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BNT162b1 is one of four advanced mRNA-based vaccines being developed through "Project Lightspeed," a joint program between Pfizer and BioNTech. BNT162b1 is a nucleoside modified mRNA (modRNA) vaccine encoding the receptor-binding domain (RBD) of the SARS-CoV-2 spike (S) protein together with a "foldon" trimerization domain derived from T4 fibritin to increase immunogenicity. The modRNA is formulated in lipid nanoparticles for delivery via intramuscular injection. Early results from a phase 1/2 study in 45 healthy adult volunteers demonstrated RBD-binding immunoglobulin levels and 50% serum neutralizing titers higher than those observed in COVID-19 convalescent plasma 28 days after initial immunization of either 10 or 30μg of BNT162b1, with further improvements following a second dose. BNT162b1 is undergoing further evaluation in clinical trials in both the USA (NCT04368728) and Germany (NCT04380701). BNT162b1 received fast track designation by the FDA on July 13, 2020.
BNT162b1 is one of four advanced mRNA-based vaccines being developed through "Project Lightspeed," a joint program between Pfizer and BioNTech. BNT162b1 is a nucleoside modified mRNA (modRNA) vaccine encoding the receptor-binding domain (RBD) of the SARS-CoV-2 spike (S) protein together with a "foldon" trimerization domain derived from T4 fibritin to increase immunogenicity. The modRNA is formulated in lipid nanoparticles for delivery via intramuscular injection. Early results from a phase 1/2 study in 45 healthy adult volunteers demonstrated RBD-binding immunoglobulin levels and 50% serum neutralizing titers higher than those observed in COVID-19 convalescent plasma 28 days after initial immunization of either 10 or 30μg of BNT162b1, with further improvements following a second dose. BNT162b1 is undergoing further evaluation in clinical trials in both the USA (NCT04368728) and Germany (NCT04380701). BNT162b1 received fast track designation by the FDA on July 13, 2020.
