Danish biotechnology company Bavarian Nordic has confirmed that the European Commission has given permission for its Imvanex vaccine to be marketed as protection against monkeypox, as recommended last week by the European Medicines Agency.
The approval comes just one day after the World Health Organization issued a high-level alert declaring the rapidly spreading monkeypox outbreak as a global health emergency.
Ireland has 69 confirmed cases of the disease as of 20 July.
"The availability of an approved vaccine can significantly improve nations' readiness to fight emerging diseases, but only through investments and structured planning of the biological preparedness," Bavarian Chief Executive Paul Chaplin said.
Bavarian's vaccine, the only one to have won approval for the prevention of monkeypox disease in the US and Canada, has in the EU so far only been approved to treat smallpox.
But the company has supplied the vaccine to several EU countries during the current monkeypox outbreak for what is known as "off-label" use.
The approval is valid in all European Union Member States as well as in Iceland, Liechtenstein, and Norway, Bavarian Nordic said in a statement.
The development of Imvanex was made possible through significant investments from the US government during the past two decades, the company added.
Bavarian Nordic also said it was in talks to potentially expand production capacity.
Its share price has risen by 122% in the last three months, driven by strong demand for the monkeypox vaccine.
Meanwhile Japan today confirmed its first case of monkeypox, detected in a man in his 30s who had travelled overseas, Tokyo governor Yuriko Koike announced.
She said the man had been hospitalised in the city, without giving further details.
Monkeypox has affected more than 16,800 people in 74 countries, according to a tally by the US Centers for Disease Control and Prevention (CDC) published on 22 July.