COPENHAGEN, Denmark, June 7, 2021 – Bavarian Nordic A/S (OMX: BAVA) today announced that the Strategic Advisory Group of Experts (SAGE) on Immunization for the World Health Organization (WHO) has released its latest recommendations in support of the use of Johnson & Johnson’s two-dose Ebola vaccine regimen, Zabdeno® (Ad26.ZEBOV) and Mvabea® (MVA-BN-Filo) from Bavarian Nordic, both during outbreaks for individuals at some risk of Ebola exposure and preventively, before outbreaks, for national and international first responders.
The recommendation from SAGE follows the Marketing Authorisation by the European Commission in July 2020 and WHO Prequalification in April 2021.
Additional details are available in Johnson & Johnson’s press release: https://www.jnj.com/statement-on-the-sage-recommendation-regarding-the-johnson-johnson-ebola-vaccine-regimen
About the Johnson & Johnson Ebola vaccine regimen
The European Commission-approved Johnson & Johnson preventive Ebola vaccine regimen, Zabdeno® (Ad26.ZEBOV) and Mvabea® (MVA-BN-Filo), utilizes a non-replicating viral vector strategy in which viruses – in this case adenovirus serotype 26 (Ad26) and Modified Vaccinia Virus Ankara (MVA) – are genetically modified so that they cannot replicate in human cells. In addition, these vectors carry the genetic code of several Ebola virus proteins in order to trigger an immune response. Mvabea® (MVA-BN-Filo) was originally developed by Bavarian Nordic and was licensed to Janssen in 2014. Bavarian Nordic has ongoing contracts with the Janssen Pharmaceutical Companies of Johnson & Johnson to manufacture the vaccine.
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 vaccines company focused on the development, manufacture and commercialization of life-saving vaccines. We are a global leader in smallpox vaccines and have been a long-term supplier to the U.S. government of a non-replicating smallpox vaccine, which has been approved by the FDA under the trade name JYNNEOS®, also for the protection against monkeypox. The vaccine is approved as a smallpox vaccine in Europe under the trade name IMVANEX® and in Canada under the trade name IMVAMUNE®. Our commercial product portfolio furthermore contains the market-leading vaccine Rabipur®/RabAvert® against rabies and Encepur® against tick-borne encephalitis. Using our live virus vaccine platform technology, MVA-BN®, we have created a diverse portfolio of proprietary and partnered product candidates designed to save and improve lives by unlocking the power of the immune system, including an Ebola vaccine, MVABEA®, which is licensed to the Janssen Pharmaceutical Companies of Johnson & Johnson. We are also committed to the development of a next generation COVID-19 vaccine based on an in-licensed capsid virus-like particle technology. The vaccine candidate, ABNCoV2, is currently being investigated in clinical trials. For more information visit www.bavarian-nordic.com.
Contacts
Europe: Rolf Sass Sørensen, Vice President Investor Relations, Tel: +45 61 77 47 43
US: Graham Morrell, Paddock Circle Advisors, graham@paddockcircle.com, Tel: +1 781 686 9600
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