mRNA “vaccines” are a form of gene therapy. According to BioNTech’s SEC filing, these drugs’ potential for undesirable side effects could slow or even prevent their regulatory approval.
Because mRNA injections are a relatively new and untested type of drug, they come with a high risk of potentially serious side effects…
Filing Date March 30, 2021
Document Date December 31, 2020
Form Description Registration of securities of foreign private issuers pursuant to section 12(b) or (g)
Filing Group Annual Filings
Issuer BioNTech SE
Our revenue depends heavily on sales of our COVID-19 vaccine, and our future revenues from our COVID-19 vaccine are uncertain.
Our COVID-19 vaccine was granted emergency use authorization in the United States and the United Kingdom, and conditional marketing approval in the European Union, in December 2020, followed by emergency or limited use authorization in a number of other countries and approval for use in certain other countries. Prior to this, we had not sold or marketed any products in our pipeline. As a result, we expect that a majority of our total revenues, and all of our product revenues, in 2021 will be attributable to sales of our COVID-19 vaccine. There is intense competition in the field of COVID-19 vaccines, including with other vaccines that have been authorized for emergency use and those in late-stage clinical development. Our future revenues from sales of our COVID-19 vaccine depend on numerous factors, including:
the extent of the spread of COVID-19 infection;
the extent to which a COVID-19 vaccine continues to be necessary beyond the current pandemic;
the safety profile of our COVID-19 vaccine, including if previously unknown side effects or increased incidence or severity of known side effects as compared to those seen during clinical trials are identified with our COVID-19 vaccine with widespread global use after approval
Risks Related to our Business
Our business is dependent on the successful development, regulatory approval and commercialization of product candidates based on our technology platforms. If we and our collaborators are unable to obtain approval for and effectively commercialize our product candidates for the treatment of patients in their intended indications, our business would be significantly harmed.
To obtain the requisite regulatory approvals to commercialize any of our product candidates, we and our collaborators must demonstrate through extensive preclinical studies and clinical trials that our products are safe and effective, including in the target populations. Successful completion of clinical trials is a prerequisite to submitting a biologics license application, or BLA, or a new drug application, or NDA, to the FDA, a Marketing Authorization Application, or MAA, to the EMA, and similar marketing applications to comparable global regulatory authorities, for each product candidate and, consequently, the ultimate approval and commercial marketing of any product candidates.
Failure to obtain marketing approval for a product candidate will prevent us from commercializing the product candidate in a given jurisdiction. Although our COVID-19 vaccine has received emergency use authorization or approval in certain countries, it is possible that it will not receive widespread regulatory approval and that none of our other product candidates, or any product candidates we may seek to develop in the future, will ever obtain regulatory approval.
mRNA drug development has substantial clinical development and regulatory risks due to limited regulatory experience with mRNA immunotherapies.
To our knowledge, other than our COVID-19 vaccine and MRNA-1273, no mRNA immunotherapies have been approved or received emergency use authorization or conditional marketing authorization to date by the FDA, the EMA or other comparable regulatory authority. Successful discovery and development of mRNA-based (and other) immunotherapies by either us or our collaborators is highly uncertain and depends on numerous factors, many of which are beyond our or their control.
Currently, mRNA is considered a gene therapy product by the FDA.
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.
As with most biological products, use of our product candidates could be associated with side effects or adverse events which can vary in severity from minor reactions to death and in frequency from infrequent to prevalent. The potential for adverse events is especially acute in the oncology setting, where patients may have advanced disease, have compromised immune and other systems and be receiving numerous other therapies. Undesirable side effects or unacceptable toxicities caused by our product candidates could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA, the EMA or comparable regulatory authorities. Results of our trials could reveal a high and unacceptable severity and prevalence of side effects.
In summary: “Safe and Effective” mRNA “vaccines”, mandated by governments all over the world, are in fact an experimental gene therapy product with “the durability of immune response which has not yet been demonstrated in clinical trials” which means the product has no proven benefit. But it has expected side effects ranging from mild symptoms to severe injuries including permanent disability and death, especially in immunocompromised people.
And who the criminal governments targeted first to get “life-saving vaccines”? The immunocompromised and the elderly.
“Undesirable side effects or unacceptable toxicities caused by our product candidates”, “Results of our trials could reveal a high and unacceptable severity and prevalence of side effects.” – these two sentences should be enough to prosecute everyone involved in this premeditated genocide as war criminals.
What we are witnessing is a war against humanity, which we were warned about many years in advance. The Luciferian elites are doing exactly what they told us they will do, demolishing the current world order by destroying the world economy and killing, injuring for life, sterilizing as many “useless eaters” as possible with the “safe and effective” bioweapon.
And the kings of the earth, and the great men, and the rich men, and the chief captains, and the mighty men, and every bondman, and every free man, hid themselves in the dens and in the rocks of the mountains; And said to the mountains and rocks, Fall on us, and hide us from the face of him that sitteth on the throne, and from the wrath of the Lamb: For the great day of his wrath is come; and who shall be able to stand? – Revelation 6:15-17
You can download the entire document here: BioNTech SEC Filing