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Are the Covid-19 vaccines “safe and effective”?

June 16, 2021

A video presentation by Steve Kirsch, Executive Director of the Covid-19 Early Treatment Fund.

Watch Video at Trial Site News

Are there any risks associated with the COVID-19 vaccines currently authorized on an emergency use basis by the U.S. Food and Drug Administration (FDA)? Presently three genetic-based vaccines have been authorized via the emergency order including two mRNA-based vaccines (Moderna and Pfizer-BioNTech) as well as the adenovirus-based Johnson and Johnson product. Developed at historical speed under Operation Warp Speed, the mRNA-based technology foretells enormous implications for healthcare including the prospect of vaccines for cancer. An amazing research prowess has unfolded in response to the COVID-19 pandemic heralding profound breakthroughs that’ll benefit society for years to come. Governmental authorities have declared the vaccines both safe and effective and as TrialSite recently reported based on a change of law that waives the need for informed consent with investigational products. Both the U.S. Centers for Disease Control and Prevention (CDC) and FDA have declared that the risk-benefit analyses strongly indicate the risks of not getting a vaccination outweigh any risk of vaccination. They argue that the risks associated with COVID-19 are materially greater. Moreover, health authorities are on record that there is absolutely no correlation associated with the COVID-19 vaccines to any deaths as indicated by the CDC declaration. But have they sufficiently probed and pursued granular investigation into their own data? Have they undertaken the comprehensive  analyses associated with what in the CDC VAERS is now close to 6,000 deaths. Are all of these unrelated to the vaccines? Steve Kirsch, the founder and executive director of the COVID-19 Early Treatment Fund (CETF),  a regular contributor to the TrialSite recently conducted a more systematic and thorough analysis of the VAERS and CDC adverse event and death numbers reported in conjunction with the COVID-19 vaccines. The results are disturbing to say the least. TrialSite offers no opinion here other than the presentation of the highly successful MIT-trained engineer who has invested millions of his own funds into early stage treatment options targeting COVID-19. What follows is a summary of his deep dive into VAERS presented in this video.

Official CDC Position

The CDC is on the record that the now nearly 6,000 deaths reported in VAERS since December 2020, including “A review of available clinical information, including death certificates, autopsy, and medical records, has not established a causal link to COVID-19 vaccine.”

The analysis provided by Kirsch suggests that while nearly 6,000 are now entered into the voluntary system, he suggests the actual number could be undercounted by a magnitude of up to 5 times and a review of direct CDC excess death data indicates what the notable entrepreneur counts as 25,000 deaths that could be associated with the coronavirus vaccines.

The Presentation

The Kirsch presentation starts with an introduction to the CDC Vaccine Adverse Event Reporting System known as VAERS with a review of some key indicators including reported deaths. Open to the public, he reveals by June 4th the following adverse events were associated with the COVID-19 vaccines:

Reported Event #s
Deaths 5,088
Hospitalizations 19,587
Urgent Care 43,891
Office Visits 58,800
Heart Attacks 2,190
Anaphylaxis 1,459
Bells Palsy 1,737
Thrombocytopenia/Low Platelet 1,564
Myocarditis/Pericarditis 1,087

A review of available clinical information, including death certificates, autopsy, and medical records, has not established a causal link to COVID-19 vaccines.

At 12:15 into the presentation Mr. Kirsch reveals a data distribution revealing a dramatic spike in deaths associated with the COVID-19. Moreover in this data analysis it’s revealed that the majority of deaths occur closer to the actual time of the vaccination event indicating a higher probability of a causal relationship.

At 12:49 he presents the data findings indicating that overwhelming the incidents of heart attacks associated with the VAERS COVID-19 vaccine spike within a day to three days after the vaccination event.  He also emphasizes that the indication of Myocarditis/Pericarditis actually increases with vaccination as age decreases which is counter intuitive in that young people should have less probability of experiencing such heart related troubles. Is the vaccine causally connected to this data?

At 15:51 in the presentation Kirsch depicts again the growing numbers of deaths corresponding to the release of the vaccines under emergency use authorization by mid-December 2020. At 18:55 he reveals a corresponding increase in excess deaths reported by the CDC.

Kirsch goes on at 26:13 to discuss the imperative to consider a time out in the process to at least investigate these safety data signals.  At 28:09 Kirsch raises the imperative for informed consent under the Declaration of Helsinki. Although as TrialSite reported the law was changed in 2016 thus waiving the need for informed consent with investigational products deemed safe.

At 32:22 Mr. Kirsch discusses early treatment options for COVID-19.  He shares that considerable research has gone on pointing to a number of potential treatments for early onset COVID-19 that can serve to help combat COVID-19.  A risk-benefit comparison at 41:50 showcases at least one argument that early stage treatments currently under study should be accelerated.

The presenter offers a plethora of other information that merits review for those interested in a debate on this topic.

Kirsch commented on the findings “The narrative is that the COVID-19 vaccines are safe and effective but the truth is that the data points to an otherwise alternative conclusion.”  Kirsch declared that “if anyone was paying attention they would have picked up these safety signals by the end of January.”

Data-Driven Truth or Random Coincidence?

TrialSIte cannot advocate one position over another but rather can serve to share information that fits within the guidelines of the platform for purposes of discussion and hopefully healthy debate.  This isn’t a platform for attacking others but rather one that fosters awareness, transparency and engagement.  The data present in the CDC VAERS database as well as the CDC death reports do indicate a material spike in activity associated with the coronavirus vaccines.  Does the CDC’s position that none of these deaths are conclusively correlated to the vaccine itself despite the data in this presentation revealing a disturbing trend of adverse events and death within a day to three days within the vaccination event?  It’s not clear but TrialSite invites the CDC and others on to the platform to put forth an explanation.

June 17, 2021 - Posted by | Science and Pseudo-Science, Video | , , ,

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