J&J’s COVID-19 vaccine is in rolling review by EMA

Recently, Johnson & Johnson (J&J) announced that it has initiated a rolling request to the European Medicines Agency (EMA) for its single-dose investigational vaccine to prevent COVID-19.

The rolling review of the Janssen COVID-19 single-dose investigational vaccine candidate was based on encouraging non-clinical data, illustrating that, as shown by neutralizing antibodies, the vaccine produces a robust immune response. Johnson & Johnson will continue to cooperate closely with the Committee for Medicinal Products for Human Use of the EMA to promote if considered necessary, a conditional Marketing Authorization Application (MAA) and complete the rolling review process.

Also, Janssen is in discussions with other regulatory authorities globally as it prepares to begin regulatory review processes during the pandemic response timeframe for the use of its investigational single-dose COVID-19 vaccine.