Bavarian Nordic receives European approval for vaccine label extension to include monkeypox
Details Category: Vaccines Published on Tuesday, July 26, 2022 10:14 a.m. Visits: 283
COPENHAGEN, Denmark I July 25, 2022 I Bavarian Nordic A/S (OMX: BAVA) today announced that the European Commission (EC) has extended the marketing authorization for the company’s smallpox vaccine, IMVANEX®, to include protection against monkeypox and vaccine virus disease. The approval, which follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on 22 July 2022, is valid in all member states of the European Union, as well as in Iceland, Liechtenstein and Norway.
The label extension was approved following the submission of a type II variation application in June 2022, in line with the Emergency Working Group (ETF) of the European Medicines Agency , the speakers and the European Health Emergency Preparedness and Response Authority (HERA). The EC approved the full indication for IMVANEX as: Active immunization against smallpox, monkeypox and vaccine virus disease in adults. The approval of the monkeypox indication is an example of great cooperation between the Bavarian and European regulators, as this indication extension usually takes at least 6-9 months to achieve.
Paul Chaplin, Chairman and CEO of Bavarian Nordic, said: “We are pleased to receive approval from the European Commission, expanding the label of our vaccine to include monkeypox. The availability of an approved vaccine can improve significantly prepare nations to fight emerging diseases, but only through investments and structured biological preparedness planning.The development of IMVANEX was made possible by significant investments by the United States government over the past two decades, which they paved the way for other governments to develop plans and prioritize the future to protect their citizens against threats to public health. With this approval, we look forward to working more closely with the EU and its member states to solve this important task.” .
About IMVANEX®IMVANEX® (MVA-BN or Modified Vaccinia Ankara-Bavarian Nordic) is a non-replicative smallpox vaccine developed in collaboration with the US government to ensure the supply of a smallpox vaccine for the entire population, including immunocompromised individuals for whom vaccination with traditional smallpox replication vaccines is not recommended. The vaccine was approved by the European Commission in 2013 for immunization against smallpox in adults aged 18 years and older and has subsequently obtained regulatory approvals in Canada (marketed as IMVAMUNE®) and the USA (marketed as JYNNEOS®), where approvals have been extended. include the monkey pox indication as the only vaccine that has gotten it so far.
Bavarian Nordic has ongoing supply contracts with the US and Canada and has delivered the vaccine to several undisclosed countries around the world as part of its national biologics readiness. In recent years, smaller quantities of the vaccine have been supplied in response to sporadic cases of monkeypox. During the 2022 monkeypox outbreak, Bavarian Nordic has worked with various governments to meet immediate vaccine demand through various supply agreements and is working to secure vaccine manufacturing to meet medium and long-term demand.
About Bavarian NordicBavarian Nordic is a fully integrated vaccine company focused on developing, manufacturing and commercializing vaccines that can save lives. We are a world leader in smallpox vaccines and have been a long-term supplier to the US government of a non-replicating smallpox vaccine that has been approved by the FDA for protection against smallpox as well . The vaccine is also approved for protection against smallpox and monkeypox in Canada, and as a smallpox vaccine in Europe. In addition, our commercial product portfolio contains market-leading vaccines against rabies and 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, which is licensed to Johnson & Johnson’s Janssen Pharmaceutical Companies. We are also committed to the development of a next-generation vaccine against COVID-19. For more information, visit www.bavarian-nordic.com.
SOURCE: Bavarian Norse