Therapy Areas: Oncology
Bavarian Nordic's partner submits MAAs to EMA for investigational Ebola vaccine regimen
8 November 2019 -

Bavarian Nordic A/S (CPH:BAVA)(OTC: BVNRY), a biotechnology company focused on the development of innovative therapies against infectious diseases and cancer, announced on Thursday the submission by its partner, Janssen Pharmaceutical Companies of Johnson & Johnson, of Marketing Authorisation Applications (MAAs) to the European Medicines Agency (EMA) seeking licensure for an investigational Ebola vaccine regimen for the prevention of Ebola Virus Disease (EVD) caused by Zaire Ebola virus.

Reportedly, two MAAs have been submitted in parallel supporting each vaccine in the two-dose regimen (Ad26.ZEBOV, MVA-BN Filo). The EMA's Committee for Medicinal Products for Human Use (CHMP) granted an Accelerated Assessment in September 2019, which will shorten the review time for these applications.

This vaccine regimen includes Ad26.ZEBOV as the first dose, which is based on Janssen's AdVac technology, and MVA-BN Filo as the second dose, which is based on Bavarian Nordic's MVA-BN technology and is administered approximately eight weeks later.

These MAAs are supported by data from phase 1, 2 and 3 clinical studies evaluating the safety and immunogenicity of the vaccine regimen in adults and children, preclinical studies, and immunobridging analyses. To date, more than 6,500 volunteers across the US, Europe and Africa have participated in over 10 clinical studies of the vaccine.

Also, Janssen has ongoing discussions with the US Food and Drug Administration (FDA) to define the required data set for filing of the Ebola vaccine regimen under the FDA's Animal Rule licensure pathway and is also working in collaboration with the World Health Organisation (WHO) to enable registration of the Ebola vaccine regimen in African countries.

On 31 October 2019, Janssen announced that it will provide up to 500,000 regimens of its investigational vaccine to the Democratic Republic of Congo (DRC) for use in a new clinical trial organised by the DRC government and global health stakeholders in an effort to contain the country's Ebola outbreak.

Upon EMA approval of the MVA-BN Filo vaccine, Bavarian Nordic would be eligible to receive a milestone payment of USD10m under the licence agreement with Janssen.