AstraZeneca to discuss with U.S. FDA changing vaccine trial design

The British drugmaker on Monday released interim data from late-stage trials that showed the shot was on average about 70% effective in preventing coronavirus. The executive said the company will need to change the design of its U.S. trials, which are continuing, to include the potential for two different dose regimens.

AstraZeneca will start discussions this week with the U.S. Food and Drug Administration (FDA) to change the design of its experimental COVID-19 vaccine trial to add a likely more effective dosage regime, a senior executive said on Monday. The British drugmaker on Monday released interim data from late-stage trials that showed the shot was on average about 70% effective in preventing coronavirus.

The executive said the company will need to change the design of its U.S. trials, which are continuing, to include the potential for two different dose regimens. "In terms of how quickly, we will try and do that as quickly as possible," said Mene Pangalos, executive vice president of biopharmaceuticals research and development, adding it would be a "matter of weeks".

He said the regimen that includes a half dose being administered followed by a full dose one month later was better tolerated than using two full doses.