Bavarian Nordic A/S (OMX: BAVA) announced today that the Swiss Agency for Therapeutic Products, Swissmedic, has approved JYNNEOS® (MVA-BN) for active immunization against disease caused by smallpox, mpox and vaccinia viruses in adults 18 years of age and older.
The approval represents the first national marketing authorization issued to Bavarian Nordic since 2019 and was facilitated by the Swiss authorities in response to the 2022 global mpox outbreak. During the outbreak, Bavarian Nordic supplied its mpox vaccine under emergency use provisions to countries where the vaccine was not approved, and which previously had not stockpiled the vaccine. In Switzerland, Bavarian Nordic committed to seeking marketing authorization of the vaccine and thus initiated the submission of its application in late December 2022. The review and subsequent approval with Swissmedic were completed in just 14 months, 4 months less than the standard review time.
With the approval from Swissmedic, MVA-BN is now approved for the prevention of smallpox and mpox disease in the U.S., Canada, EU/EEA, United Kingdom and Switzerland. Bavarian Nordic has also filed applications in several additional countries reflecting the larger customer base post the mpox outbreak.
“During public health emergencies, speed and agility in the distribution of life-saving vaccines is paramount. For many countries, the absence of an approved vaccine during the mpox outbreak initially presented a significant barrier for access to our vaccine among risk populations. We are therefore pleased to obtain a national approval in Switzerland, which will help facilitate easier access to our vaccine,” said Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic.
