Mpox

The European Medicines Agency (EMA) responded to the 2022 outbreak of mpox disease by taking special measures to ensure the availability of critical treatments and vaccines, in close cooperation with its partners in the European medicines regulatory network. EMA's actions were in line with its newly formalised responsibilities for crisis preparedness and management under EU legislation. EMA also provided a range of recommendations on medicines against mpox to help national authorities tackle infections.

Mpox is a disease caused by the monkeypox virus.

In 2022, there was a worldwide outbreak of mpox disease, which the World Health Organization (WHO) declared a public health emergency of international concern (PHEIC) in July 2022.

EMA responded to the outbreak by taking special measures to ensure the availability of critical medicines, in line with its crisis preparedness and management responsibilities.

Information on mpox disease is available on the website of the European Centre for Disease Prevention and Control (ECDC).

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 that has been authorised to protect adults against mpox disease since 22 July 2022. It is also authorised to protect against smallpox and vaccinia.

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

WHO declared the 2022 mpox outbreak a PHEIC in July 2022.

In response, EMA undertook the following actions in line with its responsibilities for crisis preparedness and management:

• 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)

EMA's actions to combat the mpox outbreak were in line with the Regulation on EMA's Reinforced Role (Regulation (EU) 2022/123). The Regulation came into effect in March 2022.

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

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: