The name says it all. BioNTech, together with Pfizer, is surging from success to success at the speed of light with its ‘Lightspeed’ R&D project to find a corona vaccine. The high point to date is the start (except in China) of a global phase 2/3 safety and efficacy trial for the planned approval application. The randomised, blinded and placebo-controlled trial is set to include up to 35,000 test subjects aged between 18 and 85. It will be concentrating on the vaccine candidate BNT162b2 from the mRNA-based vaccine programme against SARS-CoV-2, which emerged as the most highly-promising vaccine candidate from the previous phase 1/2 trial. The trial is to involve BNT162b2 being administered in two 30 µg doses.
“We have selected BNT162b2 as our main candidate for this phase 2/3 trial following careful evaluation of the data generated so far. This decision reflects our primary goal of bringing a well-tolerated and highly effective vaccine on to the market as quickly as possible, while continuing to evaluate our other vaccine candidates as part of a differentiated COVID-19 vaccine portfolio,” explains Dr. Ugur Sahin, CEO and co-founder of BioNTech.
It is planned that regions with a high risk of SARS-CoV-2 transmission should be included in the trial as well. This will make it possible to investigate in parallel whether the selected vaccine candidate is able to prevent infection with COVID-19. If the trial is successful, approval for the vaccine could be applied for as early as Autumn 2020. BioNTech, the former winner of the GO-Bio competition, would then at last be able to take its deserved place at the table with the big German biotechnology firms thanks to its early and far-sighted commitment to the global race for a corona vaccine.