It European Medicines Agency (European Medicines Agency) has taken a series of measures to respond to the ongoing outbreak of monkeypoxissued by the World Health Organization (WHO) on Saturday, July 23, 2022 escalated to a Public Health Emergency of International Concern (PHEIC).
This is the first new public health emergency of international concern to be declared since the regulation to strengthen EMA’s role in crisis preparedness and management for medicines and medical devices came into effect.
Since the onset of the recent monkeypox outbreak, the EMA has been closely monitoring the situation and has already taken several actions to prepare and support the EU response. This includes the agency’s July 22 recommendation to approve an extension of the Imvanex vaccine indication to protect adults against monkeypox disease. The new powers given to the agency under its expanded mandate will lead to additional activities as monkeypox has been declared a public health emergency.
Monitoring demand, supply and shortages of medicines. The EMA’s Executive Steering Committee on Drug Deficiencies and Safety (MSSG), established by the new regulation, will establish and maintain a formal list of drugs critical to the monkeypox emergency. The list will be drawn up in a collaborative process involving Member States, healthcare professionals, patients and consumers.
The marketing authorization holders of the listed medicines will be requested to provide the EMA regularly with relevant information on possible or actual shortages and available stocks, as well as forecasts of supply and demand. In addition, Member States will regularly report on the estimated demand for these medicines at national level.
This will enable the MSSG to recommend and coordinate appropriate action at EU level to the European Commission and EU Member States to prevent or mitigate potential or current shortages of critical medicines and thus protect public health.
There are currently two medicines specifically authorized for monkeypox in the EU:
-The medicine Tecovirimat SIGA is approved for use in the treatment of smallpox, monkeypox and cowpox.
-The vaccine Imvanex is approved for the protection of adults against smallpox and monkeypox. Imvanex is marketed in the US under the name Jynneos and given the limited availability of Imvanex, the ETF recommended that Jynneos can be used to protect against monkeypox disease in the EU.
Emergency Task Force (ETF). The mandate of the Emergency Task Force (ETF) of the EMA will be formally expanded to cover both COVID-19 and monkeypox. The ETF was established during the COVID-19 pandemic to bring together the best expertise available in the EU network for medicines regulation. The central role of the ETF in directing and accelerating the development and authorization of emergency medicines has been formalized in the new regulation.
In connection with the monkeypox outbreak, the ETF has already been activated to discuss available treatments and vaccines and possible medical countermeasures. Following the declaration of a public health emergency of international concern, the composition of the ETF will be reviewed and formally approved by the EMA Board, taking into account specific expertise relevant to the therapeutic response to the outbreak of monkeypox.
The ETF’s tasks will then be formally extended to monkeypox, including providing scientific advice and assessing the available scientific data on drugs that can address the public health emergency, coordinating independent monitoring studies on the use, effectiveness and safety of medicines intended to be used against monkeypox, as well as making recommendations to Member States on the use of an unauthorized medicine, at the request of the European Commission or of a Member State.
Of particular importance is the need to advise on clinical trial protocols and to advise developers on clinical trials for drugs intended to treat, prevent or diagnose the disease causing the public health emergency. The ETF can also provide scientific support to facilitate clinical trials. The aim of these support activities for developers, including academics, is to enable rapid adoption and execution of large-scale, well-designed trials, including platform trials, that can provide the robust data needed to enable decision-making and avoid duplication of research. to prevent.
monkeypox disease is caused by monkeypoxvirus, a human orthopoxvirus of the family Poxviridae, which is common in Central and West Africa. The disease can spread from animals to humans and between humans through close contact. The current outbreak is caused by a monkeypox virus from West African organisms. Monkeypox is similar to smallpox, but less severe. The symptoms usually last between two and four weeks and usually disappear without treatment.
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