When the Government Asked the MHRA to Grant Emergency Approval to the Covid Vaccines, Why Did a Minister Intervene to Reply On its Behalf?
Here’s something for the Covid Inquiry to investigate.
In January, I wrote about the possibility of the ‘blame game’ starting between MHRA and Health Ministers. I had got hold of a letter dated November 17th 2020 from Professor Van Tam, then Deputy Chief Medical Officer (England), to June Raine, Head of MHRA, seeking her view on the suitability of the Pfizer/BioNTech Covid vaccine Batch EJ0553 for Regulation 174 emergency authorisation. I had asked MHRA for a copy of June Raine’s reply to Van Tam but it said there wasn’t one and that ministers had taken all decisions regarding the Covid vaccines.
It’s taken me a while to find out what actually happened and I think it’s really odd. Judge for yourself.
In a normal world, MHRA would just have replied to Van Tam and copied it to ministers, given the significance of the issue. Instead, Lord Bethell, one of the Health Ministers, intervened and instructed MHRA to draft a reply for him to send to Van Tam, which he did on December 1st 2020.
That’s beyond weird. We’ve got a senior DHSC official – Van Tam – writing to the head of the MHRA asking for advice about invoking emergency approval of a new medicine after less than one year of trials (compared with the normal 10 years). But MHRA doesn’t reply. Instead, a Health Minister – Lord Bethel – intervenes and, in effect, tells Van Tam to get on with it. Really? I’m not a fan of MHRA, but it really makes me wonder if MHRA actually had safety reservations but were overruled by Ministers.
One possibility is the ‘bait and switch’ issue. The approved batch (EJ0553) came from large-scale ‘Process 2’ manufacture. The clinical trials had been done using product from the different, small-scale ‘Process 1’ manufacture. There was supposed to have been some safety testing of ‘Process 2’ product prior to approval (bottom of page 46 here) but there is a strong possibility that this didn’t happen in time. That would open up a whole can of worms. I submitted an FOI to MHRA on July 13th asking for a copy of Pfizer’s report of that testing but its is being evasive. Perhaps MHRA was aware of the associated risks but was overruled by ministers.
Either way, the Covid Inquiry must get to the bottom of why MHRA wasn’t allowed to reply to Van Tam. I would suggest the Inquiry gets hold of MHRA’s ‘Background Brief’ – these briefs always accompany draft letters for Ministers to send. I know because I used to be a Senior Civil Servant and I did hundreds of them over the years.
But that’s not all. There are some concerning issues in Lord Bethell’s reply:
- It says: “Pfizer/BioNTech must provide a robust root cause analysis on the visible lipid particles as soon as this is available.” Has anyone seen this ?
- It says that NHS Trusts do not need a manufacturing licence even though hospitals, GPs and Health Centres would be involved in unpacking and thawing of the product. These are legally considered part of the manufacturing process and therefore subject to licensing. There is an exemption if they are conducted under the supervision of a qualified pharmacist but I would be amazed if that happened in all cases.
For anyone interested, it was the same story for the subsequent Regulation 174 emergency authorisations of the AstraZeneca and Moderna Covid vaccines: Van Tam wrote each time to MHRA but the Minister intervened and replied himself.
All very odd. But I’m sure the Covid Inquiry will get to the bottom of it. Or maybe not.
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.
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This whole sorry saga is completely incomprehensible.
A novel technology is used (mRNA and lipid nanoparticles). You could just about justify its use for extremely vulnerable people, but no one else.
The global safety and efficacy monitoring of this novel technology is abysmal.
But the novel technology is continued despite increasing concerns about safety and efficacy. Moderna is going to open new plants in the U.K.
I simply don’t comprehend.
Maybe it is all about the money- Moderna’s 400 million USD to the NIH?
I hope the truth will out….
Let me aid with your comprehension: they are treasonous, psychopathic scum involved in democide, which they intend to attempt also in the future under the guise of WHO mandates, once they roll out Digital ID and CBDCs.
We are at open war with elements of the Deep State apparatus and must act accordingly.
Makes sense?
I suggest the political class is equally complicit. Where the boundary lies between the deep state and politicians has become unclear as the former often seems to take decisions which should be the role of the latter.
And in reality the notion of nations, and boundaries, and independent legal systems is an illusion at that level. Marching in lockstep, quite a few of them.
Thanks for repeating a message that will not wear thin through repetition.
