EU drugs watchdog backs Bavarian Nordic’s mpox vaccine for adolescents
The decision comes a week after the WHO approved the vaccine for adults.
The European Commission has greenlit Bavarian Nordic’s mpox and smallpox vaccine for approval for kids aged 12 to 17.
The European Medicines Agency carried out an expedited and positive review of the data in this patient group, the company said, with the Commission accepting the regulator’s opinion.
Bavarian Nordic’s mpox shot is the first approved in Europe for anyone under the age of 18. The decision comes a week after the World Health Organization approved the vaccine for adults.
A clinical study, in 211 adults and 312 adolescents aged 12 to 17, found a “similar safety profile” and “non-inferiority of the immune responses” in both age groups after two doses of the vaccine.
“This represents an important milestone in our efforts to make our vaccine available for all populations and will help improve access for some of the most vulnerable individuals mostly impacted by the ongoing mpox outbreak in Africa,” Bavarian Nordic CEO Paul Chaplin said.
A clinical trial to assess the effectiveness and safety of the vaccine in children aged between 2 and 12 is expected to begin next month.
The mpox outbreak has killed 723 people in Africa so far this year, out of a suspected 25,000 cases, according to the World Health Organization.
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