Scientific studies report a new virus in China.
The genetic code of SARS-CoV-2 is sequenced and published.
BioNTech starts Project Lightspeed to develop a vaccine against this new virus.
BioNTech selects several vaccine candidates and conducts initial non-clinical studies.
BioNTech, Pfizer, and Fosun Pharma agree to cooperate on the development and commercialization of an mRNA-based vaccine against COVID-19.
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.
The first study subject is vaccinated with the BioNTech mRNA vaccine candidate.
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.
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.
The first emergency use authorization worldwide is granted by the UK.
The U.S. FDA approves the emergency use of the vaccine for people 16 years of age and older.
The vaccine receives conditional marketing authorization from the European Commission. This is valid in all 27 Member States of the European Union.
In Marburg Hessen, manufacture of the MRNA required for the vaccine is initiated at the new BioNTech production sites.
BioNTech and Pfizer start a global phase 2/3 clinical trial to study the COVID-19 vaccine in pregnant women.
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.
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).
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.