Transcript of a call to Pfizer.
Susie: So what was approved?
Cindy (Pfizer): Nothing. The license command (inaudible) vaccine has the same formulation as the authorized vaccines, the Pfizer BioNTech COVID-19 vaccines, and the products can be used interchangeably to provide the vaccinations series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not affect safety or effectiveness. Emergency uses of the vaccine have not been approved or licensed by the FDA but have been authorized by the FDA under emergency use authorization to prevent Coronavirus disease and individuals 12 years of age and older. The emergency use of they’re only authorized for the duration of the declarations that circumstances exist justifies authorization of emergency use of the medical product under Section 564b1 of the FD and C act unless the declaration is terminated or authorization is revoked sooner.
Susie: So was the old vaccine approved under the other name?
Cindy (Pfizer): No, nothing has been approved. It’s only approved under the emergency use authorization.
Susie: So we have no FDA-approved COVID vaccine in the US under any name, fully approved?
Cindy (Pfizer): Correct.
