Germany-based BioNTech is working with Pfizer Inc. to develop a potential COVID-19 vaccine. The collaboration aims to accelerate the development of BioNTech’s potential COVID-19 mRNA vaccine program, BNT162, which is expected to enter clinical testing by the end of April.
In an email exchange, a member of BioNTech communications teams, Laura Mittmann, answered these questions:
What’s Happening With Your Trial?
At the beginning of 2019, as evidence of the danger of a COVID-19 pandemic was growing, we initiated an internal R&D effort to develop a vaccine to induce immunity and prevent the COVID-19 infection. We named our internal efforts “Project Lightspeed.”
The resulting product candidate, BNT162, is a potential first-in-class mRNA vaccine against COVID-19.
What Are the Next Steps?
The next step in the development process is to initiate clinical testing for BNT162, pending approval from the regulatory agencies, as part of a global clinical development program in Europe, the United States, and China.
We are accelerating operational plans to manufacture the vaccine for clinical trials along with our partner, Polymun, at our state-of-the-art GMP-certified mRNA manufacturing facilities in Europe.
Where Do You See This Going in Coming Months?
We are committed to working as quickly as possible internally and with our partners to advance BTN162 with the goal of saving lives. That means we will continue to follow the regulatory guidelines and rules to ensure a safe and effective vaccine.
Like any other pharmaceutical product, a potential vaccine has to go through stringent clinical testing and must be manufactured to high standards (termed “GMP” or good manufacturing practice) consistently and reliably.
We received German regulatory authority approval in 2011 to manufacture mRNA under GMP and have been producing mRNA for clinical testing since then. At this stage, safety is our biggest priority.
As soon as we possibly can, we will provide updates on the development process. It is important to remember that this is not a competitive race. We, together with all companies, research institutes, and governments, represent a global effort to battle a pandemic and save lives.