The MVA-BN vaccine is not officially licensed for use in people under the age of 18, although it may be administered “off-label” in infants, children, and adolescents, as well as pregnant and immunocompromised people in countries experiencing mpox epidemics.
The World Health Organisation (WHO) on Friday announced the MVA-BN vaccine as the first vaccine against mpox to be added to its prequalification list, which is expected to improve access to the vaccine, particularly among communities urgently needing it.
The prequalification process, based on information submitted by the manufacturer, Bavarian Nordic A/S, and review by the European Medicines Agency, is intended to facilitate the rapid procurement and distribution of the vaccine.
WHO Director-General Dr Tedros Adhanom Ghebreyesus emphasised the importance of the crucial step in curbing current mpox outbreaks, particularly in Africa.
“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,” he said.
He called for an urgent scale-up of vaccine procurement, donations and distributions to ensure equitable access. “Alongside other public health tools, this vaccine will help prevent infections, stop transmission, and save lives,” he stated.
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The MVA-BN vaccine, administered as a two-dose injection given four weeks apart, is approved for people over 18 years old. After being stored in cold conditions, it can remain stable at temperatures between 2 to 8 degrees Celsius for up to eight weeks.
Dr Yukiko Nakatani, WHO’s Assistant Director-General for Access to Medicines and Health Products, stated, “The WHO prequalification of the MVA-BN vaccine will 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,” he added.
Available data shows that a single-dose MVA-BN vaccine given before exposure has an estimated 76 per cent effectiveness in protecting people against mpox, with the two-dose schedule achieving an estimated 82 per cent effectiveness, WHO said.
