#Death road to canada save editor trial#

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.

#Death road to canada save editor trial#

Moderna’s trial is designed to find out if the vaccine can prevent covid-19 disease, says Zaks. “Neither of these I think are acceptable in the current public need for knowing expeditiously that a vaccine works,” he told The BMJ. Zaks confirms that Moderna’s trial will not demonstrate prevention of hospitalisation because the size and duration of the trial would need to be vastly increased to collect the necessary data. “The same is true regarding whether it can save lives or prevent transmission: the trials are not designed to find out.” “Hospitalisations 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,” he adds. 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. Part of the reason may be numbers, says Doshi. But Tal Zaks, Chief Medical Officer at Moderna, told The BMJ that their trial lacks adequate statistical power to assess that endpoint. Moderna, for example, called hospitalisations a “key secondary endpoint” in statements to the media. Yet Doshi argues that vaccine manufacturers have done little to dispel the notion that severe covid-19 was what was being assessed. 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. 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. Nor are the vaccines being studied to determine whether they can interrupt transmission of the virus,” he writes. “None of the trials currently underway are designed to detect a reduction in any serious outcome such as hospitalisations, intensive care use, or deaths. Yet the current phase 3 trials are not actually set up to prove either, says Doshi. And a robust way to interrupt viral transmission.

Many may assume that successful phase 3 studies will mean we have a proven way of keeping people from getting very sick and dying from covid-19. 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”? Vaccines are being hailed as the solution to the covid-19 pandemic, but the vaccine trials currently underway are not designed to tell us if they will save lives, reports Peter Doshi, Associate Editor at The BMJ today. None of the current trials are designed to detect a reduction in any serious outcome such as hospitalisations, intensive care use, or deaths Covid-19 vaccine trials cannot tell us if they will save lives