Bavarian Nordic A/S is a fully integrated biotechnology company focused on the development, manufacturing and commercialization of vaccines. The company is headquartered in Hellerup, Denmark, with manufacturing facilities in Kvistgård, Denmark and Thörishaus [de] near Bern, Switzerland.[3] The company has research and development facilities in Martinsried, Germany and San Diego, California, as well as offices in Zug, Switzerland, and Morrisville, North Carolina. The company uses viral vectors and virus-like particles in its research and development.
Technologies
MVA-BN
MVA-BN is a proprietary technology developed by Bavarian Nordic. It is derived from the Modified vaccinia Ankara virus. MVA-BN is characterized by the inability to replicate in human cells,[7] contrary to other vaccinia-based vaccines, which may replicate in humans, thus potentially causing severe and life-threatening side effects. Developed as the non-replicating smallpox and mpox vaccine, MVA-BN is approved in Canada as Imvamune,[8] in the European Union, as Imvanex,[9] and the United States as
Jynneos.[10][11][12] The vaccine was supplied for emergency use to the U.S. Strategic National Stockpile as well as other government stockpiles.[citation needed]
The vaccine is being deployed worldwide to combat the 2022 mpox outbreak, leading to concerns over vaccine nationalism and hoarding by countries with pre-existing contracts.[13]
Ebola vaccine development and production
The company has worked for several years with the NIAID[14] on the development of a filovirus vaccine for Ebola and Marburghemorrhagic fever diseases. In October 2014, following a successful pre-clinical demonstration of the combination vaccine regimen of its multivalent MVA-BN Filovirus vaccine and Crucell/Janssen's AdVac technology based on adenoviral vectors, Bavarian Nordic joined efforts with Crucell Holland B.V., one of the Janssen Pharmaceuticals companies of Johnson & Johnson to develop and manufacture this vaccine regimen intended for emergency use to help contain the outbreak in West Africa.[15][16][17] In January 2015, the company had produced the first 400,000 doses of the vaccine and the first clinical trial of the vaccine regimen was initiated in the UK, with additional trials planned in the US and Africa.[18] It was approved for medical use in the European Union in July 2020.[19]
Acquisition completed on 31 December 2019. Bavarian Nordic assumes full sales and marketing responsibility from start 2020; manufacturing transfer takes place 2020–25 – during this period Bavarian Nordic will purchase remaining inventory of vaccines from GSK at different levels in the supply chain.[citation needed]
Acquisition completed on 31 December 2019. Bavarian Nordic assumes full sales and marketing responsibility from start 2020; manufacturing transfer takes place 2020–25 – during this period Bavarian Nordic will purchase remaining inventory of vaccines from GSK at different levels in the supply chain.[citation needed]
Licensed to Janssen. One dose of Janssen's primer Zabdeno (Ad26.ZEBOV) followed 8 weeks later by a dose of Bavarian Nordic's booster Mvabea® (MVA-BN Filo) collectively constitutes Janssen's Ebola vaccine regimen.
Ph1 topline results announced 8 June 2020.[27] A Phase 2 clinical study is planned for initiation in 2024.[28]
Associations
Bavarian Nordic is a member of the Medical Countermeasures Coalition, a group of companies, academic institutions, and other organizations dedicated to building an effective medical countermeasure enterprise through sound public policy and strong public-private partnerships.[29]
^"Archive.ph". Archived from the original on 13 March 2022. Retrieved 8 September 2023.{{cite web}}: CS1 maint: bot: original URL status unknown (link)
^"Jynneos". U.S. Food and Drug Administration (FDA). 24 September 2019. STN 125678. Archived from the original on 17 October 2019. Retrieved 16 October 2019. This article incorporates text from this source, which is in the public domain.
