Paul-Ehrlich-Institut

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The CHMP Rec­om­mends an In­di­ca­tion Ex­ten­sion of Im­vanex

The Committee for Medicinal Products for Human Use (CHMP), at the European Medicines Agency (EMA), recommended on 22 July 2022 that the indication of the smallpox vaccine Imvanex be extended to cover protection against monkeypox in adults. The European Commission followed the recommendation of the CHMP and approved the indication extension on 22 July 2022. Imvanex has been authorised in the EU for use in adults to protect against smallpox since 2013. The vaccine contains a modified, non-replicating form of the Ankara vaccinia virus (modified vaccinia virus Ankara, MVA), which is related to the smallpox virus (variola virus). Imvanex's suitability for vaccination against monkeypox is based on the similarity between MVA/Imvanex and the monkeypox virus. The marketing authorisation holder is Bavarian Nordic A/S.

Vial with vaccine (Source: A. Deco/Shutterstock.com)

Study Data

The CHMP's recommendation is based on data from Imvanex vaccinations. The CHMP concluded that the effectiveness of Imvanex for the protection of humans against monkeypox could be inferred from these studies. In order to confirm the effectiveness of the vaccine against monkeypox in humans, the company will collect data from an observational study that will be carried out during the ongoing monkeypox outbreak in Europe.

Safety Data

The safety profile of Imvanex is favourable – the side effects known from its use in humans are mild to moderate and are resolved within a short period of time. Therefore, the CHMP concluded that the benefit-risk profile of the vaccine is favourable.

The CHMP also recommended that Imvanex be approved not only for the prevention of monkeypox in adults, but also for protection against the milder infectious disease which may be caused by exposure to the vaccinia virus.

Updated: 25.07.2022