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Source: COVID-19 Scams  Oct 22, 2020  2 months ago
BREAKING! COVID-19 Scams: British Medical Journal Says Current COVID-19 Vaccine Clinical Trials Cannot Tell Us If These Vaccines Will Save Lives!
BREAKING! COVID-19 Scams: British Medical Journal Says Current COVID-19 Vaccine Clinical Trials Cannot Tell Us If These Vaccines Will Save Lives!
Source: COVID-19 Scams  Oct 22, 2020  2 months ago
COVID-19 Scams: Associate Editor at the British Medical Journal (BMJ) Professor Dr Peter Doshi, in a daring but truthful revelation yesterday warned that vaccine trials currently underway are not designed to tell us if they will save lives.
https://www.bmj.com/content/371/bmj.m4037


  
Although several COVID-19 vaccine trials are now in their most advanced phase 3 stage, but what will it mean exactly when a vaccine is declared "effective"?

Most ignorant individuals may assume that successful phase 3 studies will mean we have a proven way of keeping individuals from getting very sick and dying from COVID-19 and a robust way to interrupt viral transmission. COVID-19 vaccines are being overly promoted and hailed as the solution to the COVID-19 pandemic by greedy, corrupted and lying individuals and groups including the Trump administration but in reality the emerging  truth is far from it. Some of these vaccines might be effective and useful but not in the way most people think or have been brainwashed to think.

Dr Doshi said that none the current phase 3 trials are actually set up to prove that they will save lives or will help end the pandemic.

None of the trials currently under way are designed to detect a reduction in any serious outcome such as hospital admissions, use of intensive care, or deaths. Nor are the vaccines being studied to determine whether they can interrupt transmission of the virus.

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

Dr Doshi 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.

For example, in the Pfizer and Moderna's trials, individuals with only a cough and positive lab test would bring those trials one event closer to their completion.

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

Alarmingly Moderna, for example, called hospitalizations 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.

Interestingly part of the reason may be numbers, says Dr Doshi. Because most individuals 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.

He further adds, "Hospitalizations and deaths from COVID-19 are simply too uncommon in the population being studied for an effective vaccine to demonstrate statistically significant differences in a trial of 30,000 people. The same is true regarding whether it can save lives or prevent transmission: the trials are not designed to find out."

Interestingly Zaks confirms that Moderna's trial will not demonstrate preven tion of hospitalization because the size and duration of the trial would need to be vastly increased to collect the necessary data.

Zak commented, "Neither of these I think are acceptable in the current public need for knowing expeditiously that a vaccine works." 

Zak said that Moderna's trial is designed to find out if the vaccine can prevent COVID-19 disease. Like Pfizer and Johnson and Johnson, Moderna has designed its study to detect a relative risk reduction of at least 30% in participants developing lab-confirmed COVID-19, consistent with FDA and international guidance.

He also points to influenza vaccines, saying they protect against severe disease better than mild disease. 

Dr Doshi said, "To Moderna, it's the same for COVID-19, if their vaccine is shown to reduce symptomatic COVID-19, they will feel confident it also protects against serious outcomes.”

However Dr Doshi raises another important issue that few or perhaps none of the current vaccine trials appear to be designed to find out whether there is a benefit in the elderly, despite their obvious vulnerability to COVID-19.

He warns that if the frail elderly are not enrolled into vaccine trials in sufficient numbers to determine whether there is a reduction in cases in this population, "there can be little basis for assuming any benefit against hospitalization or mortality." 

Dr Doshi says that we still have time to advocate for changes to ensure the ongoing trials address the questions that most need answering.



For instance why children, immunocompromised people, and pregnant women have largely been excluded; whether the right primary endpoint has been chosen; whether safety is being adequately evaluated; and whether gaps in our understanding of how our immune system responds to COVID-19 are being addressed.

He argues, "The COVID-19 vaccine trials may not have been designed with our input, but it is not too late to have our say and adjust their course. With stakes this high, we need all eyes on deck.”

Dr Peter Doshi is an associate editor at The BMJ and on the News & Views team. Based in Baltimore, he is also an assistant professor of pharmaceutical health services research at the University of Maryland School of Pharmacy. His research focuses on policies related to drug safety and effectiveness evaluation in the context of regulation, evidence-based medicine, and debates over access to data. Dr Doshi also has strong interests in journalism as a vehicle for encouraging better practice and improving the research enterprise. Since 2009, Dr Doshi has worked on a Cochrane systematic review of neuraminidase inhibitors for influenza. This review has developed innovative methods for evaluating regulatory information including clinical study reports. Dr Doshi completed a fellowship in comparative effectiveness research at Johns Hopkins and received his Ph.D. in history, anthropology, and science, technology and society from the Massachusetts Institute of Technology.

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