This website is intended for a global audience.
Aiming to address the global coronavirus pandemic:
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:
- Ugur Sahin read a publication in the Lancet about a new virus that emerged in the Chinese province of Wuhan.
- Immediately, Ugur realized that this virus had the potential to spread beyond Chinese borders. Not only was the virus novel and highly infectious, but treatments were also unavailable and several infected individuals did not show any symptoms. In addition, Wuhan is a heavily populated city with over one million inhabitants that is highly connected to the rest of the world.
- He discussed this with Özlem Türeci and the management team and, a few days later, BioNTech initiated “Project Lightspeed” in order to develop a potential vaccine against COVID-19.
- Subsequently, BioNTech selected potential vaccine candidates and conducted non-clinical studies.
- Shortly thereafter, the team initiated GMP production of its vaccine candidates (in Germany) for potential clinical studies.
- BioNTech announced a development and commercialization collaboration with Fosun Pharma. Together, the companies aim to develop BioNTech’s mRNA vaccine candidate in China to prevent COVID-19 infections.
- BioNTech and Pfizer signed a letter of intent to develop and commercialize the mRNA-based vaccine against the coronavirus outside of China. The collaboration with Pfizer built on the existing influenza partnership.
- The German regulatory authority, the Paul-Ehrlich-Institut, approved the initiation of the clinical Phase 1/2 study of BioNTech’s vaccine program, against COVID-19 infections. The vaccine program consists of four different COVID-19 mRNA vaccine candidates that were included in the dose-finding study.
- On April 23rd, the first subject was vaccinated with BioNTech's mRNA vaccine candidate, making him the first research participant to be vaccinated with a potential COVID-19 vaccine in Europe.
- In parallel, the phase 1/2 study in the U.S. was initiated, also with the objective of dose-finding. This study also included elderly subjects.
- BioNTech and Pfizer announced initial results from the U.S. study for one of the four clinical COVID-19 mRNA vaccine candidates.
- Two of BioNTech's four COVID-19 mRNA vaccine candidates received Fast Track designation from the U.S. FDA.
- The Fast Track process is designed to facilitate the development, and expedite the review of, new drugs and vaccines that are intended to treat or prevent serious conditions.
- BioNTech and Pfizer announced initial data from their ongoing German Phase 1/2 dose-escalation trial.
- BioNTech and Pfizer announced an agreement with the UK for the supply of 30 million doses of mRNA based vaccine candidate.
- BioNTech and Pfizer signed an agreement with the U.S. Department of Health and Human Services for the supply of 100 million doses of a vaccine against COVID-19 and the option to acquire up to an additional 500 million doses.
- BioNTech and Pfizer signed an agreement with the Japanese Ministry of Health, Labour and Welfare to supply 120 million doses of their BNT162 mRNA-based vaccine candidate against SARS-CoV-2.
- Following an extensive review of preclinical and clinical data from Phase 1/2 clinical trials, Pfizer and BioNTech chose to advance one out of four COVID-19 mRNA vaccine candidates into the global phase 2/3 efficacy and tolerability study. The phase 2/3 study is planned to include > 30,0000 volunteers and to be conducted at about 120 sites across the U.S., Argentina, Brazil, and Germany. (The study was later expanded to approximately 44,000 volunteers and more than 150 sites).
- BioNTech and Fosun Pharma announced that the first volunteers in China received their first dose of the COVID-19 mRNA vaccine candidate, after approval of the Phase 1 study by the Chinese regulatory authority, National Medical Products Administration. The vaccine is now in clinical trials across three continents. This underlines BioNTech’s efforts to support a global supply of a potential vaccine upon regulatory approval.
- BioNTech is one of the few non-Chinese companies conducting a clinical trial in China.
- Furthermore, BioNTech and Pfizer signed an agreement with the Canadian government for the supply of the mRNA-based vaccine candidate against SARS-CoV-2 in 2021.
- Data from the phase 1/2 study with the lead COVID-19 mRNA vaccine candidate was made available.
