BERLIN, Sept. 7 (Xinhua) -- German pharmaceutical company BioNTech SE and U.S. company Pfizer Inc. received approval on Monday for the Phase 2/3 clinical trial of their COVID-19 vaccine candidate BNT162b2 in Germany.

The permission was granted by the Paul-Ehrlich-Institut (PEI), Germany's Federal Institute for Vaccines and Biomedicines responsible for the authorization of pharmaceuticals, the two companies said in a joint press release.

The clinical study in Germany is part of a global study by BioNTech and Pfizer, which started at the end of July, according to the companies.

"The placebo-controlled trial evaluates the safety and efficacy of BNT162b2 in up to 30,000 participants between 18 and 85 years of age," the companies noted. "As of today, more than 25,000 participants had already taken part in the study."

"A large, controlled Phase 3 study is a crucial prerequisite to prove the safety and efficacy of a vaccine," said BioNTech Chief Executive Officer (CEO) and co-founder Ugur Sahin. "The integration of sites in Europe, and now especially in Germany, is aimed at supporting approval in Europe."

BNT162b2 is still not approved for distribution anywhere in the world but BioNTech and Pfizer are aiming to file for regulatory approval in October if the current clinical study on the potential COVID-19 vaccine proves successful.

Once approval is granted, BioNTech and Pfizer plan to supply up to 100 million vaccine doses worldwide by the end of 2020 and over 1.3 billion doses by the end of 2021, according to the companies.