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).
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