The World Health Organization (WHO) recently announced the MVA-BN vaccine as the first vaccine against mpox to be added to its prequalification list. According to WHO, 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.
WHO’s assessment for prequalification is based on information submitted by the manufacturer, Bavarian Nordic, and review by the European Medicines Agency, the regulatory agency of record for this vaccine.
The MVA-BN vaccine can be administered in people 18 years of age and older 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.
“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 Dr Tedros Adhanom Ghebreyesus, said in a statement. “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.”1
Just a few weeks ago, the company announced they were prepared to increase production to meet the needs for vaccines.
What You Need to Know
The World Health Organization (WHO) prequalified the MVA-BN vaccine, making it the first vaccine for mpox added to its prequalification list.
Bavarian Nordic, the vaccine manufacturer, has scaled up production and plans to supply up to 10 million doses by 2025.
Mpox has become a significant global health issue, leading to declarations of public health emergencies in Africa and by WHO.
“We are manufacturing at a larger scale; building up an inventory for orders that we anticipate for this year, while ensuring that we have some surge capacity in the event of another outbreak or a large order,” Thomas Duschek, communications partner, Bavarian Nordic, said in an interview with Contagion. “This means that—in addition to our existing commitments—we will be able to supply a total of 10 million doses by the end of 2025, including up to 2 million doses this year.”
Back in May, the Centers for Disease Control and Prevention’s (CDC) MMWR published data around the Jynneos mpox vaccine. Investigators reported the vaccine is highly effective in preventing mpox virus infection after receipt of 2 Jynneos doses. In fact the estimated incidence rate to have occurred is less than 0.8% in fully vaccinated persons.2
In the period from May 2022 – May 2024, 271 mpox cases in fully vaccinated persons were reported to CDC from 27 US jurisdictions. The CDC data shows that among 32,819 probable or confirmed mpox cases during this time period, a total of 24,507 (75%) occurred in unvaccinated persons.2
The situation became very significant on both a continental and global scale in August when both the Africa Centers for Disease Control and Prevention (Africa CDC) declared the ongoing mpox outbreak a Public Health Emergency of Continental Security (PHECS)—the first such declaration by the agency since its inception in 2017. And WHO declared the mpox outbreaks in Congo and elsewhere in Africa a global emergency.
WHO reports that as of September 8, 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.
As this continues to be an evolving story, check back periodically for updated coverage.
