In a press release yesterday, Pfizer announced positive data from Phase I/II clinical trials for their BNT162b1 vaccine for SARS-CoV2.
The study is a placebo-controlled, observer-blinded clinical trial with 45 participants 18 to 55 years of age. After 28 days, the study confirmed elevated RBD-binding IgG antibodies in those receiving the vaccine over two separate doses.
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Pfizer released the news jointly with partner Biopharmaceutical New Technologies or BioNTech, a "next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases."
“We are encouraged by the clinical data of BNT162b1, one of four mRNA constructs we are evaluating clinically, and for which we have positive, preliminary, topline findings,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer. “We are dedicated to develop potentially groundbreaking vaccines and medicines, and in the face of this global health crisis, we approach this goal with the utmost urgency. We look forward to publishing our clinical data in a peer-reviewed journal as quickly as possible.”
“These preliminary data are encouraging in that they provide an initial signal that BNT162b1 targeting the RBD SARS-CoV-2 is able to produce neutralizing antibody responses in humans at or above the levels observed in convalescent sera – and that it does so at relatively low dose levels. We look forward to providing further data updates on BNT162b1,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech.
The company expects to deliver 100 million doses of the vaccine by the end of 2020 and "potentially more than 1.2 billion doses by the end of 2021." At this point the vaccine would be available worldwide except for China where BioNTech has an existing partnership with Fosun Pharma.
Earlier in June we reported on Pfizer's CEO's announcement the vaccine could potentially be available as early as October. We spoke with Pfizer today and confirmed October remains feasible but is contingent on successful aquisition of an Emergency Use Declaration. Should the company meet this goal, the same 100 million doses would be available at that time. These timelines could make Pfizer the first company to deliver a vaccine in many countries including the U.S.