Janssen-Cilag International, a subsidiary of Johnson & Johnson has submitted a conditional marketing authorisation application (cMAA) to the European Medicines Agency (EMA) for its investigational single-dose Janssen COVID-19 vaccine candidate.
The company stated that the submission of authorisation application is based on Phase 3 ENSEMBLE clinical trial’s topline efficacy and safety data.
Once the cMAA is approved, Johnson & Johnson is required to fulfil specific obligations within defined timelines, including the supply of additional data.
Johnson & Johnson chief scientific officer and Executive Committee vice-chairman Paul Stoffels said: “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.
“We stand ready to begin distributing our vaccine within the European Union in the second quarter of 2021.”
In December, the company’s Covid-19 vaccine was under a rolling review by the EMA.
Additionally, Johnson & Johnson has initiated a rolling submission for the investigational single-dose COVID-19 vaccine in several countries across the world as well as with the World Health Organization (WHO).
It has also filed for Emergency Use Authorization (EUA) in the US on 4 February.
The Janssen vaccine, which uses the company’s AdVac vaccine platform, is said to be compatible with standard vaccine distribution channels.
The AdVac vaccine platform was used to develop and manufacture the Ebola vaccine regimen and construct its investigational Zika, RSV, and HIV vaccines.