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.

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 4 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 are 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.