BNT162b1 and BNT162b2 Covid-19 vaccine candidates get FDA fast track status
Pfizer and BioNTech said that BNT162b1 and BNT162b2, two vaccine candidates developed to give protection against the SARS-CoV-2 virus have been given the fast track designation from the USFood and Drug Administration (FDA).
The two vaccine candidates are part of the four investigational vaccine candidates that are being jointly developed by the companies under their BNT162 mRNA-based vaccine program in response to the COVID-19 pandemic.
Pfizer said that BNT162b1 and BNT162b2 are the most advanced vaccine candidates in the BNT162 program. The COVID-19 vaccine candidates are presently being assessed in ongoing phase 1/2 clinical trials in the US and Germany.
The fast track designation from the FDA for the coronavirus vaccine candidates was given based on preliminary data noted from the phase 1/2 clinical trials and also from animal immunogenicity studies.
Özlem Türeci – Chief Medical Officer at BioNTech 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.”
BNT162b1 and BNT162b2 are said to be nucleoside modified RNAs that have been formulated in lipid nanoparticles.
According to Pfizer, the BNT162b1 Covid-19 vaccine candidate encodes an optimized SARS-CoV-2 receptor-binding domain (RBD) antigen. On the other hand, the BNT162b2 vaccine candidate encodes an optimized SARS-CoV-2 full-length spike protein antigen.
Peter Honig – Pfizer Global Regulatory Affairs Senior Vice President 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.”
If given regulatory approval, Pfizer and BioNTech plan to begin a phase 2b/3 Covid-19 clinical trial later this month and are looking to register up to 30,000 participants.