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myocarditis and blood clots, in March 2021, a few weeks after approval of the AstraZeneca vaccine (now effectively withdrawn) and later other heart issues, neurological problems and immunosuppression with Pfizer and Moderna.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:
- 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);
- It’s never had a safety audit (FOI 22/562);
- 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;
- It doesn’t (or can’t) define the quantitative level of risk which is ‘acceptable’ as the basis of “acceptably safe” (FOI 22/390);
- It lost 20% of posts in 2021 due to funding cuts and has 20% vacancies below that new baseline (FOI 22/1007);
- 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;
- It has hidden safety data (FOI 22/1083), redacting numbers in tables on the pretext of maintaining patient confidentiality;
- 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.
To join in with the discussion please make a donation to The Daily Sceptic.
Profanity and abuse will be removed and may lead to a permanent ban.
https://t.me/cxemu/4013
What’s really going on?
Ukraine develops its own long range cruise missile.
The driver for this development is the reluctance of Ukraine’s partners to provide long-range weapons
The R-360 Neptune anti-ship cruise missile, two of which were used to sink the Russian missile cruiser Moskva a year previously, clearly offered a suitable platform for modification as a long-range surface-to-surface missile (SSM).
Technological improvements to the R-360 include a new stand-alone GPS guidance system which takes the missile close to its target before a seeker head homes in on a pre-loaded image of the final objective and guides a terminal attack.
This system, a combination of two target acquisition technologies called Digital Scene Matching Area Correlation (DSMAC) and Automated Target Recognition (ATR) means the missile will be hard to jam.
The system can deliver a 150-kilogram high explosive fragmentation warhead out to 300 km.
Part of the missile development will be to extend the range of the missile to enable it to strike Moscow (a distance of at least 600 km) and other targets inside Russia.
If the missile can achieve that range, it represents a step-change in Ukraine’s ability to strike Russian rear area locations with big implications for the conduct of the war.
Historically Ukraine was a centre for the development of both missile and aviation technology while part of the Soviet Union.
Latest update:
31 May 2024 Cruise missile attack on Russian Kavkaz port near Kerch.
The Russian Federation Ministry of Defence announced attacks by anti-ship missiles “Neptune” on the territory of the Russian Federation.
The partial damage to the oil depot, as well as the disabling of the “Avangard” railway ferry, as a result of a missile attack on the Kerch port the day before, will complicate logistics for the Russian army in Crimea and on the southern fronts.
It is a shame that military supplies for Crimea go by rail using the land route skirting the Sea of Azov. It means yet more missiles wasted on vengeance attacks
The destruction accomplished by this attack now forces Russia to rely on road and rail links across occupied Ukraine — which puts trains and trucks into easier range of Ukrainian attack.
“Considering the fact that the railway line Russians are building through the occupied territories of Ukraine is not finished yet, this civil ferry was their army’s main logistics route,” Pletenchuk said. “Their sea logistics is also long gone after Ukraine destroyed four and damaged five of their landing ships,”
I don’t blame Nigel Farage for choosing to focus on the US election rather than stand in the UK one. Whoever wins here will sign us up to any global agreement going and kowtow to any global body – the UN, the WHO, Human Rights courts. America, with Trump in charge, still has enough clout to refuse to comply or endorse as he showed with NATO. And if they can do that, we have some chance in the UK that these treaties fail and be spared what any of the parties will merrily sign us up to.
“Keir Stamer caves in and says Diane Abbott can stand as candidate”
Good grief, Starmer is about as tough and decisive as a wet rag! What a disastrous choice for a so called leader
At risk of sounding like a right biatch ( but being a ”better out than in” type of person I’ll plough on anyway ), I think Diane Abbot looks like a hippo. Especially if you see photos of her with her mouth agape. She totally needs a stylist because that severe bob and blunt fringe do no favours for a person with that sort of face. Even the glasses don’t suit her. She should try different shape frames or contacts. Just her entire look is completely unflattering, in my opinion.
