EC Approves Bavarian Nordic's Imvanex for Adolescent Use

The European Commission (EC) has expanded the usage of Bavarian Nordic’s smallpox and mpox vaccine, Imvanex (MVA-BN), to include adolescents aged 12 to 17 years. Previously, Imvanex was already authorized in the European Union (EU) for adults to protect against smallpox, mpox, and diseases caused by the vaccinia virus.

This extension comes after the European Medicines Agency’s (EMA) human medicines committee endorsed the change. The recommendation was bolstered by interim results from a study that evaluated the vaccine's immune response in 315 adolescents compared to 211 adults. The trial showed that the vaccine induced an immune response in adolescents that was not inferior to the response in adults, with both age groups displaying similar safety profiles when vaccinated with two standard doses.

Since the global outbreak of mpox began in 2022, over 103,000 cases have been reported in more than 120 countries. Smallpox, on the other hand, was declared eradicated in 1980. Imvanex was initially developed as a smallpox vaccine in collaboration with the U.S. government. It contains a weakened form of the vaccinia virus, a virus closely related to both smallpox and mpox.

Given the escalating mpox cases, the EMA prioritized the assessment of Imvanex for adolescents. The EMA is also collaborating with African regulators to expedite vaccine authorizations, aiming to curb the outbreak in the region.

Stella Kyriakides, the EU Commissioner for Health and Food Safety, emphasized that despite the low overall risk of mpox infection for the general EU population, continuous efforts are being made at the EU level to ensure preparedness. She affirmed that the EU, in partnership with the European Centre for Disease Prevention and Control, member states, the World Health Organization, the African Union, including the Africa Centres for Disease Control and Prevention, and various local and international partners, will persist in their efforts to control the mpox spread in Africa.

Bavarian Nordic’s president and CEO, Paul Chaplin, commented that this authorization milestone is significant in their mission to make the vaccine accessible to a broader range of populations. This expansion will particularly benefit vulnerable individuals who are most affected by the ongoing mpox outbreak in Africa.

The company has announced plans to further broaden the age group for the vaccine’s usage. Bavarian Nordic is preparing for a clinical trial to assess Imvanex’s efficacy in children aged two to 12 years. This move underscores the company's commitment to extending protection against these diseases to younger populations, enhancing overall public health safety.