WHO pre-qualifies Mpox vaccine, paving the way for access

The World Health Organization (WHO) recently announced that the MVA-BN vaccine will be the first MPOX vaccine to be added to its prequalification list. According to WHO, the prequalification approval is expected to improve timely access to this critical product in communities in urgent need, helping to reduce transmission and contain the outbreak.

The WHO's prequalification assessment is based on information submitted by the manufacturer, Bavarian Nordic, and a review by the vaccine's regulator, the European Medicines Agency.

The MVA-BN vaccine can be administered in two doses, four weeks apart, to people over the age of 18. The vaccine can be stored at 2-8°C for up to eight weeks after prior refrigeration.

“The prequalification of this first MPOX vaccine marks an important step in the fight against the disease, both in the current outbreak in Africa and in the future,” WHO Director-General Dr. Tedros Adhanom Ghebreyesus said in a statement. “We need urgent scale-up of procurement, donations and deployment to ensure equitable access to vaccines where they are most needed, alongside other public health tools to prevent infection, interrupt transmission and save lives.”¹

Just a few weeks ago, the company announced it was ready to ramp up production to meet demand for the vaccine.

What you need to know

The World Health Organization (WHO) prequalified the MVA-BN vaccine, making it the first mpox vaccine added to the prequalified list.

Vaccine manufacturer Bayern Nordic AG plans to scale up production and supply up to 10 million doses of the vaccine by 2025.

Mpox has become a significant global health issue, leading to the declaration of a public health emergency in Africa and by the WHO.

““We are producing on a larger scale. We are building up stocks for expected orders this year, while also reserving some supply capacity in case of new outbreaks or large orders,” said Thomas Duszek, communications partner at Bavaria Nordic. Interview Transmission. “This means we could supply a total of 10 million doses of vaccine by the end of 2025, including up to two million doses this year, in addition to our existing commitments.”

In May, the U.S. Centers for Disease Control and Prevention (CDC) MMWR The investigators published data on the Jinneos MPOX vaccine. Vaccines are highly effective Two doses of Jynneos can prevent MPOX virus infection, and in fact, the estimated incidence in fully vaccinated people is less than 0.8%.²

Between May 2022 and May 2024, 271 MPOX cases in fully vaccinated individuals were reported to CDC from 27 jurisdictions in the United States. Of the 32,819 suspected or confirmed MPOX cases during this time period, a total of 24,507 (75%) occurred in unvaccinated individuals, according to CDC data.²

This situation has become extremely significant on both a continental and global scale. August When the Africa Centers for Disease Control and Prevention (Africa CDC) declared the ongoing MPOX outbreak a Public Health Emergency of Continental Security (PHECS), it marked the first such declaration by the agency since its establishment in 2017. The WHO also declared the MPOX outbreak in Congo and other parts of Africa a global emergency.

The WHO reports that as of September 8, more than 103,000 cases of MPOX have been confirmed in more than 120 countries since the start of the global epidemic in 2022. In 2024 alone, various outbreaks have caused 25,237 suspected and confirmed cases and 723 deaths in 14 countries in the African region.

This story continues to evolve, so check back regularly for the latest coverage.

References

1. WHO prequalifies first vaccine against MPOX. WHO. September 13, 2024. Accessed September 15, 2024.
https://www.who.int/news/item/13-09-2024-who-prequalifying-the-first-vaccine-against-mpox
2. Guagliardo SA, Kracalik I, Carter RJ, et al. Monkeypox virus infection after two doses of JYNNEOS vaccine – United States, May 2022-May 2024. MMWR Morb Mortal Wkly Rep 2024;73:460–466. DOI: http://dx.doi.org/10.15585/mmwr.mm7320a3

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