BioNTech is a German biotechnology company based in Mainz that develops and manufactures active immunotherapies for patient-specific approaches to the treatment of diseases.
The company formed a partnership with Pfizer in 2020 to develop an experimental COVID-19 mRNA injection.
Pfizer explains their partnership:
- Pfizer and BioNTech to jointly develop COVID-19 vaccine, initially in the United States and Europe, and scale-up manufacturing capacity to support global supply
- Potential to supply millions of vaccine doses by the end of 2020 subject to technical success of the development program and approval by regulatory authorities, and then rapidly scale up capacity to produce hundreds of millions of doses in 2021.
- BioNTech will contribute multiple mRNA vaccine candidates as part of its BNT162 COVID-19 vaccine program, which are expected to enter human testing in April 2020
- Pfizer will contribute its leading global vaccine clinical research and development, regulatory, manufacturing and distribution infrastructure and capabilities
- BioNTech will receive an upfront payment of $185 million, including an equity investment of approximately $113 million, and be eligible to receive future milestone payments of up to $563 million for a potential total consideration of $748 million
But digging through past BioNTech reports reveals the company expressed serious doubts about their mRNA technology.
As late as 2019, they didn’t think the technology would earn approval.
In September 2019, BioNTech submitted their SEC filing and stated their mRNA immunotherapies have substantial risks, may not be effective, could cause harm, and earn the classification of gene therapy.
Before Covid & ever changing definitions of a “vaccine”, BioNTech didn’t think that mRNA technology would ever be approved.
9 Sept 2019 before the pandemic, BioNTech submitted their SEC filing acknowledging new mRNA drugs have substantial clinical risks may not work may cause harm and are classified as GENE therapy by the FDA which creates increased regulatory burdens for themhttps://t.co/h3qxEmJGwm pic.twitter.com/qlvrbkzlyx
— Djindji_5 (@5Djindji) November 11, 2021
BioNTech’s SEC filing explained that mRNA immunotherapies have substantial risks.
I’ve highlighted these intriguing excerpts from pages 15 & 16 of the SEC filing:
No mRNA immunotherapy has been approved, and none may ever be approved. mRNA drug development has substantial clinical development and regulatory risks due to the novel and unprecedented nature of this new category of therapeutics.
Currently, mRNA is considered a gene therapy product by the FDA. Unlike certain gene therapies that irreversibly alter cell DNA and may cause certain side effects, mRNA-based medicines are designed not to irreversibly change cell DNA. Side effects observed in other gene therapies, however, could negatively impact the perception of immunotherapies despite the differences in mechanism. In addition, because no mRNA-based product has been approved, the regulatory pathway in the United States and may other jurisdictions for approval is uncertain. The pathway for an individualized therapy, such as our iNeST mRNA-based immunotherapy where each patient receives a different combination of mRNAs, remains particularly unsettled. The number and design of the clinical and preclinical studies required for the approval of these types of medicines have not been established, may be different from those required for gene therapy products or therapies that are not individualized or may require safety testing like gene therapy products. Moreover, the length of time necessary to complete clinical trials and submit an application for marketing approval by a regulatory authority varies significantly from one pharmaceutical product to the next and may be difficult to predict.
Our product candidates may not work as intended, may cause undesirable side effects or may have other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following marketing approval, if any.
Despite the doubts, the Pfizer/BioNTech COVID-19 mRNA injection shipped to countries around the world.
Millions of people rolled up their sleeves and received the experimental injections, believing them as a “safe and effective” inoculation against COVID-19.
You’d think the first individuals to set a public example of the Pfizer/BioNTech COVID-19 jab’s safety and efficacy would be the two CEOs.
In a recent interview, BioNTech CEO Uğur Şahin made these intriguing comments when asked if he would receive the experimental COVID-19 jab to alleviate hesitancy.
“I would, of course, uh, love to be vaccinated as well.”
Şahin rambles about legalities to protect his employees, but is unclear about the COVID-19 inoculation policies for BioNTech workers.
He makes more ambiguous statements in this interview:
He’s “legally not allowed to take the vaccine at the moment.”
When the reporter presses Sahin for the legalities, he stutters that he doesn’t fit the priority.
Sahin must ensure the functionality of BioNTech to manufacture the experimental injections.
Does that mean avoiding potential adverse reactions for his employees?
Unsurprisingly, he doesn’t provide an answer to the sought “legal and fair solution.”
You’d think Sahin would want to ensure the recipients of BioNTech’s 1.3 billion doses that the company’s product is ‘safe and effective.’
While he’s not legally allowed to take the experimental injection, governments want to coerce it on their populations.
That doesn’t sound fishy whatsoever!