"An emergency use authorization request for the Covid-19 vaccine developed by Pfizer and BioNTech was expected to be filed with the FDA on Friday, the US government and BioNTech's co-founder said.
This type of Food and Drug Administration authorization is temporary or conditional and is granted in response to an emergency situation such as a pandemic.
"Pfizer's partner BioNTech has announced that tomorrow they intend to file for emergency use authorization at the FDA," health secretary Alex Azar told a press conference Thursday in Washington.
BioNTech co-founder Ugur Sahin earlier told AFP in a Zoom interview: "The documents will be finalized today and tomorrow and submitted to the FDA."
The FDA did not say how long it would take to review the data on vaccine efficacy and safety, the two main criteria.
The scientific head of the US operation to develop a vaccine, Moncef Slaoui said Monday that the green light would probably come in December -- a timeframe echoed by Sahin.
He told AFP there is a chance they could receive the green light from the US "this year," and even starting delivering the vaccine by December."