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Pfizer and BioNTech have reported positive, preliminary results from the ongoing Phase I / II clinical trial of mRNA-based Covid-19 vaccine candidate, BNT162b1, in the US.
Peer-reviewed data were published in the journal Nature.
BNT162b1 is a nucleoside-modified messenger RNA (modRNA) candidate designed to encode an optimized SARS-CoV-2 receptor binding domain (RBD) antigen.
Data found that the administered dose of the vaccine candidate was well tolerated and produced dose-dependent immunogenicity, determined with RBD-binding IgG concentrations and SARS-CoV-2 neutralizing titers.
According to the published results, 30 ug of the vaccine candidate, by seven days after the second dose, triggered a SARS-CoV-2 neutralizing geometric mean titer (GMT) which was 2.8 times the GMT of a SARS-CoV- 2 convalescent human serum panel.
BioNTech added that new data showed continuous increase in neutralizing titers and, by 14 days after the second dose of 30 µg, the GMT was 4.6 times the convalescent serum panel GMT.
Pfizer senior vice president and chief vaccine research and development Kathrin Jansen said: “The publication of peer-reviewed data from our mRNA-based vaccine development program against SARS-CoV-2 in a world-renowned publication such as Nature provides further validation of our rapid progress toward it. developing a safe and effective potential vaccine to tackle this current pandemic.
“We are encouraged by the overall progress of the program and look forward to generating additional data from our ongoing studies.”
Peer review process is ongoing for early data placed on medRxiv for BNT162b1 in Phase I / II study in Germany.
Pfizer and BioNTech recently advanced another Covid-19 vaccine candidate, BNT162b2, in a Phase II / III clinical trial. This is a trial run set up to register up to 30,000 subjects aged 18 to 85 years.
The companies continue to capture data from the Phase I / II trials and expect to submit findings on BNT162b2 in the near future.
