Bavarian Nordic races in Copenhagen thanks to monkeypox vaccine

(Il Sole 24 Ore Radiocor) - Bavarian Nordic continues to rally on the Copenhagen Stock Exchange, after the World Health Organisation declared the monkeypox epidemic a public health emergency of international significance. The stock of the Danish group, which produces the only vaccine against the disease so far licensed in North America and Europe, is up on top of strong gains in recent days. In five sessions the share price has risen by more than 40% and since the beginning of the year by more than 50%. According to traders, Bavarian could be 'flooded' with orders for its vaccine approved under the name Jynneos in the US and Switzerland and Imvanex in Europe. The company could also benefit from an extension to use on children and adolescents, for which it has applied for authorisation. Bavarian Nordic reported that it has submitted clinical data to the European Medicines Agency (Ema) in support of extending the indication of its smallpox and mpx (monkeypox) vaccine Imvanex to include adolescents aged 12-17 years. Although currently only indicated for adults at least 18 years of age, the Fda has granted the vaccine an emergency authorisation for use in adolescents during the global mpox epidemic of 2022, the company recalls, emphasising that 'it remains the only vaccine against the disease approved by the Fda and the Ema'.

The licence application is based on provisional results of a clinical study, sponsored by the US National Institutes of Allergy and Infectious Diseases, of 315 adolescents aged 12-17 years and 211 adults aged 18 years and older, which demonstrated a non-inferior level of immune responses, as well as a similar safety profile, among both age groups after vaccination with two standard doses of the vaccine, Bavarian points out. The company hopes to market the vaccine to adolescents during the fourth quarter of 2024. Bavarian is also preparing for a clinical trial to evaluate the immunogenicity and safety of the vaccine in children between the ages of 2 and 12. The trial, partially funded by the Coalition for Epidemic Preparedness Innovations (Cepi), is expected to be launched in the Democratic Republic of Congo and Uganda by the end of the year, potentially also supporting regulatory approval of the vaccine in African countries, where mpox is endemic, Bavarian points out. "Children and adolescents are disproportionately affected by monkeypox in the ongoing epidemic in Africa, highlighting the importance and urgency of expanding access to vaccines and treatment for this vulnerable population. We are pleased to report data that supports the use of our vaccine in adolescents and adds to the growing body of evidence that it is well tolerated and capable of generating a relevant immune response in adolescents and adult populations," Bavarian Nordic's president and CEO, Paul Chaplin, said in a note.