WHO grants first mpox vaccine approval to ramp up response to disease in Africa and beyond

The World Health Organization (WHO) said Friday (13 September) it has granted its first authorization for use of a vaccine against mpox in adults, calling it an important step toward fighting the disease in Africa and beyond.

The pre-qualification of the vaccine by Bavarian Nordic A/S means that donors like GAVI the Vaccine Alliance and Unicef can buy it. But supplies are limited because there's only a single manufacturer.

"This first pre-qualification 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," said WHO Director-General Tedros Adhanom Ghebreyesus.

The U.N. health agency chief called for "urgent" scale-up of procurement, donations and rollout to get the vaccine where it is needed most, along with other response measures.

Under the WHO authorization, the vaccine can be administered in people aged 18 or above in a two-dose regimen. The approval says that while the vaccine is not currently licensed for those under 18 years old, it may be used in infants, children and adolescents "in outbreak settings where the benefits of vaccination outweigh the potential risks."

Officials at the Africa Center for Disease Control and Prevention said last month that nearly 70% of cases in Congo — the country hardest hit by mpox — are in children younger than 15, who also accounted for 85% of deaths.

On Thursday, the Africa CDC said 107 new deaths and 3,160 new cases had been recorded in the past week, just a week after it and WHO launched a continental response plan.

Mpox belongs to the same family of viruses as smallpox but causes milder symptoms like fever, chills and body aches. People with more serious cases can develop lesions on the face, hands, chest and genitals.