durobinet schreef op 12 augustus 2020 19:21:
De markten knallen omhoog omdat er spoedig een vaccin beschikbaar zal zijn volgens de verhalen in de pers en geruchten. Maar is dat wel zo?
Behind the scenes
Dr. Peter Marks, director of the Center for Biologics Evaluation and Research (CBER) in the U.S. Food and Drug Administration (FDA), noted in an event with the National Press Foundation on Wednesday that despite the vaccine race moving full steam ahead, regular press releases from pharmaceutical companies should be taken with a grain of “kosher salt.”
“I’m not sure that all of this noise that we are hearing from all of the companies is really all that helpful. This is a stock price issue,” he said.
Marks said that the news is encouraging, but positive early trial results don’t always translate to a successful vaccine.
The FDA anticipates being able to issue an emergency use approval for a vaccine, but officials have repeated that nothing will be rushed. Marks reiterated that point, adding that in the past the FDA has been able to approve vaccines on an accelerated basis, but only when more is known about the disease.
“Because we don’t have that now, for the first vaccines ... we don’t expect to be using our accelerated approval provisions because we don’t think we’ll have enough knowledge” to correlate to the clinical outcomes, Marks said.
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