bonus2010
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British Medical Journal: Will covid-19 vaccines save lives? Current trials aren’t designed to tell us (published 21st October 2020)
Exactly! Trials involving 30,000 or more would turn up relatively few cases of severe disease
I'm no scientist, but I don't think anyone has to be to agree we're talking about very very low numbers of events that of which isn't even taking account of the 'severity' count
Yeah, rushed!
Where on earth are they getting that information from ? Surely Can't be from Tal Zaks, Chief Medical Officer of Moderna, after reading his comments here, the trials simply were unable to test for this.
>>>>> Link to British Medical Journal article <<<<<
Peter Doshi said:The world has bet the farm on vaccines as the solution to the pandemic, but the trials are not focused on answering the questions many might assume they are. Peter Doshi reports
Peter Hotez dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston said:“Ideally, you want an antiviral vaccine to do two things . . . first, reduce the likelihood you will get severely ill and go to the hospital, and two, prevent infection and therefore interrupt disease transmission.”
Yet the current phase III trials are not actually set up to prove either (table 1). 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.
Evaluating mild, not severe, disease
In a September interview Medscape editor in chief Eric Topol pondered what counts as a recorded “event” in the vaccine trials. “We’re not talking about just a PCR [polymerase chain reaction test]-positive mild infection. It has to be moderate to severe illness to qualify as an event, correct?” he asked.
“That’s right,” concurred his guest, Paul Offit, a vaccinologist who sits on the FDA advisory committee that may ultimately recommend the vaccines for licence or emergency use authorisation.
But that’s not right. In all the ongoing phase III trials for which details have been released, laboratory confirmed infections even with only mild symptoms qualify as meeting the primary endpoint definition.9101112 In Pfizer and Moderna’s trials, for example, people with only a cough and positive laboratory test would bring those trials one event closer to their completion. (If AstraZeneca’s ongoing UK trial is designed similarly to its “paused” US trial for which the company has released details, a cough and fever with positive PCR test would suffice.)
Part of the reason may be numbers. Severe illness requiring hospital admission, which happens in only a small fraction of symptomatic covid-19 cases, would be unlikely to occur in significant numbers in trials. Data published by the US Centers for Disease Control and Prevention in late April reported a symptomatic case hospitalisation ratio of 3.4% overall, varying from 1.7% in 0-49 year olds and 4.5% in 50-64 year olds to 7.4% in those 65 and over.13 Because most people with symptomatic covid-19 experience only mild symptoms,14 even trials involving 30 000 or more patients would turn up relatively few cases of severe disease.
Exactly! Trials involving 30,000 or more would turn up relatively few cases of severe disease
In the trials, final efficacy analyses are planned after just 150 to 160 “events,”—that is, a positive indication of symptomatic covid-19, regardless of severity of the illness.
I'm no scientist, but I don't think anyone has to be to agree we're talking about very very low numbers of events that of which isn't even taking account of the 'severity' count
Tal Zaks Chief Medical Oficer at Moderna said:“Would I like to know that this prevents mortality? Sure, because I believe it does. I just don’t think it’s feasible within the timeframe [of the trial]—too many would die waiting for the results before we ever knew that.”
Yeah, rushed!
Stopping transmission
Hmmm I'll stop quoting things now, add link to full article so members can read for themselves, but only to finish off by saying, I can't understand how the general public can be so confident that getting the jab will make it safer for everyone by stopping transmission or preventing people suffering the most severe of symptoms if catching this vurus.Where on earth are they getting that information from ? Surely Can't be from Tal Zaks, Chief Medical Officer of Moderna, after reading his comments here, the trials simply were unable to test for this.
>>>>> Link to British Medical Journal article <<<<<