The mpox vaccine used in the U.S. has been added to the World Health Organization's (WHO) prequalification list, the first time one has received this approval.
The WHO declared mpox to be a "public health emergency of international concern" in August as cases across Africa continue to surge.
At least 14 African countries have reported mpox outbreaks this year, with more than 17,000 suspected cases across the continent since the start of 2024 and 724 confirmed deaths, the Africa Centres for Disease Control and Prevention reported.
More than 96 percent of all cases and deaths have occurred in the Democratic Republic of the Congo, with many of those affected being children.
Mpox, formerly known as monkeypox, drew global attention in 2022 during an outbreak that affected the U.S., Europe, Australia and many other countries. The virus comes in two distinct forms, or "clades"—clade I and clade II—and spreads through close contact.
The previous outbreak in the U.S. and Europe was driven by the clade II form of the virus and was mostly spread through sexual and intimate contact, with men who have sex with men being at the highest risk of infection.
In the past, clade I was not thought to be transmitted through sexual contact. However, a new version of the virus, called clade Ib, has emerged and appears to be more transmissible than previous forms of the virus.
Existing mpox vaccines are thought to offer at least some level of cross-immunity against the new variant. The problem is getting enough vaccine to where it is needed.
The WHO's vaccine prequalification program was established in 1987 to ensure that vaccine supplies were consistently safe, effective, and suitable for use in low- and middle-income countries. The list helps the United Nations, partner procurement agencies, and member states make decisions on vaccine procurement.
According to the WHO, the approval is expected to facilitate timely and increased access to mpox vaccines in the communities where they are most needed to help reduce the spread of the virus.
"This first prequalification of a vaccine against mpox is an important step in our fight against the disease, both in the context of the current outbreaks in Africa, and in future," WHO Director General Dr. Tedros Adhanom Ghebreyesus, said in a statement.
"We now need urgent scale-up in procurement, donations and rollout to ensure equitable access to vaccines where they are needed most, alongside other public-health tools, to prevent infections, stop transmission and save lives."
The approved vaccine is the MVA-BN, produced by Bavarian Nordic A/S, which can be found in the U.S. under the brand name JYNNEOS. Over 1 million doses of the vaccine have been administered in the U.S. alone, the Centers for Disease Control and Prevention reported.
In the U.S., vaccination is recommended for people who fall into the following risk groups:
- Persons who are gay, bisexual or transgender or nonbinary people who in the past six months have had:
- A new diagnosis of at least one sexually transmitted disease
- More than one sex partner
- Sex at a commercial sex venue
- Sex in association with a large public event in a geographical area where mpox transmission is occurring
- Persons who are sexual partners of the persons described above.
- Persons who anticipate experiencing any of the situations described above.
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