There are currently two drugs specifically authorized for monkeypox in Europe: the drug ‘Tecovirimat SIGA’ and the vaccine ‘Imvanex’
The Executive Steering Group of the European Medicines Agency (EMA) on Shortage and Safety of Medicines (MSSG) will prepare a formal list of essential medicines for the public health emergency of the monkey pox.
The list, which is going to be launched after the World Health Organization (WHO) declared hemonkeypox as a public health emergency of international concern, will be developed through a collaborative process involving the Member States, healthcare professionals, patients and consumers.
Likewise, and as reported by the agency, the holders of the marketing authorizations of the medicines included in the list shall regularly update the EMA with relevant information on potential or actual shortages and available stocks, supply and demand forecasts. In addition, the countries will provide periodic reports on the estimated demand for these drugs at the national level.
This will allow the MSSG to recommend and coordinate appropriate actions to the countries of the European Union to prevent or mitigate potential or actual shortages of critical medicines to safeguard public health.
Currently there are two drugs specifically authorized for monkeypox in Europe: the drug ‘Tecovirimat SIGA’, licensed for use in the treatment of smallpox, monkeypox, and cowpox, and ‘Imvanex’ vaccinelicensed to protect adults against smallpox and monkeypox.
In addition, the mandate of EMA’s Emergency Task Force (ETF), created during the coronavirus pandemic, will be formally extended. to deal with both COVID-19 and monkeypox. In relation to the monkeypox outbreak, the ETF has already been activated to discuss available treatments and vaccines, and possible medical countermeasures.
Its work will be formally extended to cover monkeypox, including providing scientific advice and review of available scientific data on medicines that have the potential to address the public health emergency, coordinating independent follow-up studies on the use, efficacy, and safety of medicines intended for use against monkeypox, as well as providing recommendations to countries on the use of an unauthorized drug, upon request from the European Commission or from a country.
The ETF can also provide scientific support to facilitate clinical trials. The goal of these support activities for developers, including academics, is to enable the rapid approval and conduct of “large, well-designed” trials that can provide the robust data needed to enable decision-making and avoid duplication of research.
In the context of the monkeypox outbreak, the ETF has already been facilitating large multinational trials in the EU on the use of the antiviral ‘tecovirimat’ and the vaccine ‘Imvanex’ by revising trial protocols and liaison with the Clinical Trials Coordination Group (CTCG) and national regulatory bodies to coordinate and facilitate the approval of clinical trial applications by the competent national authorities.