The two investigational vaccine candidates, BNT162b1 and BNT162b2, are part of the Pfizer and BioNTech’s BNT162 mRNA-based vaccine programme
The entrance to Pfizer World Headquarters in Manhattan, New York. (Credit: Coolcaesar/Wikipedia.)
Pfizer and BioNTech have received the US Food and Drug Administration (FDA) Fast Track designation two of their investigational Covid-19 vaccine candidates.
The two investigational vaccine candidates, dubbed BNT162b1 and BNT162b2, are part of the companies’ BNT162 mRNA-based vaccine programme, aimed at developing vaccine candidates against SARS-CoV-2, the virus that causes Covid-19.
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 program, Project Lightspeed, to evaluate the safety and efficacy of these vaccine candidates.”
The FDA fast track status is based on initial data from the ongoing Phase 1/2 clinical trials
The US regulatory agency has granted the Fast Track designation, based on the initial data from the ongoing Phase 1/2 clinical trials, along with animal immunogenicity studies. Early data from the US Phase 1/2 study for BNT162b1 has been released on 1 July 2020.
The BNT162 programme is evaluating at four advanced investigational vaccines, each of which represents a unique combination of messenger RNA (mRNA) format and target antigen.
Both BNT162b1 and BNT162b2 are the nucleoside modified RNAs, formulated in lipid nanoparticles, where BNT162b1 encodes an optimised SARS-CoV-2 receptor-binding domain (RBD) antigen while BNT162b2 encodes an optimised SARS-CoV-2 full-length spike protein antigen.
Project Lightspeed is a joint vaccine development programme, where BioNTech is leveraging its mRNA-based technology platforms and Pfizer is leveraging its global vaccine development capabilities.
BioNTech chief medical officer ÖzlemTüreci 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.”