The Food and Drug Administration (FDA) has granted Fast Track designation to 2 of Pfizer and BioNTech’s vaccine candidates against coronavirus disease 2019 (COVID-19).
The vaccine candidates, BNT162b1 and BNT162b2, are both nucleoside-modified messenger RNA (modRNA) vaccines. BNT162b1 encodes an optimized severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike glycoprotein receptor binding domain (RBD) antigen, while BNT162b2 encodes an optimized SARS-CoV-2 full-length spike protein antigen.
The Companies recently announced positive preliminary results from a phase 1/2 study evaluating BNT162b1. Initial findings from the US trial showed the vaccine candidate produced neutralizing antibody responses similar to those seen in convalescent human serology samples obtained from patients with confirmed SARS-CoV-2 infection. Data from a similar trial in Germany is expected to be released in July.
If regulatory approval is granted, a phase 2b/3 trial, which may include upwards of 30,000 individuals, could begin this July after an appropriate dose level is determined.
According to the Companies, manufacturing efforts are also increasing to keep up with potential demand. If a vaccine is approved, the Companies expect to produce up to 100 million doses by the end of 2020 and possibly more than 1.2 billion doses by the end of 2021.