I’m off for a saucer of milk now…
I like pussy cats.
Worse than her appearance are her arrogant character and hoity toity personality.
I recall her on Andrew Neil’s late night discussion show with the equally egregious Michael Portillo. She was reasonably presentable then, but her insistence that all and sundry should be allowed to come to the UK was strident and grating.
Immigrants always seem to think they’re much more important and necessary than the historical population that created this country. To ‘enrich it’ as Leftards always dribble. Our culture has not been ‘enriched’ but degraded beyond what anyone could have imagined before mass immigration was forced on us without a ‘by-your-leave’.
Pity the poor constituency flippy floppy Queer Smarmer lets Abbott stand in, though it’s probably going to be a Labour stronghold, so Labour voters will get what they deserve.
Chosen or Placed ! SIR is a clue & member of The Tri Lateral commission the rubber stamp that Starmer is upto no good !!…
The WHO assembly draws to a close.
For now the Pandemic treaty and IHR amendments are off the table.
Big protest in Tokyo.
Today a freedom rally in Geneva (wish I was there…).
They will keep trying though, so this will need to be a long campaign.
Yes it’s ongoing ,also have you seen Tedros the Terror-st telling us that anti vaxers are the cause of people being wary of Fauci,s brew !
Tedros – the disgusting lackey of the Chinese communists.
Not being a specialist in legal or tax matters, let alone American ones, my question is whether Donald trump personally filled in his company tax returns or simply takes responsibility for everything his tax advisers write by signing them off.
If they are good enough for the tax man and at least two previous jurisdictions who declined no to take action, surely Trump himself would not be expected to spot these irregularities.
And the real criminal, to me, is Daniels, who apparently signed a legal document and accepted the cash ensuring her silence, and who then totally ignored her contractual commitment to silence.
Does all this make him a criminal or a dupe? Maybe he would rather be seen as a victim in this election.
“With Starmer floundering, Farage flailing and Ed Davey acting a fool, a Tory revival is now on the cards, says Camilla Tominey in the Telegraph.”
Please, no.
Can’t Ms Tominey have the decency to call out the likes of Fishy and Kneel for the treasonous bar stewards that they are?
https://www.telegraph.co.uk/money/tax/dwp-worker-benefits-fraud-checks-not-enough-stop/
I can confirm that I was routinely in the same position as this DWP whistlblower. I used to say to colleagues that If I had been paid just 10% of the value of the frauds I detected I would have been able to retire a millionaire after twelve months. Fraud is rampant in the benefits system.
About fifteen years ago our office suffered a presentation from a senior manager. Said manager went in to some detail about how in the previous twelve months DWP had achieved a 15% reduction (something ludicrous) in benefit fraud. Unable to avoid stating the obvious I pointed out to the manager that as in the previous twelve months one third of fraud investigators had been re-allocated (non fraud jobs) the reduction in fraud was hardly a surprise because “If you don’t look for it you don’t find it.”
hux received a wagging finger summons for that statement of the bleeding obvious.
The tales I could tell.
Never try to present truth or reason to a lying fool.
“This is horrific and I want to see it fail as a political strategy” says Lionel Shriver
“Trump’s victory is now more likely, not less” says Boris
Of course! That was the whole idea, to stir up mass sympathy for the AntiChrist Drumpf. As he boasted,
“I could stand in the middle of Fifth Avenue and shoot somebody, and I wouldn’t lose any voters.”
It’s like watching Mass Hypnosis take over the minds of patriots everywhere…
I’m not a “fan” of Trump or any politician for that matter, but how would you vote if you were in the US? Trump or Biden or Kennedy or someone else? And who would you have voted for in the Republican primaries (assuming you’d be a registered Republican)?
Florida Governor Ron De Santis
Yup with you on that
I would vote Trump now though, because the Democrats are just terrible- clearly you see grave dangers from Trump that I don’t