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J&J files for European approval of Ebola vaccine

By Ben Hargreaves contact

- Last updated on GMT

(Image: Getty/Ijeab)
(Image: Getty/Ijeab)

Related tags: Johnson & johnson, Bavarian Nordic, Ebola vaccine, Merck

J&J applies to the EMA for marketing approval of its two-dose vaccine for the prevention of the Ebola virus.

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.

Only last month​, MSD, known as Merck in North America and Mexico, received conditional approval​ from the EMA’s CHMP for its own Ebola vaccine.

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​.

Related topics: Markets & Regulations, Pipelines

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