Bavarian Nordic Vaccine Gets EU Expanded Approval for Monkeypox

Bavarian Nordic’s Imvanex (modified Vaccinia Ankara-Bavarian Nordic) vaccine has received expanded marketing authorization from the European Commission for monkeypox in addition to smallpox.

The expanded indication follows a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) earlier this month.

With the expanded authorization, Imvanex is now approved for active immunization against smallpox, monkeypox and disease caused by vaccinia virus in adults.

The World Health Organization has declared the monkeypox outbreak to be a public health emergency of international concern. There have been almost 14,000 monkeypox cases and five deaths reported globally.