GENEVA

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

The UN agency said in a statement that the prequalification approval is expected to facilitate timely and increased access to this product in communities with urgent need, to reduce transmission and help contain the outbreak.

It added that WHO’s assessment for prequalification is based on information submitted by the manufacturer, Bavarian Nordic A/S, and review by the European Medicines Agency, the regulatory agency of record for this vaccine.

"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 future," WHO Director-General Tedros Adhanom Ghebreyesus 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," Tedros urged.

The MVA-BN vaccine can be administered in people over the age of 18 as a two-dose injection is given four weeks apart, according to the WHO.

Regarding the storage conditions, it said that after prior cold storage, the vaccine can be kept at 2-8°C (35-46F) for up to eight weeks.

Yukiko Nakatani, WHO assistant director-general for access to medicines and health products, said this prequalification of the MVA-BN vaccine will "help accelerate ongoing procurement of the mpox vaccines by governments and international agencies such as Gavi (vaccine alliance) 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.