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BREAKING: A BioNTech Fill Shows That The Company Doubted That The mRNA Technology Would Ever Get Approved!

BioNTech is actually a German-based company, with its HQ located in Meinz, that partnered up with Pfizer in 2020, in order to develop the experimental mRNA COVID shot.

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And what’s even funnier, is the fact that “philanthropist” Bill Gates made some recent investments exactly in the BioNTech company!

Here are some bullet points in the partnership between Pfizer and BioNTech:

* 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 the 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 is 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 potential total consideration of $748 million

But, according to the report published by Business Wire,

“BioNTech SE, a clinical-stage biotechnology company focused on patient-specific immunotherapies for the treatment of cancer and other serious diseases, announced today that it has signed an agreement with the Bill & Melinda Gates Foundation (the Gates Foundation) to develop HIV and tuberculosis programs, further expanding the Company’s infectious disease portfolio. This partnership includes an initial equity investment of $55 million, which is expected to close within the next week. The funds will be used to develop preclinical vaccine and immunotherapy candidates to prevent HIV and tuberculosis infection as well as to lead to durable antiretroviral therapy-free remission of HIV disease. Total funding under the collaboration could reach $100 million through potential future grant funding from the Gates Foundation that would be used to underwrite the evaluation of these candidates in the clinic and support the initiation of new infectious disease projects.

“We are thrilled about the partnership with the Gates Foundation and the outstanding network of infectious disease specialists that it has built,” said Prof. Ugur Sahin, CEO of BioNTech. “Targeting severe infectious diseases such as tuberculosis and HIV infection is in line with our mission to leverage our immunotherapy capabilities not only for cancer but also beyond, in disease areas of high medical need.

“Despite remarkable advances in global health since 1990, current approaches to preventing and treating tuberculosis – the world’s leading cause of death from infectious disease – and HIV infection remain inadequate,” said Lynda Stuart, Deputy Director, Vaccines and Human Immunobiology, Discovery and Translational Sciences at the Gates Foundation. “BioNTech’s innovative mRNA-based approach and in-depth understanding of the immune system offer exciting pathways to develop effective new immune-based therapies that could dramatically reduce the global incidence of HIV and tuberculosis. We believe this partnership will add to our portfolio of innovative tools and could make a significant impact.”

https://twitter.com/StefanAntonino/status/1435681614600626176?s=20

digging down into the company’s history, as late as 2019, they didn’t think the technology would earn approval.

https://twitter.com/DrFedes/status/1459497872999727107?s=20

“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,” is written on page 16.

From this report, it’s obvious BioNTech expressed lots of concern about their mRNA immunotherapies.

Source
twitter.combusinesswire.comwelovetrump.comsec.gov

Ava Garcia

A small town girl, dreaming big, expecting to change the world with presenting the truthful events of the world today. Law degree with a master in criminology, and a devoted journalist for over 7 years, and counting. "The pen is mightier than the sword."

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