WHO Prequalifies First Mpox Vaccine: What It Means for Global Health and Children**

**Introduction: A New Chapter in the Fight Against Mpox**

In a significant step towards global health equity, the World Health Organization (WHO) has prequalified the first mpox vaccine, Bavarian Nordic’s MVA-BN, marking a turning point in the battle against this once-neglected disease. The vaccine, marketed under the names Jynneos and Imvamune, is now on the WHO's prequalification list, enabling it to be distributed worldwide, especially in low- and middle-income countries. But this approval comes with more than just regulatory significance—it's a lifeline for communities facing mpox outbreaks and signals a shift in how we approach public health emergencies. In this article, we’ll dive into the implications of this decision, including its impact on children, who are particularly vulnerable in regions like Africa.

---

### **1. The First Mpox Vaccine to Be WHO Prequalified: Why It Matters**

The prequalification of Bavarian Nordic's MVA-BN vaccine is a major milestone in the fight against mpox, a viral infection that has plagued parts of Africa for years but only gained global attention after a worldwide outbreak in 2022. With over 103,000 confirmed cases in 120 countries since the outbreak, the demand for an effective vaccine has never been higher. This WHO prequalification means that governments, international agencies like UNICEF, and global health organizations can now expedite the procurement and distribution of the vaccine.

The vaccine’s prequalification ensures that it meets the highest standards for safety, efficacy, and quality, which is crucial when addressing health emergencies in resource-constrained settings. This move opens the door to ensuring equitable access to the vaccine for countries that need it most, particularly in Africa, where outbreaks are most severe.

---

### **2. The Shift to Single-Dose Vaccination: A Game-Changer for Supply-Limited Areas**

One of the most striking recommendations from the WHO is the shift to administering a single dose of the MVA-BN vaccine in outbreak settings with limited supplies. Typically given in two doses four weeks apart, the WHO now suggests a single-dose regimen when vaccines are in short supply. Data shows that a single dose can provide 76% effectiveness in preventing mpox, while the two-dose schedule offers 82% protection. This slight reduction in efficacy is outweighed by the ability to protect more people with fewer doses, especially in regions facing high transmission rates.

This strategy could be critical in preventing further spread of mpox in regions like the Democratic Republic of the Congo (DRC) and neighboring countries, where healthcare systems are already overburdened, and vaccine supplies are scarce.

---

### **3. Protecting the Vulnerable: “Off-Label” Use for Children and Pregnant Women**

One of the most impactful decisions made by the WHO is allowing the MVA-BN vaccine to be used “off-label” for children, pregnant women, and immunocompromised individuals. This recommendation is particularly important because, while the vaccine isn’t officially approved for those under 18, data from various studies support its efficacy in children. In the DRC, where a large number of mpox cases occur in children, this off-label use could be a life-saving measure.

Dr. Ana-Maria Restrepo, the head of WHO’s Research and Development, emphasized the need for this flexibility, citing evidence that the vaccine is effective and safe for younger populations. Pregnant women and immunocompromised individuals, who face higher risks of severe mpox, are also eligible for this “off-label” use in outbreak settings, where the benefits outweigh the risks.

This decision to expand access is a critical step toward protecting the most vulnerable populations, ensuring that no one is left behind in the global fight against mpox.

---

### **4. Accelerating Global Access: What This Means for Governments and Health Organizations**

The prequalification of the MVA-BN vaccine doesn’t just have implications for individuals—it’s also a boon for national regulators and health agencies worldwide. Governments and organizations like Gavi and UNICEF can now fast-track the approval and procurement processes for mpox vaccines. This means that communities on the frontlines of the mpox crisis, especially in Africa, will get quicker access to life-saving vaccines.

Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, praised the decision, highlighting that this prequalification will accelerate the ongoing procurement of mpox vaccines by various health bodies. This could help stem the tide of infections and prevent future outbreaks from escalating into public health emergencies.

---

### **5. Looking Ahead: The Race to Expand Vaccine Approval for Children**

While the MVA-BN vaccine is not yet officially approved for children, efforts are already underway to change that. Bavarian Nordic has submitted an application to the European Medicines Agency to extend the vaccine's approval to adolescents aged 12-17. In addition, the company is working with partners to evaluate the safety and efficacy of the vaccine in children aged 2-12. Given that children have been disproportionately impacted by mpox in countries like the DRC, these efforts are crucial for long-term protection.

The company has pledged to produce two million doses of the vaccine by the end of 2024, with the potential for up to 13 million doses by the end of 2025. This scale-up in production is essential for meeting the growing demand and ensuring that vulnerable populations, including children, have access to this critical vaccine.

---

A New Era in Mpox Prevention**

The WHO’s prequalification of the MVA-BN vaccine marks a pivotal moment in global health, particularly in the fight against mpox. From single-dose recommendations to off-label use for children and pregnant women, these developments underscore the urgency of addressing the mpox crisis in a way that is both equitable and effective. With over 103,000 cases since the 2022 outbreak, the need for global cooperation and swift action has never been more apparent.

This milestone also serves as a reminder that public health emergencies require innovative solutions and adaptability. The decision to prequalify the vaccine will not only help protect those at high risk but also accelerate global access to vaccines in regions that need it most.

If you found this article informative, be sure to like, comment, and subscribe to our channel for more updates on global health initiatives. Let us know your thoughts on the WHO’s decision and what you think it means for the future of mpox prevention. Stay informed, stay safe, and help spread the word!