WHO Greenlights Mpox Vaccine, Accelerates Access to Outbreak Zones in Africa

The World Health Organization (WHO) has granted its first authorization for a vaccine against mpox, a crucial move to aid the Democratic Republic of Congo amid the ongoing outbreak. The decision, announced unexpectedly on Friday, surprised even the vaccine’s producer, Bavarian Nordic.

The Jynneos vaccine, developed by the Danish firm, had already received approvals from European and U.S. regulators. However, until now, the WHO had not given it a prequalification stamp, a key requirement for use in low- and middle-income countries. This delay had drawn criticism, particularly after the WHO declared a global public health emergency for mpox last month.

The WHO’s recent swift approval is significant for addressing the current outbreaks in Africa. Dr. Tedros Adhanom Ghebreyesus, WHO Director-General, emphasized the importance of this step for combating the disease both now and in future outbreaks.

Bavarian Nordic’s CEO, Paul Chaplin, expressed surprise at the rapid approval but welcomed it as a positive development. The vaccine, which had been pending WHO’s evaluation since 2023, will now facilitate smoother regulatory processes.

Mpox, historically endemic in the Democratic Republic of Congo, saw a resurgence globally in 2022. While the worldwide spread has diminished, Congo continues to experience high infection rates. The arrival of 245,000 donated doses in Kinshasa last week marks a pivotal moment, with distribution expected to begin by October 2.

The WHO’s decision also bypassed a planned emergency use meeting, an expedited move that experts like Prashant Yadav have praised. African health officials, who had previously expressed frustration with the slow response, will find this development encouraging.

The vaccine is approved for adults, with potential use for children at healthcare providers’ discretion, reflecting concerns about the high incidence of mpox in younger populations. Gavi and UNICEF are now tasked with procuring and distributing the vaccine, with Bavarian Nordic ready to supply millions of doses in the coming years.

The logistical challenges of transporting and administering the vaccine, especially in low-resource settings, remain. Ensuring that vaccine deliveries align with national vaccination programs and addressing liability concerns for off-label use in children will be crucial for the success of this initiative.