“The safety profile of the medicine is favorable, with mild to moderate side effects, and the EMA committee concluded that the benefits of the medicine outweigh the risks.”
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended extending the indication of the smallpox vaccine Imvanex to include use for the protection of adults from monkeypox.
The Imvanex vaccine has been approved in the EU since 2013 for the prevention of smallpox.
It contains a modified (weakened) live form of the Vaccinia virus called “Vaccinia Ankara”, which is related to the smallpox virus.
It has also been considered a potential vaccine for monkeypox due to the similarity between the two viruses. The holder of the marketing authorization is Bavarian Nordic A/S.
The EMA’s Committee for Medicinal Products for Human Use based its recommendation on data from several animal studies that showed protection against monkeypox virus in non-human primates vaccinated with Imvanex. The committee considered that the efficacy of Imvanex in the prevention of monkeypox in humans could be inferred from these studies.
To confirm the effectiveness of the monkeypox vaccine, the company will collect data from an observational study that will be conducted during the ongoing monkeypox epidemic in Europe. The safety profile of the medicine is favorable, with mild to moderate side effects, and the EMA committee concluded that the benefits of the medicine outweigh the risks.
ANSA.it report (in Italian)
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