Bavarian Nordic A/S (OTC: BVNRY) submitted clinical data on Thursday to the European Medicines Agency (EMA) to support the extension of the Imvanex (MVA-BN) smallpox and mpox vaccine indication to include adolescents 12 to 17 years of age.
Jynneos is known internationally as Imvamune or Imvanex.
While currently only indicated for adults 18 years and older, the FDA granted an Emergency Use Authorization for pre- and post-exposure use in adolescents during the 2022 global pox outbreak.
It remains the only FDA and EMA-approved pox vaccine.
The submission is based on interim results from a clinical study 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 and older.
The study demonstrated 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.
Following EMA's review of the data, the marketing authorization for Imvanex could be extended to include the use of the vaccine for adolescents during the fourth quarter of 2024.
Bavarian Nordic is also preparing for a clinical trial to assess the immunogenicity and safety of MVA-BN in children between 2 and 12, aiming to extend the vaccine's indication into younger populations.
The trial, partially funded by the Coalition for Epidemic Preparedness Innovations, is planned for initiation in the Democratic Republic of Congo and Uganda later this year.
In a recent interview with Stat News, CEO Paul Chaplin addressed Bavarian Nordic's current production capabilities and the state of its vaccine inventory.
The European Union's Health Emergency Preparedness and Response Authority has ordered 175,000 doses of Jynneos, intended as a donation to the Africa Centers for Disease Control and Prevention.
Bavarian Nordic supplemented this donation with an additional 40,000 doses, bringing the total supply to 215,000 doses, enough to vaccinate 107,500 individuals, as the vaccine is administered in two doses.
Chaplin clarified that the company currently has a stock of ready-to-ship doses stored in vials.
Additionally, the company holds vaccine inventory in bulk, which can be converted into ready-to-use doses within one to two months.
Bavarian Nordic expects to deliver 2 million doses by the end of this year and potentially produce an additional 7.5 million doses next year.
However, these additional doses have not yet been committed to any buyers and will only be produced if contracts are signed, the CEO highlighted during the interview.
Reuters highlighted that Gavi, a global vaccine alliance, has up to $500 million available to combat the growing mpox outbreak in Africa.
Gavi typically focused on childhood vaccines but shifted to broader health crises during the COVID-19 pandemic. The funds, sourced from leftover COVID-19 donations, are part of the organization's "First Response" fund.
BVNRY Price Action: Bavarian Nordic stock is up 15.39% at $14.02 at last check Friday.