Smallpox monkeys, ok Ema to smallpox vaccine also for Monkeypox

Green light from the Medicines Committee to extend the indication of Imvanex

Green light from the European Medicines Agency Ema to use the smallpox vaccine Imvanex * also against monkeypox. The CHMP, Committee for Medicinal Products for Human Use of the EU regulatory body, has in fact recommended extend the current product indication to include adult protection against the Monkeypox virus.

The vaccine from the Danish Bavarian Nordic – Ema recalls – has been approved in the European Union since 2013 for the prevention of smallpox. Contains an attenuated (weakened) form of the ‘Vaccinia Ankara’ virus, related to the smallpox virus, and is considered a potential ‘shield’ also against monkeypoxdue to the similarity between the Monkeypox virus and the smallpox virus.

In the United States, Imvanex is available under the trade name Jynneos *, already authorized by the Fda Drug Agency also for the prevention of monkeypox.

The CHMP – explains the EMA in a note – based its recommendation on data from several studies conducted in animals, according to which non-human primates vaccinated with Imvanex also showed protection against the monkeypox virus. The experts therefore believed that from these researches it is possible to deduce the efficacy of the product in the prevention of Monkeypox virus in humans, but to confirm it “the company will collect data from an observational study to be conducted during the ongoing monkeypox epidemic in Europe“, specifies the EU agency.

The safety profile of Imvanex is “favorable, with mild to moderate side effects“, and the CHMP concluded that” the benefits are greater than the risks “, continues the EMA.

In addition to its use for the prevention of monkeypox – concludes the regulatory body – the CHMP has recommended authorizing Imvanex also for the protection against diseases caused by the Vaccinia virus, which causes symptoms similar to those of smallpox, but milder.