Janssen in Rolling Submission for Single-dose COVID-19 Vaccine Candidate to European Medicines Agency

Janssen-Cilag International N.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, has initiated a rolling submission with the European Medicines Agency (EMA) for its investigational single-dose vaccine candidate for the prevention of COVID-19.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) enabled a rolling review of the investigational single-dose Janssen COVID-19 vaccine candidate based principally on positive non-clinical data showing that the vaccine candidate elicits a robust immune response, as demonstrated by neutralising antibodies. 

Janssen will continue to work in close collaboration with the EMA’s CHMP to complete the rolling review process and to facilitate a conditional Marketing Authorisation Application (MAA) when appropriate. In addition to the EMA, Janssen is in discussions with other regulatory authorities worldwide, as it prepares to initiate regulatory review processes for use of its investigational single-dose COVID-19 vaccine candidate during the pandemic response period.

https://www.janssen.com/emea/sites/www_janssen_com_emea/files/jj_announces_initiation_of_rolling_submission_for_its_single_dose_janssen_covid19_vaccine_candidate_with_the_ema.pdf