Heres Why COVID-19 Vaccine Trials Cannot Tell Us If Vaccines Will Save Lives

 

May 22, 2021

None of the current COVID-19 vaccine trials are designed to detect a reduction in any serious outcome such as hospitalisations, intensive care use, or deaths. Here’s why COVID-19 vaccine trials cannot tell us if the vaccines will save lives.

Vaccines are being hailed as the solution to the covid-19 pandemic, but the vaccine trials are not designed to tell us if they will save lives, reports Peter Doshi, Associate Editor at The BMJ (read full report below).

Many may assume that successful phase 3 studies mean we have a proven way of keeping people from getting very sick and dying from covid-19. And a robust way to interrupt viral transmission.

Yet the phase 3 trials are not actually set up to prove either, says Doshi. 

“None of the trials currently underway are designed to detect a reduction in any serious outcome such as hospitalisations, intensive care use, or deaths. Nor are the vaccines being studied to determine whether they can interrupt transmission of the virus,” he writes.

He explains that all ongoing phase 3 trials for which details have been released are evaluating mild, not severe, disease – and they will be able to report final results once around 150 participants develop symptoms.

In Pfizer and Moderna’s trials, for example, individuals with only a cough and positive lab test would bring those trials one event closer to their completion.

Yet Doshi argues that vaccine manufacturers have done little to dispel the notion that severe covid-19 was what was being assessed. 

Moderna, for example, called hospitalisations a “key secondary endpoint” in statements to the media. But Tal Zaks, Chief Medical Officer at Moderna, told The BMJ that their trial lacks adequate statistical power to assess that endpoint.

Part of the reason may be numbers, says Doshi. Because most people with symptomatic covid-19 infections experience only mild symptoms, even trials involving 30,000 or more patients would turn up relatively few cases of severe disease.  ... Continue reading >>>

 

 

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Children’s Health Defense Petitions US Federal Drug Agency Over Plans To Vaccinate For COVID

 

Children’s Health Defense, an organisation headed by Robert F Kennedy Jnr. some of murdered US Presidential candidate Bobby Kennedy who was shot by an extremist while campaigning in 1969 and  Dr Meryl Nass MD, has filed a Citizen Petition with the US Food and Drug Administration, urging that  Emergency Use Authorizations be revoked for all COVID vaccines.

The petition, which is signed by Maas and Kennedy requests the following:

“We request the Acting Commissioner of the Food and Drug Administration (FDA) to issue, amend, revoke, or refrain from taking the administrative actions listed below regarding emergency use authorizations (EUAs), current and future new drug applications (NDAs), and biologics license applications (BLAs) for all COVID vaccines.”

The petition, which can be viewed on the FDA website on a page open for public comments, addresses a number of concerns about the safety of the COVID vaccines and particularly their use on children which is the latest stage of the United Nations / WHO / Big Pharma / Gates Foundation plan to vaccinate everybody in the world despite current evidence suggesting over 90% of us have natural immunity to COVID.

DANGER TO CHILDREN

The petition highlights empirical evidence that the risk of severe COVID in children is  so extremely low and the risk to children of vaccine death and injury to those under twelve appears to be too slight to be meaningfully measured exceed the risk of COVID.

Citing US Centre for Disease Control (CDC) reports, the petition states that….

the death rate following either vaccination in this age group, assuming these children were trial enrollees, is approximately 2 in 2,000 or 0.1%. There are 74 million children in the United States. So far, 282 have died “involving Covid.” Two hundred eighty-two in 74 million is a rate of 0.00038%. While many children may not have been exposed to COVID, CDC estimated that 22.2 million children aged 5-17 had had COVID and 127 had died, at the May 12, 2021 meeting of the Advisory Committee on Immunization Practices, or 0.00057%.

“Available evidence strongly suggests that the vaccine is much more dangerous to children than the disease,” the Maas / Kennedy report reminds the FDA bureaucrats, going on to request the following:

Given the extremely low risk of severe COVID illness in children, FDA should immediately refrain from allowing minors to participate in COVID vaccine trials,refrain from amending EUAs to include children,and immediately revoke all EUAs that permit vaccination of children under 16 for the Pfizer vaccine and under 18 for other COVID vaccines. FDA should immediately revoke tacit approval that pregnant women may receive any EUA or licensed COVID vaccines and immediately issue public guidance to that effect.

The petition also addresses the right of refusal of members of the military and states that “The FDA should issue guidance to the Secretary of the Defense and the President not to grant an unprecedented Presidential waiver of prior consent regarding COVID vaccines for Service members…”

Anti - Vaxxers and Conspiracy Theorists?

Dispite their having been dismissed as anti - vaccine extemists and con spiracy theorists, the petition's authors fearlessly challenge the CDC pro - vaccine propaganda and charge it with inadequate reporting of COVID vaccine related deaths and adverse reactions serious enough to warrant hospital admissions, as well as noting the refusal of health authorities and government agencies to respond to requests for information, stating that “Children’s Health Defense asked CDC for information on post-vaccination deaths and injuries in early March 2021 and has yet to receive a response.”

They then allege that only 1 to 13% of adverse reactions have been reported to the FDA and CDC via the VAERS passive reporting system,” and state that even so, “the high number of adverse events and deaths following COVID vaccines is alarming.”

Kennedy and Nass note that “Vaccine Adverse Event Reporting System (VAERS) data reveal unprecedented levels of deaths and other adverse events since the FDA issued Emergency Use Authorizations( EUAs) for three COVID vaccines. As of May 10, 2021, VAERS reported 4,434 deaths of people who received at least one COVID vaccination.”

According to reports that made a ripple in mainstream media, the numer of sudden, unexplained deaths chronologically liked to COVID vaccines so far outnumbers deaths that can be similarly linked to all other deaths over the past ten years.

Casting further doubt on the CDC data relating to COVID vaccines, the petition cites the Massachusetts General - Bingham study on COVID vaccine reactions and notes that “anaphylaxis rates (were) approximately 50-100 times greater than the rates CDC calculated using VAERS data.”

Once again we have evidence of the fascist / Stalinist tactics being used by people determined to prolong this manufactured crisis in orderr to further their political and economic agendas.

 

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