• The World Health Organisation (WHO) has announced the MVA-BN vaccine (Modified Vaccinia Ankara - Bavarian Nordic) as the first vaccine against mpox to be added to its prequalification list.

• This first prequalification of a vaccine against mpox is an important step in the fight against the disease, both in the context of the current outbreaks in Africa, and in future.

• The MVA-BN vaccine can be administered in people over 18-years of age as a two-dose injection given four weeks apart. After prior cold storage, the vaccine can be kept at 2–8°C for up to eight weeks.

• The WHO Strategic Advisory Group of Experts (SAGE) on Immunization reviewed all available evidence and recommended the use of MVA-BN vaccine in the context of an mpox outbreak for persons at high risk of exposure. 

• While MVA-BN is currently not licensed for persons under 18 years of age, this vaccine may be used “off-label” in infants, children and adolescents, and in pregnant and immunocompromised people. 

This means vaccine use is recommended in outbreak settings where the benefits of vaccination outweigh the potential risks.

• WHO’s assessment for prequalification is based on information submitted by the manufacturer, Bavarian Nordic, and review by the European Medicines Agency, the regulatory agency of record for this vaccine.

• The prequalification approval is expected to facilitate timely and increased access to this vital product in communities with urgent need, to reduce transmission and help contain the outbreak. 

• The escalating mpox outbreak in the Democratic Republic of the Congo and other countries was declared a PHEIC by the WHO Director-General on August 14. 

• Over 120 countries have confirmed more than 103,000 cases of mpox since the onset of the global outbreak in 2022. 

• In 2024 alone, there were 25,237 suspected and confirmed cases and 723 deaths from different outbreaks in 14 countries of the African Region.

What is mpox?

• Mpox (monkeypox) is an infectious disease caused by the monkeypox virus (MPXV). 

• Mpox virus belongs to the Orthopoxvirus genus in the family Poxviridae. The Orthopoxvirus genus also includes variola virus (which causes smallpox), vaccinia virus (used in the smallpox vaccine), and cowpox virus.

• Mpox has symptoms similar, but less severe, to smallpox. While smallpox was eradicated in 1980, mpox continues to occur in countries of central and west Africa.

• Mpox is zoonosis: a disease that is transmitted from animals to humans.

• Mpox was formerly called monkeypox. Following a series of consultations with global experts, WHO began using “mpox” as a synonym for monkeypox. 

• Monkeypox was first discovered in 1958 when outbreaks of a pox-like disease occurred in monkeys kept for research, hence the name ‘monkeypox’.

• The first human case was recorded in 1970 in the Democratic Republic of the Congo (then known as Zaire), and since then the infection has been reported in a number of central and western African countries. Most cases are reported from Congo and Nigeria. 

• In 2003, monkeypox was recorded in the United States when an outbreak occurred following importation of rodents from Africa. Cases were reported in both humans and pet prairie dogs. All the human infections followed contact with an infected pet and all patients recovered. 

• Mpox is endemic in densely forested regions of West, Central and East Africa, particularly in the northern and central regions of Congo. 

• Mpox outbreaks are caused by different viruses called clades. Clade 1 has been circulating in Congo for years, while clade 2 was responsible for the global outbreak which began in 2022.

Transmission

• Mpox does not spread easily between people.

• Spread of mpox may occur when a person comes into close contact with an animal (rodents are believed to be the primary animal reservoir for transmission to humans), human, or materials contaminated with the virus. 

• The virus enters the body through broken skin (even if not visible), the respiratory tract, or the mucous membranes (eyes, nose, or mouth).

Person-to-person spread is very uncommon, but may occur through:

• Contact with clothing or linens (such as bedding or towels) used by an infected person.

• Direct contact with mpox skin lesions or scabs.

• Coughing or sneezing of an individual with a mpox rash.

Symptoms

Initial symptoms include fever, headache, muscle aches, backache, swollen lymph nodes, chills and exhaustion. A rash can develop, often beginning on the face, then spreading to other parts of the body. The rash changes and goes through different stages before finally forming a scab, which later falls off.

Treatment

• Detection of viral DNA by polymerase chain reaction (PCR) is the preferred laboratory test for mpox. 

• Mpox, in most cases, is a mild condition which will resolve on its own and have no long-term effects on a person’s health. Most people recover within a few weeks. However, severe illness can occur in some individuals.

• Treatment of mpox patients is supportive dependent on the symptoms. Various compounds that may be effective against mpox virus infection are being developed and tested.

• Prevention and control of human mpox rely on raising awareness in communities and educating health workers to prevent infection and stop transmission.

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