July 20, 2020 -- Pfizer and BioNTech have released initial data from an ongoing phase I/II clinical trial for the COVID-19 messenger RNA (mRNA)-based vaccine candidate BNT162b1.
The data from the open-label, nonrandomized, nonplacebo-controlled, dose-escalation trial have been made available on medrxiv and are currently undergoing scientific peer review. The vaccine candidate is a lipid nanoparticle-formulated nucleoside-modified mRNA that encodes a SARS-CoV-2 receptor-binding domain antigen. The results correspond with a recent U.S.-based clinical trial.
The Germany-based immunogenicity trial evaluated SARS-CoV-2 neutralizing titers and immunoglobulin G concentrations of the vaccine candidate. The results demonstrated that BNT162b1 induces high levels of CD4+ and CD8+ T-cell responses against SARS-CoV-2. Moreover, the data suggest that the vaccine may be safe and tolerable.
The preliminary data will be used to determine a dose level and move the vaccine candidate to a global phase IIb/III safety and efficacy clinical trial that may enroll up to 30,000 healthy individuals, expected to begin in late July.
Upon successful clinical development and regulatory approval, the companies expect to manufacture up to 100 million doses by the end of 2020 and potentially more than 1.3 billion doses by the end of 2021.
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