Pfizer and Biopharmaceutical New Technologies (BioNTech) have secured fast track designation from the US Food and Drug Administration (FDA) for two investigational mRNA-based vaccine candidates against SARS-CoV-2, the novel coronavirus responsible for the Covid-19 disease.
The two of the firms’ four investigational vaccine candidates from their BNT162 mRNA-based vaccine programme, including BNT162b1 and BNT162b2, are being developed to treat SARS-CoV-2.
BioNTech chief medical officer Özlem Türeci said: “We are pleased to have received Fast Track designation from the FDA for two of our vaccine candidates and look forward to working closely with the FDA, along with our partner Pfizer, to expedite the clinical development path forward.”
At present, the BNT162b1 and BNT162b2 vaccine candidates are being assessed in ongoing phase 1/2 clinical studies in the US and Germany.
The BNT162 programme is assessing up to four experimental vaccines, of which each includes a unique combination of messenger RNA (mRNA) format and target antigen.
The BNT162b1 and BNT162b2, which are both nucleoside modified RNAs, formulated in lipid nanoparticles.
The BNT162b1 is said to encode an optimised SARS-CoV-2 receptor-binding domain (RBD) antigen while BNT162b2 is designed to encode an optimised SARS-CoV-2 full-length spike protein antigen.
The Project Lightspeed vaccine development programme, which is based on BioNTech’s mRNA-based technology platforms, is supported by Pfizer’s global vaccine development capabilities.
Pfizer global regulatory affairs senior vice president Peter Honig said: “The FDA’s decision to grant these two COVID-19 vaccine candidates Fast Track designation signifies an important milestone in the efforts to develop a safe and effective vaccine against SARS-CoV-2.
“We look forward to continue working closely with the FDA throughout the clinical development of this programme, Project Lightspeed, to evaluate the safety and efficacy of these vaccine candidates.”
In May this year, Pfizer and BioNTec have dosed the first participants of a phase 1/2 trial for their Covid-19 vaccine candidate BNT162 in the US.