2022-07-28| PolicyTrending

EMA Responds to Monkeypox Public Health Emergency

by Max Heirich
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Monkeypox Virus Sample (US CDC 2022)

The World Health Organization (WHO) escalated the monkeypox outbreak to a Public Health Emergency of International Concern (PHEIC) on July 23. As a result, the European Medicines Agency (EMA) responded on July 27 by initiating a series of actions to manage the outbreak. Among these efforts is a continuation of the EMA’s Emergency Task Force (ETF) to deal with monkeypox on top of COVID-19 and the monitoring of medical supplies to treat the outbreak.

Related Article: WHO Sounds Monkeypox Alarm as Cases Continue Rising Worldwide

Making Sure Critical Medicines Don’t Run Out

The EMA is ensuring that the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) appropriately manages supplies. In conjunction with Member States of the EU, healthcare providers, and patients, the MSSG has committed to both the creation and maintenance of a list of critical medicines for monkeypox.

Among the products authorized explicitly for monkeypox are Tecovirimat SIGA and Imvanex. Tecovirimat SIGA is an antiviral that slows the infection by interfering with a protein called VP37. This protein is a component of monkeypox as well as other viruses of its family (orthopoxviruses). Imvanex is a vaccine that prevents smallpox. However, the EMA has authorized its use to prevent monkeypox infection.

As outlined in a statement by the EMA, companies with the authorization to market these medicines in EU member states will regularly report their stocks of the medicines, including any forecasted shortages, to the EMA. In turn, EU Member States will give regular updates as to the demand they are expecting for these treatments. 

The ETF Will Handle Both COVID-19 and Monkeypox

The EMA established the ETF to handle the COVID-19 pandemic by providing scientific advice and reviewing data to improve the medical response to the European Union (EU) outbreak. In addition, they also supported the facilitation of clinical trials for relevant medicines and provided scientific recommendations on certain medicines before their authorization by the EMA.

In regards to the outbreak of monkeypox, the ETF has already begun to discuss possible responses to the PHEIC. Included in this response are effective vaccines and other treatments. The ETF could swiftly guide these treatments through the development stage to authorization for use.

In addition, the ETF has also begun to facilitate numerous clinical trials within the EU for using the antiviral Tecovirimat and the vaccine Imvanex to treat or prevent monkeypox. The ETF cooperates with competent national authorities and other EU boards and agencies for these clinical trials to swiftly facilitate approval.

With the cooperation of these bodies within the EMA, EU Member States, and providers of treatments for monkeypox, the response to the WHO’s escalation of monkeypox to a PHEIC will be both competent and coordinated.

Related Article: First Polio Case in the US Since 2013 Has Been Detected in New York

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