The clinical study in children aged 2 to 11 years follows the recent EMA and WHO approval of the MVA-BN mpox vaccine in adolescents aged 12 to 17 years.
Copenhagen, Denmark, October 29, 2024 – Bavarian Nordic A/S (OMX: BAVA) today announced the start of a clinical study of its MVA-BN® mpox/smallpox vaccine in children aged 2 to 11 years. Announced.
The study, which has now vaccinated its first children, is currently enrolling in the Democratic Republic of Congo (DRC) and will also include sites in Uganda. The study will involve a total of 460 people and will compare the safety and immunogenicity of the vaccine between children aged 2 to 11 years and adults. This study (NCT06549530) was partially funded by the Coalition for Epidemic Preparedness Innovations (CEPI).
The results of this study may support extending the current approval of MVA-BN to include children aged 2 years and older. Last month, the WHO prequalified the vaccine for adolescents aged 12 to 17, adopting the European Medicines Agency’s (EMA) recent approval for this age group.
Paul Chaplin, President and CEO of Bavarian Nordic, said: “Children remain highly vulnerable to mpox infections during the outbreak in Africa, and this young “This underscores the importance and urgency of expanding access to effective vaccines that can be safely administered to people across the world.” Following the recent approval of MVA-BN for adolescents, we are pleased to begin this study. This study may provide additional data to further expand the indication to include children. We would like to thank CEPI and our African partners for supporting this important research. ”
Dr. Nicole Lurie, CEPI’s Executive Director of Preparedness and Response, said: “The results of this study are critical to developing an mpox vaccine strategy that can protect children and end this devastating and widespread epidemic, as well as providing vital vaccine guidance. Targeting local endemic area residents to address possible future mpox outbreaks. ”
Although this study represents the first study of MVA-BN as a Mpox/smallpox vaccine for young children, a recombinant version of MVA-BN (Mvabea®) is a prime-boost vaccine regimen for prophylaxis. Approved by the EMA in 2020 as part of the Rate of illness caused by the Ebola virus in individuals over 1 year of age. The clinical studies supporting this approval included more than 3,300 people in Europe, the United States, and Africa, including more than 800 children and adolescents aged 1 to 17 years in Africa2. The safety profile of Mvavea in children 1 to 17 years of age was generally similar to that observed in adults.
About mpox vaccine
MVA-BN or Modified Vaccinia Ankara Bavarian Nordic is the only non-replicating MPOX vaccine approved in the US, Switzerland, Singapore, Mexico (sold as JYNNEOS®), Canada (sold as IMVAMUNE®), EU/EAA and the US is. Kingdom (sold as IMVANEX®). MVA-BN was originally developed as a smallpox vaccine in collaboration with the U.S. government to ensure the availability of smallpox vaccine to the entire population, including immunocompromised individuals for whom traditional replication smallpox vaccines are not recommended. However, MVA-BN is now used for general purpose use. Population of individuals (12 years of age and older) who have smallpox or who are considered at risk for smallpox infection.
About Bavarian Nordic
Bavarian Nordic is a global vaccine company with a mission to improve health and save lives through innovative vaccines. We are a preferred supplier of mpox and smallpox vaccines to governments to strengthen public health preparedness and have a leading portfolio of travel vaccines. For more information, please visit www.bavarian-nordic.com.
Forward-looking statements
This announcement contains forward-looking statements that involve risks, uncertainties, and other factors, many of which are beyond the Company’s control and that actual results may not be discussed in the forward-looking statements. The results may differ significantly from those shown. Forward-looking statements include statements regarding our plans, objectives, goals, future events, performance and/or other information that is not historical. All such forward-looking statements are expressly qualified by these and other cautionary statements accompanying the forward-looking statements. The Company undertakes no obligation to publicly update or revise any forward-looking statements to reflect subsequent events or circumstances after the date on which they are made, except as required by law.
contact address
Europe: Rolf Sass Sørensen, Vice President Investor Relations, rss@bavarian-nordic.com, Tel: +45 61 77 47 43
USA: Graham Morrell, Paddock Circle Advisor, graham@paddockcircle.com, Phone: +1 781 686 9600
1 Mvabea® was licensed to Johnson & Johnson in 2014 as part of the prime-boost vaccine regimen.
2 https://www.ema.europa.eu/en/documents/assessment-report/mvabea-epar-public-assessment-report_en.pdf
