The European Medicines Agency (EMA) has initiated a series of actions to respond to the monkeypox outbreak. The epidemic has now been declared a ‘public health emergency of global concern’ by the World Health Organization (WHO) (see EUROPE 12999/10).
Following the extension of the use of Imvanex vaccine for the prevention of monkeypox (see EUROPE 12999/10), for which there is a European joint purchase contract (see EUROPE 12995/35), the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) has established a ‘list of critical medicines’ for the monkeypox public health emergency. This type of formal list is established under Regulation EU/2022/123 strengthening the mandate of the EMA. The first list was for Covid-19 (see EUROPE 12968/31). These lists are used to prevent and monitor potential shortages of medicines used in a specific public health emergency, in this case monkeypox. Market authorisation holders for monkeypox medicines will have to inform the EMA about stock levels and shortage risks. Two medicines have been authorised for monkeypox in the EU: the antiviral Tecovirimat SIGA and the vaccine Imvanex.
In addition, the scope of the EMA’s Emergency Task Force (ETF), formally confirmed by the new EMA mandate, will be extended to deal not only with Covid-19, but also with monkeypox. This group coordinates work, accelerates the circulation of expertise and the authorisation of medicines in the context of health emergencies. At the request of the European Commission or any Member State, in cases of health emergency, the group may issue recommendations to Member States on the use of as yet unauthorised medicines.
The group also helps to improve and accelerate clinical trials. It provides advice on trial protocols and may provide scientific advice or guidance to clinical trial developers and researchers.
The EMA noted that the working group has already worked in this way in the context of monkeypox.
The group facilitated the implementation of large-scale clinical trials of Imvanex and Tecovirimat by reviewing protocols and liaising with the Clinical Trials Coordination Group (CTCG), which facilitated the approval of the clinical trial protocols by the relevant national authorities.
The membership of the working group now needs to be updated to include experts dealing with monkeypox. The EMA Management Board will have to formally approve the new composition of the group.
Two email addresses have been opened in this context to facilitate communication between medicine developers and clinical trial sponsors with the EMA and with the Health Threats and Vaccines Strategy Offices that support the ETF. (Original version in French by Émilie Vanderhulst)