The race to find a cure for the COVID-19 pandemic continues globally. A potential vaccine by major phamacuetical company Pfizer and German partner BioNTech has shown promising results, and is expected to advance to the next trial phase by the end of July.
In a statement released on July 1, the companies announced that one of their four potential vaccine candidates has shown promising preliminary clinical data. Each vaccine represents a unique combination of mRNA format and target antigen. This vaccine, called BNT162b1, is the most advanced of the four.
The vaccine is being tested in an an ongoing US Phase 1/2 randomised, placebo-controlled, observer-blinded clinical trial, and the study aims to evaluate the safety, tolerability, and immunogenicity of escalating dose levels of BNT162b1.
The initial part of the study included 45 healthy adults ranging from 18 to 55 years of age, of which 36 received varying doses of the vaccine and nine received placebo-controlled doses. After 28 days, those who received the vaccine had elevated levels of neutralising antibodies, meaning it appeared to prevent the virus from functioning.
“Overall, the preliminary data demonstrated that BNT162b1 could be administered in a dose that was well tolerated and generated dose dependent immunogenicity, as measured by RBD-binding IgG concentrations and SARS-CoV-2 neutralizing antibody titers,” said Pfizer..
“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 at 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.”
The compay is now aiming to progress to a large, global Phase 2b/3 safety and efficacy trial. That trial may involve up to 30 000 healthy participants and is anticipated to begin in late July 2020, if regulatory approval to proceed is received.
“If the ongoing studies are successful and the vaccine candidate receives regulatory approval, the companies expect to manufacture up to 100 million doses by the end of 2020 and potentially more than 1.2 billion doses by the end of 2021,” adds Pfizer.
The vaccine would then be distributed worldwide except in China, where BioNTech has a collaboration with Fosun Pharma for BNT162 for both clinical development and commercialisation.
According to the World Health Organisation, there are curently 17 potential vaccines in human trials, and 132 in preclinical trials. Positive lab results have made the vaccines by AstraZeneca and Moderna the front runners.