GENEVA, Switzerland – The World Health Organization, WHO, has added the first mpox vaccine to its prequalification list, a significant milestone in the fight against the virus as outbreaks surge across Africa.
The WHO declared mpox, formerly known as monkeypox, a “public health emergency of international concern” in August as the virus continues to spread rapidly, particularly in the Democratic Republic of the Congo (DRC).
At least 14 African countries have reported mpox outbreaks this year, with more than 17,000 suspected cases and 724 confirmed deaths since the start of 2024, according to the Africa Centres for Disease Control and Prevention (CDC).
The DRC has been the hardest hit, accounting for over 96% of all cases and deaths, with children being disproportionately affected.
The newly approved vaccine, MVA-BN, produced by Bavarian Nordic A/S, is the first mpox vaccine to receive WHO prequalification.
In the U.S., it is marketed under the brand name JYNNEOS, and over 1 million doses have been administered in the country since the 2022 mpox outbreak.
The WHO prequalification system, established in 1987, ensures vaccines are safe, effective, and suitable for use in low- and middle-income countries.
WHO Director-General Dr Tedros Ghebreyesus hailed the approval as a critical step in addressing both the current African outbreaks and future threats.
“We now need urgent scale-up in procurement, donations, and rollout to ensure equitable access to vaccines where they are needed most,” Ghebreyesus said in a statement.
Spread of a More Transmissible Variant
Mpox has two distinct genetic clades—clade I and clade II—which spread through close contact.
The 2022 global outbreak in the U.S. and Europe was primarily driven by clade II, which spread largely through sexual and intimate contact, particularly among men who have sex with men.
However, a more transmissible variant of clade I, called clade Ib, has emerged, posing a new challenge.
The clade I variant has historically been less associated with sexual transmission, but this new version has changed that assumption, leading to broader concerns about its spread.
Equitable Vaccine Distribution
While existing mpox vaccines are believed to offer some level of protection against the new clade Ib variant, getting vaccines to the communities most affected remains a significant hurdle.
The WHO’s prequalification of the MVA-BN vaccine aims to address these logistical challenges and ensure that vaccines are readily available in the regions where they are most urgently needed.
“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 the future,” Dr Ghebreyesus emphasised.
He called for an increase in vaccine procurement and donations to prevent further transmission and save lives.
In the U.S., mpox vaccination is recommended for people who fall into certain high-risk groups.
These include individuals who are gay, bisexual, transgender, or nonbinary, especially those who have had multiple sex partners, been diagnosed with a sexually transmitted disease, or engaged in sexual activity at commercial sex venues or large public events where mpox transmission is occurring.
With the WHO’s new approval and the push for increased vaccine availability, global health authorities hope to curb the spread of mpox and prevent future outbreaks.
However, significant challenges remain in ensuring that vaccines reach the communities that need them most, particularly in Africa.
