EU Approves Label Extension for Bavarian Nordic's Imvanex Mpox Vaccine to Children Aged 2 and Older
核心洞察
The European Commission has extended Imvanex (MVA-BN) marketing authorization to children aged 2 to less than 12 years, making it the only non-replicating mpox (搜索) vaccine approved for all individuals aged 2 and older in the EU.
The approval is supported by a Phase II study (NCT06549530) demonstrating non-inferior immune responses in children compared to adults, with similar safety profiles between both populations.
Children have been disproportionately affected during recent mpox (搜索) outbreaks, particularly in Africa, and this label extension addresses a critical regulatory gap for a vulnerable population.
The European Commission has approved a label extension for Bavarian Nordic's Imvanex (MVA-BN) vaccine, expanding its authorized use to children aged 2 to less than 12 years. The decision, announced Monday, converts a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) into a binding marketing authorization across the EU, making MVA-BN now authorized for all individuals aged 2 years and older in the region.
The approval marks a significant regulatory milestone for a population that has been disproportionately affected during recent mpox (搜索) outbreaks. Prior to this decision, the EU authorization covered individuals aged 12 and older, leaving younger children without a formally approved vaccination option despite documented exposure risk.
Addressing an Unmet Need in Pediatric Mpox (搜索) Prevention
Children have carried a substantial burden during recent mpox (搜索) outbreaks, particularly across parts of Africa, where clade Ib transmission has driven sustained community spread. Bavarian Nordic Chief Executive Paul Chaplin stated that children had "carried a disproportionate burden during recent mpox outbreaks," describing the approval as an important step in broadening access to the vaccine for a vulnerable population.
The World Health Organization declared the mpox (搜索) outbreak a global health emergency, with the virus affecting over 16,000 people in 75 countries since May, according to WHO statistics. Monkeypox (搜索) causes disease with similar but less severe symptoms to smallpox, including fever, rash, and swollen lymph nodes. Human-to-human transmission can occur through contact with bodily fluids, skin lesions, respiratory droplets, and contaminated objects.
Clinical Evidence Supporting the Pediatric Indication
The approval is supported by data from NCT06549530, a Phase II study enrolling 227 children aged 2 to less than 12 years and 224 adults. The primary endpoint assessed immunogenicity, with the study demonstrating non-inferior immune responses in children compared to adults following two standard doses of the vaccine. Safety profiles were reported as similar between the two populations. The study was co-funded by the Coalition for Epidemic Preparedness Innovations (搜索) (CEPI).
The approval is structured as a type II variation to the existing marketing authorization. MVA-BN is administered as a two-dose subcutaneous regimen, with no modified dosing schedule reported for the pediatric age group — the same regimen used in adults.
Vaccine Profile and Competitive Positioning
MVA-BN is a live attenuated, non-replicating viral vaccine derived from the Modified Vaccinia Ankara strain. Because it cannot complete replication in human cells, it produces viral antigens sufficient to prime orthopoxvirus-specific humoral and cellular immunity without the replication-associated adverse effects associated with earlier smallpox vaccines. This profile makes it suitable for immunocompromised individuals — a population for whom traditional replicating vaccinia vaccines are contraindicated.
MVA-BN is the only non-replicating mpox (搜索) vaccine with regulatory approval across the US, Canada, the EU/European Economic Area, the UK, Switzerland, Singapore, and Mexico — marketed as Jynneos in the US and several other markets, and as Imvamune in Canada. Its closest comparator in the pediatric orthopoxvirus space is LC16m8, a live attenuated, minimally replication-competent vaccinia vaccine developed by Japan-based KM Biologics (搜索), which holds a Japanese approval covering children aged one year and older and received a WHO Emergency Use Listing for mpox in November 2024. Emergent BioSolutions' ACAM2000, a replication-competent vaccinia vaccine approved in the US for smallpox, lacks dedicated pediatric trial data and carries contraindications that limit its use in immunocompromised individuals — a meaningful practical distinction from MVA-BN in the pediatric context.
The pediatric label extension further consolidates MVA-BN's position as the leading globally licensed orthopoxvirus vaccine and expands Bavarian Nordic's regulatory lead in a market where few alternatives have demonstrated comparable pediatric safety data.