EMA response to the monkeypox public health emergency

News 27/07/2022
The European Medicines Agency (EMA) has initiated a series of actions to respond to the ongoing monkeypox outbreak, which has been escalated by the World Health Organization (WHO) to a Public Health Emergency of International Concern (PHEIC) on Saturday 23 July. This is the first new PHEIC to be declared since the regulation reinforcing EMA’s role in crisis preparedness and management of medicinal products and medical devices has become applicable.

Since the start of the recent monkeypox outbreak, EMA has been monitoring the situation closely and already taken multiple actions to prepare for and support the EU response.
This includes the Agency’s recommendation on 22 July to approve an extension of indication for the vaccine Imvanex to protect adults from monkeypox disease. The new powers given to the Agency under its extended mandate trigger additional activities now that monkeypox has been declared a public health emergency.

There are currently two medicinal products authorised specifically for monkeypox in the EU:

The medicine Tecovirimat SIGA is authorised for use to treat smallpox, monkeypox and cowpox.
The vaccine Imvanex is authorised to protect adults against smallpox and monkeypox. Imvanex is marketed as Jynneos in the US and considering the limited availability of Imvanex, the ETF has recommended that Jynneos can be used to provide protection against monkeypox disease in the EU.

G Mohan.