The European Medicines Agency (EMA) recommended expanding the indication of the smallpox vaccine Imvanex for the protection of adults against monkeypox. The drug has been approved in the EU since 2013 for the prevention of smallpox.
It contains an attenuated (weakened) form of the "Ankara modified vaccinia virus", which is related to the smallpox virus. It was also considered a potential vaccine for monkeypox due to the similarity between both pathogens. The marketing authorization holder is Bavarian Nordic A/S.
Data from previous studies
The EMA’s Committee for Human Medicinal Products (CHMP) based its recommendation on data from several animal studies. In primates that received this vaccine, they showed protection against monkeypox
To confirm the effectiveness of this immunization against monkeypox, the company will collect data from an observational study that will be carried out during the outbreak in Europe.
Given that the safety profile of the medicine is favorable, with mild to moderate side effects, the CHMP concluded that the benefits of the medicine outweigh the risks.
In addition to use for the prevention of monkeypox, the CHMP recommended authorizing Imvanex to protect people against the disease caused by the vaccinia virus, which produces symptoms similar to those of smallpox, but milder.
Imvanex prepares the body to defend itself against infection with the variola (smallpox), monkeypox, and vaccinia viruses.
Due to the similarity between the virus in this vaccine and these viruses, antibodies produced against it are expected to protect against monkeypox, smallpox, and vaccinia.
