Skip to comments.Are the Covid-19 vaccines “safe and effective”?
Posted on 06/16/2021 10:50:28 AM PDT by absalom01
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 and age 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.
Posting not to advocate full agreement or disagreement with Mr. Kirsch's views, but he is making an important and impelling case, that is at least deserving of a serious reply by the public health authorities.
3,700,000 global CCP virus deaths out of a global population of 7,900,000,000 = 0.05%, the average age was 80, the median age was 78.
The overwhelming number of the people who died were obese and old with one foot in the grave and the other on a banana peel.
This is not the case with the people dying from the “cure.”
We don’t need an experimental “vaccine,” and experimenting on unwilling human subjects is a crime against humanity.
or are they attempted suicide
Disappointingly, the word “effective” appears in the title, and nowhere else.
Can the “vaccines” eradicate the virus to the extent that Polio was eradicated? That would be an effective vaccine.
The secret from the Battle of Athens, TN is that one only needs to have enough weapons to get into the Armory.
“Are the Covid-19 vaccines “safe and effective”?”
Yes. Why Yes they are.
They are safely and effectively destroying human bodies exactly as designed.
In the Gates Depop world, that’s called a “Win-Win”.
absalom01 wrote: “Good video at the link, by Steve Kirsch, who was on the now-famous Darkhorse podcast with Bret Weinstein and Robert Malone the other day.”
From the article: “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.”
The Declaration of Helsinki isn’t a law. Can anyone show where it has been incorporated into the US Code either by legislation or by Treaty?
The author assumes that the vaccines are ‘experimental’ in the context of this Declaration although there is no mention of vaccines in the Declaration. It’s equally valid to assume that the physicians administering these vaccines are fully in compliance with the Declaration. Otherwise, one has to assume that all physicians administering the vaccines are unethical and are not following these principals:
3. The Declaration of Geneva of the WMA binds the physician with the words, “The health of my patient will be my first consideration,” and the International Code of Medical Ethics declares that, “A physician shall act in the patient’s best interest when providing medical care.”
4. It is the duty of the physician to promote and safeguard the health, well-being and rights of patients, including those who are involved in medical research. The physician’s knowledge and conscience are dedicated to the fulfilment of this duty.
If I understand his argument correctly, he’s making an ethical, not a legal argument, and citing Helsinki as evidence of broad acceptance of the notion of requiring informed consent.
That seems a fairly strong case, particularly in light of the relative risks faced by the younger cohorts now being offered (some might say coerced) the vaccine.
What I find engaging about Steve’s discussion is that he’s not at all anti-vax in the traditional sense of the out in left field claims that are often offered. He’s got a cogent argument, and it’s the sort of thing that deserves a substantive response.
Specifically this: in light of the alarming currently reported rates of myocarditis in young adults and teenagers, does the relatively miniscule risk of serious disease justify the current push vaccinate that population?
Is Charles Manson a good houseguest? Does sewage flow upstream on its own accord? Do the bears in Yellowstone use the port-a-potties for bowel movements instead of going in the woods?
In America, the Kodex and the related Declaration of Helsinki form the basis for the Code of Federal Regulations Title 45 Part 46, which are the regulations issued by the United States Department of Health and Human Services for the ethical treatment of human subjects, and are used in Institutional Review Boards (IRBs).
absalom01 wrote: “That seems a fairly strong case, particularly in light of the relative risks faced by the younger cohorts now being offered (some might say coerced) the vaccine.”
Fine, but no one is being ‘coerced’ into getting the vaccine. In fact, EEOC/OSHA has stated: “Under the ADA, employers may offer an incentive to employees for voluntarily receiving a vaccine administered by the employer or its agent, but the incentive (which includes both rewards and penalties) cannot be “so substantial as to be coercive.”
I beg to differ, but you’re placing undue emphasis on my admittedly snarky parenthetical remark. But let’s go with that for a minute and see where it leads.
I have two examples, both from California. Here, Cal OSHA has mandated that while offices are “allowed” to return to work, ALL employees must wear masks while indoors until 100% of the staff are vaccinated. The intent is clearly to get people to pressure their colleagues to “just get the jab so we can take these stupid masks off.”
The University of California just announced that any student or faculty who wanted to return to class in person in the fall must be “fully” vaccinated.
Are they holding a gun to anyone’s head? No. Is it a fairly substantial level of pressure? I would say yes. Perhaps the use of the word “coercion” is a bit of hyperbole, but not excessively so.
And in the case of college students, reasonable people can come to different conclusions on the risk/benefit of accepting any of the currently available vaccines.
I’m not anti-vax, and took the Moderna myself when it was offered, and would make the same decision today, even with the additional information contained in the more recent media reports. But exerting undue pressure in this instance is at best morally suspect.
absalom01 wrote: “Are they holding a gun to anyone’s head? No. Is it a fairly substantial level of pressure? I would say yes. Perhaps the use of the word “coercion” is a bit of hyperbole, but not excessively so.”
Well, the judge in Houston does not agree ruling that a hospital can terminate any employee who refuses to get vaccinated. He specifically stated that such termination was not ‘coercion’.
I’d like to see a comparison with other western nations. Do they have their own versions of VERS? Is the US above or below median? DNA profiles of the deceased would also be helpful since we know that certain groups are more succeptible - common genetic background or irrespective of genetics?
If the government says they are, you can bet the farm that they are not.
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