MVA-mBN226B
- Generic Name
- MVA-mBN226B
- Drug Type
- Biotech
Bavarian Nordic Initiates Phase II Trial to Expand Mpox Vaccine Label to Toddlers
• Bavarian Nordic has commenced a Phase II trial to assess the safety and immunogenicity of its MVA-BN mpox vaccine in children aged 2 to 11 years.
• The trial, partly funded by CEPI, will compare the vaccine's performance in children with that in adults, with recruitment planned in the Democratic Republic of Congo and Uganda.
• MVA-BN, marketed as Jynneos in the US and Imvanex in Europe, has already received label expansions for adolescents and is a significant revenue driver for Bavarian Nordic.
• A recombinant version of the vaccine, Mvabea, was previously 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.
Bavarian Nordic's MVA-BN Mpox/Smallpox Vaccine Trial Enrolls First Children
• Bavarian Nordic has initiated a clinical study of its MVA-BN mpox/smallpox vaccine in children aged 2 to 11 years, with the first vaccinations administered.
• The study, involving 460 participants, will assess the vaccine's safety and immunogenicity in children compared to adults, potentially supporting label expansion.
• Partially funded by CEPI, the trial is being conducted in the Democratic Republic of Congo and Uganda, with results potentially extending MVA-BN's approval to younger children.
• MVA-BN has already received WHO prequalification for adolescents and EMA approval for ages 12-17, and a recombinant version is approved for Ebola prevention in young children.
Bavarian Nordic Initiates Clinical Trial of Mpox Vaccine in Young Children
• Bavarian Nordic has begun a clinical study to assess its MVA-BN mpox vaccine in children aged 2-11 years, following approvals for adolescent use.
• The trial, enrolling participants in the Democratic Republic of Congo and Uganda, will evaluate the vaccine's safety and immunogenicity compared to adults.
• CEPI is partially funding the study, with results potentially supporting the expansion of MVA-BN's approval to include children aged 2 years and older.
• This initiative addresses the vulnerability of children to mpox in ongoing African outbreaks, aiming to broaden access to safe and effective vaccines.
Bavarian Nordic's Mpox Vaccine Shows Promise in Adolescents, Securing EMA Approval
• Bavarian Nordic's mpox vaccine, MVA-BN (Imvanex), has received EMA approval for use in adolescents aged 12-17, potentially expanding access in Africa.
• A NIH-sponsored clinical trial demonstrated that adolescents showed non-inferior immune responses and similar safety profiles to adults after two doses.
• The WHO has prequalified Imvanex for 'off-label' use, which may facilitate its use in infants, pregnant women, and immunocompromised individuals during outbreaks.
• Bavarian Nordic is planning a Phase II clinical trial to assess the immunogenicity and safety of MVA-BN in children aged 2-12 years.
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