Johnson & Johnson has announced that Janssen-Cilag International has submitted a conditional Marketing Authorization Application (cMAA) to the European Medicines Agency (EMA) seeking authorization for its investigational single-dose Janssen COVID-19 vaccine candidate.
The submission is based on efficacy and safety data from the Phase 3 ENSEMBLE clinical trial.
Ready to begin distributing in Q2 2021
“Throughout Europe, there remains an urgent need for additional COVID-19 vaccines, and today’s submission is a significant step forward in ensuring the European Union has another option to help reduce the impact the pandemic has had in Europe and around the world,” says Paul Stoffels, Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson. “We stand ready to begin distributing our vaccine within the European Union in the second quarter of 2021.”
Once a conditional Marketing Authorization has been granted, the company must fulfill specific obligations within defined timelines, including the supply of additional data.
The company announced in December it had initiated a rolling submission with the EMA for its investigational Janssen COVID-19 vaccine, enabling the EMA to review data as they become available. In addition, rolling submissions for the investigational single-dose COVID-19 vaccine have been initiated in several countries worldwide and with the World Health Organization (WHO). The company filed for Emergency Use Authorization (EUA) in the United States on February 4, 2021.