This is a tale about the U.K. drugs regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), and its consultation with its independent safety adviser, the Commission on Human Medicines, and two of its subcommittees – the Pharmacovigilance Expert Advisory Group (PEAG) and the COVID-19 Vaccines Benefit Risk Expert Working Group (VBR-WG). I know that sounds a bit tedious and forensic but bear with me. It reveals that the MHRA is at it again, redacting vaccine safety data without a proper reason and trying to avoid revealing further safety data.
In February 2021, MHRA announced four strands of its “proactive vigilance” to monitor the safety of the Covid vaccine rollout.
One of those strands was new: the MHRA’s Yellow Card Vaccine Monitor (YCVM) programme. A proactive programme, working closely with the NHS, where a random selection of Covid vaccinees would be invited to register (before vaccination and therefore before the onset of any side-effects) for follow-up at set intervals to ask whether any adverse reaction had occurred. As someone who had a senior role in a safety critical sector for over 20 years, that proactive programme seemed like a very sensible thing to do – not least to overcome the massive under-reporting of side-effects to MHRA’s main Yellow Card system, the lack of medium and long term safety data from the rushed Covid vaccine trials, and to try address concerns in the Cumberlege Report that the MHRA does not listen to patients. In the event, 30,000 people registered by mid 2021.
Having seen no trace of the YCVM programme since its announcement, I recently decided to ask for a copy MHRA’s latest report about it. MHRA very helpfully sent me a copy of its report dated August 2021 to the Commission on Human Medicines (CHM) Pharmacovigilance Expert Advisory Group (PEAG). It contains comparisons of the ethnic, gender and age profiles and top side-effects between the proactive YCVM programme and its wider but passive Yellow Card scheme, but no details about the frequency or severity of the side-effects.
Call me cynical but I suspect that’s all they wanted me to believe is the purpose of the YCVM programme. Unfortunately for MHRA, the report also included vaccine safety data presented the previous month (July 2021) to a different group – the CHM’s COVID-19 Vaccines Benefit Risk Expert Working Group (VBR-WG). The safety data from the YCVM programme related to Covid vaccines in pregnancy and breastfeeding (para 25) and about menstrual disorders (para 27) with the data reproduced at Appendices 2 and 3.
So, for its reply to my FOI request to be true – that the August 2021 report to the PEAG was the most recent about its YCVM programme – the MHRA must not have presented any further safety data from the YCVM to the VBR-WG subsequent to July 2021.
I therefore did a bit of digging. I found the minutes of the CHM PEAG August 2021 meeting with MHRA about the report. And it’s true, the PEAG has not subsequently discussed the YCVM programme. However, I could not find any minutes of the VBR-WG. Imagine my surprise when I found MHRA’s reply to FOI 22/592: that the VBR-WG is “not a permanent body and minutes are not published”.
I cannot believe that MHRA did not make any subsequent presentations to the VBR-EWG, its independent safety adviser, about Covid vaccine safety data from the YCVM, not least because the benefit-risk balance associated with the Covid vaccines has changed so markedly since the vaccine rollout began. The AstraZeneca Covid vaccine has been as good as withdrawn and there are eligibility criteria for the other Covid vaccines. So I have pointed all this out to MHRA and requested that it conducts an Internal Review about how my FOI request was handled.
There was another concerning aspect. Some data in Appendix 2 of the August 2021 paper were redacted, namely the number of YCVM reporters with ongoing problems from Covid vaccine side-effects. The reason the MHRA gave was “to maintain patient confidentiality”. This appears to be an entirely specious argument. Numbers in a table are, by definition, anonymous. Rather than just trot out ‘patient confidentiality’, MHRA needs to explain how not redacting a number would compromise patient confidentiality. That was also part of my requested Internal Review.
Finally, those who have stayed with me so far will have spotted one glaring loose end – that the minutes of the CHM’s COVID-19 Vaccines Benefit Risk Expert Working Group, which the MHRA uses as an independent safety adviser, are not published. Regardless of the YCVM programme, it is inevitable that the CHM reviewed the evidence for continuing the vaccine roll-out as COVID-19 reduced in lethality and safety risks emerged over time. This is not the transparency the public deserves or was promised. The CHM is not a Public Body so it is not subject to the Freedom of Information Act. Someone in authority needs to demand that the minutes of this pivotal meeting are published. Perhaps an MP would like to ask a Parliamentary Question.
Until Nick retired a few years ago, he was a Senior Civil Servant in a Government Department.
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Universities are offensive to me – what can I do about it?
Until now I’ve always been a royalist, even if only because, like democracy, it’s perhaps the least worst option. But frankly, with the wretched new incumbent and the obnoxious behaviour of one of his offspring and associated wife, I’m having to rethink.
