Today saw the release of minutes for the working group set up to advise MHRA on the covid vaccines.
They knew the issues but ignored them...🧵
On 27th November they briefly discussed a lack of any potential benefit for the under 50s but quickly concluded that there was a favourable risk/benefit for anyone aged over 16 years!
assets.publishing.service.gov.uk/media/67503fbc…
They made the case that the already infected should be injected because of lack of evidence of risk!
What about the fact they didn't need it!
They noted issues with early batches.
These were process 2 batches - not the bespoke process 1 batches given in the trial.
"it is not currently feasible to compare these two batches to those given to subjects in clinical studies."
"it may be the case that the batches the FDA are evaluating are further along the development lifecycle than those allocated for the UK"
The meeting ended with a reminder to put profits ahead of public health.
They reconvened the next day.
That evening they were told that they were to assess to worse batches.
For one they noted visible particulate matter in the vials.
They noted that another had degraded mRNA.
assets.publishing.service.gov.uk/media/67503fbc…
The batch with floaters in it was the infamous EJ0553.
This was used in the trial resulting in a 13 fold higher incidence of lymphadenopathy compared with trial doses.
These were "rejected vials" and they had not done a potency test.
Don't worry - the particles "disappear after the product is diluted"!
Also they "were not understood to be associated with a change in concentration of RNA containing LNPs" - but no measurement to confirm this!
It was a problem at the "end of the filling line" - i.e. it was from the dregs of the barrel.
Nucleic acids clump and lipid nanoparticles float - both could result in a higher concentration of product in the last batches to be filled.
The manufacturer admitted "no IPCs [in-process controls] or visual inspection is performed during the manufacturing process until after filling"
There was no data on the process 2 batch performance in humans and no stability data either - both were extrapolated from process 1 in the trial.
Barely any testing on stability.
And evidence that the RNA was degraded.
They ended with a request for more data on the particles.
Three days later Lord Bethel signed off on the drug.
A week after that injections began.
dailymail.co.uk/news/article-1…
They returned on 7th December - the day before injections began.
PHE were looking at serology (antibody levels in blood) in individuals that "have been vaccinated." Who are these people injected before 8th December?
They had not had the answers they requested on stability.
They detail all the issues then say - let's release the batches!
What on earth is redacted here?
The rest of the minutes that day were about AZ and Moderna.
No futher comment about the Pfizer batches that were going to be injected into people from the next day.
assets.publishing.service.gov.uk/media/6750518f…
Distribution was acknowledged as being all over the body. assets.publishing.service.gov.uk/media/6750518f…
The RNA was worse that the CT = clinical trial batches.
The batches in use had a "higher potency".
assets.publishing.service.gov.uk/media/6750518f…
Share this Scrolly Tale with your friends.
A Scrolly Tale is a new way to read Twitter threads with a more visually immersive experience.
Discover more beautiful Scrolly Tales like this.