Johnson & Johnson’s pharmaceutical division Janssen has announced the submission of a marketing authorisation application (MAA) with the European Medicines Agency (EMA) for the approval of its Ebola vaccine regimen.
This announcement comes hot-on-the-heels of Merck/MSD winning a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) for its own investigational V920 Ebola Zaire vaccine.
Now, J&J is looking to catch up – it is seeking licensure for its own investigational Ebola vaccine regimen in Europe. The company has submitted two MAAs to the EMA in parallel, to support each vaccine in a two-dose regimen (Ad26.ZEBOV, MVA-BN-Filo).
The regimen is delivered through a first dose of Ad26.ZEBOV and MVA-BN-Filo as the second dose, approximately eight weeks later. The latter vaccine is based on Danish biotech Bavarian Nordic’s technology.
J&J has already won an accelerated assessment from the CHMP for these applications, meaning that a verdict will likely be delivered sooner rather than later.
The application is supported by data from phase 1, 2 and 3 studies evaluating the safety and tolerability of the vaccine regimen in adults and children. According to J&J, more than 6,500 volunteers across the US, Europe and Africa have participated in over ten clinical studies of the vaccine.
“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,” said Johan Van Hoof, global therapeutic area head, vaccines and managing director, Janssen vaccines & prevention.
“We are grateful to our many global partners who have helped us reach this important stage of development,” he added.
Although both J&J and Merck have already made their respective vaccines available in the Democratic Republic of the Congo (DRC) in Africa, this has only been part of an effort to combat the outbreak of the Ebola Zaire virus in the country.
The outbreak in the DRC is ongoing, with the World Health Organization (WHO) reporting a total of 3,286 cases this year alone, as of 7 November 2019. This includes 2,190 deaths and 1,059 survivors, with many patients still receiving care.
Meanwhile, J&J and Merck are now looking to gain official regulatory approvals for their Ebola vaccines with global healthcare agencies.
In addition to filing its Ebola vaccine regimen with the EMA, J&J has also announced that it is in discussion with the US’ FDA, to define the data needed to support an application under the FDA’s Animal Rule licensure pathway.
It is also working with WHO to enable official registration of its Ebola vaccine regimen in a number of African countries.