128447
  • 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

U.K. Medicines Regulator MHRA Says it Has “No Process” to Follow Up Vaccine Adverse Event Yellow Card Reports

by Nick Denim
5 August 2022 11:48 AM

I’m retired but I worked for 20-plus years in a safety critical sector where I was legally accountable for the safety of hundreds of products which I authorised for use. So I know a robust safety management system when I see it.  From what I’ve found out about the MHRA, I don’t think its safety management is as robust as those responsible for it seem to think. Consider two pieces of evidence: safety audits and the processes for investigating reports of adverse events linked to medicines including vaccines.

In the organisation in which I worked, we were subject to safety audits at least once a year. I know it’s similar in other safety critical sectors like aviation, nuclear, oil and gas and transport. But not, it turns out, in the MHRA, the organisation responsible for authorising medicines for public use.

I submitted an FOI request for a copy of MHRA’s last independent safety audit report. I was sent the two pages covering safety management from a 50-page audit report (dated February 2020) by the British Standards Institute against the requirements of ISO9001, a Quality Management standard.

Believe me, there’s a world of difference between a Quality Management audit and a Safety Management audit. First, quality is about compliance; safety is about risk. Here’s a simple example of the difference in another sector. If you’re still not convinced, consider that an ISO9001 auditor requires no knowledge, qualifications or experience in safety management. So the safety extract from the Quality audit report is just saying that the auditor had seen a selection of MHRA safety-related documents or processes, or seen evidence that they existed. The auditor can’t say whether they are the right processes for robust safety management or ask searching questions about safety. I could go on but you get the picture.

There’s another major problem. The Human Medicines Regulations – which are the legislation governing medicines for public use in the U.K. – require (Part 11, Section 180) “audit of MHRA’s pharmacovigilance system every two years”. So, not only has it been meeting that requirement with Quality audits not Safety audits, but the most recent one it sent me in May 2022 was dated February 2020. This means that it is either defaulting against the Human Medicines Regulations or it’s got someone to approve it not doing the statutory audits while it’s busy monitoring the Covid vaccines rollout. Was that the work of the Secretary of State for Health? Was Parliament informed? I’ve got another FOI pending to find out.

But, either way, a cautious person would actually want a safety audit of MHRA during the biggest and fastest vaccination programme in U.K. history.

Turning to the process for investigating individual Yellow Card reports, I asked MHRA for its internal document specifying how its staff follow up individual Yellow Card reports for adverse events from medicines. This is the process which would tell its staff which Yellow Card reports to follow up and which not, as there is obviously a spectrum of severity from sore arm to death. It replied: “The MHRA does not hold a process for investigation of individual Yellow Card reports.” However, in response to someone else’s FOI request (21/1109) MHRA outlined the steps it took to investigate individual Yellow Card reports related to myocarditis. But if, as it told me, there is no documented internal MHRA process, how do staff know what steps to take and how does the Chief Executive, Dr. June Raine, know whether or not they are taking those steps? The answer seems to be that she doesn’t, as that same FOI asked how many Yellow Card reports of deaths linked to myocarditis had been investigated. MHRA invoked a Section 12 exemption – it would take too long to find out. They don’t know. So far as I can tell, they just cooperate with Coroner’s Inquests but they have no set process for this either, so it’s all anybody’s guess.

I’ve raised these concerns with both Dr. June Raine, MHRA’s Chief Executive, and Alison Cave, MHRA’s Chief Safety Officer. But so far, no replies. For me, the lack of response just underlines my concern that MHRA’s safety management does not appear to be as robust as those responsible for it think.

I hope to follow up this article later with some observations about MHRA’s process for signal detection from the accumulation of Yellow Card reports for the Covid vaccines. At face value, it appears that MHRA’s first filter on the data is a weekly review of those types of adverse events which are more common than for other vaccines. That ‘relative’ approach seems a very peculiar way to measure safety and not how it’s done in other safety critical sectors. Then there’s the question of how MHRA rolls into that process the issue that the benefit from the Covid vaccines appears to be significantly less than when it originally authorised them for emergency use. So the risk/benefit balance is likely worse than for other vaccines. Which makes the ‘relative’ approach all the more peculiar. But I’ve got more digging to do first.

One final thought in the meantime: Has anyone else noticed that the Terms of Reference for the Covid Public Inquiry do not even mention the word ‘safety’.

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

Tags: Adverse eventsMHRASafetyVaccine safetyVaccinesYellow Card Reporting System

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

Guardian Claims The Phrase “White Working Class” Is a “Fiction”

Next Post

Losing Trust in ‘The Science’

Subscribe
Login
Notify of
Please log in to comment

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

20 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 St. Gary’s Struggle to Call People Nazis, the Truth About January 6th and a Victory Against ‘Non-Crime Hate Incidents’

by Will Jones
14 March 2023
6

LISTED ARTICLES

  • Most Read
  • Most Commented
  • Editors Picks

Freedom of Preach – How a Street Preacher Was Arrested for ‘Misgendering’

20 March 2023
by Nick Dixon

News Round-Up

20 March 2023
by Nick Dixon

Net Zero Must Be Brought Forward by a Decade to Stop “Climate Time Bomb”, Says UN

20 March 2023
by Will Jones

The 14-Day Isolation Rule Cost Me Weeks of Education. Now We Know Matt Hancock Ignored Advice to Scrap it Just to Save Face

20 March 2023
by Jack Watson

Police Failing to Teach Officers Importance of Free Speech While Spending Thousands on Pronoun Training

20 March 2023
by Will Jones

News Round-Up

60

Net Zero Must Be Brought Forward by a Decade to Stop “Climate Time Bomb”, Says UN

33

Freedom of Preach – How a Street Preacher Was Arrested for ‘Misgendering’

32

Uncensored Enid Blyton Books Kept Under Counter in Public Libraries

26

Attenborough Ramps Up Climate and Ecological Breakdown Fears

52

Intelligence of German Children May Have Fallen During Lockdown

20 March 2023
by Noah Carl

It Was A ‘Vaccine Strategy’ From The Start

18 March 2023
by Alex Starling

Lancet Pushes Dangerous Theory That People Are Worth No More Than Rats

17 March 2023
by Dr David Bell

Excess Deaths Return After Five-Week Hiatus – But They Only Disappeared Due to ONS Trickery

17 March 2023
by Will Jones

Cutting Through the Web of Global Censorship Bankrolled by Billionaires

16 March 2023
by Alex Kriel

POSTS BY DATE

August 2022
M T W T F S S
1234567
891011121314
15161718192021
22232425262728
293031  
« Jul   Sep »

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