153071
  • Log in
The Daily Sceptic
No Result
View All Result
  • Articles
  • About
  • Archive
    • ARCHIVE
    • NEWS ROUND-UPS
  • Forum
  • Donate
  • Newsletter
The Daily Sceptic
No Result
View All Result

Blame Game Begins as MHRA Passes the Buck: “All the Covid Vaccine Authorisation Decisions Were Taken by the Government Minister”

by Nick Denim
19 January 2023 1:42 PM

I have just received a very interesting MHRA reply to an FOI request about whether the Healthy Secretary delegated Covid vaccine decisions to the MHRA.

The MHRA said: “All the Covid vaccines and therapeutics authorisation decisions were taken by the Licensing Minister and were not delegated.”

What makes this so interesting is the wider context. Under the Human Medicines Regulations, the Licensing Authority is the Secretary of State for Health. He or she delegates to MHRA all the work associated with that – licensing of medicines, pharmacovigilance, inspection of manufacturers, enforcement and so on. 

But for the Covid vaccines, MHRA is saying that the Secretary of State personally took all the decisions.

I read that as the blame game having started. I’ll explain why.

Back in 2020, MHRA would have known only too well that the clinical trials had been rushed (10 months compared with typical time to market of 5-10 years), had not been comprehensive (e.g. limited pharmacokinetics/pharmacodynamics) and wouldn’t finish until 2024. There were many warnings from experts around the world.  MHRA’s line about ‘rolling review’ was, and remains, bunkum.

MHRA scientists and officials would have known about the problems (with all medicines) of scaling up production from small-scale, laboratory-based production for trials purposes to full-scale production. For example, larger quantities of ingredients can be more difficult to mix. They wouldn’t therefore have been surprised to have seen batch problems with the Covid vaccines around the world. One batch resulted in the hospitalisation of 120 children in Vietnam. One batch caused ocular injury to nurses when a vial was broken. In Japan, 1.63 million doses were recalled due to metallic contamination. Probably just the tip of the iceberg.

MHRA then saw adverse event reporting starting to reveal serious safety issues in the U.K. and around the world. First, myocarditis and blood clots, in March 2021, a few weeks after approval of the AstraZeneca vaccine (now effectively withdrawn) and later other heart issues, neurological problems and immunosuppression with Pfizer and Moderna. 

MHRA knew in 2020 that the risk to younger age groups from Covid was very low and after rollout it would have seen assessments of vaccine effectiveness falling month on month. It wriggled hard against the evidence in the UKHSA weekly surveillance reports that vaccine effectiveness was even negative for younger age groups.

Since then the Covid vaccine narrative has continued to take a pounding as more clinicians around the world speak up, the research evidence about cardiac, neurological and immunosuppression problems continues to pile up, and the 1,000 per week excess deaths have still not been explained.

MHRA might have been criticised by Baroness Cumberlege for being “unresponsive and defensive”, but its staff aren’t all deaf, blind or stupid. They knew.

So my inference is that the blame game has started. 

Mind you, MHRA is on a sticky wicket in any blame game. There are serious shortfalls in its own safety management:

  1. It doesn’t have a process for investigating individual Yellow Card reports. It says it tries to investigate individual fatal and serious Yellow Card reports but it doesn’t have a process so it doesn’t know how many it has investigated (FOI 21/1109);
  2. It’s never had a safety audit (FOI 22/562);
  3. It doesn’t actively seek out real-world data – for example, real-world population-level data such as hospitalisation for ‘adverse events of special interest’ segmented by vaccination status and age. In January 2022, MHRA did not hold such data (CSC 88243) and in August 2022, UKHSA (FOI 22/472) only held population level info on thrombosis with thrombocytopenia syndrome (TTS). Instead, it wait for signal detection from Yellow Card reports of adverse events, which are massively under-reported;
  4. It doesn’t (or can’t) define the quantitative level of risk which is ‘acceptable’ as the basis of “acceptably safe” (FOI 22/390);
  5. It lost 20% of posts in 2021 due to funding cuts and has 20% vacancies below that new baseline (FOI 22/1007);
  6. It doesn’t have a process for delegating the authority to approve medicines for public use (FOI 22/1002) or governance of individuals competence (qualification, experience and training) (FOI 22/1007) to MHRA officers;
  7. It has hidden safety data (FOI 22/1083), redacting numbers in tables on the pretext of maintaining patient confidentiality;
  8. It appears quietly to have dropped a key strand of its Covid vaccine surveillance: Targeted Active Monitoring. FOI 22/1083 asked for a copy of the latest report but it was 15 months old (August 2021).

