Pfizer and BioNTech have submitted their Covid-19 vaccine to the European Medicines Agency for conditional approval, the companies said in a statement on Tuesday, aiming to make their drug available in Europe by the end of the year.
The partners - a US pharma giant and a small German biotechnology firm specializing in nascent mRNA technology - said receipt of their application had been confirmed after it was submitted on Monday.
This puts the companies neck and neck with US firm Moderna, which also applied to the EU regulator for the conditional approval of its Covid-19 vaccine on Monday.
Pfizer chief executive Albert Bourla hailed the approval request as "another key milestone" in its efforts to alleviate the health crisis together with BioNTech.
Their vaccine has been found to be 95% effective against Covid-19 in clinical tests.
Like Moderna, Biontech and Pfizer have also applied to the US Food and Drug Administration (FDA) for emergency approval.