Bavarian Nordic A/S (OMX: BAVA) announced today that the European Commission has granted marketing authorization for IMVANEX® (MVA-BN) for active immunization against smallpox disease for the general adult population, including people with weakened immune systems (people diagnosed with HIV or atopic dermatitis). The authorization covers all 27 European Union member states and European Economic Area countries Iceland, Liechtenstein and Norway.
IMVANEX will be made available for governments to purchase and use in accordance with official national recommendations.
“The marketing authorization of IMVANEX marks a significant milestone for our company and our MVA-BN vaccine technology platform, which we have taken from early research through regulatory approval and now serves as the foundation for multiple candidates in our development pipeline,” said Anders Hedegaard, President and CEO of Bavarian Nordic. “We are delighted to receive our first regulatory product approval, and we look forward to working with the European governments to address the requirements for their national preparedness plans, focusing on the advantages that IMVANEX brings in terms of safety and administration for people at risk.”
IMVANEX is the only smallpox vaccine approved through the centralized procedure and available to all EU member states. Known as IMVAMUNE® in the U.S., it has been developed under contracts with the U.S. Government. To-date, Bavarian Nordic has manufactured and delivered 17 million doses of the vaccine to the U.S. Strategic National Stockpile for emergency use in immune compromised individuals, such as people with atopic dermatitis and HIV who are not recommended to receive conventional, replicating smallpox vaccines. IMVANEX has also been supplied to other government stockpiles around the world.
About IMVANEX (MVA-BN)
MVA-BN (Modified Vaccinia Ankara – Bavarian Nordic) is a robust and adaptable vaccine platform suitable for addressing a wide variety of infectious diseases, including biological threats. In addition to developing MVA-BN (trade name IMVANEX) as a safer smallpox vaccine essential to protecting the immune-compromised population, Bavarian Nordic has conducted preclinical and clinical studies of recombinant MVA-BN-based vaccines for a variety of infectious diseases and numerous types of cancer. Almost 5,800 individuals, nearly 1,000 of whom are immunocompromised, have been vaccinated with MVA-BN-based vaccines, showing the platform displays high immunogenicity and a favorable safety profile.
An advantage of MVA-BN is the virus’ inability to replicate in a vaccinated individual. The replication cycle is blocked at a very late stage, which ensures that new viruses are not generated and released. This means that the virus cannot spread in the vaccinated person and none of the serious side effects normally associated with replicating vaccinia viruses have been seen with MVA-BN.