Mpox

The European Medicines Agency (EMA) is monitoring the evolution and spread of mpox disease. When required, EMA is prepared to take special measures to ensure availability of critical medicines, devices and vaccines, in close cooperation with its partners in the European medicines regulatory network and at international level. These measures can include recommendations on medicines against mpox to help national authorities tackle infections.

Mpox is a disease caused by the monkeypox virus.

Although mpox is typically mild, its clade I virus strain is known to cause a severe form of mpox in humans. Mpox can be fatal for people with weak immune systems.

In August 2024, the World Health Organization (WHO) declared a public health emergency of international concern (PHEIC) for mpox. This followed the growing spread of the mpox clade I strain in non-endemic African countries. 

Currently, there is a low overall risk of infection for the general population in Europe, according to the European Centre for Disease Prevention and Control (ECDC). 

EMA is closely monitoring the situation, in line with its crisis preparedness and management responsibilities. Find out more in the 'EMA preparedness activities for 2024 mpox outbreak' section on this page.

For more information, see:

• ECDC risk assessment for the EU/EEA of the mpox epidemic caused by monkeypox virus clade I in affected African countries
• WHO Director-General declares mpox outbreak a public health emergency of international concern
• Public health threats

Authorised treatments and vaccines against mpox

There is one antiviral treatment and one vaccine against mpox authorised in the EU.

Antiviral treatment

Tecovirimat is a treatment authorised to treat mpox as well as smallpox and cowpox.

It works by interfering with a protein called VP37 that is found on the surface of the virus, slowing down the spread of infection.

For more information on Tecovirimat, how it works and how EMA assessed it, see:

• Tecovirimat

Vaccine

Imvanex is a vaccine authorised to protect against mpox as well as smallpox and disease caused by vaccinia virus. 

For mpox, Imvanex is authorised to use in adults and adolescents aged 12 to 17. It has been authorised to protect adults since July 2022, and adolescents since September 2024.  

Imvanex contains a weakened form of a virus that is closely related to the smallpox and mpox viruses but does not cause disease in humans and cannot reproduce in human cells. 

For more information on Imvanex, how it works and how EMA assessed it, see:

• Imvanex

EMA response to 2024 mpox outbreak

EMA is collaborating closely with international and EU partners to protect public health. This includes:

• Monitoring evolving evidence and emerging data - in particular, in relation with the EU approved medicines for mpox
• Engaging with international partners to support authorisation of mpox medicines in African countries
• Encouraging conduct of clinical studies and providing scientific and regulatory support to ensure high-quality evidence
• Working in close cooperation with partner organisations in the EU, including the European Centre for Disease Prevention and Control (ECDC) and the European Health Emergency preparedness and Response Authority (HERA)

EMA's actions to address the mpox outbreak are in line with the preparedness tasks set out in Regulation on EMA's Reinforced Role (Regulation (EU) 2022/123).

For more information, see:

• Crisis preparedness and management
• European Commission: Factsheet - EU response to the mpox outbreak
• ECDC recommends enhancing preparedness as more imported cases of clade I mpox highly likely
• ECDC: Mpox (Monkeypox)
• Emergency Task Force (ETF)

Recommendation on use of mpox vaccine during 2024 outbreak

EMA's Emergency Task Force (ETF) considered that Imvanex could be used to prevent mpox in children under 12 years of age who are at risk of mpox disease during the public health emergency. National health authorities in the affected countries are responsible for deciding whether to use Imvanex in this age group. 

The ETF took into account the limited options for preventing mpox in children and data on the safety profile of Imvanex and of vaccines based on the same construct.

More information:

ETF statement on the use of Imvanex for the prevention of mpox in children below 12 years of age

Reference Number: EMA/528419/2024

EMA response to 2022 mpox outbreak

WHO previously declared a PHEIC for mpox in 2022, following an outbreak in Europe and worldwide of the clade II mpox strain. This is a less virulent virus strain, causing milder forms of the disease.

EMA responded to the 2022 outbreak by taking special measures to ensure the availability of critical medicines:

• Worked to accelerate the development of mpox vaccines and treatments, in close cooperation with the European medicines regulatory network
• Provided rapid scientific advice for products under development
• Facilitated clinical trials, including large multinational clinical trials, and accelerated clinical trial assessment and approval
• Supported the fast-track approval of vaccines and treatments
• provided early support to developers of mpox medicines and clinical trial sponsors
• Established a list of critical medicines for mpox in order to prevent and address any potential shortages
• Worked in close cooperation with partner organisations in the EU, including the European Centre for Disease Prevention and Control (ECDC) and the European Health Emergency preparedness and Response Authority (HERA)

The PHEIC ended in May 2023.

More information:

• Crisis preparedness and management
• Emergency Task Force (ETF)
• Executive Steering Group on Shortages and Safety of Medicinal Products

List of critical medicines for Monkeypox public health emergency (PHE) under Regulation (EU) 2022/123 (obsolete)

Reference Number: EMA/662490/2022

Recommendations on use of mpox medicines during 2022 outbreak

EMA's Emergency Task Force (ETF) provided recommendations on temporary measures that national authorities could consider adopting, given the limited supplies of Tecovirimat and Imvanex in the EU during the 2022 mpox outbreak.

These included:

• importing Tecovirimat (marketed as TPOXX in the United States) and Imvanex (marketed as Jynneos in the United States) from the United States;
• using Imvanex as an intradermal injection instead of a subcutaneous injection.

More information:

Possible use of the medicinal product TPOXX for the treatment of monkeypox

Reference Number: EMA/904994/2022

Possible use of the vaccine Jynneos against infection by monkeypox virus

Reference Number: EMA/600064/2022

Considerations on posology for the use of the vaccine Jynneos/ Imvanex (MVA-BN) against monkeypox

Reference Number: EMA/700120/2022