Agreed, but it’s the National Anthem, a song which symbolises our Nation as well as a plea for the King to be saved. Personally I’d far sooner have Land of Hope and Glory, but the Woke rabble would hate that even more.
I think of it as a plea for the King to be saved from his moronic Net Zero opinions.
Another example of the abandonment of national pride! I’m no lover of saving the king either but, national pride is an important concept or, what are we?
Land of hope and glory would be a far better anthem, I’m sure we could all get behind that one? F Chortles!
Judge what we are by the number of rainbow, Ukrainian and Palestinian flags flying from homes and public buildings over the last few years instead of the Union Jack.
I know what you mean
it leads you to despair sometimes doesn’t it?
Considering what a great nation Britain once was!
Isn’t flying the Union Jack or, heaven forbid, the George Cross now considered incitement to ‘terror’, whatever TF that means? Are we the only country doing this, or are other Western countries doing the same?
The thing is, I would’ve been happy to sing along to ‘God Save The Queen’ but I wouldn’t be singing the updated ‘King’ version now out of principle, because basically Charles is a globalist, WEF sock-puppet nob who I have nothing but contempt for. So I wouldn’t partake, just for different reasons to that of the students mentioned above. I’d be there getting scolded for wearing my ”Not My King” T-shirt instead.
”Not My King” T-shirt
Can I get one?
Get a “No Smoking” t-shirt and modify to suit.
I’d be there getting scolded for wearing my ”Not My King” T-shirt instead.
If you’re a citizen of some Commonwealth monarchy, he is your king. Nobody gets to choose that. He may be (and probably is) a bad king. OTOH, what kind of wonders are to be expected from a guy who’d have become an OAP long before he had become anything other than an eternal pretender-in-waiting and national laughing stock if he ever had had something resembling a normal life? Nobody can be nothing but The Crown Prince® from age 4 to age 74 and remain mentally sane.
But if he kept his mouth shut he might just get away with it but like Mark Twain pointed out. “It is better to stay quiet and let people think your stupid rather than open it to confirm you are”.
The state should stop underwriting universities.
Here’s a answer to all our immigration and integration problems!
Mandatory national service!
Oh watch the buggers bail out of Britain by the cruise ship full! There would not be enough small boats to meet the market requirements of getting out quickly enough! and the “students” wouldn’t be far behind!
A real world way of sorting the wheat from the chaff!
https://off-guardian.org/2023/12/07/imf-head-wants-world-wide-carbon-taxes/
The only details we don’t have are how these additional taxes will be hidden.
There will come a point at which taxation will bottom out simply because there is no more squeezing to be done. How desperately poor we will be at that point is anybody’s guess.
Celebrating personal achievement should not require the singing of any anthem. No contempt is implied by not singing the national anthem.
Celebrating a university achievement or anniversary – as part of history and heritage – one might argue differently.
Shall we just rip up the flag as well? Maybe we should just call ourselves a “region” rather than a “nation” because that is what we are turning into.
I contribute money to the Republic campaign and any time I’m at an event which plays the dirge which is our national anthem with it’s ridiculous words I just turn my back or remain seated.
Vigilante Bomber:https://www.youtube.com/watch?v=AQww-UvxvqA
https://www.globalresearch.ca/police-state-wants-us-nation-snowflakes/5842324
Another excellent essay from John and Nisha Whitehead detailing the wanton destruction of our history and traditions. There is rightly an emphasis on this Christmas time.
The ‘National Anthem’ is a dirge. It’s dull and uninspiring and more funeral music than a ‘national anthem’. It panders to being sung out of tune. I can’t stand the bloody thing!
Especially NOW!
Not to worry . ——In 50 years we will have a bit of rap as the anthem ——Mutha Fucka Yo
God save us from the King
Keith Emerson’s arrangement of Jerusalem should be the national; anthem.
As long as they don’t replace it with “The Call To Prayer” I couldn’t careless says me , a lifelong defender of the Monarchy but not anymore ! Charlie & William have shown their hand – WEF to the core ! Can’t call them traitors because they don’t work on our behalf & probably never have !!!…
Maybe we need a Globalist Anthem ———“God save our gracious UN, long live our noble UN, God save the planet, da da da da, Happy but having nought, cold but houses stuffed with foam, happy to reign like Club of Rome, God save UN”.
Personally I don’t see the point in the national anthem but it is tradition. How about those who are “offended” (god, I hate that word) that the anthem is not to be used?
Why not axe the mortar boards and gowns? They are surely old fashioned. While you’re about it ditch the sitting around waiting to be given a slip of paper and just email them.