As doubts about the FDA’s credibility grow as the agency awaits the initial results from the frontrunner’s “Phase 3” trials, the leading vaccine makers are working to further expedite the approval process by streamlining procedures to try and make a determination about whether their vaccine “works or not” within the next month or so.
The issue, as Bloomberg reports, is that the leading vaccine companies are shooting for low targets for the number of confirmed infections among the tens of thousands of patients they’ve recruited for their trials.
Remember, half of the test subjects have been given a vaccine, while the other half haven’t.
Leading candidates will reportedly conduct their first round of analysis after just 32 people have been sickened, with Pfizer and BioNTech giving their joint project a goal of 164 cases before they move ahead with the application for emergency approval.
The projects will also give reglators several “early looks” at their data so they can decide whether any red flags have emerged that require halting the trial, or – if the data are overwhelmingly positive – call for an early end to the trial.
This “rush for results” could make it “harder to get clear answers about how well the vaccines work,” one expert told Bloomberg. “We want to know this vaccine has strong efficacy, and that means two things: It works in the majority of people and htat it works to prevent serious infections, not just soar throats.”
These questions simply reinforce the notion, touched on earlier Tuesday by UK PM Boris Johnson, that citizens shouldn’t view the delivery of a vaccine by the end of the year as a foregone conclusion. – READ MORE
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