In an interview with the newspaper Financial Times, Stephen Hahn, commissioner of the US Food and Drug Administration (FDA), said the agency could consider authorizing or approving the emergency use of a Covid-19 vaccine before they are completed. Phase 3 trials.
“It is up to the sponsor (developer of the vaccine) to request authorization or approval and we make an award of their request,” Hahn said.
“If they do it before the end of phase 3 we may find it appropriate. We may find it inappropriate, we will make a determination.”
“Our emergency use authorization is not the same as a full approval,” he said. “The legal, medical and scientific standard for that is that the benefit outweighs the risk in a public health emergency,” the senior official added, noting that the decision on the vaccine would be based on data, not politics.
Hahn’s comments came as drug makers around the world are working to develop a vaccine that protects people from the coronavirus, which has already infected nearly 6 million people in the United States and caused more than 182,000 deaths.