The US Food and Drug Administration could issue an emergency use authorization (US) for a coronavirus vaccine in a matter of weeks, once a vaccine meets the efficacy requirements, Dr. Peter Marks , director of the FDA’s Center for Biological Research and Evaluation, which approves the vaccines, said Wednesday.
“We are ready to use emergency use authorization in an appropriate environment,” Marks said during an online event called the Disease Control and Prevention Summit.
A US would give the green light to a coronavirus vaccine for expedited use.
Marks said the increased attention the agency is paying to coronavirus vaccine trials should speed up the process of granting emergency use authorization to a vaccine that crosses an efficacy limit in a clinical trial.
“We would like to hope that when that happens, it will be a matter of weeks before we can have something like an emergency use authorization,” said Marks, who added that he hopes the EUA will apply to a relatively large population. . “The authorization of emergency use will be for the population for which we have appropriate data.”
Marks emphasized that safety will not be sacrificed in the race for a vaccine.
“The first vaccines that appear may be slightly at a disadvantage compared to those that appear later,” said Marks, who suspects that “pioneering” vaccines will reveal information that may speed up the process for subsequent vaccine candidates.
Some context: Two potential vaccines began advanced trials this week in the United States.
“There are aspirational deadlines, and I think it’s really wonderful here, that people have aspirations to move forward as quickly as possible, but we all know that real life generally doesn’t go as well as our aspirations,” said Marks.
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