Bavarian Nordic A/S has initiated groundbreaking clinical trials for its MVA-BN® mpox/smallpox vaccine, targeting some of the most vulnerable populations. The studies focus on infants under two years and pregnant or breastfeeding women, aiming to expand vaccine accessibility amid the ongoing mpox outbreak in the Democratic Republic of Congo (DRC).
Expanding Vaccine Reach in High-Risk Areas
The first trial (NCT06844487) commenced with the vaccination of 344 infants aged between four and twenty-four months. Simultaneously, recruitment has begun for a second study (NCT06844500), which plans to enroll 359 women who are either pregnant or breastfeeding. Both studies are crucial in assessing the safety and immunogenicity of the MVA-BN vaccine in these groups, providing essential data for potential regulatory approvals.
Collaborative Efforts and Funding Support
These initiatives are part of the PregInPoxVac research project, led by the University of Antwerp and the University of Kinshasa, with additional support from ACE Research in Kenya and the Penta Foundation in Italy. Funding from the European Union Global Health EDCTP3 and the Coalition for Epidemic Preparedness Innovations (CEPI) underscores the global commitment to combating mpox. Bavarian Nordic is also sponsoring a related trial for children aged two to eleven years, with results expected in the third quarter of 2025.
- The trials address significant gaps in vaccine data for infants and pregnant women.
- Conducting research in the DRC directly targets the epicenter of the current outbreak.
- Collaborations with international partners enhance the study’s impact and reach.
MVA-BN, known commercially as JYNNEOS® in the U.S. and IMVANEX® in Europe, is the only non-replicating mpox vaccine approved in multiple regions. Originally developed as a smallpox vaccine, it offers a safer alternative for immunocompromised individuals and is indicated for those at risk of mpox or smallpox infection.
The successful completion and subsequent approval of these trials could significantly enhance public health responses to mpox by providing a vaccine tailored for the youngest and most vulnerable populations. This advancement not only strengthens immunity in high-risk groups but also contributes to broader efforts in epidemic preparedness and response.
Access to safe and effective vaccines for infants and pregnant women ensures comprehensive protection and reduces the potential for severe outcomes in these sensitive groups. As mpox continues to pose a global health threat, Bavarian Nordic’s proactive approach in expanding vaccine research and development is instrumental in safeguarding public health and preventing the spread of the virus.
By prioritizing the needs of vulnerable populations and fostering international collaborations, Bavarian Nordic sets a precedent for future vaccine initiatives. Their commitment to innovation and public health underscores the importance of inclusive research in combating infectious diseases, ultimately leading to more resilient and prepared healthcare systems worldwide.
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