“6 other country openings for our trial in last several weeks. But it really -- the clinical hold lift and authorization for Phase 3 in the U.S., it provides us additional validation, and it shows that we have met all of the concerns of the U.S. FDA satisfactorily. That being said, we're really pleased that -- to say that the dosing for INNOVATE Phase 3 trial has already begun and it's underway. And interim efficacy -- it's a case-driven study so magic number is around 150 lab-confirmed cases and of course, interim will be at the 50% of those cases.
So faster re-enroll and the percent of attack rate in those countries or those regions will really impact when exactly where we will meet that 50% efficacy -- these are all blinded until we hit about 75 cases. So that's why we left that as a broadly first half 2022. So that's what we're looking for. And it's always been the same design from when we started the INNOVATE Phase 3 trial. “ JK 11/10/21
“So our team is working really hard to open these sites, get approvals in the country's open sites, and in all subjects. Separately, the Solidarity trial is operating independently, and we're really grateful that the WHO has selected, or their independent panel has selected INO-4800 as one of 2 initial vaccines.
And I think there's 2 more being added in the future, but out of 20 or so candidates of second wave COVID-19 vaccines out there, so we're highly grateful for that selection. Obviously, we think we are the leader of the second wave of COVID-19 vaccines, and we have the opportunity to demonstrate our efficacy and safety. I have no qualms about our safety, but we still have to get to that efficacy data. And we have two shots on the goal with our INNOVATE Phase 3 trial that we're conducting with our partner vaccine, as well as WHO's Solidarity trials. We couldn't be any happier. We're excited in our opportunities here and our team is working really hard to achieve that.”
