EN | DE TOP BAR MENU Investors & Media Careers Connect Healthcare Professionals Our DNA How We Translate Science For Patients COVID-19 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 on the development of a vaccine against COVID-19, we, at BioNTech, are also working around the clock to develop a COVID-19 vaccine to contribute to global efforts to combat the global COVID-19 pandemic and protect against COVID-19. Our effort to accelerate the rapid development of a vaccine to fight COVID-19 has been named „Project Lightspeed.“ The project leverages BioNTech’s proprietary mRNA-based technology, with which we have more than 20 years of experience, and is also 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, and has been producing mRNA for clinical testing since then, including the entire clinical supply for our COVID-19 mRNA vaccine. “We feel a duty to exploit our full technology and immunotherapy expertise to help address the COVID-19 pandemic emergency. Our aim is clear: Making a potential vaccine available to the public as quickly as possible – worldwide.” Prof. Ugur Sahin, M.D., Chief Executive Officer Where are we with Project Lightspeed, our COVID-19 vaccine development program? These are the milestones at a glance: SARS-CoV-2 genetic sequence Start of global development program Collaborations Phase 1/2 Study in Germany Start of two Phase 1/2 trials in Germany and the U.S. First results from U.S. Phase 1/2 study U.S. FDA Fast Track Designation First data from German Phase 1/2-study First supply agreements Global Phase 2/3 efficacy study in the U.S. started Start of the clinical study in China and supply agreement with Canada Preliminary data from ongoing Phase 1/2 study of lead COVID-19 mRNA vaccine candidate Start of Phase 2/3 study in Germany Acquisition of GMP manufacturing site Rolling submissions initiated Preliminary data: first positive interim analysis from global phase 3 study Vaccine Supply Agreement with the EU Approval of Phase 2 study in China Conclusion of global Phase 3 study Emergency Use Authorization Request submitted to U.S. FDA Start of clinical Phase 2 study in China Conditional Marketing Authorization Submission to EMA First approval of a temporary emergency supply in UK U.S. FDA authorizes COVID-19 mRNA vaccine for emergency use Conditional Marketing Authorization in the European Union for BioNTech’s COVID-19 mRNA vaccine For more information about our manufacturing capabilities please visit: https://biontech.de/how-we-translate/manufacturing For more information on the current status of the vaccine program please follow: Press releases Read also Meet our leadership team Get to know our partners We offer multiple services Explore our pipeline BNTCom00081_2 We look forward to connecting with you SEND US A MESSAGE BioNTech Manufacturing GmbH An der Goldgrube 12 55131 Mainz Germany T: +49 6131 9084-0 For questions on logistics, handling or other issues: service@biontech.de For any other questions, please use our contact form at connect.biontech.de We aspire to utilize the full potential of the immune system to fight cancer and infectious diseases Footer Main Connect Our DNA How We Translate Science For Patients Investors & Media Careers Footer Manufacturing GmbH 2 Imprint Terms Of Use General Terms And Conditions General Conditions Of Purchase Data Privacy Statement Data Processing Terms Business Partners Adverse Event Reporting Cookie Settings Follow us Open configuration options © Copyright BioNTech Manufacturing GmbH 2021. All Rights Reserved. Feel invited to ask me your questions about our COVID-19 mRNA vaccine! Cookies are used by us and third parties on our site. For all cookies that are not technically necessary, we require your consent (e.g. cookies for statistical purposes, tracking, analytics, advertising, if necessary configuration). By selecting or deselecting the cookies, you consent to or reject the processing of your personal data (e.g. your IP address) for the respective purpose. You can revoke or give your consent at any time in our Data Privacy Policy under the item "Cookies". Essential Statistics Marketing Performance External Media Personalisation Save preferences ACCEPT ALL COOKIES