A recently published Securities and Exchange Commission (SEC) filing from BioNTech, the company who partnered with Pfizer to codevelop their iteration of the COVID shot, revealed an astonishing admission regarding concerns over the “efficacy or safety” of their COVID shot.

More specifically, BioNTech revealed to investors in the filing that they may not be able to acquire or maintain any sort of “permanent regulatory approval” due to issues related to efficacy or safety.

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On March 30th, BioNTech released a Form 20-F detailing their annual report for the fiscal year ending on December 31st, 2021. For those unaware, a Form 20-F is a specific SEC form utilized by foreign companies where 50% or less of their shares are held by U.S. citizens and can be traded within the American markets.

These annual SEC reports host a litany of information for investors and would-be investors so that they can make an informed decision when it comes to entertaining stock in the company.

Among the information contained within the SEC filing is a section aptly dubbed “Risk Factors,” which spells out all the variables that could result in some not-so-favorable scenarios for investors that could cause stock prices to plummet.

When going to page six, section “D,” within the risk factors portion of the filing, BioNTech plainly stated that one of the critical risk factors relates to their number one product – the COVID shot – in the realm of “efficacy or safety” that could disrupt “regulatory approval.”

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“We may not be able to demonstrate sufficient efficacy or safety of our COVID-19 vaccine and/or variant-specific formulations to obtain permanent regulatory approval in the United States, the United Kingdom, the European Union, or other countries where it has been authorized for emergency use or granted conditional marketing approval.”

As it stands, the Pfizer/BioNTech COVID shot “has been granted full U.S. FDA approval for individuals 16 years and older,” per the SEC filing, with all other uses consisting of a string of Emergency Use Authorizations (EUA) for various age groups for the original shots and subsequent boosters.

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But BioNTech seems to see the writing on the wall, in that their shots may eventually be officially outed by regulatory agencies as not being safe or effective in younger demographics (not to mention their booster shot hustle).

Furthermore, also contained within the risk factors section of the SEC filing relates to the possibility of “significant adverse events” that could arise even after regulatory approval is attained – with BioNTech stating that could also present some bumps in the road for investors.

“Significant adverse events may occur during our clinical trials or even after receiving regulatory approval, which could delay or terminate clinical trials, delay or prevent regulatory approval or market acceptance of any of our product candidates.”

For all the talk of “safe and effective,” it seems quite curious that BioNTech would warn investors that perhaps the oft-repeated slogan was just that – a mere slogan.

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Red Voice Media would like to make a point of clarification on why we do not refer to any shot related to COVID-19 as a "vaccine." According to the CDC, the definition of a vaccine necessitates that said vaccine have a lasting effect of at least one year in preventing the contraction of the virus or disease it's intended to fight. Because all of the COVID-19 shots thus far available have barely offered six months of protection, and even then not absolute, Red Voice Media has made the decision hereafter to no longer refer to the Pfizer, Moderna, or Johnson & Johnson substances as vaccinations.