The clinical trial in Germany will evaluate the safety and efficacy of potential Covid-19 vaccine candidate BNT162b2 in approximately 30,000 participants aged between 18 and 85 years, compared to placebo


Pfizer and BioNTech Covid-19 vaccine patient dosing. (Credit: BioNTech SE.)

Pfizer and BioNTech have secured the German regulatory approval to begin the Phase 2/3 clinical trial of their potential Covid-19 vaccine candidate BNT162b2.

The German regulatory authority Paul-Ehrlich-Institut has approved the clinical trial, which a part of the companies’ global Phase 2/3 clinical trial programme, initiated in July 2020.

The German clinical trial is designed to evaluate the safety and efficacy of BNT162b2 in nearly 30,000 participants aged between 18 and 85 years, compared to placebo.

The placebo-controlled clinical trial is expected to be conducted across 120 sites around the world, including in regions with significant SARS-CoV-2 transmission. The clinical trial has enrolled more than 25,000 participants until today.

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

Pfizer Germany Country Manager Peter Albiez said: “It’s great news that we have approval from the Paul-Ehrlich-Institut to extend this pivotal study to Germany and draw upon the expertise of the German scientific community to support our efforts.”

Pfizer and BioNTech intend to seek regulatory review for BNT162b2 in October 2020

Pfizer and BioNTech have partnered on the BNT162 development programme, which comprises four investigational vaccine candidates, based on BioNTech’s mRNA technology, backed by Pfizer’s global vaccine development and manufacturing capabilities.

Two of the four candidates, dubbed BNT162b1 and BNT162b2, have been granted the US Food and Drug Administration (FDA) Fast Track designation, based on preliminary data from on-going Phase 1/2 studies and animal immunogenicity studies.

In the preclinical and clinical studies, BNT162b1 and BNT162b2 have demonstrated superior safety and immune response assessments. Pfizer and BioNTech have selected BNT162b2 vaccine candidate to progress into the Phase 2/3 trials, in July 2020.

The companies’ decision was based on the thorough review of preclinical and clinical data from Phase 1/2 clinical trials and talks with the FDA Centre for Biologics Evaluation and Research (CBER) and other global regulators.

BNT162b2 is designed to encode an optimised SARS-CoV-2 full-length spike glycoprotein (S), which is the target of virus neutralising antibodies.

The companies said that their investigational vaccine candidate BNT162b2 is currently under clinical study and is not approved for distribution anywhere in the world.

Furthermore, Pfizer and BioNTech intend to seek regulatory review for BNT162b2 in October 2020, subject to achieving regulatory authorisation or approval.

The companies plan to supply up to 100 million doses by the end of 2020 and approximately 1.3 billion doses by the end of 2021.