Couldn’t agree more. We must have retribution.
Not really. The regulators have been captured by big pharma, and the government is either corrupt or incompetent, allowing or facilitating the corruption.
Not surprisingly Van Tam has secured a lofty position in Moderna! If it looks like a rat and stinks like a rat …..
It appears that it was a political choice. Perhaps the MHRA knew perfectly well that it was early days yet for any such product, and there was a transfer of risk to the Government by overriding any normal decision process in the trade.
So does Lord Bethal have any personal financial interests in Big Pharma? Usually “follow the money” makes it very clear what the real motive was.
Bethell is a scummy fixer. He was forced from his job under Johnson for using his private email for parliamentary business including details of numerous meetings with the Tory donor chumocracy companies which netted £1.4 billion in govt contracts (which he ‘omitted’ to mention until forced). He also conveniently ‘lost’ a phone with (probably incriminating) Whatsapp and text messages relating to Abingdon Health, and sorted the govt pass for Wankock’s bit of skirt. Nice bloke. Not.
At least Van Tam, didnt work for one of the drug companies involved as that would be a conflict of interest.
Doesn’t he now? Astra Zeneca.
Moderna
The MHRA blocked many people on Twitter, which they claimed was ”in error”, some time ago. Somebody did a FOI request to find out why that was and here is the response he got;
https://twitter.com/Fiddaman/status/1697291011658023002
”Here’s an idea to protect the reputation of the @MHRAgovuk
.
Release all your documents relating to drug approvals.
Every document and email.
The public has the right to know what went on.
If everything has been done correctly, your reputation will be glowing.” Jikkyleaks.
Seriously though, why can’t this happen?
Because it Won’t be a glowing record!
Ding Ding! 🙂
Bethel is one of the worst Covidiots.
100 Million quid of our money spent so far on the so called covid inquiry ! Don’t expect anything for us plebs benefit to come out of it .. on & on & on it goes 🤯
As looting exercises go it’s a small one.
The answer may be in the Human Medicine Regulations 2012 where the “licensing authority” means either or both of the Ministers. That said, I’m not sure whether it should have been Bethell as he was Under Secretary of State. The licensing authority and the Ministers 6.—(1) The licensing authority is responsible for the grant, renewal, variation, suspension and revocation of licences, authorisations, certificates and registrations under these Regulations. (2) In these Regulations “the licensing authority” means either or both of the Ministers. (3) Any function that— (a) is conferred on “the licensing authority” by these Regulations; or (b) is a function within paragraph (4), may be exercised by either of the Ministers acting alone or by both of them acting jointly. (4) The functions of a member State, or of the competent authority of a member State, under any of the relevant EU provisions are to be exercised by the licensing authority if— (a) they relate to medicinal products; and (b) they are to be exercised by, or by any authority of, the United Kingdom. (5) Paragraph (4) does not apply to any function that is conferred by these Regulations on a person or body other than the licensing authority. (6) In these Regulations “the Ministers”… Read more »
The country deserves total transparency around Bethell’s correspondence and actions 2019-2023.
Until that happens, and he is fully exonerated or otherwise, the stench around the man will only grow.
Hoping that the Covid inquiry will get to the bottom of anything is naive. It is a carefully controlled cover up of a crime against humanity. A scandal of epic proportions that the public has so far largely failed to comprehend. The vaccine trials were fraudulent, serious side effects suppressed, and the 86% Big Pharma funded MHRA was the willing, complicit lackey. Even its management of Yellow card data is woeful, ignoring safety red flags to stuff experimental injections into our children and pregnant women. And so it continues to this day.
We don’t need to waste £100-£300m on a Covid inquiry, we need a Nuremberg 2 trial, complete with gallows.
The only silver lining from this dark cloud of evil is that the fraudulent trials by Big Pharma make their indemnity null and void. They should be asset stripped to utter destruction and a fund set up to compensate families of those killed and those injured.
Absolutely, well said
If it seems odd to a civil servant, it MUST have seemed odd to Van Tam surely….?
..then for it to happen again…and again?
..and now he takes up a job with Moderna?
There’s no need for tinfoil hats, or conspiracy theories, it’s right there in the open…
Corruption, self-interest, and yes, downright evil….
For millions of us the suspicion and cynicism we have for ‘the system’ will never heal….it is well and truly broken….
Lord Bethell is a qualified and experienced night club manager.