June 2022: In the context of the current multi-country mpox (monkeypox) outbreak, WHO has developed interim rapid response guidance for the clinical management and infection prevention and control of mpox for health care and community settings. 

It includes guidance for certain populations such as patients with mild disease with considerations for community care, patients with moderate to severe disease, sexually active persons, pregnant or breastfeeding women, children and young persons. The guidance also addresses considerations for clinical management such as the use of therapeutics, nutritional support, mental health services and post-infection follow up. 

The document provides guidance for clinicians, health facility managers, health workers and infection prevention and control practitioners including but not limited to those working in primary care clinics, sexual health clinics, emergency departments, infectious diseases clinics, genitourinary clinics, dermatology clinics, maternity services, paediatrics, obstetrics and gynaecology and acute care facilities that provide care for patients with suspected or confirmed mpox.

On 23 July 2022, the WHO Director-General declared the escalating global mpox outbreak a Public Health Emergency of International Concern (PHEIC). [1] The temporary recommendations state (Section 2.e.iii), “When the use of vaccines and antivirals for mpox in the context of a collaborative research framework is not possible, use under expanded access protocols can be considered, such as the Monitored Emergency Use of Unregistered and Experimental Interventions (MEURI), [2] under certain circumstances, using harmonized data collection for clinical outcomes (such as the WHO Global Clinical Platform for Mpox)”. 

In April 2022, WHO updated its ethical framework to guide the Emergency use of unproven clinical interventions outside of clinical trials. The framework has three major ethical categories, each with specific criteria that need to be met for it to be permissible to use a clinical intervention outside of clinical trials.

In the context of the current multi-country mpox outbreak there are global efforts underway to gather evidence on the use of novel antivirals such as tecovirimat and their benefit within the clinical course of mpox disease. 

While there is not yet sufficient evidence to inform clinical management guidelines, WHO has developed the emergency use protocol for tecovirimat for mpox under the MEURI framework. This framework supports two objectives:

1. To provide access to tecovirimat to patients with mpox during the multi-country outbreak while clinical trials cannot be immediately initiated, maintaining ethics and regulatory oversight; and ensuring data monitoring, reporting, and sharing.   
2. To characterize the clinical characteristics of the cohort including the monitoring of any adverse or serious adverse events during the drug course and description of time to lesion resolution.

This emergency use protocol complies with all the predefined criteria for the use of unproven clinical interventions.

WHO encourages Member States using tecovirimat to participate in the emergency use protocol under the MEURI framework.

[3] Emergency use protocol for tecovirimat for mpox under MEURI framework (protocol ID; CERC.0179), V-1.0

For more information on how access the protocol please e-mail: [email protected]

Severe mpox is defined in the WHO Clinical management and infection prevention and control for monkeypox: interim rapid response guidance and incudes patients with severe pain, lower respiratory tract impairment (pneumonia, need for oxygen), ocular impairment (keratitis), neurologic impairment (encephalitis, confusion), cardiac impairment (cardiomyopathy, myocarditis), severe dehydration, or progressive, severe, or recurrent lesions, severe proctitis or urethritis/balanitis.

Global understanding of the natural history of mpox, its clinical features, risk factors for severe disease and outcomes remains incomplete. In response, WHO has created a global clinical platform of patient-level anonymized clinical data. It is a secure, limited-access, password-protected platform hosted on REDCap.

The objectives of the platform are to:

• describe the clinical characteristics of mpox;
• assess the variations in clinical characteristics of mpox;
• identify the association of clinical characteristics of mpox with outcomes; and
• describe the temporal trends in clinical characteristics of mpox.

WHO invites Member States, health facilities and other entities to participate in the global effort to collect anonymized clinical data relating to suspected or confirmed cases of mpox and contribute data to the WHO Global Clinical Platform for Mpox.

For any additional questions, please contact: [email protected] 

This compilation of images of mpox lesions shows examples of the effects of monkeypox virus infection on the skin and mucosa.

Purpose

The Atlas has been developed in parallel with the emergency use protocol for tecovirimat for mpox under the MEURI framework. The MEURI ethical framework makes provision for the emergency use of unproven clinical intervention outside of clinical trials. 

For mpox, the initiative provides access to tecovirimat during the multi-country outbreak, pending the availability of evidence from randomised clinical trials. MEURI maintains ethics and regulatory oversight, and ensuring data monitoring, reporting, and sharing. The use of tecovirimat within this framework can be recorded using the WHO Global Clinical Data Platform for mpox which allows collection of anonymised patient data, and will contribute to our understanding of the clinical characteristics, variation and associations of mpox disease. The Atlas will support those collecting data to harmonise their assessments of lesions, and improve the quality of the collected data.

The Atlas may also be beneficial to the wider medical community as a teaching and learning resource, including in dermatology and sexual health clinics. It is one of many such resources, and it should be noted that this is not a comprehensive tool, nor does it focus on atypical lesions or those relating to other disease processes.