Pfizer Inc and German partner BioNTech SA said on Friday they have started an application process with the U.S. Food and Drug Administration for full approval of their COVID-19 vaccine, currently only authorized for emergency use.
If approved, the vaccine will be the first fully approved COVID-19 shot and could help ease vaccine hesitancy due to longer-term data required for an FDA approval.
The companies said they would submit data to support the so-called biologic license application, which requires longer-term follow-up data, on a rolling basis over the next few weeks.
In April, Pfizer-BioNTech said their vaccine was around 91%