Pharmaceutical Technology

Bavarian eyes Mpox vaccine label expansion to include toddlers, kickstarts Phase II trial

The registrational trial is expected to support the Bavarian’s mpox/smallpox vaccine use in children between 2 and 11 years of age.

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

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

The Danish vaccine company intends to recruit participants across 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 type of the virus spread from the Democratic Republic of Congo to neighbouring countries.

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

Bavarian Nordic noted that whilst the Phase II trial marks the first investigation of MVA-BN as an mpox/smallpox vaccine for younger children, a recombinant version of the vaccine, Mvabea, was approved by the EMA in 2020 as part of a prime-boost vaccine regimen for the prevention of disease caused by Ebola virus in individuals one year of age and older.

“The findings of this study will be crucial in shaping mpox vaccine strategies that could protect children and bring an end to this devastating and widespread outbreak, while also providing pivotal vaccine guidance in local endemic populations to tackle mpox outbreaks that could strike in the future,” said Dr Nicole Lurie, executive director of preparedness and response at CEPI.

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

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