The European Medicines Agency’s (EMA) Committee on Medicinal Products for Human Use (CHMP) has recommended expanding the indication for the smallpox vaccine ‘Imvanex’ from the Bavarian Nordic to include protection for adults against monkeypox.
The vaccine has been approved in the European Union since 2013 for the prevention of smallpox, but not for monkeypox. Despite this, many European countries are already administering it in the event of an outbreak that broke out months ago, as scientific evidence suggests it is useful against this form of smallpox. In fact, it already had sanctions against monkeypox in the United States.
The CHMP based its recommendation on data from several animal studies showing protection against monkeypox virus in non-human primates vaccinated with Imvanex. The CHMP recognized that the efficacy of Imvanex in preventing monkeypox disease in humans “can be inferred from these studies”.
To confirm the effectiveness of the monkeypox vaccine, Bavarian will collect data from an observational study conducted during the ongoing monkeypox outbreak in Nordic Europe.
The EMA concluded, “The drug’s safety profile is favorable, with mild to moderate side effects. The drug’s benefits outweigh the risks.”
In addition to its use for the prevention of monkeypox, the CHMP recommends authorizing Imvanex to protect people from disease caused by the vaccinia virus, which has similar, but milder, symptoms than smallpox.
Monkeypox begins with fever, headache, muscle aches, tiredness, and swollen lymph nodes. One to three days after the onset of fever, a rash develops that first appears on the face and spreads to other parts of the body, including the hands and feet.
Monkeypox can be fatal, although it is usually milder than smallpox. It is transmitted from various wild animals, such as rodents and primates, to people, but can also be transmitted through direct or indirect contact between people. The outbreak reported since May is the first outside Africa with no link to endemic areas.