EMA Approves Bavarian Nordic's Mpox Vaccine for Adolescents

Bavarian Nordic A/S, a well-regarded vaccine manufacturer, announced a significant milestone on September 19, 2024. The European Commission has adopted the Committee for Medicinal Products for Human Use (CHMP) recommendation to approve a type II variation for IMVANEX® (MVA-BN) smallpox and mpox vaccine. This approval extends the existing marketing authorization to include adolescents aged 12 to 17 years.

This decision follows the submission of data from a clinical study (NCT05740982) sponsored by the U.S. National Institutes of Health’s National Institute of Allergy and Infectious Diseases. The study included 315 adolescents aged 12 to 17 and 211 adults aged 18 and older. Results demonstrated that the immune responses in adolescents were non-inferior to those seen in adults, and the safety profile was similar in both age groups after vaccination with two standard doses of the MVA-BN vaccine.

This marks the first approval of MVA-BN as a smallpox and mpox vaccine for adolescents. However, a recombinant version of MVA-BN, known as Mvabea®, was approved by the European Medicines Agency (EMA) in 2020 for use as part of a prime-boost vaccine regimen for the prevention of Ebola virus in individuals aged one year and older. Clinical studies supporting this approval included more than 3,300 individuals across Europe, the USA, and Africa, including over 800 children and adolescents aged 1-17 years in Africa. The safety profile of Mvabea in children and adolescents was comparable to that observed in adults and similar to the safety profile of MVA-BN in individuals aged 12 years and older.

Paul Chaplin, President & CEO of Bavarian Nordic, expressed appreciation for EMA's expedited review and approval process. He highlighted the significance of this milestone in improving access to the vaccine for vulnerable populations, particularly those affected by the ongoing mpox outbreak in Africa.

Bavarian Nordic is currently preparing for another clinical trial (NCT06549530) to evaluate 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), aims to further extend the vaccine's indication to younger populations and is expected to commence next month.

CEPI has also co-funded a clinical study (NCT05745987) led by McMaster University in Canada. This study aims to assess the effectiveness of post-exposure vaccination with MVA-BN in reducing the risk of secondary mpox cases or mitigating the severity of the illness. The study will include over 1,500 participants, including children in households with laboratory-confirmed mpox infections, at sites in the Democratic Republic of Congo, Uganda, and Nigeria. The findings from this study could significantly inform vaccination strategies in regions affected by the mpox outbreak.

MVA-BN, or Modified Vaccinia Ankara-Bavarian Nordic, is the only non-replicating mpox vaccine approved in several countries, including the U.S., Switzerland, Singapore, Mexico, Canada, and EU/EAA and the United Kingdom. Initially developed as a smallpox vaccine in collaboration with the U.S. government, it was designed to ensure the availability of a smallpox vaccine for the entire population, including those immunocompromised who are not recommended for traditional replicating smallpox vaccines. MVA-BN has been indicated for use in the general adult population at risk for smallpox or mpox infection.

Bavarian Nordic has a history of supplying vaccines to national stockpiles, supporting governments, and expanding vaccine access to over 70 countries during the 2022-2023 mpox outbreak. The company is committed to protecting and saving lives through innovative vaccines and remains a global leader in smallpox and mpox vaccines.