The World Health Organization (WHO) announced on Friday the approval of the MVA-BN vaccine, developed by Bavarian Nordic A/S, as the first-ever mpox vaccine to be added to its prequalification list.
This prequalification approval is expected to greatly improve access to the vaccine in regions facing urgent outbreaks, especially in Africa, aiding efforts to reduce transmission and control the spread of the disease.
"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," WHO Director-General Tedros Adhanom Ghebreyesus said.
He stressed the need to scale up vaccine procurement and distribution to ensure equitable access for those most at risk.
The vaccine is administered in two doses, four weeks apart, for adults aged 18 and over.
The prequalification decision will accelerate procurement by international agencies and speed up national regulatory approvals, according to WHO Assistant Director-General Yukiko Nakatani.
Current data indicate that the vaccine is 76 percent effective after a single dose and 82 percent effective after two doses. WHO emphasized the need for continued data collection on the vaccine's safety and effectiveness.
The total number of mpox cases in Africa has climbed to 26,543, including 5,732 confirmed cases and 724 deaths, in 2024.
Africa CDC Director-General Jean Kaseya, while addressing a special online media briefing on the multi-country mpox outbreak in Africa Thursday evening, said the African continent reported 3,160 new cases during the past week alone, including 434 confirmed cases and 107 deaths, eventually bringing the total number of cases reported this year to 26,543.
Data from the African Union's specialized healthcare agency show that the cases were reported from 15 African countries across all five regions of the continent, with a case fatality rate of 2.73 percent.
It said children under 15 years of age account for 41 percent of all confirmed mpox cases reported on the African continent so far, and males account for 63 percent of all confirmed cases.
In mid-August, the Africa CDC declared the ongoing mpox outbreak in Africa as a Public Health Emergency of Continental Security (PHECS). Soon after that, WHO also declared mpox a public health emergency of international concern, activating its highest level of global alert for mpox for the second time in two years.
With the rapid spread of the virus, countries in other continents, including Pakistan, Singapore and Thailand in Asia, have tightened screening of international travelers and implemented precautions against it.