Project Lightspeed
From development to approval
How was it possible to develop COMIRNATY® and get it approved so quickly?
- No research or process steps were skipped.
- The results of these trials were evaluated while the trials were still ongoing (instead of after the end of each phase), and the European Medicines Agency (EMA) performed an accelerated approval procedure.
- The safety and efficacy of the vaccine were tested and evaluated according to the global standards of clinical research at each phase of the approval process.
- All steps in the approval procedure were completed in full.
There are several reasons why COMIRNATY® was developed and approved so quickly:
- BioNTech has been researching mRNA for quite a long time, and was able to apply this technology toward the development of potential vaccine candidates.
- BioNTech also saved time by carrying out some of the clinical trial phases on safety and efficacy at the same time.
- The European Medicines Agency assessed the data from these studies in a “rolling” procedure, meaning that the data was submitted to and evaluated by EMA on a continuous basis, and not just once data collection was complete.
- All of the necessary regulatory and medical steps were carried out in full.
- BioNTech applied for approval of this new drug with EMA based on the available study data. This application procedure involved close collaboration between BioNTech and EMA.
The timeline to approval of COMIRNATY®
Early January 2020
Scientific studies report a new virus in China.
January 12, 2020
The genetic code of SARS-CoV-2 is sequenced and published.
Mid-January 2020
BioNTech starts Project Lightspeed to develop a vaccine against this new virus.
BioNTech selects several vaccine candidates and conducts initial non-clinical studies.
Mid-March 2020
BioNTech, Pfizer, and Fosun Pharma agree to cooperate on the development and commercialization of an mRNA-based vaccine against COVID-19.
April 2020
The German regulatory agency Paul Ehrlich Institute approves the start of the first clinical trial in BioNTech’s vaccine program with the goal of choosing the best vaccine candidate from the four available.
April 23, 2020
The first study subject is vaccinated with the BioNTech mRNA vaccine candidate.
Late April – November 2020
Multiple clinical trials with over 44,000 subjects at more than 150 sites in the US, Germany, Brazil, and Argentina are carried out to evaluate the vaccine and investigate its protective effects against SARS-CoV-2. Studies also begin in China.
November 2020
The data required for approval is ready. The first applications are submitted to agencies including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency. Other applications for approval are started around the world, including the United Kingdom (UK), Australia, Canada, and Japan.
December 2, 2020
The first emergency use authorization worldwide is granted by the UK.
December 11, 2020
The U.S. FDA approves the emergency use of the vaccine for people 16 years of age and older.
December 21, 2020
The vaccine receives conditional marketing authorization from the European Commission. This is valid in all 27 Member States of the European Union.
February 10, 2021
In Marburg Hessen, manufacture of the MRNA required for the vaccine is initiated at the new BioNTech production sites.
February 18, 2021
BioNTech and Pfizer start a global phase 2/3 clinical trial to study the COVID-19 vaccine in pregnant women.
March 31, 2021
BioNTech announces that the COVID-19 mRNA vaccine is well tolerated by study participants aged 12-15 years and shows antibody levels that may exceed the robust antibody levels in vaccinated people aged 16-25 years.
May 17, 2021
The European Medicines Agency (EMA) confirms the following improvements: vials with the defrosted and undiluted COVID-19 mRNA vaccine COMIRNATY® can be stored at 2-8°C for up to 1 month (31 days instead of the 5 days previously).
May 28, 2021
The COVID-19 mRNA vaccine from BioNTech receives conditional authorization from the European Commission for the prevention of COVID-19 in adolescents aged 12–15 years.
