WHO prequalifies MVA-BN as first vaccine against Mpox

The World Health Organisation (WHO) has announced the MVA-BN vaccine as the first vaccine against mpox to be added to its prequalification list.

The prequalification approval is expected to facilitate timely and increased access to this vital product in communities with urgent need to reduce transmission and help contain the outbreak of mpox.

Director-General of WHO, Dr. Tedros Adhanom Ghebreyesus, in a statement on Friday, said that the first prequalification of a vaccine against mpox was an important step in the fight against the disease, both in the context of the current outbreaks in Africa and in future.

He said: “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 MVA-BN vaccine can be administered in people over 18-years of age as a two-dose injection given four weeks apart. After prior cold storage, the vaccine can be kept at 2–8°C for up to eight weeks.

Also commenting on the development, the WHO Assistant Director-General for Access to Medicines and Health Products, Dr. Yukiko Nakatani, said the prequalification of the MVA-BN vaccine would help accelerate ongoing procurement of the mpox vaccines by governments and international agencies such as Gavi and UNICEF to help communities on the frontlines of the ongoing emergency in Africa and beyond.

“The decision can also help national regulatory authorities to fast-track approvals, ultimately increasing access to quality-assured mpox vaccine products,” Nakatani said.

Over 120 countries have confirmed more than 103,000 cases of mpox since the onset of the global outbreak in 2022. In 2024 alone, there were 25,237 suspected and confirmed cases and 723 deaths from different outbreaks in 14 countries of the African Region (based on data as of September 8, 2024).

The Director-General of WHO had declared a Public Health Emergency of International Concern.

On Aug 13, 2024, the Africa Centres for Disease Control and Prevention (Africa CDC) also declared mpox a Public Health Emergency of Continental Security (PHECS).