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WASHINGTON: The head of the US Food and Drug Administration raised the possibility in an interview published on Sunday (August 30) that a future coronavirus vaccine could receive emergency approval before the end of the designed trials. to ensure its safety and effectiveness.
Such an extraordinary request for approval would have to come from the developer of the vaccine, Stephen Hahn told the Financial Times.
“If they do it before the end of Phase Three,” which involves large-scale human testing, “we may find it appropriate. We may find it inappropriate, we will make a determination.”
But Hahn insisted she was not acting under pressure from President Donald Trump, who has been pushing hard for a vaccine, saying it could be ready before the Nov.3 election.
“This will be a science, medicine and data decision,” Hahn said. “This is not going to be a political decision.”
Three Western drug makers are doing well in their Phase 3 clinical trials, involving tens of thousands of participants.
The three are AstraZeneca, which is associated with the University of Oxford in England; Moderna, in collaboration with the US National Institutes of Health and the Pfizer / BioNTech alliance.
Due to the nature of trials, it is difficult to predict when reliable results will emerge.
Half of the participants in these trials receive an experimental vaccine, while the other half receive a placebo.
In normal procedures, test administrators must wait, probably months, to see if there is a statistically significant difference in the infection rate of the two groups.
While the world desperately awaits an effective vaccine against the deadly virus, China and Russia have already approved vaccines without waiting for the completion of trials, drawing criticism from public health officials in other countries, including the US.
Hahn also said that an emergency clearance would not necessarily cover everyone, but could be granted for specific high-risk groups.
“Our emergency use authorization is not the same as a full approval,” he said.
Hahn has faced mounting criticism from the medical community for giving in to political pressure from the Trump administration, which largely involved two incidents.
FDA Commissioner Stephen Hahn has come under fire for giving in to pressure from President Donald Trump as the United States fights the AFP / Al Drago pandemic
In March, the FDA granted an emergency authorization for the use of hydroxychloroquine to treat Covid-19 after Trump repeatedly praised its use; the authorization had to be withdrawn in June after serious side effects emerged.
READ: Hydroxychloroquine, an antimalarial drug, does not prevent COVID-19 in high-profile study
More recently, Hahn delivered an overly optimistic assessment, during a press conference with Trump, of the effectiveness of convalescent plasma against the virus. He said it could save 35 out of 100 patients; the most likely number, experts said, is five out of 100.
“It’s fucking outrageous to speed up * any * approval of a # SARSCoV2 vaccine, regardless of @ SteveFDA’s subordination to Trump,” Eric Topol, director of the Scripps Translational Research Institute, said on Twitter.
“We won’t know about safety for many months.”
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