Bavarian Nordic A/S(OTC:BVNRY) (OTC:BVNKF) submitted clinical data on Thursday to the European Medicines Agency (EMA) to support the extension of the Imvanex (MVA-BN) smallpox and mpox vaccine indication to include adolescents 12 to 17 years of age.
Jynneos is known internationally as Imvamune or Imvanex.
While currently only indicated for adults 18 years and older, the FDA granted an Emergency Use Authorization for pre- and post-exposure use in adolescents during the 2022 global pox outbreak.
It remains the only FDA and EMA-approved pox vaccine.
The submission is based on interim results from a clinical study sponsored by...
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