Tuesday, September 1, 2020

COVID-19 Vaccine May Be Given Emergency Approval Before End Of Trials

The head of the US Food and Drug Administration raised the possibility in an interview published Sunday that a future vaccine against the coronavirus might be given emergency approval before the end of trials designed to ensure its safety and effectiveness.

A request for such extraordinary approval would have to come from the vaccine developer, Stephen Hahn told the Financial Times. "If they do that before the end of Phase Three," which involves large-scale human testing, "we may find that appropriate. We may find that inappropriate, we will make a determination.” But Hahn insisted he was not acting under pressure from President Donald Trump, who has been pushing hard for a vaccine, saying one might be ready before US elections November 3.

"This is going to be a science, medicine, data decision," Hahn said. "This is not going to be a political decision." Three Western drugs makers are well along with their Phase 3 clinical trials, involving tens of thousands of participants. -Full Report