Bavarian Nordic Wins EU Approval to Expand Mpox/Smallpox Vaccine to Children as Young as 2

The European Commission has adopted the Committee for Medicinal Products for Human Use's (CHMP) positive opinion recommending approval of a type II variation for IMVANEX (MVA-BN), Bavarian Nordic's smallpox and mpox vaccine, extending its marketing authorization to include children 2 to less than 12 years of age.¹ With this approval, MVA-BN is now authorized across the EU for individuals aged 2 and older, a significant expansion of access to what the company describes as the only non-replicating mpox vaccine approved globally.¹

What data supported the expanded approval?

The approval is based on a phase 2 clinical study (NCT06549530) involving 227 children ages 2 to 11 compared against adult participants.¹ Consistent with Bavarian Nordic's prior pediatric and adolescent expansions of the vaccine, the study was designed to demonstrate non-inferiority of immune responses in children relative to adults, along with a similar safety profile between the two age groups following two standard vaccine doses.¹

Why does pediatric access to this vaccine matter?

Children have borne a disproportionate share of the burden during the mpox clade I outbreak centered in the Democratic Republic of the Congo and other parts of Central Africa. As of May 2024, more than 7,000 suspected cases had been reported in the DRC that year, with a case fatality ratio of 5.3%; children 15 years and younger accounted for 67% of suspected cases and 84% of deaths, and children under age 1 were reported to be four times more likely to die than those over 15.² Until this approval, MVA-BN's authorization in the EU began at age 12, meaning the population facing the highest mortality risk from the outbreak had been outside the vaccine's approved age range.

What did company leadership say?

Paul Chaplin, president and chief executive officer of Bavarian Nordic, said, "The European Commission's approval of MVA-BN for children aged 2 to less than 12 years represents an important advancement in our efforts to broaden access to protection against mpox and smallpox. Children have carried a disproportionate burden during recent mpox outbreaks, particularly in parts of Africa, underscoring the importance of making safe and effective vaccines available to this vulnerable population. We are grateful to the study participants, investigators, CEPI, and our partners whose collaboration helped generate the data supporting this approval."¹

What happens next?

The approval marks the vaccine's third pediatric expansion since 2024, following authorization for adolescents ages 12 to 17 and the current extension down to age 2.¹ Bavarian Nordic said the approval adds to the growing body of clinical evidence supporting MVA-BN's use across age groups and reinforces the company's role in supporting global public health preparedness and outbreak response.¹ The vaccine is marketed under different brand names depending on region, including JYNNEOS in the US and IMVAMUNE in Canada, though this specific regulatory action applies to the EU/EEA authorization under the IMVANEX brand.¹

References

1. Bavarian Nordic receives European Commission approval of mpox/smallpox vaccine for children aged 2 to less than 12 years. News release. Bavarian Nordic A/S; August 7, 2026. Accessed August 7, 2026.
2. Cevik M, Tomori O, Mbala P, et al. The 2023-2024 multi-source mpox outbreaks of Clade I MPXV in sub-Saharan Africa: alarm bell for Africa and the World. Int J Infect Dis. 2024;146:Article 107159. doi:10.1016/j.ijid.2024.107159