WHO Approves Mpox Vaccine by Bavarian Nordic for Adolescent Use

In August, the World Health Organization (WHO) declared mpox a global public health emergency for the second time in two years. This decision followed the emergence of a new variant of the virus, which spread from the Democratic Republic of Congo to neighboring countries. The resurgence of mpox has raised global health concerns, prompting immediate action to control its spread.

Approval of Bavarian Nordic's Mpox Vaccine

On October 8, the WHO announced the approval of Bavarian Nordic's mpox vaccine, specifically designed for adolescents aged 12 to 17 years. This age group is considered particularly vulnerable to outbreaks of the disease, making the vaccine's availability crucial in protecting their health. The vaccine, known as Jynneos, has been prequalified by the WHO, facilitating access for nations grappling with mpox outbreaks.

Previous Vaccine Approval for Adults

In September, the WHO had already approved the Jynneos vaccine for adult use, marking it as the first shot against mpox in that demographic. This early approval was pivotal in providing African countries, which have been severely affected by the virus, with improved access to necessary vaccines. The global health body has prioritized making vaccines available to regions most impacted by mpox.

Vulnerability of Children and Adolescents

Mpox is a viral infection that typically presents with flu-like symptoms and skin lesions filled with pus. It poses a significant risk to children, adolescents, and individuals with weakened immune systems. The WHO's recent decision to authorize the vaccine for adolescents highlights the organization's commitment to safeguarding the health of younger populations during this ongoing public health crisis.

EU Approval and Future Trials

Following the WHO’s lead, the European Union (EU) approved the Jynneos vaccine for adolescents in September. The Danish biotech firm, Bavarian Nordic, is also planning to conduct a clinical trial aimed at assessing the vaccine's safety in children aged two to 12. This initiative, partially funded by the Coalition for Epidemic Preparedness Innovations, is set to commence in October, potentially expanding the vaccine's use to younger age groups.

FDA's Position on Bavarian Nordic's Vaccine

While the U.S. Food and Drug Administration (FDA) has approved Bavarian Nordic's mpox vaccine for adults aged 18 and older, it also granted Emergency Use Authorization for its application in adolescents during the mpox outbreak of 2022. This dual approval underscores the ongoing efforts to manage and mitigate the impact of mpox across various age demographics.

Alternative Vaccine Options

In addition to the Jynneos vaccine, another mpox vaccine known as LC16, developed by Japan’s KM Biologics, is already available for children, as confirmed by Japanese regulators. However, it requires a specific type of needle for administration, which could pose additional logistical challenges.

Conclusion

The WHO's recent approval of Bavarian Nordic's mpox vaccine for adolescents signifies a vital step forward in combating the disease. With the rising threat of mpox and its variants, especially among younger populations, the availability of safe and effective vaccines is paramount. As the global health community rallies to address this public health emergency, ongoing research and clinical trials will be essential to ensure comprehensive protection for all age groups against mpox.