Scanning electron micrograph of a single filamentous Ebola virus particle. Credit: National Institute of Allergy and Infectious Diseases.

Johnson & Johnson subsidiary Janssen Pharmaceutical has filed marketing authorisation applications (MAAs) with the European Medicines Agency (EMA) for the approval of an Ebola vaccine regimen.

The two-dose regimen is intended to prevent Ebola virus disease (EVD) caused by Zaire ebolavirus species. Janssen submitted two MAAs for each vaccine in the regimen.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

Based on Janssen’s AdVac technology, Ad26.ZEBOV is the first dose of the Ebola vaccine regimen. The second MVA-BN-Filo dose is based on MVA-BN technology from Bavarian Nordic.

The doses are to be administered approximately eight weeks apart.

For the vaccine regimen, adenovirus serotype 26 (Ad26) and Modified Vaccinia Virus Ankara (MVA) are genetically modified to prevent replication in human cells.

The vectors are also modified to generate one of the Ebola virus proteins to induce an immune response.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

In the MAAs, Janssen included results from Phase I, II and III clinical trials, which were conducted to assess the safety and immunogenicity of the vaccine regimen in adults and children.

The applications are also supported by data from preclinical studies and immunobridging analyses.

More than 6,500 individuals in the US, Europe and Africa have participated in more than ten trials of the Ebola vaccine to date.

Janssen Pharmaceutica global therapeutic area head Johan Van Hoof said: “Our goal is to deliver a vaccine that can be used both in response to Ebola outbreaks and also more proactively as a prophylactic tool to help countries protect their populations.”

This September, EMA’s Committee for Medicinal Products for Human Use (CHMP) awarded an accelerated assessment for the MAAs.

Janssen is in discussions with the US Food and Drug Administration (FDA) about the data set necessary to seek approval for its vaccine regimen.

The company also partnered with the World Health Organization (WHO) to register the product in African markets.