Our website uses cookies to improve and personalise your experience and to display advertisements(if any). Our website may also include third-party cookies like Google Adsense, Google Analytics, and Youtube. By using the website, you consent to the use of cookies. We have updated our Privacy Policy. Please click on the button to check our Privacy Policy.

AstraZeneca aims to bring non-U.S. vaccine data before the FDA

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.