Bavarian Nordic’s Mpox Vaccine Demonstrates Equivalent Efficacy in Teens and Adults: NIH Study

Equivalent Efficacy:
A National Institutes of Health (NIH) study found that Bavarian Nordic's MVA-BN mpox vaccine induces an antibody response in adolescents (12-17 years) that is equivalent to that in adults (18-50 years).

Safety and Tolerability:
The vaccine was well tolerated in both age groups, with similar frequencies of adverse events. Dizziness was more common in adolescents but is also seen in other vaccines given to younger age groups.

Regulatory Approvals:
The European Medicines Agency (EMA) approved the use of MVA-BN in adolescents in September 2024. In the US, it is currently approved only for adults under the brand name Jynneos, though it has emergency use authorization for adolescents.

Future Studies:
Bavarian Nordic is planning a Phase II clinical trial to assess the vaccine's safety and efficacy in children aged 2-12 years, aiming to extend its use to younger populations.

Global Context:
The mpox outbreak has seen over 24,000 confirmed or suspected cases and more than 600 deaths, particularly affecting those under 18 in Africa. The vaccine's effectiveness in adolescents is crucial for controlling the outbreak.

WHO Prequalification:
The World Health Organization (WHO) has prequalified the use of Jynneos for adolescents aged 12-17, making it available for this vulnerable age group.

Dose-Sparing Regimens:
Previous studies have shown that even a one-fifth dose of Jynneos can elicit a similar antibody response as the standard dose, though the effect wanes sooner.