The World Health Organization (WHO) announced on Friday that it has approved the first vaccine specific to MPOX (formerly monkeypox). The WHO approval will speed up access for millions of people, helping to reduce transmission and contain the outbreak.
More than 120 countries have confirmed over 103,000 cases of mpox since 2022. In 2024 alone, there were 25,237 suspected and confirmed cases and 723 deaths from different outbreaks in 14 countries in Africa, as of 8 September 2024.
Tedros Adhanom Ghebreyesus, Director-General of the WHO, said that the prequalification of the MVA-BN vaccine is an important step in the fight against the mpox virus in Africa.
The WHO assessment was based on information provided by the manufacturer and a review by the European Medicines Agency.
Monkeypox is a viral disease that is spread from animals to humans and also between people through skin-to-skin physical contact. It can cause a painful rash, enlarged lymph nodes, fever, headache or muscle pain, and lack of energy. Most people recover completely in two to three weeks, but some become seriously ill.
Recently, the WHO declared it a “public health emergency of international concern” again due to the outbreak in the Democratic Republic of Congo, as well as infections in 12 other African countries. However, according to the WHO, the risk of transmission is “moderate” outside Africa.
About the vaccine
Since the beginning of the global outbreak in 2022, the safety and efficacy of the vaccine has been tested in clinical studies and in the real world, in different contexts, mainly with the emergence of new strains of the virus.
Other vaccines have been in use. According to the U.S. Centers for Disease Control and Prevention (CDC), two doses of the vaccine, known as JYNNEOS and developed to prevent smallpox, “work to prevent smallpox in most people” and can help protect people from “serious infections, hospitalization, and death.”
Another vaccine, LC16m8, has been approved in Japan and limited research has shown that it generates antibody responses against monkeypox without serious safety concerns. The smallpox vaccine ACAM2000 has been used in the past for monkeypox, but authorities tend to avoid it now that other options are available because of its side effects.
The new MVA-BN vaccine can be administered to people aged 18 years and over in two injectable doses four weeks apart. After prior cold storage, the vaccine can be stored at 2-8°C for up to eight weeks.
The health agency also recommends using a single dose in outbreak situations with supply constraints, and stresses the need to collect more data on the number of doses.
To date, data show that a single dose of MVA-BN vaccine administered prior to exposure is estimated to be 76% effective in protecting people against mpox, and the two-dose regimen is estimated to be 82% effective. Post-exposure vaccination is less effective than pre-exposure vaccination.
WHO reviewed all available evidence and recommended the use of MVA-BN vaccine in the context of an mpox outbreak for people at high risk of exposure.
Although MVA-BN is not currently approved for use in persons under 18 years of age, it can be used “off-label” in infants, children and adolescents, and in pregnant and immunocompromised individuals. This means that the use of the vaccine is recommended in outbreak contexts where the benefits of vaccination outweigh the potential risks.
Other vaccines are being evaluated
Since the WHO Director-General activated the emergency use listing for mpox vaccines on 7 August 2024, WHO has conducted programmatic and product capacity assessments.
“The findings of the assessments are particularly relevant in the context of the declaration of a public health emergency of international concern related to the resurgence of mpox in Africa,” said Dr Rogerio Gaspar, WHO Director of Regulatory and Prequalification.
Gaspar added that the health agency is advancing in the procedures for prequalification and inclusion in the list of vaccines for emergency use with the manufacturers of two other mpox vaccines.
“We have also received six expressions of interest so far for mpox diagnostic products for emergency use listing,” he added. Once the vaccine is acquired, international agencies such as the United Nations Children’s Fund (UNICEF) and Gavi, the Vaccine Alliance, will be able to help distribute it globally, particularly to communities in Africa, such as the Democratic Republic of the Congo.
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