Johnson & Johnson made the announcement that, alongside partner Bavarian Nordic, it had submitted marketing authorization applications (MAAs) to the European Medicines Agency (EMA) for the companies’ two-dose vaccine regimen.
The applications will be reviewed through the accelerated assessment pathway, after the EMA’s Committee for Medicinal Products for Human Use (CHMP) provided the designation in September 2019.
The two MAAs are necessary, as the dosing regimen for J&J’s vaccine relies on its Ad26.ZEBOV as the first dose of treatment and then Bavarian Nordic’s MVA-BN-Filo is utilized as the follow up dose.
Both J&J and MSD have been supported by the US Biomedical Advanced Research and Development Authority (BARDA) in their development of their respective vaccines, as well as providing fund for the manufacture of doses currently being used in Democratic Republic of Congo.
The country has been hit by recurrent outbreaks of Ebola, with fears that the virus could also be appearing in neighboring countries.