Project Lightspeed*
*This website is intended for a global audience
Aiming to address the global coronavirus pandemic: Project Lightspeed
Together with all companies, research institutes and governments currently working to address the global COVID-19 pandemic, we at BioNTech are also working around the clock to contribute make our COVID-19 vaccine available to as many people as possible around the world.
Our effort to accelerate the rapid development of a vaccine to address COVID-19 has been named „Project Lightspeed“. The project leverages BioNTech’s proprietary mRNA-based technology, which we have been researching and developing for more than 20 years and is supported by Pfizer’s global vaccine development capabilities.
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. BioNTech received German regulatory authority approval in 2011 to manufacture mRNA under GMP. Together with Pfizer, we were able to successfully ramp up our mRNA production capabilities in record time to enable a global supply with our COVID-19 vaccine.
From the very beginning, it has been our goal to provide access to a highly effective vaccine to as many people as possible. We continue to work diligently to respond to global vaccine needs with a commitment to ensure equitable vaccine access.
"From the very beginning, it has been our goal to provide access to a highly effective vaccine to as many people as possible. We continue to work diligently to respond to global vaccine needs with a commitment to ensure equitable vaccine access."
Where are we with Project Lightspeed, our COVID-19 vaccine development program? These are the milestones at a glance:
2020
After reading in The Lancet about a newly emerging, highly infectious virus in China, Ugur Sahin and his team initiated “Project Lightspeed” to develop a vaccine against COVID-19
2020
Collaborations: BioNTech announces partnerships with Pfizer (outside of China) and Fosun Pharma (China) for the development of an mRNA-based COVID-19 vaccine
2020
Start of Phase 1/2 trials in Germany and the U.S.
2020
Two of BioNTech's four COVID-19 mRNA vaccine candidates receive Fast Track designation from the U.S. FDA
2020
Pfizer and BioNTech selected BNT162b2 to advance and begin a global Phase 2/3 efficacy and tolerability study
2020
BioNTech and Fosun Pharma begin Phase 1 study with the COVID-19 mRNA vaccine candidate in China, following approval by the Chinese regulatory authority, National Medical Products Administration
2020
BioNTech and Pfizer begin Phase 2/3 study in Germany, following approval by the Paul Ehrlich Institut
2020
BioNTech acquired the manufacturing facility from Novartis AG to expand COVID-19 vaccine production capacity for global supply
2020
First positive interim analysis from the global Phase 3 study showing vaccine candidate to be over 90% effective in preventing COVID-19
2020
BioNTech and Fosun Pharma begin Phase 2 study in Mainland China with their lead COVID-19 mRNA vaccine candidate following approval by the China National Medical Products Administration
2020
BioNTech and Pfizer successfully conclude Phase 3 study meeting all primary efficacy endpoints demonstrating BNT162b2 to be 95% effective in preventing COVID-19
2020
The Medicines & Healthcare Products Regulatory Agency (MHRA) in the UK is the first regulatory agency to grant a temporary authorization for emergency supply for BioNTech's COVID-19 mRNA vaccine
2020
The U.S. Food and Drug Administration (FDA) grants an Emergency Use Authorization (EUA) for BioNTech's mRNA vaccine to prevent COVID-19 for use in individuals 16 years of age and older
2020
BioNTech's COVID-19 mRNA vaccine receives conditional marketing authorization (CMA) from the European Commission; by now the vaccine has been granted a CMA, EUA or temporary authorization in more than 40 countries worldwide
2021
BioNTech received the full U.S. FDA approval for their COVID-19 vaccine in individuals 16 years and older
