Bavarian Nordic Seeks EMA Approval to Expand Mpox Vaccine to Teens

The sole vaccine for the illness that has been authorised, produced by Bavarian Nordic, has presented data to the European Medicines Agency (EMA) in favour of an extension for its use in teens amidst the ongoing worldwide public health emergency related to mpox.

The marketing authorisation extension, if accepted by the European Medicines Agency (EMA), would allow teenagers between the ages of 12 and 17 to use the Imvanex (MVA-BN) vaccine. Bavarian Nordic said in a news statement on August 16 that the transition may occur in Q4 2024.

The announcement coincides with Sweden's announcement of the country's first verified case of mpox, which resulted from a more dangerous variation. This is the first instance of the highly infectious strain discovered outside of Africa.

The US National Institutes of Health (NIH)-sponsored clinical research (NCT05740982) provided the agency with results from an interim analysis. 315 teenagers participated in the Phase II experiment, which showed the vaccination functioned as safely and effectively as it did in adults.

In the US, where it is marketed as Jynneos, the Imvanex vaccine is approved for use in emergencies by the US Food and Drug Administration (FDA), however it is presently only recommended for people 18 years of age and older.

According to the Danish business, studies examining the vaccination's usage in youngsters aged two to twelve are also being planned. Later this year, the trial—which is partially supported by the Coalition for Epidemic Preparedness Innovations, or CEPI—is anticipated to begin in Uganda and the Democratic Republic of the Congo. According to Bavarian Nordic, this may also help if Imvanex is approved by regulators in African nations for that age range.