Significant WHO Approval

In a significant development in the fight against mpox (formerly known as monkeypox), the World Health Organization (WHO) has officially added the MVA-BN vaccine to its prequalification list, marking it as the first vaccine approved for this disease. This prequalification is pivotal as it aims to enhance access to vaccine distribution in communities that are urgently in need, helping to curb the transmission of the virus and manage ongoing outbreaks.

Vaccine Details and Regulatory Approval

The evaluation for prequalification was conducted based on comprehensive data submitted by the manufacturer, Bavarian Nordic, and underwent review by the European Medicines Agency, which serves as the vaccine's regulatory authority. The MVA-BN vaccine is designed for individuals aged 18 and older, requiring two doses administered four weeks apart. Notably, this vaccine, after storage under cold conditions, can remain viable at 2-8°C for up to eight weeks, making it logistically easier to distribute.

Remarks from WHO Director-General

Dr. Tedros Adhanom Ghebreyesus, WHO's Director-General, emphasized the importance of this achievement, stating, “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 efforts.” He further urged immediate action to scale up procurement, donations, and rollout of the vaccine to guarantee equitable access where it is most needed.

Bavarian Nordic's Production Plans

Bavarian Nordic has proactively ramped up its production capabilities, aiming to deliver up to 10 million doses by 2025. The company’s communications partner, Thomas Duschek, confirmed this strategy, including plans to address any surges in demand or potential new outbreaks while maintaining a steady supply for existing commitments.

Global Health Threat and Vaccination Impact

Mpox has escalated into a pressing global health threat, contributing to multiple public health emergencies declared both in Africa and by the WHO. Recent data from the Centers for Disease Control and Prevention (CDC) indicated that the Jynneos mpox vaccine demonstrated high effectiveness, with a reported incidence rate of less than 0.8% in fully vaccinated individuals.

Case Data and Public Health Emergency Declaration

From May 2022 to May 2024, the CDC recorded 271 mpox cases among vaccinated individuals across 27 U.S. jurisdictions. Alarmingly, during the same timeframe, 75% of the 32,819 probable or confirmed mpox cases were found in unvaccinated people, underscoring the critical role that vaccination plays in outbreak prevention.

Historic Public Health Declarations

The gravity of the situation spurred significant declarations in August 2023, with the Africa Centers for Disease Control and Prevention labeling the ongoing mpox outbreak as a Public Health Emergency of Continental Security (PHECS)—a historic move for the agency since its establishment in 2017. The WHO has reported over 103,000 confirmed mpox cases across more than 120 countries since the global outbreak began in 2022, with 25,237 suspected and confirmed cases reported in 2024 alone in 14 African countries, resulting in 723 fatalities.

Conclusion and Future Updates

As global vaccination efforts continue to evolve, the introduction of the MVA-BN vaccine represents a hopeful advancement in controlling the spread of mpox and protecting public health. Stay informed for further updates as this situation develops.