Bavarian Nordic begins mpox vaccine trial in pregnant women and infants
June 26, 2025
In a critical move for protecting vulnerable populations, Bavarian Nordic has launched two Phase III trials of its mpox vaccine, Jynneos, in infants under two and pregnant or breastfeeding women in the Democratic Republic of the Congo. Supported by CEPI, EDCTP3, and led by institutions in Kinshasa and Antwerp, the studies will assess vaccine safety and immunogenicity. While this research is vital, funding shortfalls—especially the U.S. withdrawal from GAVI and USAID—threaten equitable access to future doses. The trials may help expand vaccine labels, but global cooperation and sustained financial support are essential to ensure protection reaches those most at risk.
Bavarian Nordic’s recent launch of two Phase III clinical trials for its mpox vaccine, Jynneos, marks a significant step forward in safeguarding high-risk populations—infants and pregnant or breastfeeding women—in the Democratic Republic of the Congo (DRC), the epicenter of the ongoing outbreak. These trials, conducted under the PregInPoxVac project, are coordinated by the University of Antwerp and the University of Kinshasa, with regional support from Kenya and Italy. Funded by CEPI, EDCTP3, and Bavarian Nordic, the trials will generate critical safety and immunogenicity data for groups historically excluded from vaccine research.
The move fills a pressing gap in mpox vaccine data, especially as infants and expectant mothers in the DRC face disproportionate risk from the virus. Bavarian Nordic’s CEO, Paul Chaplin, acknowledged the potential for label expansion, which could pave the way for broader authorization and more inclusive vaccination programs.
However, these advancements arrive amid troubling shifts in global vaccine equity. The recent decision by U.S. Health Secretary Robert F. Kennedy Jr. to withdraw financial support from GAVI—and earlier cuts to USAID—threatens vaccine delivery and research infrastructure in low-income countries. Even with commitments like Bavarian Nordic’s 2.5 million dose agreement with UNICEF, the systemic erosion of funding could undermine access and response capacity.
Meanwhile, Bavarian Nordic continues to profit, reporting strong revenues and a $160 million windfall from selling a priority review voucher. These gains contrast starkly with the financial precarity facing vaccine distribution networks in Africa.
As science advances, so must equity. The data from these trials could inform global vaccination policy, but without renewed commitments to global health solidarity, the most vulnerable—especially in West and Central Africa—may continue to face avoidable suffering. Investing in research must be matched with accessible implementation, or progress risks becoming privilege.