The European Medicines Agency (EMA) has initiated a series of actions to respond to the monkeypox outbreak, which was declared a Public Health Emergency of International Concern by the World Health Organization late last month (July 2022).

Among the actions taken by the EMA was to approve the monkeypox vaccine, Imvanex, by Bavarian Nordic, a Copenhagen-Denmark based vaccine company, late last month (July 2022). The vaccine is a non-replicating smallpox vaccine, for which the EMA extended its authorization to include monkeypox disease. The vaccine is also approved in the US and Canada, where it is marketed under the name Jynneos.

In addition, the EMA says its Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) will produce and maintain a formal list of critical medicines for monkeypox. The list will be drawn up in a collaborative process involving European Union (EU) member states, healthcare professionals, patients, and consumers. Marketing authorization holders of medicines included in the list will be required to regularly update the EMA with relevant information on potential or actual shortages and available stocks and forecasts of supply and demand. In addition, EU member states will provide regular reports on estimated demand for these medicines at national levels. This will enable the EMA’s MSSG to recommend and coordinate appropriate EU-level actions to the European Commission and EU member states in order to prevent or mitigate potential or actual shortages.

There are currently two medicinal products authorized specifically for monkeypox in the EU: (1) tecovirimat, a small-molecule antiviral drug manufactured by SIGA Technologies, a New York-based bio/pharmaceutical company, for treating smallpox, monkeypox, and cowpox and (2) Bavarian Nordic’s Imvanex, a vaccine to protect against smallpox and monkeypox. Imvanex is marketed as Jynneos in the US, and due to the limited availability of Imvanex, the EMA’s Emergency Task Force (ETF) has recommended that Jynneos can be used to provide protection against monkeypox disease in the EU.

Additionally, the role of the ETF will be expanded to address both COVID-19 and monkeypox. The ETF was initially set up during the COVID-19 pandemic to bring together expertise in the EU medicines regulatory network and was already activated to discuss the treatments and vaccines available and possible medical countermeasures. The tasks of the ETF will be expanded to cover monkeypox, including: providing scientific advice and reviewing the available scientific data on medicinal products that have the potential to address the public health emergency; coordinating independent monitoring studies on the use, effectiveness and safety of medicinal products intended to be used against monkeypox; and giving recommendations to EU member states on the use of an unauthorized medicinal product, upon request from the European Commission or an EU member state.

The ETF will also give advice on clinical trial protocols and provide advice to developers on clinical trials for medicinal products intended to treat, prevent, or diagnose the disease. It can also provide scientific support to facilitate clinical trials.

In the context of the monkeypox outbreak, the ETF has already been facilitating the conduct of large multinational trials in the EU on the use of the antiviral tecovirimat and the vaccine Imvanex by reviewing the trial protocols and liaising with national regulatory bodies and the Clinical Trial Coordination Group, to coordinate and facilitate the approval of clinical trial applications by national competent authorities. The Clinical Trial Coordination Group is a working group of the Heads of Medicines Agencies, a network of both the human and veterinary medicines agencies of the European Economic Area, which include EU countries and Iceland, Liechtenstein, and Norway.

Source: European Medicines Agency