The federal government’s Operation Warp Speed program is hoping for emergency use authorization of AstraZeneca’s coronavirus vaccine by the end of March, a top official said Tuesday.
Britain authorized the vaccine last month and has been using it, but the US Food and Drug Administration will likely want to use US data for any emergency use authorization of the vaccine, said Operation Warp Speed's chief adviser Moncef Slaoui.
"In terms of the AstraZeneca vaccine, the assumption we are working on is that the emergency use authorization will be submitted on the basis of the ongoing Phase 3 trial in the US," Slaoui said during a briefing on Tuesday.
"Hopefully the vaccine again is efficacious, as has been shown in the trials conducted in Brazil and in the UK," Slaoui said. "So maybe an approval somewhere towards the latter part of the month of March, and a significant number of doses available around that time."
Reminder: The FDA paused US trials of AstraZeneca’s vaccine last year after questions about adverse reactions in volunteers. Those questions were cleared up and trials of the vaccine, often called the Oxford vaccine because it was developed with Britain’s Oxford University, have resumed.