- The German regulatory authority, the Paul-Ehrlich-Institut, has approved the Phase 2/3 clinical trial in Germany.
- The study in Germany is part of the global pivotal Phase 2/3 clinical study BioNTech and Pfizer initiated in July this year.
- The study will be conducted in appoximately 120 (later at more than 150 sites) sites globally.
- As of Sept 7, 2020, the trial enrollment has exceeded 25,000 participants (out of the planned approximately 44,000).
- The manufacturing site acquired from Novartis AG (CH) will expand BioNTech’s COVID-19 vaccine production capacity, once fully operational.
- The acquisition reflects BioNTech’s commitment to significantly expanding its manufacturing capacity in order to supply a potential vaccine worldwide upon authorization or approval.
- The decision by the European Medicines Agency (EMA) as well as Health Canada to start a rolling review follows the data related to the COVID-19 mRNA vaccine.
- In a rolling review, EMA’s CHMP (Committee for Medicinal Products for Human Use) reviews data as they become available from ongoing studies. Once CHMP decides that sufficient data are available, the complete application should be submitted by BioNTech.
- The study enrolled 43,538 participants to date, 38,955 of whom have received a second dose of the vaccine candidate. Approximately 42% of the global participants and 30% of the U.S. participants have racially and ethnically diverse backgrounds.
- Supply agreement provides the European Union with a supply of 200 million doses of BioNTech's COVID-19 mRNA vaccine candidate and an option to request additional 100 million doses, with deliveries starting by the end of 2020, subject to regulatory approval.
- The vaccine supply for the EU will be produced by BioNTech’s manufacturing sites in Germany and Pfizer’s manufacturing site in Belgium and based on current projections, the companies expect to produce up to 1.3 billion doses globally in 2021.
- BioNTech and Fosun now moved into phase 2 with their lead COVID-19 mRNA vaccine candidate as the China National Medical Products Administration has approved the start of the clinical trial in Mainland China.
- The safety data milestone with safety data being available for at least 2 months after the second dose as required by U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) has been achieved.
- The trial will continue to collect efficacy and safety data in participants for an additional two years.
- BioNTech and Fosun have started the evaluation of their lead mRNA COVID-19 vaccine candidate in a Phase 2 clinical trial in Taizhou and Lianshui, Jiangsu Province, China.
- The online recruitment of volunteers will commence with the recruitment of healthy participants including elderly to assess the safety and immunogenicity of the vaccine candidate and to support a future Biologic License Application (BLA) in China.
- Formal application for BioNTech's lead COVID-19 mRNA vaccine candidate submitted to European Medicines Agency (EMA).
- Rolling submissions across the globe including in UK, Australia, Canada and Japan have been initiated so far.
- These submissions demonstrate BioNTech’s commitment to enable a rapid worldwide supply upon potential approval of lead COVID-19 mRNA vaccine candidate, contributing to global joint efforts to regain normal pace of life.
- Medicines & Healthcare Products Regulatory Agency (MHRA) in the UK has granted a temporary authorization for emergency supply for BioNTech's COVID-19 mRNA vaccine, against COVID-19.
- This is the first temporary authorization for emergency supply following a worldwide Phase 3 trial of a vaccine.
- Earlier this year, a contract with the UK for the delivery of mRNA vaccine was closed. The deliveries will occur throughout 2020 and 2021, in stages, to ensure an equitable allocation of vaccines across global geographies with executed contracts.
- The U.S. Food and Drug Administration (FDA) has authorized the emergency use of BioNTech's mRNA vaccine against COVID-19.
- The Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. Please see EUA Fact Sheet at www.cvdvaccine.com.
- BioNTech's COVID-19 mRNA vaccine received conditional marketing authorization (CMA) from the European Commission. The CMA is valid in all 27 member states of the European Union (EU).
- Pfizer and BioNTech are ready to immediately ship initial doses to the 27 EU member states. The distribution by the EU member states will be determined according to the populations identified in EU and national guidance.
- BioNTech's mRNA vaccine has now been granted a conditional marketing authorization, emergency use authorization or temporary authorization in more than 40 countries worldwide.