Bad dog - deadly lot number EJ0553 – manufactured using a different process than clinical trials – emblematic of regulatory virtue signalling/ineptitude?
Regulators have one job – to ensure the safety and effectiveness of products. Here is an example of their criminal negligence and how it is endemic throughout their activities – thy take the taxpayers money and exhibit “no care and no responsibility”.
I am unable to cross-post the article linked below,
(100) Pfizer Process 2 Poojab Lot EJ0553 - by GeoffPainPhD (substack.com)
Dr Pain’s article focusses on a specific lot and warrants a reading for the tangled web it involves.
Here are the first few paragraphs:
“UK government ordered this Lot knowing that it was produced in filthy tanks of Bacteria, different in only 1 respect from the stuff used in Clinical Trial Jabs 1 and 2.
You might have heard about the Process 1 to Process 2 “Bait & Switch”, but it is useful to focus on one particular Lot EJ0553 to understand the impact it had on up to 980,000 people, mainly in UK. Here is a museum piece - the first vial used in Coventry to jab Margaret Keenan, the first person vaccinated in the UK's mass vaccination campaign on 8th December 2020.”
As a reminder, the US FDA granted EUA to Pfizer/BioNTech on 11 December 2020:
Regulatory approval of Pfizer/BioNTech vaccine for COVID-19 - GOV.UK (www.gov.uk)
“Immediate Release: December 11, 2020
Today, the U.S. Food and Drug Administration issued the first emergency use authorization (EUA) for a vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. The emergency use authorization allows the Pfizer-BioNTech COVID-19 Vaccine to be distributed in the U.S.”
The UK MHRA, however, approved the Pfizer/BioNTech injection 9 days earlier on 2 December 2020.
Regulatory approval of Pfizer/BioNTech vaccine for COVID-19 - GOV.UK (www.gov.uk)
“Regulatory approval of Pfizer/BioNTech vaccine for COVID-19
Published 2 December 2020”
Even “warpier” warp speed!
The Europeans did noy approve the Pfizer brand name “Cominarty” until 21 December 2020:
https://www.ema.europa.eu/en/news/ema-recommends-first-covid-19-vaccine-authorisation-eu
“Comirnaty is now authorised across the EU. This follows the granting of a conditional marketing authorisation by the European Commission on 21 December 2020. “
Enquiring minds want to know how the UK could approve an American manufacturers product nine days before the American regulator had approved it.
“Here I collect more information about Lot EJ0553 from the date of its manufacture, use in a small US trial, its extraordinary particle contamination and devastating Endotoxin harms with 22 known Deaths.”
Which brings us to a few snippets from Geff Pain’s article around the manufacturing process:
“I first wrote about Lot EJ0553 here on Substack in January 2023 while I was suspended from Twitter.3 There I mentioned the Drug Substance 20Y513C101 was manufactured by Pfizer at its Andover plant in 37.6 Litre vats, the LNPs were made at Polymun Austria and the Drug Product at Pfizer Puurs in Belgium. I also showed that it contained residual template DNA and dsRNA contamination from the bacterial production.”
“It now looks like EJ0553 was manufactured in Belgium and Germany with the latter source containing much more Endotoxin evidenced by huge increase in Late Migrating Species.”
Enquiring minds want to know firstly, what site inspections did the UK health regulator conduct that the US FDA did not, if any, that enabled it to authorize the Pfizer injections 9 days before the US regulator?
Secondly, who at the UK MHRA had the expertise to approve an EXPERIMENTAL gene modification “treatment” (or “harmment?”) and had the competence to vet the EMA’s site design, manufacturing inspection and quality control (compliance) t make sure that the EMA had the relevant competence.
I would be willing to bet that no such expertise in design, manufacturing or compliance existed in either the EMA r UK’s MHRA around modified mRNA or viral vector technology– they made assumptions ad did n on site testing of quality- ad that persists to this day.
One feather in the European Medical Agency’s cap is that, noticing people dropping dead and being rushed to the ER, it withdrew the Oxford Biomedica/AstraZeneca injection after just a few months. At least it withdrew it when it noticed harms!
Makes you wonder what site inspections and quality compliance measures the EMA undertook before authorizing that shot in the dark.
Hedley Rees is on the case of why Oxford Biomedica’s deletion of press releases from its website – you know, the press releases relied upon by investors (in AstraZeneca as well) to make informed decisions about investments – sort of informed consent for investors!
“The only conclusion I can draw from this is that OXB wants to distance itself from working with the MHRA, UK Government, and AstraZeneca to bring these their injections to market at breakneck speed.”
Onwards!!!
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Thank you, for your reporting, Peter.
In a spreadsheet image supplied by my friend Chris Edwards, there were 2 entries for Lot EJ0553 indicating it was was manufactured in Belgium and Germany with the latter source containing much more Endotoxin evidenced by huge increase in Late Migrating Species.
Chris has just sent me a file that contradicts his earlier image with one of the entries now changed to EK4175 using LNPs manufactured at Dermapharm on 12 October 2020.
I am now chasing information on two types of Cholesterol that Pfizer used in its European Drug Product (that is finished vials) operations sold into UK and many other countries.
https://geoffpain.substack.com/p/moderna-ordered-to-get-its-endotoxin