Pfizer has announced plans to submit an application to the US Food and Drug Administration (FDA) seeking approval for its Covid-19 vaccine candidate next month.
The vaccine is being developed in partnership with German biotech firm BioNTech.
Pfizer is testing the effectiveness of vaccine versus placebo and a committee of independent researchers will review the complete data.
The analysis is based on predetermined criteria at key interim analysis points throughout the trial.
Pfizer will carry out the trial to its final analysis point even if it meets all endpoints at an earlier stage.
To obtain an emergency use authorisation (EUA) from the FDA, the companies must submit two months of safety data from the trial conducted on half of the participants following the final dosing of the vaccine.
Pfizer chairman and CEO Albert Bourla said in a statement: “Based on our current trial enrolment and dosing pace, we estimate we will reach this milestone in the third week of November.
“Safety is, and will remain, our number one priority, and we will continue monitoring and reporting safety data for all trial participants for two years.”
Pfizer has considerable time to obtain a possible US authorisation of a coronavirus vaccine this year.
The regulatory filing will conclude as soon as the safety data of the trial becomes available.
In July, two investigational Covid-19 vaccine candidates of Pfizer and BioNtech received fast track status from the FDA.
Earlier this week, the companies entered into an agreement with the New Zealand Government to supply 1.5 million doses of their potential Covid-19 vaccine.