Self-incriminating evidence from former head of vaccine task force (VTF) and head of MHRA
Delivered in a light-hearted, self-congratulatory tone
The Somerville video recording
Below you will see a video recorded at Somerville College Oxford. It is a remarkable account of the workings of the Vaccine Task Force (VTF) that was set up to help the UK fight the SARS-Cov-2 outbreak. It is in the public domain (YouTube), so I am not giving away any secrets here. All I am going to do is to provide an account of what I thought I had heard, and provide honest, expert feedback.
You do not have to watch the video, as I will cover the main points, but it helps if you do watch, to get a flavour of the ‘light-hearted’ tone of the delivery. You may also detect a healthy dose of self-congratulation all-round.
Dame Bingham’s speech
Accepting the post
Dame Bingham tells the audience that she had known Sir Patrick Vallance for a long time, since they both worked in the pharmaceutical industry. It was he who approached her to head up the task force. Declaring she knew nothing about vaccines, Sir Patrick’s response was that “no-one did”, when it came to SARS-CoV-2.
That persuaded her to accept the post.
The early steps
Then her foot was firmly put down, demanding she report directly to the Prime Minister (PM) and that she should have carte blanch in decision-making (remember I am paraphrasing here, please refer to the video for the exact translation).
Dame Bingham immediately set up an Investment Committee, drawing on her experience as a venture capitalist in biotech and pharma. This Committee would identify the spending required to get the vaccines going, but only Government Ministers could approve the spending.
An early decision by the Committee was to sanction the spending for scale-up activities, BEFORE knowing the vaccines were ‘safe and effective’. This ‘kick-arse’ team (her words not mine) decided to scale-up production of vaccines to commercial (massive) quantities, without knowing if they could produce safe and effective vaccines for much smaller quantities of clinical trial supplies.
Where was the safety testing of the scaled-up batches?
Even if they had known the clinical trial batches had been proven safe and effective, they would still have needed to put the scaled-up batches through extensive safety testing again, at the larger scale, to prove there had been no change in the compound’s molecular structure (known as a polymorph). A polymorph can turn what was a safe medicine (eg vaccine), into a toxic one - that is well known across the industry.
There is no further indication in the speech of the degree of safety testing that was carried out on any batches intended for administration in humans.
This is a red flag in terms of the safety of all the SARS-CoV-2 injections, and should be investigated further, in my expert opinion.
Dr June Raine, the game changer
Dame Bingham went on to declare Dr Raine “a game changer”, as she threw her full support behind these plans which we have discovered could have broken a golden rule of biopharmaceutical development and manufacture (to be further investigated).
Together, they decided to “take what was there, and scale-up”.
This appears to mean, if I have interpreted correctly, they turned to a network of UK-based companies that had been working on getting gene therapy products to market for at least 10 years, with little or no success. The network is identified in the speech. At best, it is a loose association of companies, some that have been getting UK Government grant support for a substantial number of years.
It seems the scale-up was to move from 200 litre batches of active drug substance, to 2,000 litre batches. Wow, that’s some scale up!
This surely is where Dr Raine steps in to call a halt, while studies are undertaken to assure proper safety measures are in place to support a 10 fold scale up.
Sadly, no. While Dame Bingham praises MHRA for it’s ‘close’ relationship with Pfizer, Dr Raine introduces something termed a ‘Rolling Review’.
Never before, across the globe, has there ever been a Regulatory Authority medicines’ evaluation process known as a Rolling Review. Keep that in mind.
Dr Raine’s speech
Did I really hear that?
Dr Raine’s speech is titled “From watchdog to enabler”.
That sent a bit of a chill down my spine at the start. The chill turned into a full-blown cold sweat when I heard her say (paraphrased):
“People think all regulators want to do is carry out inspections and hold things up”.
Now I’m lost for words, probably you are too. I took to looking up the definition of a ‘watchdog’ in the Cambridge Dictionary:
“a person or organization responsible for making certain that companies obey particular standards and do not act illegally”
That’s the definition that anyone would expect for an organization that defines itself as responsible for Licensing, Inspection and Enforcement of Medicines, isn’t it? (reference available on request).
Then, the coup de grâce:
“We tore up the rule book”
I’ve gone all of a panic now!!!
The comment is mildly retracted later on in the speech, but whether she tore up all of it, or just the inconvenient bits, a significant portion of long established pharmaceutical legally binding laws were consigned to the bin (plentiful examples in other INSIDE PHARMA posts).
The Rolling Review
Dr Raine didn’t elaborate on the validity of a Rolling Review to evaluate an application to market a medicinal product (even conditionally).
Fortunately, I have written on the topic of scale-up previously, to explain.
In effect, a Rolling Review is like evaluating an early prototype model of an aircraft and approving it for sale BEFORE the fully developed and manufactured aircraft has
gone through it’s final pre-launch testing.
Finally, where are the experts?
Anyone watching the video will soon detect these people are not experts, not even close. In fact, I don’t see anyone skilled in drug development, manufacture and supply of medicinal products being consulted in any of this.
Let’s remember the crucial fact - patients don’t get ‘science’ injected into their bodies, they get whatever ever arrives at the doctor’s door at the end of a journey through a long, complex, technically challenging supply chain.
PS I try to keep as many as possible of my posts free, since the knowledge I have is not in plentiful supply. I will owe a debt to gratitude to anyone of a mind to support my work with a paid subscription.