The more than 90% efficacy with 94 cases suggests the final analysis with 164 cases will in all likelihood exceed the FDA’s efficacy criteria of 50%, Risinger said in a note.
Based on this and the lack of any serious safety concerns, the analyst raised the vaccine’s probability of success from 65% to 100%.
With Pfizer planning to submit emergency use authorization in the third week of November — when it has two months of median safety data — Risinger said he expects the FDA to hold a panel meeting to discuss the data by early-to-mid December.
An emergency use authorization approval for health care workers and certain high-risk populations could come by late December, he said.
Following six months of safety data, full approval is likely to come in the spring, Risinger said.
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