Damning Data from the Pfizer/BioNTech Supply Chain, leaked from EMA Review

Find out, for example, that BioNTech didn't produce the SARS-CoV-2 injections, Novartis did!

[first published September 2024]

Leaked EMA Chemistry, Manufacturing & Controls (supply chain) data

The data below were leaked in the very early days of COVID. As far as I know, it has been widely shared by people fighting the jabs. The data are taken from the ‘rolling review’ CMC (supply chain) assessment carried out in late 2020 by the European Medicines Agency (EMA), headed:

Invented name of the medicinal product: COVID-19 mRNA Vaccine BioNTech

INN (international non-proprietary name) of the active substance(s): BNT162b2, 5’ capped mRNA encoding full length SRAS-CoV-2 Spike protein.

Applicant: BioNTech Manufacturing GmbH

Applied Indication(s): TBD

Pharmaco-therapeutic group (ATC Code): J07BX

Pharmaceutical form(s) and strength(s): Concentrate for suspension for injection 0,225 mg.

These are the manufacturers and test facilities for the drug substance (DS):

We see three manufacturers of drug substance:

• Wyeth Biopharma, Andover, MA

• BioNTech Manufacturing GmbH

• BioNTech Innovative Manufacturing Services GmbH

Now prepare yourself for a shock!

BioNTech Manufacturing GmbH didn’t exist until over 5 years after development of BNT162 commenced. It was owned by big pharma’s Novartis, and only ‘transferred’ to BioNTech at the end of Q4, 2020, see:

BioNTech Acquiring Novartis’ Marburg Site

22.09.2020 - German biotech BioNTech has signed a share purchase agreement with Novartis to acquire the Swiss drugmaker’s GMP-certified manufacturing facility in Marburg, Germany. The deal will expand the Mainz-based company’s Covid-19 vaccine production capability by up to 750 million doses per year, or over 60 million doses per month, when fully operational.

BioNTech said the Marburg facility will become one of the largest mRNA manufacturing sites in Europe and the third site in its own manufacturing network in Germany expected to produce BNT162 for global supply.

The transaction with Novartis is due to close in the upcoming fourth quarter. BioNTech  hopes to be able to produce up to 250 million doses of the vaccine candidate in the first half of 2021, leveraging the site’s established team, along with its  well-established drug substance and drug product manufacturing capabilities.

Novartis’ Marburg plant is a state-of-the-art, multi-platform GMP certified manufacturing facility that currently employs around 300 staff, all of which will transfer to the new owner.  The fully equipped infrastructure will facilitate production of recombinant proteins as well as cell and gene therapies, cell culture labs and viral vector production capabilities, with further potential for long-term growth and expansion, BioNTech said.

Over the past five years, the Basel-based drugmaker [Novartis] has significantly invested in the Marburg site located in a life science industry park that is home to more than 10 companies with 6,000 employees. As part of the erstwhile Behringwerke, the location has a long history of vaccine development.

BioNTech said it expects to operate the former Novartis plant as one of the largest mRNA manufacturing sites in Europe alongside two of its existing GMP facilities currently producing the Covid-19 vaccine candidates for clinical trials and in addition to at least four Pfizer production sites in the US and Europe.

The Marburg facility is expected to start production of mRNA and the LNP formulation for the Covid vaccine in the first half of 2021, pending regulatory authorization or approval of the candidate.

Back to the Rolling Review Documents

Meanwhile, these are the initial batch details for BNT162, from 05 March 2020, onward:

Note that the first batches, in March 2020, were 35 ml (0.035 L) of drug substance (DS) for toxicology testing, manufactured at BioNTech Pharmaceuticals GmbH, Mainz, Germany (non-GMP lab).

THESE BATCHES COULD NOT HAVE BEEN PRODUCED BY BIONTECH STAFF

Now we know the site only transferred to BioNTech in 2021, then they could not have produced those batches - it had to be the previous owner Novartis. That is a company with a gene therapy product already on the market from August 2017 (Kymriah).

What Conclusion Should We Draw?

Novartis’ Kymriah, a gene-modified cell therapy, was approved by the FDA in August 2017. We know that the price was $475,000 per treatment then. It has since received an FDA Black Box warning, the strongest warning the the FDA can give.

Here it is on the Kymriah package insert:

“WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGICAL TOXICITIES, and SECONDARY HEMATOLOGICAL MALIGNANCIES

See full prescribing information for complete boxed warning.

• Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving KYMRIAH. Do not administer KYMRIAH to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids. (2.3, 2.4, 5.1)

• Neurological toxicities, which may be severe or life-threatening, can occur following treatment with KYMRIAH, including concurrently with CRS. Monitor for neurological events after treatment with KYMRIAH. Provide supportive care as needed. (5.2)

• T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19- directed genetically modified autologous T cell immunotherapies, including KYMRIAH. (5.8)”

The conclusion that I draw, based on the above, it that Kymriah, and products of the same class, were not selling due to cost and the side effects that were beginning to emerge after launch (eventually resulting in a black box warning from FDA). The blockbuster era was beginning to slip away…

…so they created two “new kids on the block”, to pretend they could develop drugs 10X faster than ever before.

The result was BioNTech and Moderna, who were ‘gifted’ the manufacturing facilities already making gene-modified cell therapies such as Kymriah, bringing warp speed drug development to the world.

What do you think?