Facts about SARS-CoV-2 Injections (aka DNA vaccines) and advanced therapy medicinal products (ATMPs)
Facts about SARS-CoV-2 Injections (aka DNA vaccines) and advanced therapy medicinal products (ATMPs)
...helping you do your own research
Basics on SARS-CoV-2 Injections (DNA vaccines)
I thought it may be useful to list some important facts about the SARS-CoV-2 injections (DNA vaccines) as they relate to the EU/UK, beginning with the basics. Hopefully, this will increase your ability to research the immaturity & experimental nature of these products that have been thrust on the world:
SARS-CoV-2 injections (DNA vaccines) are classified as Advanced Therapy Medicinal Products (ATMPs)
They are specifically designated as DNA vaccines within the ATMP classification.
ATMPs are termed ‘Advanced’ therapies as they have the potential to cure disease, rather than merely treat symptoms or modify the effects of disease. That potential is still to be properly investigated.
ATMPs comprise somatic-cell therapy, gene therapy and tissue-engineered products.
DNA vaccines come under the heading of gene therapy within the ATMP classification.
The competent authority responsible for licencing, manufacture, and distribution of ATMPs in the UK is the Medicines and Healthcare products Regulatory Agency (MHRA).
The competent authority responsible for licencing, manufacture, and distribution of ATMPs in the EU is the European Medicines Agency (EMA).
The legal and regulatory framework for ATMPs in the EU/UK was established by the EU Commission in 2007 (Regulation EC No. 1394/2007) and first applied in December 2008.
The contract development and manufacturing organisations involved
The conditional marketing authorisation holders do not have the capability to manufacture DNA vaccines to the required standards. That capability was outsourced many years ago, read more here:
How Big Pharma's mass outsourcing led to SARS-CoV-2 injections
Pfizer/BioNTech, Moderna and AstraZeneca pretend they can do it, but below the surface, the real work of developing, manufacturing and distributing the injections was and is being carried out by third-party organisations.
Oxford Biomedica (OXB) developed and manufactured the AstraZeneca adenovirus DNA vaccine drug substance (DS or active pharmaceutical ingredient):
Oxford Biomedica signs new three year agreement with AstraZeneca
OXB is a contract development & manufacturing organisation (CDMO). It also produces a viral vector similar to the adenovirus vector (Lentiviral vector) for Novartis’ Kymriah, approved in the US August 2017. This is a statement on the approved label:
“Serious side effects occur in most patients. The most common serious side effects are cytokine release syndrome and decreases in platelets (components that help the blood to clot), haemoglobin (the protein found in red blood cells that carries oxygen around the body) or white blood cells including neutrophils and lymphocytes.
In addition, serious infections are very common side effects in patients treated for DLBCL and FL.”
Notice any similarity with the injection side effects?
…and there’s more
Similar companies developed and manufactured the injections:
Lonza, Switzerland DS:
Rentschler, Germany:
Rentschler slapped with FDA Form 483 citing lax manufacturing procedures
Pfizer/BioNTech claim capability itself, but it really is fantasy land, read more here:
BioNTech—the virtual company with a virtual moral compass
This is an extract:
“In 2014, with nothing more than safety studies (Phase 1) started in melanoma, BioNTech struck numerous deals through 2014 - 2018:
“Strategic collaborations across the pipeline (Bayer Animal Health, Genentech, a member of the Roche Group, Genmab, Siemens, Sanofi, Regeneron, Genevant, Pfizer, University of Pennsylvania)”
Excuse me, why would all these companies do business with BioNTech—they had nothing of proven value, diddly squat, in the pipeline. In normal times, going to these companies with just two safety studies in the bag would be a certain route out the door onto the pavement (sidewalk for our US colleagues).
Then suddenly, in 2020, BioNTech buys a large manufacturing plant in Marburg from Novartis:
Facility will become one of the largest mRNA manufacturing sites in Europe and the third site in the BioNTech manufacturing network in Germany expected to produce BNT162 for global supply
Expected to be fully operational in the first half 2021 with an annual production capacity up to 750 million doses of potential COVID-19 vaccine
Rapid transition expected due to well-established biotechnology drug substance and drug product manufacturing equipment as well as an experienced team
BioNTech will take over the entire site with currently approximately 300 employees, enabling a rapid transition to BNT162 production upon transaction closing”
Having never run a manufacturing facility in their lives, suddenly they buy one and it’s up and running with a totally novel therapy in months!
Or did Novartis do it for them?
…but Novartis wouldn’t have the capability either—they have outsourced everything but the kitchen sink, and that’s already on the list to go :O).
Here’s a challenge?
If you have the time and inclination, try finding the CDMO producing the Moderna filled and finished injections - clue, it begins with a ‘C’.
Do the same for the AZ injections - clue, it begins with a ‘W’.
Do the same for Pfizer/BioNTech - clue, you won’t find anything about CDMOs being involved. My guess is it’s exactly the same as Moderna.
Maybe we should ask Trevor Mundel, President, Global Health at the Bill & Melinda Gates Foundation?”
“Prior to joining the foundation in 2011, Trevor was global head of development with Novartis and previously was involved in clinical research at Pfizer and Parke-Davis.”
What to look for?
We are looking for linkages in the whole sorry saga. Mundel worked for Big Pharma’s Novartis prior to joining BMGF.
Ian Hudson, Ian Hudson, Senior Advisor, Integrated Development at he Bill & Melinda Gates Foundation was CEO of UKs MHRA prior to joining BMGF.
Hudson also set up and Chaired the International Coalition of Medicines Regulatory Authorities (ICMRA) in 2016. This is a self-appointed body with no legitimacy, but long tentacles.
You will see on the link that the next and current Chairs were/are Executive Director’s of the European Medicines Agency (EMA), currently Ms Emer Cooke.
Oh, by golly, what’s this?:
“Before taking up her current role, she [Ms Emer Cooke] was the Director responsible for all medical product related regulatory activities at the World Health Organization (WHO) in Geneva between November 2016 and November 2020.”
Any of this making sense? If so, why not do your own digging? You’ll be surprised at what you find!
Thank you Hedley,
Perfect explanation. This issue is extremely important and nobody is talking about this. No one in the general public knows about it. Most people even think that this products are just like any other vaccine, like the ones that have been there for decades. It is astonishing. My own uncles and aunts, my grandmother... they do not understand what I mean when I try to explain this, they are brainwashed with what's on TV, it is a horror.
Thank you very much for bringing this to light.
What’s too little known follows on from Hedley’s findings that the proprietor companies couldn’t & didn’t manufacture their “Covid vaccines”.
Even worse, nobody had conducted the necessary manufacturing R&D required to consistent product.
It’s not the case that you simply press a button & out comes the product. There are many steps involved in making the generic code itself, the drug substance. Then there are several further steps involved in formulating the drug substance into finished drug product.
Regulations dictate acceptable variation from dose to dose & batch to batch. The EMA dossiers I’ve seen (Pfizer/BioNTech & Moderna) are emblematic of hopelessly unready products, all over the place.
And surely, these are the exhibition batches. They wouldn’t use data from a poor batch to file.
Check out Sasha Latypova’s Substack articles on these hideously badly made agents.