.

75
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WyrdWoman
WyrdWoman
1 year ago

Let’s just remind ourselves of ‘that’ presentation slide that was put out by Pfizer in what, early 2020, shall we? If it was out on the internet, the MHRA can’t possibly say they didn’t know. Toxic lying genocidal scumbags.

CBER-Slide-16ii
58
0
MikeAustin
MikeAustin
1 year ago

The latest MHRA Yellow Card Report figures came out yesterday for the period up to 29th November.

The current totals are 2,621 deaths and 1,664,308 total adverse reactions. There are currently 25 deaths and 6,768 serious reports for under 19s. 17 of these are ages 10-19.

There is an increase this month of 3 deaths in the age group 0-9. Who in their right mind would even consider subjecting these poor children to an unnecessary, toxic experimental injection?

31.2% of deaths are ‘general disorders’ – the vast majority are ‘sudden death’. Cardiac disorders are 18.8% of deaths. Half the deaths could be from a similar or related cause – heart, clots etc.

More details here.

Last edited 1 year ago by MikeAustin
65
0
JeremyP99
JeremyP99
1 year ago
Reply to  MikeAustin

Nota bene. MHTA stated publicly that the reporting level is from 1% to 10% of actual incidents. Being generous, and saying 10%, that c25k dead, and 15 million adverse reactions – one in two jabbed?

16
0
MikeAustin
MikeAustin
1 year ago
Reply to  JeremyP99

Yes, I am aware of those reporting percentages. We can have a quick guess here.
The last available jab totals that I used were in November 2022. That was when the previous Yellow Card Report format was used – a set of Acrobat files.
On 3rd November, I estimated that the reported death rate was 1 in 62k per jab overall average and 1 in 12k over the last three weeks. At that time, the jabbed people had taken an average of 2.7 jabs.
I have attached the ONS weekly deaths. For the last three years, we have a total of of 151,031 excess deaths. If they were all due to the jab, it would mean a reporting rate of 2,621/151,031 = 1.74%. This is unlikely to be the case, of course, but the numbers look likely to be in the 1% to 10% range.

ONSweekly-20231212
7
0
JohnK
JohnK
1 year ago

The concept of safety in many industries is managed via the Safety Integrity Level (SIL). Lots of descriptions of how it works, such as: https://blog.msasafety.com/what-safety-integrity-level-means/ . That one seems to be related to manufacturing processes, but the concept is also relevant to equipment that involves human interfaces, such as automotive equipment, or railway equipment, aviation etc. It may be that something similar is used in the pharmacy trade, but if it is, there is evidently a simplistic approach to any presentation to the potential customers.

15
0
RTSC
RTSC
1 year ago

MHRA announced that it was a “vaccine” enabler.

Trusting them to be transparent about the risks of a particular medical product would be an exercise in rank stupidity.

42
0
bertieboy
bertieboy
1 year ago

Good article – thanks!
For me, words have a meaning. The word ‘safe’ is an absolute term and applied to a product means that I can’t be harmed by it.
This ‘safe’ pharmaceutical product caused a serious heart injury to my son-in-law (clinically acknowledged) who now has to carry medications with him at all times and for the rest of his life.

51
0
huxleypiggles
huxleypiggles
1 year ago

https://www.conservativewoman.co.uk/canada-reports-300-increase-in-unspecified-causes-of-death-sparking-calls-for-investigation/

There is another “pandemic” in Canada at least – “unspecified cause of death.”

That is Orwell speak for…we know the cause but we are not making the information public.

48
0
Sforzesca
Sforzesca
1 year ago

Brilliant research and I bet an eye opener for the author re the frauds/lies/deceits/crimes of bigpharma and their associates ie in this case the worldwide vax safety bodies.
They’ve been at it for over a century. They spend millions on stats., lawyers etc..
Turtles All the Way Down innit.

For a laugh just google criminal fines of bigpharma –
Merck.
Pfizer,
G.S.K.
Johnson/Johnson.
etc, etc.

And people are dumb enough to trust the bastards.

33
0
D J
D J
1 year ago

The other fact that outraged me from the start was that there were absolutely no contraindications for the medications.
Look at the British National Formulary,everything has contraindications,even water in some circumstances.
Nothing for these medications:newborn,pregnant,suffering from certain illnesses. No, it was all just fine for everyone everywhere.
Madness!

33
0
Jabby Mcstiff
Jabby Mcstiff
1 year ago

The most obvious point is seldom made and that is the assumption that we are allowed to tinker at that level. We aren’t allowed and the same goes for nuclear technology. When you look at the encounters with beings who have turned up around nuclear test sites they look avery sad and are crying because you ripped a hole into their dimension and caused destruction. That’s why they try to send warnings by deactivating missile silos. On the cellular level such warnings aren’t available. This tampering brought about the catasprophe that occurred 12,500 years ago. This molecular understanding of reality is being discarded and I hope it happens quickly enough. I have faith that it will be.

1
0
Jabby Mcstiff
Jabby Mcstiff
1 year ago

The manufacturers well knew that it wouldn’t matter if you had been vaccinated or not. Just one vaccinated person creates enough toxic haze to spread Mr Spike to twenty other people. You aren’t getting away from this toxin. So the question is really how do you fight it. It is circulating in your blood whether you know it or not. Look at what it is and try to be the opposite of that.

9
-1
JeremyP99
JeremyP99
1 year ago

I FOIed MHRA way back, noting that other jabs had been stopper with less than a hundred deaths – we were up to c 2000 by then, to ask if they had a figure at which they would be pulled.

No. Was the answer. No limit to how many may die.

26
0
Jabby Mcstiff
Jabby Mcstiff
1 year ago

It is easy to see a business model developing over many decades based upon certain unspoken truths about models of reality and given the reign of cupidity in our time you can see how certain instruments and certain interest groups might form a happy coalescence. In a sense this whole horrible situation is the most natural thing in the world given the antecedents. It is like we are asking a patient to vomit in order to expel the toxins.

7
0

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