The EMA has recommended the approval of the smallpox vaccine Imvanex to protect against Monkeypox disease.


Monkeypox symptoms include head and muscle aches, exhaustion, fever and a rash. It can be fatal although it is typically milder than smallpox. Last month, the WHO declared the recent monkeypox outbreak, which began in May of this year, a global health emergency, therefore vaccination against the disease is very much in the news.


Smallpox vaccines were demonstrated through several observational studies to be about 85% effective in preventing monkeypox, according to the WHO. Imvanex has been approved in the EU since 2013 for protection against smallpox and as such is considered suitable as a monkeypox vaccine.


Several animal studies conducted by the EMA’s human medicine committee (CHMP) showed potential for human protection against the monkeypox virus and led them to conclude that it’s relatively risk free. They will conduct an observational study in Europe to confirm this.


Product information for Imvanex will be updated with information for healthcare professionals and the public, and an assessment report with details of EMA’s evaluation of the medicine will be published on their website.



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