Bavarian Nordic receives EMA approval of Mpox vaccine for adolescents – Bavarian Nordic

Bavarian Nordic A/S announced  that the European Commission has adopted the Committee for Medicinal Products for Human Use (CHMP) recommendation for the approval of a type II variation for Imvanex  (MVA-BN) smallpox and mpox vaccine, extending the current marketing authorization to include adolescents 12 to 17 years of age. The CHMP recommendation follows the submission last month to EMA of data from a clinical study (NCT05740982), sponsored by the U.S. National Institutes of Health’s (NIH) National Institutes of Allergy and Infectious Diseases (NIAID), in 315 adolescents 12-17 years of age and 211 adults aged 18 years and older, demonstrating non-inferiority of the immune responses as well as a similar safety profile between both age groups after vaccination with two standard doses of the MVA-BN vaccine.

While this represents the first approval of MVA-BN as a smallpox/mpox vaccine for adolescents, a recombinant version of MVA-BN (Mvabea) was approved by EMA in 2020 as part of a prime-boost vaccine regimen for the prevention of disease caused by Ebola virus in individuals greater than 1 year of age. Clinical studies supporting this approval encompass more than 3,300 individuals across Europe, USA, and Africa including over 800 children and adolescents 1-17 years of age in Africa. The safety profile of Mvabea in children 1-17 years of age was generally similar to that observed in adults and similar to the safety profile of MVA-BN in individuals 12 years and older.

Paul Chaplin, President & CEO of Bavarian Nordic, said: “We applaud EMA for their expedited review and decision to recommend approval of MVA-BN for adolescents. 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.”

Bavarian Nordic is preparing for a clinical trial (NCT06549530) to assess the immunogenicity and safety of MVA-BN in children 2-12 years of age, aiming to further extend the indication of the vaccine into younger populations. The trial, partially funded by the Coalition for Epidemic Preparedness Innovations (CEPI), is expected to start next month.

CEPI has also co-funded a clinical study (NCT05745987), led by McMaster University in Canada, to assess post-exposure vaccination with MVA-BN, i.e. if the vaccine helps reduce the risk of secondary mpox cases, or, in case of mpox infection, can reduce the severity of illness. The study will include over 1.500 participants including children in households with a laboratory-confirmed mpox infection at sites in the DRC, Uganda and Nigeria. Results of the study could provide important findings to inform vaccination strategies in areas impacted by the mpox outbreak.