Bavarian Nordic is taking significant strides toward expanding the approval of its MVA-BN mpox/smallpox vaccine to include children aged two to 11 years. This ambitious move comes as the company launches a Phase II clinical trial designed to assess the safety and immunogenicity of the vaccine in younger populations compared to adults.

The Phase II study, registered under NCT06549530, is partially funded by the Coalition for Epidemic Preparedness Innovations (CEPI), reflecting a growing commitment to combat infectious diseases. Recruitment for the trial will take place across the Democratic Republic of Congo and potentially Uganda, targeting regions that have been significantly affected by the recent mpox outbreaks.

In August, the World Health Organization (WHO) declared mpox a global public health emergency for the second time in just two years, underscoring the urgency of developing effective vaccination strategies against this virus which has spread across borders from the Democratic Republic of Congo.

MVA-BN, also known as Jynneos in the United States and Imvanex in Europe, is a non-replicating vaccine that has been a game-changer in the fight against mpox/smallpox. Just last month, the European Medicines Agency (EMA) expanded the vaccine's approval to include adolescents over the age of 12. Additionally, the Global Alliance for Vaccines and Immunization (GAVI) has secured a purchase agreement for 500,000 doses, aimed at supporting vaccination efforts in African nations.

It's worth noting that this Phase II trial is a pioneering effort to evaluate MVA-BN specifically for younger children. Previously, Bavarian Nordic had developed a recombinant version named Mvabea, which the EMA approved in 2020 for use as part of a prime-boost regimen to protect against the Ebola virus, starting at one year of age.

Dr. Nicole Lurie, executive director of preparedness and response at CEPI, emphasized the importance of the upcoming study, stating, "The findings will be crucial in shaping mpox vaccine strategies that could protect children and potentially halt this devastating outbreak. This research will also provide essential guidance for tackling mpox in endemic regions, helping to prevent future outbreaks."

Bavarian Nordic has seen impressive financial growth due to its vaccine products. Last year alone, the mpox/smallpox vaccine generated revenue of DKK5 billion (approximately $724 million) from global sales and government contracts, solidifying its role as a major revenue stream for the company.

As the situation evolves, experts and communities will eagerly await the results of this trial, which could pave the way for a new generation of vaccine strategies and ultimately protect our youngest populations from serious health threats. Stay tuned for updates on this critical development in public health!