Vaccine Regimen from Janssen and Bavarian Nordic to Support Republic of Rwanda’s Preparedness Against Ebola Outbreak

COPENHAGEN, Denmark, December 9, 2019 – Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) today announced, that its partner Janssen Pharmaceutical Companies of Johnson & Johnson will provide up to 200,000 regimens of its investigational Ebola vaccine to the Republic of Rwanda to support a new immunization program led by the Rwanda government. The vaccine regimen, which consists of the MVA-BN^® Filo vaccine from Bavarian Nordic and the Ad26.ZEBOV vaccine from Janssen, will help protect the citizens of Rwanda from the current Ebola outbreak in the neighboring country, the Democratic Republic of Congo (DRC).

The World Health Organization (WHO) has declared the Ebola outbreak in the DRC a Public Health Emergency of International Concern (PHEIC). More than 3,300 cases, including more than 2,200 deaths, have been reported to date, making the outbreak second only to the 2014-2016 West Africa epidemic. In October, Johnson & Johnson announced a donation of up to 500,000 regimens of the investigational vaccine to be part of an expanded response in DRC.

In July 2019, the fear of further spread of Ebola to Rwanda heightened due to two cases of the disease being reported in the DRC city of Goma, a major trading hub located near the Rwandan border. Because a significant number of Rwandan citizens cross the border to the DRC on a regular basis as part of their everyday life, the Rwanda Ministry of Health has established a large-scale vaccination campaign involving approximately 200,000 Rwandan citizens from age two and older in the regions bordering the DRC judged to be at risk. The program is initiated with the objective of creating a protective barrier to prevent Ebola from impacting the Rwandan citizens and from spreading further.

“We applaud the decision by the Rwandan authorities to introduce the Janssen/Bavarian Nordic vaccine to help prevent the Ebola virus from spreading in to the country, and we are proud to be a contributing partner in the development of a vaccine which is now actively being used in large-scale efforts to contain the virus in both the DRC, Uganda and Rwanda,” said Paul Chaplin, President and CEO of Bavarian Nordic.

Background
In 2014, in response to the Ebola epidemic in West Africa, Johnson & Johnson accelerated the development of a preventive Ebola vaccine regimen with multiple global partners across the U.S., Europe and Africa. The regimen (Ad26.ZEBOV, MVA-BN-Filo) uses a combination of two vaccines based on AdVac® technology from Janssen, and MVA-BN® technology from Bavarian Nordic. The first dose primes the immune system, and the second aims to enhance the duration of the immune response. These vaccines both use a viral vector approach, where a virus is genetically modified so that it cannot replicate but is used to safely express key proteins of the target virus, in this case Ebola virus. To date, nearly 8,000 individuals across the U.S., Europe and Africa have participated in multiple Janssen-sponsored and partner-led clinical studies. The available clinical data suggest that the vaccine regimen has a favorable safety profile, is well tolerated, and induces robust and durable immune responses against the Ebola virus Zaire strain – the cause of the DRC outbreak. In November 2019, Janssen submitted Marketing Authorisation Applications to the European Medicines Agency seeking licensure for the investigational Ebola vaccine regimen.

Under the agreement with Janssen in 2014, Bavarian Nordic licensed MVA-BN Filo to Janssen and manufactured a significant amount of vaccines for the stockpile, which is now being deployed in the DRC and Rwanda.

The vaccine regimen was developed in a collaborative research program with the NIH and received direct funding and preclinical services from the National Institute of Allergy and Infectious Diseases, part of NIH, under Contract Numbers HHSN272200800056C, and HHSN272201000006I and HHSN272201200003I, respectively. Further funding for the Ebola vaccine regimen has been provided in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, BARDA under Contract Numbers HHSO100201700013C and HHSO100201500008C.

About Bavarian Nordic
Bavarian Nordic is a fully integrated biotechnology company focused on the development of innovative therapies against infectious diseases and cancer. Using our live virus vaccine platform technology, MVA-BN^®, we have created a diverse portfolio of proprietary and partnered product candidates intended to unlock the power of the immune system to improve public health with a focus on high unmet medical needs. In addition to our long-standing collaboration with the U.S. government on the development and supply of medical countermeasures, including the only FDA-approved, non-replicating smallpox vaccine, our infectious disease pipeline comprises a proprietary RSV program as well as vaccine candidates for Ebola, HPV, HBV and HIV, which are developed through a strategic partnership with Janssen. Additionally, we have developed a portfolio of active cancer immunotherapies, designed to alter the disease course by eliciting a robust and broad anti-cancer immune response while maintaining a favorable benefit-risk profile. For more information visit www.bavarian-nordic.com or follow us on Twitter @bavariannordic.