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

Company BioNTech

Issuer BioNTech SE

Excerpts:

Pages 7-8

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

Page 26

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.

Page 27

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.

Page 28

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 therapiesUndesirable 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

See also  Forensic Report: Self-Assembling Graphene Particles in mRNA Vials

Moderna SEC Filing: We May Be Delayed or Prevented From Receiving Full Regulatory approval. Unexpected Safety Issues Could Significantly Damage Our Reputation and That of Our mRNA Platform

On February 25, 2022, Moderna released its Annual SEC Filing.

Just like Pfizer in its SEC FIling, Moderna admits that due to safety and efficacy concerns their investigational mRNA Covid – 19 Gene Therapy “Vaccines” may be delayed or prevented from receiving full regulatory approval.

Excerpts:

Page 59

Item 1A. Risk Factors

We may be delayed or prevented from receiving full regulatory approval of our COVID-19 vaccine in certain jurisdictions or for certain demographics

Efficacy, effectiveness, safety, and immunogenicity data with respect to our COVID-19 vaccine, as well as real-world evidence, continue to accumulate. Further results from clinical trials, as well as the experience of vaccinated individuals, could show diminished protection compared to the results released to date, as efficacy and antibody persistence wane over time.

Additionally, we may observe new, more frequent or adverse events of greater severity in subjects participating in ongoing clinical trials or among those individuals vaccinated with our COVID-19 vaccine. For example, some studies have suggested that our vaccine may be associated with higher rates of myocarditis and pericarditis in young males compared to other COVID-19 vaccines.

Unexpected safety issues could significantly damage our reputation and that of our mRNA platform, and lead to other issues, including delays in our other programs, the need to re-design our clinical trials and the need for significant additional financial resources.

The assays used to estimate the effectiveness of COVID-19 vaccines have only recently been developed and continue to evolve. Validation reports for these assays have been submitted for review to regulatory agencies.

Results obtained in clinical studies of mRNA-1273 with later versions of these assays may be less positive than the results we have obtained to date.

The future results in clinical studies of mRNA-1273 may not be as positive when compared to the antibody levels in other blood samples.

We may be unsuccessful in developing future versions of our COVID-19 vaccine to protect against variants of the SARS-CoV-2 virus, or booster doses of our vaccine may not protect against such variants, and a market for vaccines and boosters against these variants may not develop.

…Additionally, administration of booster doses of our vaccine may prove to be ineffective, or less effective than desired, against certain variants. We have several development candidates against variants of concern, and may develop others in the future. If these efforts are unsuccessful, we are slower to develop variant-specific vaccines than competitors, or these vaccine candidates prove less effective than competitors’ vaccines, these shortcomings may lead to reputational harm, loss of market share, and adverse financial results. (Safe and Effective!)

Page 64

mRNA drug development has substantial clinical development and regulatory risks due to the novel nature of this new class of medicines, and the negative perception of the efficacy, safety, or tolerability profile of any investigational medicines that we or others develop could adversely affect our ability to conduct our business, advance our investigational medicines, or obtain regulatory approvals.

No mRNA medicine has been granted full or conditional approval by the FDA or other regulators, other than COVID-19 vaccines. Successful discovery and development of mRNA medicines by us or our strategic collaborators is highly uncertain and depends on numerous factors, many of which are beyond our or their control. We constantly make business decisions and take calculated risks to advance our development efforts and pipeline, including those related to mRNA technology, delivery technology, and manufacturing processes, which ultimately may be unsuccessful. (Safe and Effective!)

Page 65

Some of our investigational medicines are classified as gene therapies by the FDA and the EMA. The association of our medicines with gene therapies could result in increased regulatory burdens, impair the reputation of our investigational medicines, or negatively impact our platform or our business.

There have been few approved gene therapy products in the United States or foreign jurisdictions, and there have been well-reported significant adverse events associated with their testing and use. Regulatory requirements governing gene and cell therapy products have evolved and may continue to change in the future, and the implications for mRNA-based therapies are unknown (Safe and Effective!)

From BioNTech SEC Filing:

BAYER EXECUTIVE: MRNA SHOTS ARE ‘GENE THERAPY’ MARKETED AS ‘VACCINES’ TO GAIN PUBLIC TRUST

You can download the entire document here: Moderna Annual Report SEC Filing

In this twisted and evil world a company that never developed a product prior to the plandemic, can play God by calling its mRNA technology “The software of life”, present a strategy to bring to market mRNA based pan-respiratory annual booster vaccine, vaccines against latent viruses, seasonal influenza vaccine (mRNA-1010, mRNA-1011, mRNA-1012, mRNA-1020 and mRNA-1030), cancer vaccine, and therapeutics based on mRNA-encoded proteins while admitting that implications for mRNA-based therapies are unknown.

Now they are coming for our babies:

MODERNA FILES FOR AUTHORIZATION OF ITS COVID-19 VACCINE IN YOUNG CHILDREN SIX MONTHS TO UNDER SIX YEARS OF AGE

Implications like injuries and deaths don’t matter when you have strategic alliances with government organizations and foundations such as Defense Advanced Research Projects Agency (DARPA), Biomedical Advanced Research and Development Authority (BARDA), and The Bill & Melinda Gates Foundation”

Page 41

Because mRNA injections are a relatively new and untested type of drug, they come with a high risk of potentially serious side effects...

Page 42

By Steafon

Leave a Reply

Your email address will not be published.

You cannot copy content of this page