ASTRAZENECA will start discussing emergency approval of its experimental COVID-19 vaccine with U.S. regulators once it has good trial data from Britain, South Africa and Brazil, as it has no indication the watchdog would favour U.S. data.
If and when AstraZeneca reaches the first statistically reliable efficacy and safety results from those trials, based on more than 25,000 volunteers in total, it would present them to the U.S. Food and Drug Administration (FDA) even though any read-out from an ongoing U.S. trial will be months later.
“If you hit those thresholds we are going to have a conversation with them,” executive team member Mene Pangalos told Reuters.
“What the FDA has signalled is what their expectations of data are for an approval,” he said, adding the company had not spoken to the U.S. watchdog about where the data should come from. – Thomson Reuters Foundation.