Bavarian Nordic submits data to EMA to extend approval of Mpox/smallpox vaccine to adolescents Page 1

• Interim results from a clinical study show that the immune response to mpox/smallpox vaccination in adolescents is non-inferior and that the safety profile is comparable to that of adults. This supports the extension of the current approval in Europe later in 2024.

COPENHAGEN, Denmark, August 16, 2024 – Bavarian Nordic A/S (OMX: BAVA) has submitted clinical data to the European Medicines Agency (EMA) to support the extension of the IMVANEX (MVA-BN) smallpox and mpox vaccine indication to adolescents aged 12 to 17 years.

Although the vaccine is currently only indicated for adults 18 years and older, the FDA granted an Emergency Use Authorization for use in adolescents during the global mpox outbreak in 2022. It remains the only mpox vaccine approved by the FDA and EMA.