Bavarian Nordic Begins Clinical Trials of Mpox Vaccine for Pregnant Women and Infants

Bavarian Nordic’s First of Two Clinical Trials

Image Credits: MedWatch

Announcement

Bavarian Nordic has initiated the first of two clinical trials to contribute to the use and approval of the MVA-BN mpox/smallpox vaccine for pregnant or breastfeeding women and 2-year-old infants. Further, the ongoing trials are a valuable contribution in approaching and making available this vaccine to vulnerable populations.

Progress So Far

Clinical trial till now has completed vaccinating the first participant under a study (NCT06844487). The study evaluates the immunogenicity and safety of MVA-BN in 344 infants ranging from 4-24 months. The second study (NCT06844500) has started looking for new participants. The study is planning to involve 359 pregnant or breastfeeding women and continue the same by evaluating the immunogenicity and safety of MVA-BN. These two studies will continue to be held in the Democratic Republic of Congo (DRC), which is the center of the mpok outbreak. A vulnerable stage where pregnant women and infants are easily prone to mpox.

These studies (trials) are associated with the PregInPoxVac research project, encouraged by the University of Kinshasa and the University of Antwerp. The project is boosted with the support of the partners in Italy (Penta foundation) and Kenya (ACE research), the European Union's Global Health EDCTP3, an alliance for Bavarian Nordic and epidemic preparedness innovations, which funded the project.

Additionally, Bavarian Nordic is sponsoring the MVA-BN trial in 2-to 11-year-old children. CEPI funded this trial. The results of this trial (NCT06549530) are expected to enter the third quarter of 2025. After receiving a full positive result, this trial will contribute to the regulatory approval of MVA-BN (for young children).

MPOX Vaccine

Modified Vaccina Ankara-Bavarian Nordic (MVA-BN) is the original mpox vaccine that is approved in Singapore, Mexico, Canada, the EU/EAA, Switzerland, and the US. The development of this vaccine with the US government's collaboration ensured access to the smallpox vaccine for everyone, also the immunocompromised population. Around 5.85 million vaccine doses will be available in the healthcare market by the end of the year.

Views and Statements

President and CEO of Bavarian Nordic, Paul Chaplin, said, “With partnerships, we have already expanded and advanced access to the mpox vaccine for adolescents and children. The new studies will add advanced data regarding the use of MVA-BN in pregnant women and infants. We are thankful to the study and funding partners (CEPI and EDCTP3). It is a huge support to this important work that will further expand MVA-BN to count the vulnerable population in it.”