Ebola Vaccine Regimen Receives European Commission Marketing Authorization

Janssen Pharmaceutical Companies, a part of Johnson & Johnson, has announced that the European Commission (EC) has granted Marketing Authorization for its 2-dose Ebola vaccine regimen.

Janssen will collaborate with the World Health Organization (WHO) on vaccine pre-qualification, in order to hasten registration in endemic countries and facilitate broader access.

The World Health Organization (WHO) has shared reports from the Democratic Republic of the Congo indicating a new outbreak of Ebola virus is occurring in the nation’s northwest region. This 11^th outbreak comes just as the 10^th outbreak, which was located in the Kivu region, ends.

The vaccine regimen was approved through 2 separate Marketing Authorization Applications submitted to the European Medicines Agency. The regimen consists of Ad26.ZEBOV and MVA-BN-Filo. The product is indicated for immunization against Ebola Virus Disease caused by Zaire ebolavirus in individuals 1 year of age and over.

The largest Ebola outbreak to date was the West African epidemic, which caused nearly 30,000 cases and more than 11,000 deaths in 2014-2016.

“The European approval of Janssen’s Ebola vaccine regimen is a landmark moment — both for our company and in the world’s battle against the deadly Ebola virus. Building on our history, we are committed to bringing forward vaccines to help overcome the threat of some of the world’s most life-threatening infectious diseases,” said Paul Stoffels, MD, Chief Scientific Officer of Johnson & Johnson.

“The approval of our Ebola vaccine symbolizes the progress Janssen has made towards achieving our vision of delivering potentially transformational vaccines to communities most at risk of deadly infectious diseases. Not only is it the first vaccine to emerge from our vaccines pipeline, it is also the first approved vaccine to be developed using Janssen’s AdVac technology. The same technology is being used to develop vaccine candidates to protect against SARS-CoV-2, as well as Zika, RSV and HIV,” said Mathai Mammen, MD, PhD, Global Head, Janssen Research & Development.

The Ebola vaccine is designed to induce long-term immunity against the Ebola virus.

“As such, it will be used to support preventive vaccination in countries most at risk of outbreaks, as well as for other at-risk groups such as healthcare workers, biosafety level 4 (BSL4) laboratory workers, military personnel deployed in the affected regions, airport staff and visitors to high-risk countries,” statement authors wrote.

Ad26.ZEBOV is the first dose of the regimen, with MVA-BN-Filo administered approximately eight weeks later.

Between clinical studies and vaccination initiatives, the company noted that approximately 60,000 people have been vaccinated with Janssen’s preventive Ebola vaccine regimen already.

Studies suggest that the vaccine regimen is well tolerated, inducing robust and durable immunity.

Johnson & Johnson cited a variety of agencies which supported and co-funded vaccine development efforts, such as the Biomedical Advanced Research and Development Authority (BARDA) at the U.S. Department of Health and Human Services, the Innovative Medicines Initiative, and the National Institutes of Health at the U.S. Department of Health and Human Services. Discussions with the U.S. Food and Drug Administration have begun in order to establish US licensure.

Ad26.ZEBOV + MVA-BN-Filo uses a non-replicating viral vector strategy in which viruses are genetically modified so that they cannot replicate in human cells. These vectors also carry the genetic code of several Ebola virus proteins in order to trigger an immune response.