In a news release today, the BNT162b1 COVID-19 vaccine under development by Pfizer and BioNTech displayed early positive results in producing neutralizing antibodies from the partnership's Phase I/II trial.
“It is encouraging that the data on BNT162b1 from the German study cohort are very much in line with what we have seen in the U.S. study cohort. The preliminary data indicate that our mRNA-based vaccine was able to stimulate antibody as well as T-cell responses at remarkably low dose levels. We believe both may play an important role in achieving effective clearance of a pathogen such as SARS-CoV-2,” said Özlem Türeci, M.D., CMO and Co-founder of BioNTech.
BNT162b1 was shown to produce high virus-neutralizing titers as well as strong CD4+ and CD8+ T cell responses, a first for this vaccine. BNT162b1 is a "lipid nanoparticle formulated, nucleoside-modified messenger RNA that encodes an optimized SARS-CoV-2 receptor binding domain (RBD) antigen."
The study was conducted over 60 healthy participants between the ages of 18 to 55 years. Four dosing levels were distributed amongs four groups of 12 subjects and were vaccinated twice at approximately three weeks apart.
“These interim results from the German study, combined with initial data from the U.S. study, highlight the potential of this mRNA-based vaccine approach and represent an important step forward in our development efforts for the BNT162 program,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer. “We remain dedicated to developing an effective vaccine to fight the COVID-19 pandemic, with safety at the forefront and look forward to sharing additional data as the program progresses.”
Using this data, the company will progress to a "large, global Phase 2b/3 safety and efficacy trial." At this stage, the participant enrollment will increase to 30,000 with a planned start date of late July 2020 pending regulatory approval. Currently the partnership expects to produce 100 million doses by the end of 2020 with a following of 1.3 billion additional doses by the end of the following year.
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