13.03.2024 13:29:22 - dpa-AFX: GNW-Adhoc: Bavarian Nordic Receives Approval of Smallpox and Mpox Vaccine in Switzerland
COPENHAGEN, Denmark, March 13, 2024 - 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.
About the smallpox/mpox vaccine
MVA-BN or Modified Vaccinia Ankara-Bavarian Nordic is a non-replicating smallpox
vaccine and the only mpox vaccine approved in the U.S. and Switzerland (marketed
as JYNNEOS(®)), Canada (marketed as IMVAMUNE(®)), and the EU/EAA and United
Kingdom (marketed as IMVANEX(®)). Originally developed in collaboration with the
U.S. government to ensure the supply of a smallpox vaccine for the entire
population, including immunocompromised individuals who are not recommended
vaccination with traditional replicating smallpox vaccines, MVA-BN has been
indicated for use in the general adult population in individuals considered at
risk for smallpox or mpox infection.
Bavarian Nordic has been a long-term supplier of the vaccine to the U.S. and
Canada as well as several other countries as part of their national biological
preparedness. During the 2022-2023 mpox outbreak, Bavarian Nordic has
furthermore supported governments and supranational organizations by expanding
access to the vaccine to more than 70 countries worldwide.
About Bavarian Nordic
Bavarian Nordic is a fully integrated vaccine company with a mission to protect
and save lives through innovative vaccines. We are a global leader in smallpox
and mpox vaccines, supplied to governments to enhance public health preparedness
and have a strong portfolio of vaccines for travelers and endemic diseases. For
more information visit www.bavarian-nordic.com (http://www.bavarian-nordic.com).
Forward-looking statements
This announcement includes forward-looking statements that involve risks,
uncertainties and other factors, many of which are outside of our control, that
could cause actual results to differ materially from the results discussed in
the forward-looking statements. Forward-looking statements include statements
concerning our plans, objectives, goals, future events, performance, and/or
other information that is not historical information. All such forward-looking
statements are expressly qualified by these cautionary statements and any other
cautionary statements which may accompany the forward-looking statements. We
undertake no obligation to publicly update or revise forward-looking statements
to reflect subsequent events or circumstances after the date made, except as
required by law.
Contacts
Europe: Rolf Sass Sørensen, Vice President Investor Relations, Tel:
+45 61 77 47 43
US: Graham Morrell, Paddock Circle Advisors, graham@paddockcircle.com
(mailto:graham@paddockcircle.com), Tel: +1 781 686 9600
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