The European Medicines Agency (EMA) has approved Bavarian Nordic's mpox vaccine, known as MVA-BN (marketed as Imvanex in Europe and Jynneos in the US), for use in adolescents aged 12-17. This decision, based on promising clinical trial data, could significantly improve access to the vaccine for vulnerable populations, particularly in Africa where mpox outbreaks continue to pose a serious threat. The approval follows a type II variation application submitted by Bavarian Nordic last month.
Clinical Trial Data Supports расширение Authorization
The EMA's Committee for Medicinal Products for Human Use (CHMP) based its recommendation on data from a Phase II clinical trial (NCT05740982) sponsored by the U.S. National Institutes of Health (NIH). The study involved 315 adolescents aged 12-17 and 211 adults aged 18 and older. Results demonstrated that adolescents exhibited non-inferior immune responses compared to adults, with a similar safety profile observed in both age groups after two standard doses of the MVA-BN vaccine.
According to the NIH, after two doses, antibody levels in adolescents were equivalent at day 43 to those in adults aged 18 to 50 years. The overall frequency of adverse events was comparable between the study groups, with the vaccine well tolerated through day 210 of the study. Dizziness was reported more often in the adolescent group, but the NIH stated this is also seen in many other vaccines given to a younger age group.
Implications for Global Mpox Control
The EMA's approval could pave the way for broader use of the vaccine in adolescents in Africa, where mpox cases have been steadily increasing. The World Health Organization (WHO) has declared mpox a global public health emergency, with children and adolescents being particularly vulnerable. As of recent reports, there have been nearly 25,100 cases and more than 720 deaths in Africa since the beginning of the year, with the Democratic Republic of Congo (DRC) being the most affected country.
Paul Chaplin, President & CEO of Bavarian Nordic, stated, "This represents an important milestone in our efforts to make our vaccine available for all populations and will help improve access for some of the most vulnerable individuals mostly impacted by the ongoing mpox outbreak in Africa."
Ongoing and Future Research
Bavarian Nordic is also planning a Phase II clinical trial (NCT06549530) to assess the immunogenicity and safety of MVA-BN in children aged 2-12 years. This trial, partially funded by the Coalition for Epidemic Preparedness Innovations (CEPI), is expected to begin next month and aims to further extend the vaccine's indication to younger populations.
Additionally, CEPI is co-funding a clinical study led by McMaster University in Canada to assess post-exposure vaccination with MVA-BN. This study will evaluate whether the vaccine can reduce the risk of secondary mpox cases or mitigate the severity of illness in infected individuals. The study will include over 1,500 participants, including children in households with laboratory-confirmed mpox infections in the DRC, Uganda, and Nigeria.
Current Mpox Landscape
MVA-BN is the only non-replicating mpox vaccine approved in the U.S., Switzerland, Singapore, and Mexico (marketed as JYNNEOS), Canada (marketed as IMVAMUNE), and the EU/EEA and United Kingdom (marketed as IMVANEX). While the WHO says the vaccine can be used "off-label" for people below 18, it has only backed its use in adults. The Democratic Republic of Congo (DRC), worst-hit by the current outbreak, is not planning to vaccinate under-18 year olds in its first wave of immunisations with the Bavarian vaccine.
Bavarian Nordic has been a long-term supplier of the vaccine to national stockpiles, and during the 2022-2023 mpox outbreak, the Company supported governments and supranational organizations by expanding access to the vaccine to more than 70 countries worldwide.
