Watchman: According to BioNTech SEC Filing, mRNA “Vaccines” Are Gene Therapy Might Have Unfavorable Side Effects That Will Hinder or Delay Regulatory Approval


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


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 durability of immune response generated by our COVID-19 vaccine, which has not yet been demonstrated in clinical trials;

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


Watchman’s Update: “COVID Jabs Also Infect the Unvaccinated.” mRNA Nanoparticles From Vaccines Not Approved by the FDA for Children Are Being Shed From Parents to Children Death For Sure!, Without Consent or Knowledge of Either Parents, or Children. All of This Is Followed by Denials by Gates and Authorities–Jesus, Where Will I Shelter My Sheep?

By StevieRay Hansen | May 21, 2024

HNewsWire: A study conducted by scientists at the University of Colorado confirms the vast majority of humanity has had absolutely no choice in the matter of whether they wish to get the Covid-19 injection or not because the vaccinated have been transmitting antibodies generated by the injections through aerosols. The findings should however come as no surprise because a confidential Pfizer document had already confirmed exposure to the mRNA injections was perfectly possible by skin-to-skin contact and breathing the same air as someone who had been given the Covid-19 jab. They also, unfortunately, add weight to the claims made by Dr Phillipe van Welbergen, who demonstrated that graphene, an alleged undisclosed ingredient of the Covid-19 injections, is being transmitted from the vaccinated to the not-vaccinated and destroying red blood cells and causing dangerous blood clots. The study, titled ‘Evidence for……...

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Update: Trump’s Operation Warp Speed: The mRNA Vaccines Have Been in Development by the US Department of Defense (DARPA) Since 2011, “Kill Shot,” the Government Has Lied, People Have Died or Been Injured, and There Has Been No Recourse

By StevieRay Hansen | April 2, 2024 |

HNewsWire: These mRNA injections were never health products; this was a military operation (not just the distribution of the vaccine); no, the Department of Defense ran OWS; HHS and FDA were a front! a military operation but a freemason operation using the military. In 1921, the Council on Foreign Relations was founded, to infiltrate and control democracy, by freemasons David Rockefeller, Paul Warburg, Herbert Hoover, Allen Dulles, Walter Lippmann and Edward M. House. The impressive 10-thousand members list proves the power grab was successful.1 Since 1921, the CFR has chosen almost every single Secretary of State. Similar mason institutions, most with similar names, were founded in over 100 countries, including Britain’s Royal Institute of International Affairs and the European Council on Foreign Relations2: practically, there’s no war where the CFR isn’t involved on both sides. 3 Their magazine Foreign Affairs…

Watchman: mRNA Vaccines (Kill Shots) Produce Persisting Spike Protein, Likely Causing Clots, Heart Inflammations, Cancers: Dr. Ryan Cole, Who’s Going To Jail First?

By StevieRay Hansen | June 17, 2023 |

The Government Exempted Itself and Big Pharma From Litigation, Then Told Everyone They Had to Drink the Juice or Lose Everything HNewsWire: So, which government official, Biden,Trump or Johnson, will be arrested first? There are plenty to select from, and they are all guilty of genocide. Which doctors are losing their licenses and going to prison as a result of mandatory gene therapies? The whole Nuremberg Code and medical ethics were thrown out. Those who promoted this should be harshly punished. Political leaders, as well as useless, illiterate attorneys and judges, should be removed and tried for crimes against humanity, if not murder. Period. Forcing therapy on someone in order to rescue another is medically unethical. If someone are forced to take a “vaccine” and die as a consequence of the treatment, this is not informed consent and may be…

Watchman Reports Medical Practitioners Have Begun to Openly Express Their Concerns About the mRNA Immunizations and Have Begun to Advise People Not to Agree to Further Boosts

By StevieRay Hansen | May 22, 2023 |

It was planned to do this. Deaths will increase soon. Dr luv montagnier said two years after injection Sudden Death Effect. He won the Nobel prize for discovering HIV. HNewsWire: Believe it or not, it’s now the No. 1 cause of death for this age group. Is there a silent epidemic that’s impairing and destroying your immune system (and literally obliterating 90% of your DNA repair mechanism)? And, what extreme remedies can reverse the attack? STORY AT-A-GLANCE Mounting evidence shows the COVID shots are destroying people’s immune systems and are triggering turbo-charged cancers A survey by Steve Kirsch found sudden death is the No. 1 cause of death among those under the age of 65 who got the COVID jab Myocarditis as a cause of death is now registering across all age ranges but only for the vaccinated. Cardiac-related deaths…

Watchman Reporting: The Chinese Government Mandated Its Will on Its Citizens and Tried to on the American Political System. Attempt to Join the Hundreds of Millions of People All Across the World Who Have Already Taken the mRNA Kill Shot Vaccine. Because of  Bill Gates, Twitter and Google, Mass Death Is the New Normal All Over the World

By StevieRay Hansen | May 5, 2023 |

HNewsWire Live Stream 24/7 News UpDates and World Events Go Live Trump Owns Warp Speed a.k.a Kill Shots… “COVID Jabs Also Infect the Unvaccinated.” Pestilence Through Kill Shots: The mRNA and DNA Vaccinations Are Based on Biotech’s Revolutionary Gene-Editing Methods, Sure Death, Pale Horse In Play… HNewsWire: There never was a “virus.” Dr. Stephan Lanka, a German virologist, has offered a $100,000 reward for anyone who can show the study where the SARS-Cov-2 virus has ever been isolated or proven to cause the symptoms of Covid (hint: A fellow virologist tried to collect and lost in the German Supreme Court). China FORCED its citizens to take the SAME mRNA Kill Shot vaccine as the hundreds of millions of people around the world did. Whatever mortality figures are expected to be seen in China, we can expect to see them around…


Sources:  lionessofjudah  HNewsWire


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