Pfizer and BioNTech have secured regulatory approval from the Paul-Ehrlich-Institut in Germany to conduct a Phase II/III clinical trial of their Covid-19 vaccine candidate, BNT162b2.
BNT162b2, which encodes an optimised SARS-CoV-2 full-length spike glycoprotein (S), is part of the companies' BNT162 programme focused on Covid-19.
The BNT162 programme leverages BioNTech’s mRNA technology and Pfizer’s global vaccine development and manufacturing capabilities.
BNT162b1 and BNT162b2, two of the partners’ four investigational vaccine candidates, obtained fast track designation from the US Food and Drug Administration (FDA).
The new trial of BNT162b2 in Germany is part of the global pivotal Phase II/III programme launched by BioNTech and Pfizer in July this year.
It is designed to assess the safety and efficacy of the vaccine candidate in up to 30,000 participants aged 18 to 85 years. Volunteers will be given BNT162b2 or placebo at about 120 sites worldwide.
So far, the trial enroled more than 25,000 participants, said BioNTech.
BioNTech CEO and co-founder Ugur Sahin said: “A large, controlled Phase III 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.”
If successful in clinical trials, Pfizer and BioNTech plan to seek regulatory approval for BNT162b2 Covid-19 vaccine as early as October this year.
After potential regulatory authorisation or approval, the companies aim to supply up to 100 million doses globally by the end of this year and about 1.3 billion doses by the end of next year.
In July this year, the companies initiated a Phase II/III trial of BNT162b2 at a 30µg dose level in a two-dose regimen, in the US.
The partners decided to advance the vaccine candidate into Phase II/III trials based on a review of preclinical and clinical data from Phase I/II studies.