February 17, 2021 -- Johnson & Johnson announced that Janssen has submitted a conditional marketing authorization application to the European Medicines Agency (EMA) for its investigational single-dose Janssen COVID-19 vaccine candidate.
The submission is based on efficacy and safety data from its phase III Ensemble clinical trial. The vaccine candidate was designed using the company's AdVac vaccine platform.
The company announced in December 2020 that it had initiated a rolling submission with the EMA, enabling the agency to review data as it became available. In addition, the company has started rolling submissions in many other countries and with the World Health Organization. An emergency use authorization (EUA) was filed in the U.S. on February 4.
Janssen's investigational single-dose vaccine is estimated to remain stable for two years at -20° C (-4° F), at least three months of which can be stored in most standard refrigerators at temperatures of 2°-8° C (36° F–46° F).