Mpox Vaccine Clinical Trial for Children Launches

Bavarian Nordic A/S today announced the initiation of a clinical study of the MVA-BN® (JYNNEOS) mpox/smallpox vaccine in children 2 to 11 years of age, partially funded with $6.5 million from the Coalition for Epidemic Preparedness Innovations (CEPI).

The phase 2 study is currently enrolling children in the Democratic Republic of Congo, with plans to include sites in Uganda. Results from this study could support an extension of the current approval of MVA-BN to include young children.

Last month, the WHO prequalified MVA-BN for adolescents 12 to 17 years of age, adopting the recent approval from the European Medicines Agency (EMA) for this age group.

While this study represents the first investigation of MVA-BN as a mpox/smallpox vaccine for younger children, a recombinant version of MVA-BN (Mvabea®) was approved by EMA in 2020 as part of a prime-boost vaccine regimen or the prevention of disease caused by Zaire Ebolavirus.

Paul Chaplin, President and CEO of Bavarian Nordic, said in a press release, “Following the recent approval of MVA-BN for adolescents, we are pleased to initiate this study, which could provide additional data to extend the indication to include children. We thank CEPI and our partners in Africa for their support of this important work.”

From an access perspective, Bavarian Nordic announced an agreement with UNICEF on September 26, 2024, to supply 1 million doses of the MVA-BN® mpox vaccine for African countries impacted by the ongoing mpox outbreak. 

As of late October 2024, there have been about 2,230 clade 2 mpox cases reported to the U.S. CDC this year.

The JYNNEOS vaccine is commercially available in the United States at various clinics and pharmacies.