EU Commission approves Janssen Ebola vaccine

On Monday, the European Commission adopted the decision granting marketing authorizations to Janssen, a Johnson & Johnson (NYSE: NJ) company, for a vaccine against Ebola. The authorization was granted in one month, reducing the decision-making process timing in half, further demonstrating the Commission's commitment in placing the protection of public health as a priority.

Two Marketing Authorization Applications (MAAs) were submitted to the European Medicines Agency for the vaccines composing the two-dose regimen, Zabdeno (Ad26.ZEBOV) and Mvabea (MVA-BN-Filo). Marketing Authorization under exceptional circumstances has been granted following Accelerated Assessment of the MAAs and a positive opinion by the EMA’s Committee for Medicinal Products for Human Use (CHMP).

Enabled by this approval, Janssen says it is now collaborating with the World Health Organization (WHO) on vaccine pre-qualification, which should help accelerate registration of its preventive Ebola vaccine regimen in African countries and facilitate broader access to those most in need.