Pfizer and BioNTech pharmaceutical firms announced Friday they have initiated submitting their COVID-19 vaccine candidate in six different regions in the world.
The companies said they will file their emergency use authorization request to the US Food and Drug Administration (FDA) on Friday, and their vaccine candidate will potentially be ready to be used in high-risk populations across the US by the middle to end of December 2020.
While the firms said they have already initiated rolling submissions in Australia, Canada, Europe, Japan, and the UK for their vaccine, they also plan to submit applications immediately to other regulatory agencies around the world.
The companies said they expect to globally produce up to 50 million doses in 2020, and up to 1.3 billion doses by the end of 2021, as they will be ready to distribute the vaccine within hours after authorization.
The phase 3 trials of their vaccine started on July 27 on 43,661 global participants with 41,135 receiving a second dose on Nov. 8.
The companies announced on Nov. 9 their vaccine has an efficacy rate of more than 90%.