Bavarians eye expansion of mpox vaccine label to include young children, launch phase 2 trial


shutterstock 2186464385

Bavarian Nordic is looking to expand the approval label of its MVA-BN mpox/smallpox vaccine to include children aged two to 11 years and has started a Phase 2 trial to support the approval.

A Phase II study (NCT06549530) is planned to compare the safety and immunogenicity of the vaccine between children and adults in that age group. The trial is partially funded by the Coalition for Epidemic Preparedness Innovations (CEPI).

The Danish vaccine company intends to recruit participants in the Democratic Republic of Congo and potentially Uganda. The World Health Organization (WHO) declared Mpox a global public health emergency for the second time in two years in August after a new variant of the virus spread from the Democratic Republic of the Congo to neighboring countries.

MVA-BN is a non-replicating Mpox vaccine. It is marketed as Zynnios in the US and Imvenex in Europe. In September, the European Medicines Agency (EMA) expanded the vaccine label to include adolescents over the age of 12. The same month, the Global Alliance for Vaccines and Immunization (GAVI) signed a purchase agreement with Bavarian Nordic to secure 500,000 doses for countries in Africa.

Bavarian Nordic noted that while the phase II trial marks the first investigation of MVA-BN as a Mpox/smallpox vaccine for young children, a recombinant version of the vaccine, Mavabia, is being tested as part of a prime-boost It was approved by the EMA in 2020. Vaccine regimen for the prevention of disease caused by Ebola virus in persons one year of age and older.

“The findings of this study will be important in shaping MPOX vaccine strategies that can protect children and end this devastating and widespread outbreak, as well as to combat future MPOX outbreaks in local endemic populations.” “Can also provide important vaccine guidance.” said Dr. Nicole Lurie, Executive Director of Preparedness and Response at CEPI.

Access the most comprehensive company profiles on the market, powered by GlobalData. Save hours of research. Gain a competitive edge.

company profile unit

Company Profile – Free Sample

Your download email will arrive shortly

We are confident about the unique quality of our company profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the form below.

by GlobalData







Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information about your rights in relation to your personal data and how you can unsubscribe from future marketing communications. Can finish. Our services are for corporate clients and you guarantee that the email address submitted is your corporate email address.

The mpox/smallpox vaccine has been a major revenue driver for Bavarian Nordic. According to the company's financials, the vaccine generated DKK5bn ($724m) in revenue from global vaccine sales and government contracts last year.

Another mpox vaccine in development is Moderna's mRNA vaccine, which is currently being tested in a Phase I/II study (NCT05995275). The trial is evaluating the safety, tolerability, and immunogenicity of mRNA-1769 in healthy adults.




Leave a Comment