But back to “All the Covid vaccines and therapeutics authorisation decisions were taken by the Licensing Minister and were not delegated.” I’m left wondering what safety advice MHRA gave to Chris Whitty and ministers about the Covid vaccines back in late 2020 and early 2021 and subsequently as the serious safety issues started to emerge. And I wonder what briefings MHRA gave to the Commission on Human Medicines Expert Working Group on Covid Vaccine Benefits and Risks and to the COVID-19 Vaccines Safety Surveillance Methodologies Expert Working Group – neither publishes minutes.

It’s high time MPs and the Covid Inquiry started to ask some searching questions.

Until Nick retired a few years ago, he was a Senior Civil Servant in a Government Department.

Stop Press: A couple of rogue reporters tried to interview the CEO of Pfizer, Albert Bourla, as he made his way into Davos. He refused to answer a single question.

Amazing video of @pfizer CEO @AlbertBourla being confronted in Davos about the fraud perpetrated with his company’s garbage covid shot. So well done by these actual journalists. I loved every minute. Watch and share: pic.twitter.com/3ZBVM7udlK

— Clay Travis (@ClayTravis) January 18, 2023
Tags: Adverse eventsChris WhittyCOVID-19MHRASafetyVaccine

Donate

We depend on your donations to keep this site going. Please give what you can.

Donate Today

Comment on this Article

You’ll need to set up an account to comment if you don’t already have one. We ask for a minimum donation of £5 if you'd like to make a comment or post in our Forums.

Sign Up
Previous Post

Jacinda Ardern’s Resignation is an Admission of Failure

Next Post

We Need to Stop Saying the Woke Have Good Intentions

Subscribe
Login
Notify of
Please log in to comment

Profanity and abuse will be removed and may lead to a permanent ban.

37 Comments
Oldest
Newest Most Voted
Inline Feedbacks
View all comments

NEWSLETTER

View today’s newsletter

To receive our latest news in the form of a daily email, enter your details here:

DONATE

PODCAST

Nick Dixon and Toby Young Talk About the Davos Elites’ Prolific Use of Prostitutes, Clarkson’s Fightback and the Government’s Bizarre Plan to Ban Discouraging Teens From Becoming Trans

by Will Jones
24 January 2023
1

LISTED ARTICLES

  • Most Read
  • Most Commented
  • Editors Picks

U.K. Becomes Latest Country to Ban Covid Boosters for Under-50s

25 January 2023
by Will Jones

Andrew Bridgen Sues Matt Hancock for £100,000 Over Anti-Semitic Smear in Vaccine Row

26 January 2023
by Will Jones

You Can’t Make It Up

26 January 2023
by Noah Carl

Pfizer Doing Gain-of-Function Research to Mutate Covid and Make More Vaccines, Says Pfizer Executive in Explosive Undercover Video

26 January 2023
by Will Jones

The Link Between the Massive Drop in Birth Rates and mRNA Vaccines is Undeniable

24 January 2023
by Dr Sven Román and Dr Jonathan Gilthorpe

News Round-Up

48

Andrew Bridgen Sues Matt Hancock for £100,000 Over Anti-Semitic Smear in Vaccine Row

30

The Disastrous Covid Vaccines Risk Tarring All Vaccines With the Same Brush

70

Deaths Running 26% Above Pre-Pandemic Levels – and the Vaccines Remain a Leading Suspect

27

A Sensible Approach to Climate Change in the Classroom

19

Lockdowns Responsible for Thousands of Alcohol Deaths – ONS

27 January 2023
by Dr Carl Heneghan and Dr Tom Jefferson

Deaths Running 26% Above Pre-Pandemic Levels – and the Vaccines Remain a Leading Suspect

27 January 2023
by Will Jones

You Can’t Make It Up

26 January 2023
by Noah Carl

Alps Were Up to 7°C Warmer in the Recent Past, Dramatic New Evidence Shows

26 January 2023
by Chris Morrison

The Disastrous Covid Vaccines Risk Tarring All Vaccines With the Same Brush

26 January 2023
by Dr Angus Dalgleish

POSTS BY DATE

January 2023
M T W T F S S
 1
2345678
9101112131415
16171819202122
23242526272829
3031  
« Dec    

SOCIAL LINKS

Free Speech Union
  • Home
  • About us
  • Donate
  • Privacy Policy

Facebook

Twitter

Instagram

RSS

Subscribe to our newsletter

© Skeptics Ltd.

No Result
View All Result
  • Articles
  • About
  • Archive
    • ARCHIVE
    • NEWS ROUND-UPS
  • Forum
  • Donate
  • Newsletter

© Skeptics Ltd.

Welcome Back!

Login to your account below

Forgotten Password?

Create New Account!

Please note: To be able to comment on our articles you'll need to be a registered donor

Already have an account?
Please click here to login Log In

Retrieve your password

Please enter your username or email address to reset your password.

Log In
wpDiscuz
You are going to send email to

Move Comment