AstraZeneca CEO: 2020 Approval For COVID Vaccine Still Possible
Soriot Says Speed Has Not Compromised Safety
While AZ awaits an independent review, its CEO maintains the vaccine could soon be back on track for a late 2020/early 2021 approval.
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Transparency On COVID Vaccine Clinical Holds Needed, Sharfstein Says; US FDA Advisory Cmtes Offer Venue
Former acting Commissioner Josh Sharfstein argues that while agency officials have done a commendable job in overall communication on COVID vaccine development, more information is needed on the clinical holds.
Confidence in the vaccine has slipped in the US, regardless of political affiliation.
Neither has announced a firm timeline, and the difference between Pfizer's 'October' and Moderna's 'November' could be mere hours or a few weeks, but Pfizer, by dint of luck or experience, is now in a position to offer the more optimistic projection on when it will seek an EUA. Both firms release their Phase III trial protocols, which seem in line with US FDA guidance.