The World Health Organization (WHO) has announced the MVA-BN vaccine as the first vaccine against mpox to be added to its prequalification list.
This is according to a statement issued by WHO on Friday, September 13, 2024.
It informed that the prequalification approval was expected to facilitate timely and increased access to this vital product in communities with urgent need, to reduce transmission and help contain the outbreak.
WHO’s assessment for prequalification was 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.
WHO Director-General, Dr. Tedros Ghebreyesus stated that the pre-qualification of MPox vaccine was an important step in the fight against the disease:
“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.
“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”, he said.
The MVA-BN vaccine can be administered in people over 18-years of age as a 2-dose injection given 4 weeks apart. After prior cold storage, the vaccine can be kept at 2–8°C for up to 8 weeks.
On his part, WHO Assistant Director-General for Access to Medicines and Health Products, Dr. Yukiko Nakatani explained that, “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”.
The escalating mpox outbreak in the Democratic Republic of the Congo and other countries was declared a Public Health Emergency of International Concern by the WHO Director-General on 14 August 2024.
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 from 8 September 2024).
